510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY
DEVICE AND INSTRUMENT TEMPLATE

A. 510(k) Number: K032311

B. Analyte: Potassium, Calcium, Sodium, Chloride, Blood Gases (PCO2, PO2)

and pH, Hemoglobin, Hematocrit, Oxygen Saturation, Carboxyhemoglobin,
Oxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Lactic Acid, Glucose,
Urea Nitrogen.

C. Type of Test: Ion selective electrode – Potassium, Chloride, Sodium,

Calcium, Blood gases, pH and Urea Nitrogen
Colorimetric – Glucose
Enzymatic – Lactic Acid

D. Applicant: Jennifer Tribbett

Roche Diagnostics
Patient Care Division
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250

E. Proprietary and Established Names: Proprietary Name: The Roche OMNI

S Analyzer. Established name – Fully automated Critical Care Analyzer for
the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin,
glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxy-
carboxy and methemoglobin

F. Regulatory Information:

1. Regulation section: 862.1600, 862.1145, 862.1665, 862.1170,

862.1120, 862.1450, 862.1345, 862.1770, 864.5620, 864.5600, 864.7425,
864.7500

2. Classification: Class II

3. Product Code: Potassium - CEM, Calcium - JFP, Sodium - JGS,

Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -
GKR, Hematocrit - GKF, Oxygen saturation , Carboxyhemoglobin - GHS,
Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA,
Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.
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4. Panel: 75, 81

G. Intended Use:
1. Intended use(s): The Roche Diagnostics Omni S Analyzer is a fully
automated critical care analyzer intended to be used for the measurement
of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride,
hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen
saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and
methemoglobin in samples of whole blood, serum, plasma, and aqueous
solutions as appropriate.

2. Indication(s) for use: The Roche Diagnostics Omni S Analyzer is a fully

automated critical care analyzer intended to be used for the measurement
of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride,
hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen
saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and
methemoglobin in samples of whole blood, serum, plasma, and aqueous
solutions as appropriate.

3. Special condition for use statement(s): none

4. Special instrument Requirements: none

H. Device Description: The Roche Omni S is an analyzer with an integrated

AutoQC drawer option. Depending upon combination and configuration, the
following parameters can be measured in whole blood, serum, plasma,
acetate and bicarbonate containing dialysis solutions and QC materials.

I. Substantial Equivalence Information:

1. Predicate device name(s): Omni Modular Analyzer and Omni C

Analyzer

2. Predicate K number(s): Omni Modular Analyzer (K990092) and Omni

C Analyzer (K013373)

3. Comparison with predicate:

Similarities & Differences

Item Device Predicate
Intended use The Roche The Roche
Diagnostics Omni Diagnostics Omni
S Analyzer is Modular Analyzer
intended to be is intended to be
used for the used for the
measurement of measurement of
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pH, PCO2, PO2, pH, PCO2, PO2,

sodium, sodium,
potassium, ionized potassium, ionized
calcium, chloride, calcium, chloride,
hematocrit, hematocrit,
glucose, lactate, glucose, lactate,
urea/BUN, total urea/BUN, total
hemoglobin, hemoglobin,
oxygen saturation, oxyhemoglobin,
oxyhemoglobin, deoxyhemoglobin,
deoxyhemoglobin, carboxyhemoglobi
carboxyhemoglobi n, sulfhemoglobin,
n, and and
methemoglobin in methemoglobin in
samples of whole samples of whole
blood, serum, blood, serum,
plasma, and plasma, and
aqueous solutions aqueous solutions
as appropriate. as appropriate.

The Roche
Diagnostics Omni
C Analyzer is
intended to be
used for the
measurement of
pH, PCO2, PO2,
sodium,
potassium, ionized
calcium, chloride,
hematocrit, total
hemoglobin, and
oxygen saturation,
in samples of
whole blood,
serum, plasma,
and aqueous
solutions as
appropriate.

Parameters pH, PCO2, PO2, Roche Diagnostics

measured sodium, potassium, Omni Modular
ionized calcium, chloride, Analyzer: pH,
hematocrit, glucose, PCO2, PO2,
lactate, urea/BUN, total sodium,
hemoglobin, oxygen potassium, ionized
 Page 4 of 11

saturation, calcium, chloride,

oxyhemoglobin, hematocrit,
deoxyhemoglobin, glucose, lactate,
carboxyhemoglobin, and urea/BUN, total
methemoglobin hemoglobin,
oxyhemoglobin,
deoxyhemoglobin,
carboxyhemoglobi
n, sulfhemoglobin,
and
methemoglobin

The Roche
Diagnostics Omni
C Analyzer: pH,
PCO2, PO2,
sodium,
potassium, ionized
calcium, chloride,
hematocrit, total
hemoglobin, and
oxygen saturation
.
Sample types Samples of whole Same for both
blood, serum, predicate devices
plasma, and
aqueous solutions
as appropriate.

J. Standard/Guidance Document Referenced (if applicable): NCCLS EP6-P,

NCCLS – E5-T, and Reviewer Guidance for Computer Controlled Medical
Devices undergoing 510(k) review.

K. Test Principle: Ion Selective Electrode, Enzymatic, Sensor (O2 saturation).

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
Precision/Reproducibility: With-in run (SWR) and Total (ST)
precision were determined from 2 runs a day with 2 replicates
per run for 20 days on four Roche Omni S instruments using
samples of each specimen type suitable for measurement on
the analyzer. All assays available on the Omni S were
evaluated as appropriate for the specimen type.
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a. Linearity/assay reportable range: Linearity was established by

utilizing the NCCLS Document EP6-P.
Tonometered whole blood: Whole blood was tonometered at 37oC
to various levels of gravitimetrically prepared gases with CO2 and
O2 concentrations certified to 0.03% absolute by the
manufacturer. Expected and observed values were corrected to
760 mmHg.
Aqueous solutions : Expected values for the aqueous solutions
were based on weighted samples.
NIST Standards: NIST standards are precise serums with
accredited target values.
Hematocrit: Measurements for the hemofuge, which represents
the gold standard for hematocrit measurements, was used as
expected values for hematocrit results.
The linearity for each analyte was described as follows:

PO2 – slope 0.9904-1.0097 Intercept +/- 0.857 Correlation 0.9998

Range 0 – 800mmHg
PCO2 – slope 0.9898 – 1.0103 Intercept +/- 1.225 Correlation 0.9999
Range 4 – 200mmHg
pH – slope 0.9825 – 1.0178 Intercept +/- 0.133 Correlation 0.998
Range 6.0 – 8.0
Hct– slope 0.997 – 1.003 Intercept +/- 0.620 Correlation 0.999
Range 10 80%
Sodium – slope 0.988 – 1.012 Intercept +/- 0.365 Correlation 0.9999
Range 20 – 250mmol/L
Potassium – slope 0.960 – 1.042 Intercept +/- 0.109 Correlation 0.9999
Range 0.2 - 20 mmol/L
Ion. Calcium – slope 0.975 – 1.026 Intercept +/- 0.024 Correlation 0.9999
Range 0.1 – 4.0 mmol/L
Chloride – slope 0.959 – 1.043 Intercept +/- 2.908 Correlation 0.9999
Range 20 – 250 mmol/L
Glucose – slope 0.919 – 1.088 Intercept +/- 1.773 Correlation 0.998
Range 0.5 – 40 mmol/L
Lactate – slope 0.961 – 1.041 Intercept +/- 0.191 Correlation 0.9989
Range 0.2 – 20 mmol/L
Urea – slope 0.979 – 1.021 Intercept +/- 0.198 Correlation 0.9991
Range 0.5 – 30 mmol/L
Total Hgb – slope 0.9892 – 1.0109 Intercept +/- 0.0833 Correlation 0.9904
Range 3 - 25 g/dl
SO2 – slope 0.99999 – 1.00001 Intercept +/- 0.856 Correlation 0.9874
Range 50 – 100%

b. Traceability (controls, calibrators, or method): Tonometered

whole blood, aqueous solutions, NIST standards

c. Detection limit: : Detection Limits for analytes on the Omni S

Analyzer are defined on the Omni S Analyzer as the linear range
of each assay. The assays performed on the Omni S are
measured with established normal and critical ranges for each
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analyte. These ranges fall well within the linearity of the

respective assays.

d. Analytical specificity: Tonometered whole blood: Whole blood

was tonometered at 37oC to various levels of gravitimetrically
prepared gases with CO2 and O2 concentrations certified to
0.03% absolute by the manufacturer. Expected and observed
values were corrected to 760 mmHg.
Aqueous solutions : Expected values for the aqueous solutions
were based on weighted samples.
NIST Standards: NIST standards are precise serums with
accredited target values.
Hematocrit: Measurements for the hemofuge, which represents
the gold standard for hematocrit measurements, was used as
expected values for hematocrit results.

e. Assay cut-off: The assay cut-off is established as the linearity

range of the Roche Omni S for each analyte.

2. Comparison studies:
a. Method comparison with predicate device: ). External testing
was conducted to demonstrate the correlation of the Omni S
analyzer to legally marketed devices in a clinical setting, operated
by personnel trained to perform and report these analyses.
Specimens analyzed were remnant from patient samples of whole
blood, serum and plasma collected from routine analysis on
existing instrumentation.
The Omni S has incorporated the same blood gas modules, ISE
modules, total hemoglobin and Oxygen saturation, MSS chamber
sensors for BUN/urea nitrogen as with the predicate devices. For
lactate and glucose the Omni S utilizes Braunstein technology.
The correlations to the predicate devices are as follows:

pH, Comparison Instrument - Omni Modular, Slope/Intercept -

Y = -0.063 + 1.009 * X, Bias +0.007, Corr. Coeff. [r] = 0.990, #
samples = 134

pH, Comparison Instrument - Radiometer 725, Slope/Intercept –

Y = -0.496 + 0.933 * X, Bias +0.003, Corr. Coeff. [r] = 0.990, #
samples = 99

pO2, Comparison Instrument - Omni Modular, Slope/Intercept -

Y= -0.643 + 1.031 * X, Bias +1.6, Corr. Coeff. [r] = 0.987, #
samples = 136, Unit (mmHG)
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pO2, Comparison Instrument - Radiometer 725, Slope/Intercept

– Y = -4.433 + 1.013 * X, Bias +6.6, Corr. Coeff. [r] = 0.996, #
samples = 137, Unit (mmHG)

pCO2, Comparison Instrument - Omni C, Slope/Intercept - Y=-

1.452+1.038*X, Bias +1.6, Corr. Coeff. [r] = 0.987, # samples =
129, Unit (mmHG)

pCO2, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y = -0.301 + 1.000 * X, Bias +0.4, Corr. Coeff.
[r] = 0.988, # samples = 144, Unit (mmHG)

tHb, Comparison Instrument - Radiometer 725, Slope/Intercept

– Y = 0.581 + 1.083 * X, Bias +2.0, Corr. Coeff. [r] = 0.814, #
samples = 96, Unit (g/dl)

Sodium, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -13.193 + 1.106 * X, Bias +0.9, Corr. Coeff.
[r] = 0.948, # samples = 108, Unit (mmol/L)

Sodium, Comparison Instrument - Radiometer 725,

Slope/Intercept – Y = -2.143 + 1.106 * X, Bias +0.9, Corr. Coeff.
[r] = 0.972, # samples = 107, Unit (mmol/L)

Potassium, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -0.126 + 1.020 * X, Bias -1.4, Corr. Coeff.
[r] = 0.986, # samples = 131, Unit (mmol/L)

Potassium, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y = -2.143 + 1.106 * X, Bias +0.9, Corr. Coeff.
[r] = 0.972, # samples = 107, Unit (mmol/L)

Calcium, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -0.039 + 1.024 * X, Bias -0.8, Corr. Coeff.
[r] = 0.941, # samples = 131, Unit (mmol/L)

Calcium, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y = -0.096 + 1.073 * X, Bias -1.1, Corr. Coeff.
[r] = 0.981, # samples = 98, Unit (mmol/L)

Chloride, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -12.459 + 1.118 * X, Bias -0.7, Corr. Coeff.
[r] = 0.960, # samples = 139, Unit (mmol/L)
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Chloride, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y = 17.100 + 0.800 * X, Bias -4.0, Corr. Coeff.
[r] = 0.965, # samples = 98, Unit (mmol/L)

SO2, Comparison Instrument - Omni Modular, Slope/Intercept –

Y = 10.066 + 0.903 * X, Bias 1.1, Corr. Coeff. [r] = 0.991, #
samples = 130, Unit (%)

SO2, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y =-3.969 + 1.037 * X, Bias -4.0, Corr. Coeff. [r]
= 0.904, # samples = 102, Unit (%)

MetHb, Comparison Instrument - Omni Modular, Deviation of

mean -0.3% abs, # samples = 129

MetHb, Comparison Instrument - Radiometer 725, , Deviation

of mean +0.2% abs, # samples = 131

COHb, Comparison Instrument - Omni Modular, Deviation of

mean 0.7% abs, # samples = 130

COHb, Comparison Instrument - Radiometer 725, , Deviation of

mean +0.1% abs, # samples = 132

Hct, Comparison Instrument - Omni Modular, Slope/Intercept –

Y = 0.100 + 1.00 * X, Bias 0.4, Corr. Coeff. [r] = 0.967, # samples
= 132, Unit (%)

Hct, Comparison Instrument - Radiometer 725, Slope/Intercept

- Y =--0.689 + 1.040 * X, Bias 0.6, Corr. Coeff. [r] = 0.946, #
samples = 141, Unit (%)

Glucose, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -0.461 + 1.034 * X, Bias -3.9, Corr. Coeff.
[r] = 0.938, # samples = 134, Unit (mmol/L)

Glucose, Comparison Instrument - Radiometer 725,

Slope/Intercept - Y = -0.867 + 1.201 * X, Bias 5.2, Corr. Coeff. [r]
= 0.986, # samples = 107, Unit (mmol/L)

Urea, Comparison Instrument - Omni Modular, Slope/Intercept –

Y = -0.343 + 0.850 * X, Bias -10.8, Corr. Coeff. [r] = 0.957, #
samples = 122, Unit (mmol/L)
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Urea, Comparison Instrument - Cobas Mira, Slope/Intercept -

Y = -0.001 + 0.887 * X, Bias -11.1, Corr. Coeff. [r] = 0.981, #
samples = 129, Unit (mmol/L)

Lactate, Comparison Instrument - Omni Modular,

Slope/Intercept – Y = -0.200 + 1.000 * X, Bias -9.5, Corr. Coeff.
[r] = 0.936, # samples = 136, Unit (mmol/L)

Lactate, Comparison Instrument - Cobas Mira, Slope/Intercept

- Y = -0.297 + 1.074 * X, Bias -3.0, Corr. Coeff. [r] = 0.968, #
samples = 137, Unit (mmol/L)

b. Matrix comparison: The Omni S Analyzer utilizes the same

sample types – whole blood, serum, plasma and aqueous
material (QC material and dialysis fluids) as previously cleared on
the predicate device, the Omni C analyzer (k013373

3. Clinical studies:
a. Clinical sensitivity: None stated

b. Clinical specificity: None stated

c. Other clinical supportive data (when a and b are not

applicable): None

4. Clinical cut-off: None stated

5. Expected values/Reference range: A complete listing of critical values

and expected values are provided in the technical manual of the Omni
S. The values reflect normal or expected ranges including ranges for
neonates, children and adults as needed. Additionally, explanations of
typical disease states with each critical value for each assay is
provided. These ranges and supportive documentation are derived
from previously established literature. Specifically: “Critical Care
Testing: A Quick Reference Guide” by Andrew St. John First edition
2001, Tietz “Textbook of Clinical Chemistry” third edition 1999, and
“Labor und Diagnose” Lothar Thomas, fifth expanded edition 2000.

M. Instrument Name: Roche Diagnostics Omni S Analyzer

N. System Descriptions:

1. Modes of Operation: Routine, STAT

2. Software: The Roche Omni S utilizes a PC based interface to the user

with a touch sensitive color matrix display and a barcode reader for input
 Page 10 of 11

and display of data. Additional microcontrollers controls all operations of

the Roche Omni S. Lower level tasks are done by a network of micro-
controllers. The micro-controller network is responsible for data
acquisition and sensor/actuator handling. The programming languages
are standard for this type of task.

FDA has reviewed applicant’s Hazard Analysis and software development

processes for this line of product types:
Yes ___X_____ or No ________

3. Sample Identification: Samples are identified via Bar Code or manual

entry.

4. Specimen Sampling and Handling: Samples are a combination of whole

blood, serum, plasma and aqueous solution (QC or dialysate). Samples
are introduced via capillary tubes, syringes and sealed containers.

5. Assay Types: Ion selective Electrode, Enzymatic, MSS chamber sensors

for BUN/urea nitrogen, for lactate and glucose the Omni S utilizes
Braunstein technology.

6. Reaction Types: ISE, Enzymatic, MSS chamber sensors for BUN/urea

nitrogen as the predicate devices. For lactate and glucose the Omni S
utilizes Braunstein technology.

7. Calibration: The instrument automatically calibrates every 8, 12 0r

24hours (default) established by the user. This calibration includes:
wavelength calibration of the polychromator, cleaning with internal
cleaning solution, Automatic conditioning of the Na+ probe, Calibration of
the mixing system and 2 point calibration of all parameters. Calibration of
the O2 sensor is done every 30 minutes with ambient air and a zero
point solution. O2 is recalibrated after every measurement. User can
calibrate any parameter by performing a user activated calibration in the
instrument software. Calibrators are sold separately.

8. Quality Control: Quality Control material is sold separately and consists

of the following materials Combitrol TS+ (k032453), Auto-trol+ (AutoQC
material) (k032453), Combitrol Plus B and Auto-trol Plus B (AutoQC
Material) (k032453). QC target ranges are included with each lot of QC
material. Each analyte tested has three levels of QC range. QC timing is
established by the user via the user interface.

O. Other Supportive Instrument Performance Characteristics Data Not

Covered In The “L. Performance Characteristics” Section Of The SE
Determination Decision Summary. The Roche Diagnostics Omni S
Analyzer performs the following assays: Potassium, Calcium, Sodium,
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Chloride, Blood Gases (PCO2, PO2) and pH, Hemoglobin, Hematocrit,

Oxygen Saturation, Carboxyhemoglobin, Oxyhemoglobin, Methemoglobin,
Deoxyhemoglobin, Lactic Acid, Glucose, and Urea Nitrogen. Hemoglobin,
Hematocrit, Deoxyhemoglobin, Carboxyhemoglobin, Oxyhemoglobin,
Methemoglobin and Deoxyhemoglobin are regulated by the Office of InVitro
Diagnostics Division of Hematology and Immunology. These assays were
referred to the division for consultation. The results of that consultation are
included with the review.

P. Conclusion: Based upon the information provided, I recommend that the

Roche Diagnostics Omni S Analyzer be found substantially equivalent to the
respective predicate devices.