The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the HITACHI Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treament of numerous potentially serious disorders associated with changes in body acid-base balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Carbon Dioxide.

AI/ML Overview

The provided text describes the 510(k) summary for the Hitachi S TEST Reagent Cartridge Carbon Dioxide (CO2), a device for quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma. The document focuses on demonstrating the substantial equivalence of this device to a legally marketed predicate device (Carbon Dioxide L.3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362) through nonclinical and clinical performance studies.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather describes the performance characteristics tested and their results, often comparing them to the predicate device or established standards. I will infer acceptance criteria based on standard clinical chemistry performance requirements and the described study outcomes.

Performance Characteristic	Acceptance Criteria (Inferred/Standard)	Reported Device Performance (Hitachi S TEST CO2)
Analytical Sensitivity (Limit of Detection - LoD)	Typically, LoD should be low enough to detect clinically relevant low concentrations. LoQ (Limit of Quantitation) should have acceptable precision (e.g., %CV < 20%).	- Limit of Blank (LoB): 0.7 mmol/L - Limit of Detection (LoD): 0.9 mmol/L - Limit of Quantitation (LoQ): ~4 mmol/L with %CVs < 11%
Linearity	Visual inspection of regression, r² > 0.99, slope near 1, y-intercept near 0, within specified reportable range.	y = 0.918x + 0.091; r² = 0.9988 Range: 1.4 to 44.0 mmol/L (Reportable range: 5 to 40 mmol/L)
Precision (In-house)	%CVs should be within acceptable clinical limits for different concentration levels (typically lower %CV for higher concentrations).	Within-Run %CV (Total %CV) - Low (10.11 mmol/L): 1.3% (4.4%) - Middle (19.41 mmol/L): 1.3% (3.7%) - High (33.06 mmol/L): 1.2% (3.7%)
Precision (External POL Study)	Similar to in-house, %CVs within acceptable clinical limits.	Total %CV (n=30 for each level at each site) - Site 1: 4.1% (Low), 4.8% (Mid), 3.2% (High) - Site 2: 6.0% (Low), 4.4% (Mid), 3.7% (High) - Site 3: 3.1% (Low), 1.9% (Mid), 3.7% (High)
Interference	Recoveries between 90% and 110% of the neat value in the presence of interferents.	No interference from Lipemia (up to 1,000 mg/dL Intralipid), Ascorbic acid (up to 50 mg/dL), Hemoglobin (up to 1,000 mg/dL), Unconjugated bilirubin (up to 19.1 mg/dL)
Method Comparison (Accuracy)	Strong correlation (r > 0.95), slope close to 1, y-intercept close to 0, and agreement with predicate/reference method.	In-house (vs. standard lab system): n=96, r=0.981, Slope=1.03 (0.97-1.08), y-intercept=0.98 (-0.17-2.12) External POL Study (vs. comparative method): - Site 1: n=47, r=0.984, y=0.91x+1.49 (Slope CI: 0.87-0.95, Intercept CI: 0.67-2.32) - Site 2: n=45, r=0.970, y=0.92x+0.56 (Slope CI: 0.80-1.04, Intercept CI: -2.31-3.43) - Site 3: n=47, r=0.982, y=0.92x+0.79 (Slope CI: 0.87-0.97, Intercept CI: -0.43-2.01)
Matrix Comparison (Serum vs. Plasma)	Strong correlation between serum and plasma results (r > 0.95), slope close to 1, y-intercept close to 0.	n=50, r=0.980, Slope=1.00 (0.94-1.05), y-intercept=-0.34 (-1.97-1.30)
Stability (Shelf Life)	Claimed shelf life supported by real-time stability data.	Supported shelf life of 6 months at 2-8°C (real-time testing ongoing).
Reportable Range	Match clinical requirements; within demonstrated linearity.	5.0 to 40.0 mmol/L (Predicate: 2.9 to 50.0 mmol/L)
Detection Wavelength	Not an acceptance criterion for performance, but a technical specification.	405/508 nm (Predicate: 405/415 nm)

2. Sample Size Used for the Test Set and Data Provenance

Analytical Sensitivity (LoD/LoQ): 60 replicates of reagent blank and three low samples. Three low-level specimens in six runs with three instruments over three days for LoQ.
Linearity: 10 serial dilutions plus zero standard (n=11), assayed in duplicate.
Precision (In-house): Three levels of serum-based commercial controls, each tested in two runs, twice a day, for 20 days.
Interference Testing: Two serum pools with approximately 17 and 30 mmol/L carbon dioxide.
Method Comparison (In-house): 96 clinical specimens (including 3 spiked and 3 diluted samples).
Matrix Comparison: 50 matched serum/plasma samples (including 2 spiked and 4 diluted samples).
Precision (External POL Study): Three blinded serum samples (low, middle, high CO2 concentrations). Each sample assayed six times per day for five days, reporting 30 results per level per site.
Method Comparison (External POL Study): 47 serum specimens (including three spiked and four diluted samples) per site (Site 2 used 45 samples due to 2 below dynamic range).

Data Provenance:

The studies were performed by Hitachi Chemical Diagnostics, Inc. ("in-house") and at three external Physician Office Laboratory (POL)-type sites.
Specific countries of origin for the clinical specimens are not explicitly stated, but the company address is Mountain View, CA, USA, and POL studies suggest U.S. clinical settings.
The studies appear to be prospective for the purpose of validating the device's performance characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish "ground truth" for the test set in the traditional sense of expert consensus for diagnostic interpretation. Instead, the ground truth is established through:

Reference Methods/Comparative Methods: In the method comparison studies, a "standard laboratory system" or "comparative method as the reference method" was used. The qualifications of the operators of these reference methods are not provided.
Known Concentrations: For studies like linearity, precision, and interference, known concentrations (e.g., commercial controls, spiked samples, diluted samples) are used.
Industry Standards: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP17-A2, CLSI EP-6A, CLSI EP5-A2, CLSI EP7-A2) implies reliance on established laboratory best practices for determining analytical performance.

4. Adjudication Method for the Test Set

This type of in vitro diagnostic device (IVD) performance study (analytical and clinical chemistry accuracy/precision) typically does not involve adjudication by multiple human readers in the same way an imaging or pathology study might. Instead, the device's results are compared against:

Reference measurements: From the predicate device or a "standard laboratory system."
Known values: For controls, linearity standards, and spiked/diluted samples.
The document states that method comparison samples were assayed "in singleton and in a blinded fashion" (in-house) and "assayed on the Hitachi E40 Clinical Analyzer... and a comparative method as the reference method" (external POL study), implying direct comparison without a formal adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for diagnostic imaging or pathology devices where multiple human readers interpret cases, and the AI's impact on their performance is assessed. For an in vitro diagnostic (IVD) device like a CO2 reagent cartridge, the evaluation focuses on analytical performance characteristics (accuracy, precision, linearity, etc.) rather than human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

Yes, the studies conducted are standalone performance studies. The Hitachi S TEST Reagent Cartridge Carbon Dioxide operates as an in vitro diagnostic device on an automated analyzer (Hitachi Clinical Analyzer E40). The performance results (accuracy, precision, linearity, etc.) described are the performance of the device and its associated system without direct "human-in-the-loop" interpretive input influencing the result generation. Human operators load samples and reagents and review results, but the device itself generates the quantitative CO2 concentration.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

Reference Measurement/Comparative Method: For method comparison, results from a "standard laboratory system" or "comparative method" served as the reference.
Known Values: For analytical studies like linearity, precision, LoD, and interference, commercial controls, calibrators, and spiked/diluted samples with known or traceable concentrations were used.
Industry Standards: Adherence to CLSI guidelines ensures that the methods for establishing ground truth for these analytical parameters align with recognized best practices in laboratory medicine.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI development. This is an IVD device providing a quantitative measurement based on a chemical reaction and photometric detection. Its underlying "algorithm" is the chemistry reaction and calculation based on Beer-Lambert Law, not a learned AI model that requires a training set. Manufacturers establish internal specifications and calibration parameters based on extensive R&D and analytical validation, but this typically does not involve an external "training set" as understood in AI/ML.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" for this type of IVD device in the AI sense. The "ground truth" for manufacturing and calibration would be established through:

Primary Reference Materials: Traceability to primary reference standards (e.g., American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard for CO2).
Internal Validation: Rigorous internal testing and validation during the device's development to ensure the chemical reaction and photometric measurements yield accurate and precise results across the dynamic range.
Quality Control: Ongoing use of quality control materials with known values to monitor performance.
The document states, "Each lot of S TEST Reagent Cartridge Carbon Dioxide (CO2) is calibrated by the manufacturer prior to shipment using material referenced to a standard which is traceable to American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard." This describes the process for establishing and maintaining calibration, which is akin to "ground truth" for the device's quantitative output.

Summary

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Image /page/0/Picture/0 description: The image shows the text "510(k) SUMMARY" in a bold, sans-serif font. The text is centered and appears to be the title or heading of a document. The letters are black against a white background, providing a clear contrast.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K140248.

807.92 (a)(1): Name:	Hitachi Chemical Diagnostics, Inc.
Address:	630 Clyde CourtMountain View, CA 94043
Phone:	(650) 961 5501
FAX:	(650) 969 2745
Contact:	Mr. Charles Tsou

Official Correspondent: Erika Ammirati Regulatory Consultant to Hitachi Chemical Diagnostics, Inc. Phone: (650) 949-2768 FAX: (650) 949-5347

Date Prepared: February 19, 2014

807.92 (a)(2): Device name- trade name and common name, and classification

Trade name:

S TEST Reagent Cartridge Carbon Dioxide (CO2)

Common Name: Routine chemistry analyzer for carbon dioxide

Classification: 21 CFR § 862.1160- Bicarbonate/carbon dioxide test system, Class II, Product Code KHS

807.92 (a)(3): Identification of the legally marketed predicate devices

Carbon Dioxide L.3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362

807.92 (a)(4): Device Description

Page 1 of 1

Tal: 800 233 6278

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The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Carbon Dioxide.

Chemistry reaction: The carbon dioxide (in the form of bicarbonate HCO2) in the sample reacts with phosphoenolpyruvate (PEP) in the presence of phosphoenolpyruvate carboxylase (PEPC) and magnesium to vield oxaloacetic acid (OAA) and phosphate. In the second reaction, and in the presence of malate dehydrogenase (MDH), the reduced cofactor is oxidized by OAA. The reduced cofactor absorbs strongly at 405 nm. whereas its oxidized form does not. The difference in absorbance between the final reading and the blank, monitored bichromatically at 405 nm/508 nm, is directly proportional to the total carbon dioxide concentration in the sample.

807.92 (a)(5): Intended Use

The S TEST Reagent Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the Hitachi Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Page 2 of 2

CA 94043-2239 Tal: 800 233 6278 Fax: 850,989 2745

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807.92 (a)(6): Technological Similarities and Differences to the Predicate

The following chart describes similarities and differences between the carbon dioxide test systems.

Characteristic	Hitachi S TEST Systems	PREDICATE
Instrument Platform	Hitachi Clinical Analyzer(originally cleared under K111753)	Olympus/Beckman AU400(originally cleared under K981743)
Carbon Dioxide	K140248	Sekisui K number- K042362
Device Class, Regulation Code	Class II, 21 CFR 862.1160	Same
Classification Product Code	KHS	Same
Intended Use	Quantitative determination ofcarbon dioxide	Same
Testing Environment	Physician office or clinical lab	Clinical lab
Test Principle	Carbon dioxide (in the form ofbicarbonate HCO3-) reacts withphosphoenolpyruvate in the presenceof phosphoenolpyruvate carboxylase(and magnesium) to yieldoxaloacetic acid (OAA). In thepresence of malate dehydrogenase,reduced cofactor is oxidized byOAA. The decrease in theconcentration of reduced cofactor ismonitored, and is proportional to thecarbon dioxide concentration in thesample.	Same
Specimen Type	Human serum or lithium heparinplasma	Same
Reportable Range	5.0 to 40.0 mmol/L	2.9 to 50.0 mmol/L
Detection Wavelength	405/508 nm	405/415 nm
Detection Limit (LoQ)	1.3 mmol/L	2.9 mmol/L
Linearity	1.4 to 44.0 mmol/L	2.9 to 50.0 mmol/L
Precision	%CVs range from 1.9% to 6.0%(POL testing)	%CVs range from 1.1% to 1.7%(from product labeling)

807.92 (b)(1): Brief Description of Nonclinica! Data

A series of studies were performed that evaluated the following nonclinical performance characteristics: analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparison, and matrix s comparison between serum and lithium heparin plasma.

C Hitachi Chemical Diagnostics, Inc. 630 Cryde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850 980 2745

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Analytical Sensitivity (Limit of Detection)

The study followed CLSI EP17-A2 where 60 replicates of the reagent blank and 60 replicates of three low samples were tested. The following results were reported: limit of blank = 0.7 mmol/L; limit of detection = 0.9 mmol/L; the limit of quantitation (LoQ) study evaluated three low level specimens in six runs with three instruments over three days. The LoQ was found to be approximately 4 mmol/L, with %CVs less than 11%.

Linearity

The study followed CLSI EP-6A where 10 serial dilutions, plus the zero standard (n = 11), were assayed in duplicate and the results were averaged. The expected values (x-axis) were compared to the observed values (y-axis). The data showed the following linear regression equation: y = 0.918x + 0.091; r2-0.9988. The range of linearity was 1.4 mmol/L to 44.0 mmol/L. The reportable range is 5 to 40 mmol/L.

20-dav In-house Precision

The studies followed CLSI EPS-A2, where three levels of serum-based commercial controls were each tested in two runs, twice a day, for 20 days. The results were as follows:

Carbon Dioxide- Low Summary
Carbon Dioxide	Within-Run	Total
Mean (mmol/L)	10.11	10.11
SD (mmol/L)	0.13	0.45
%CV	1.3%	4.4%

Precision Summaries:

Carbon Dioxide- Middle Summary

Carbon Dioxide	Within-Run	Total
Mean (mmol/L)	19.41	19.41
SD (mmol/L)	0.25	0.72
%CV	1.3%	3.7%

Carbon Dioxide- High Summary

Carbon Dioxide	Within-Run	Total
Mean (mmol/L)	33.06	33.06
SD (mmol/L)	0.40	1.22
%CV	1.2%	3.7%

Interference Testing (per CLSI EP7-A2)

The data demonstrated that the carbon dioxide test system was not affected by high levels of the following substances at the levels noted:

Lipemia: no interference up to 1,000 mg/dL Intralipid

Ascorbic acid: no interference up to 50 mg/dL

Hemoglobin: no interference up to 1,000 mg/dL

Unconjugated bilirubin: no interference up to 19.1 mg/dL

Page 4 of 4

® Hitachi Chemical Diagnostics, Inc.

630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850.969 2745

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Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 17 and 30 mmol/L carbon dioxide.

Method Comparison

A total of 96 clinical specimens (including 3 spiked and 3 diluted samples) spanning the dynamic range (5.0 to 40.0 mmol/L) were assayed in singleton and in a blinded fashion by both the Hitachi E40 system and a standard laboratory system. The comparative data were analyzed by Deming regression and are shown below. (CI = confidence interval).

Regression Statistics:

n	r	Slope(95% CI)	y-intercept(95% CI)	X mean	Y mean
96	0.981	1.03(0.97 to 1.08)	0.98(-0.17 to 2.12)	22.54 mmol/L	24.07 mmol/L

Matrix Comparison

A study was performed to validate the use of lithium heparin plasma as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge Carbon Dioxide. Fifty (50) matched serum/plasma samples (including 2 spiked and 4 diluted samples) that spanned the dynamic range (5.0 to 40.0 mmol/L, serum) were assayed in singleton and the results were compared using linear regression (plasma = y-axis). The performance characteristics were as follows.

N = 50 Range (serum) = 5 4 to 38 6 mmol/L. carbon dioxide

	Lithium Heparinized Plasma
Slope (95% CIs)	1.00 (0.94 to 1.05)
y-intercept (95% CIs)	-0.34 (-1.97 to 1.30)
r	0.980

Reference Range

Reference range: 22 - 29 mmol/L 1

Tietz, Fundamentals of Clinical Chemistry, 4th Edition, WB Saunders Company, (1996)

Traceability/Calibration

Each lot of S TEST Reagent Cartridge Carbon Dioxide (CO2) is calibrated by the manufacturer prior to shipment using material referenced to a standard which is traceable to American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard. The 2D code printed on each cartridge provides the analyzer with lot-specific calibration data.

Stabilitv

Real time stability testing is ongoing. Stability testing has been performed to support a shelf life of 6 months at 2-8°C.

Hitachi Chemical Diagnostics, Inc.

330 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850 969 2745

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807.92 (b)(2): Brief Description of Clinical Data

Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridge Carbon Dioxide in one of its targeted intended use environments, the physician's office laboratory.

For the external site precision study, each site received three blinded serum samples (the Precision Panel, labeled A, B, and C) that were chosen to represent low, middle, and high concentrations of carbon dioxide. Each sample was assayed six times per day for five days, reporting 30 results per level. Precision estimates for total precision were as follows:

Site	Sample	Mean	Within-run Precision		Total Precision
			SD (mmol/L)	%CV	SD (mmol/L)	%CV
1	A	8.75	0.16	1.8	0.36	4.1
2	A	7.29	0.33	4.6	0.44	6.0
3	A	8.06	0.23	2.9	0.25	3.1
1	B	15.27	0.35	2.3	0.74	4.8
2	B	15.01	0.23	1.5	0.67	4.4
3	B	16.25	0.27	1.7	0.30	1.9
1	C	29.46	0.51	1.7	0.94	3.2
2	C	29.47	0.81	2.7	1.08	3.7
3	C	31.01	0.58	1.9	1.16	3.7

Carbon Dioxide (mmol/L) n = 30 replicates per sample per site

For the external method comparison studies, a series of 47 serum specimens (including three spiked and four diluted samples) with carbon dioxide values ranging from 5.1 to 36.8 mmol/L, were assayed on the Hitachi E40 Clinical Analyzer at three sites using S TEST Reagent Cartridge Carbon Dioxide (y) and a comparative method as the reference method (x). Deming regression vielded the following results:

Site #	n	Range(mmol/L)	RegressionEquation	"r"	CI**Slope	CI Intercept
1	47	6.6 to 36.8	y = 0.91x + 1.49	0.984	0.87 to 0.95	0.67 to 2.32
2	45*	5.5 to 34.4	y = 0.92x + 0.56	0.970	0.80 to 1.04	-2.31 to 3.43
3	47	5.1 to 35.5	y = 0.92x + 0.79	0.982	0.87 to 0.97	-0.43 to 2.01

POL ACCURACY DATA SUMMARY- Carbon Dioxide (mmol/L)

2 samples at Site 2 quantitated below to dynamic range (<5 mmol/L) and were excluded from data analysis. **95% Confidence Interval

Expected Range

22 -- 29 mmol/L (Tietz, Fundamentals of Clinical Chemistry, 40 Edition, WB Saunders Company, (1996))

807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

Nonclinical and clinical testing was performed for the Hitachi Clinical Analyzer E40 with Reagent Cartridge Carbon Dioxide. The test system was shown to be safe and effective for its intended use.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2014

HITACHI CHEMICAL DIAGNOSTICS, INC. c/o ERIKA AMMIRATI AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT LOS ALTOS. CA 94022

Re: K140248

Trade/Device Name: S TEST Reagent Cartridge Carbon Dioxide (CO2) Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: II Product Code: KHS Dated: January 29, 2014 Received: January 30, 2014

Dear Ms. Ammirati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Ammirati

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K140248

Device Name

S TEST Reagent Cartridge Carbon Dioxide (CO2)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.