In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Device Description

The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 nm is proportional to the concentration of bicarbonate in the sample.

AI/ML Overview

The provided text is a 510(k) summary for the Roche/Hitachi Bicarbonate liquid diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way medical imaging or AI-driven devices typically do.

Therefore, many of the requested categories directly related to device performance studies, such as sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance, are not explicitly provided in this type of regulatory document for a chemical assay.

However, I can extract the relevant information that is present and indicate where information is not available based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance	Comments
Intended Use	Quantitative determination of bicarbonate (HCO3-) in human serum and plasma.	In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche clinical chemistry analyzers.	Substantially equivalent to predicate.
Method	Enzymatic, colorimetric test.	Same.	Substantially equivalent to predicate.
Sample Type	Human Serum and Plasma.	Same.	Substantially equivalent to predicate.
Measuring Range	0.46 - 50 mmol/L	1.5 - 50 mmol/L	The proposed device has a slightly narrower lower limit for its measuring range (1.5 mmol/L vs. 0.46 mmol/L for the predicate). This difference was deemed acceptable for substantial equivalence.
Expected Values	22 - 29 mmol/L	Same.	Substantially equivalent to predicate.

2. Sample size used for the test set and the data provenance

The document does not explicitly mention sample sizes for a specific "test set" or data provenance (country of origin, retrospective/prospective) for performance evaluation. This type of detail is generally found in more comprehensive study reports, which are summarized rather than fully presented in a 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device based on comparable intended use, methodology, and performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of enzymatic assay. "Ground truth" in this context would refer to the accuracy of the chemical measurement, usually verified against a reference method or known concentration standards, not by expert interpretation as in medical imaging. The document does not provide details on how the accuracy was verified.

4. Adjudication method for the test set

Not applicable for this type of enzymatic assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic reagent for a chemical assay, not an AI-driven medical imaging or diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the assay itself when run on "Roche automated clinical chemistry analyzers." The performance metrics listed (measuring range, expected values, method) relate to the standalone performance of the assay system. However, specific details of a formal "standalone study" with detailed results are not provided beyond the summary table comparing it to the predicate. The FDA's substantial equivalence determination implies that this standalone performance was considered acceptable and comparable to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an enzymatic assay device, "ground truth" typically refers to the true concentration of bicarbonate in samples, established through reference methods or gravimetrically prepared standards. The document does not specify the exact methods used to establish this "ground truth" for the performance evaluation.

8. The sample size for the training set

Not applicable. This device is a chemical reagent and does not involve AI/machine learning models that require a "training set."

9. How the ground truth for the training set was established

Not applicable. This device is a chemical reagent and does not involve AI/machine learning models that require a "training set."

Summary

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AUG 2 1 2003

く032377

510(k) Summary - Roche/Hitachi Bicarbonate liquid

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence
Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831Contact person: Sherri L. CoenenDate prepared: July 30, 2003
Device Name	Proprietary name: Roche Diagnostics Hitachi Bicarbonate liquidCommon name: Bicarbonate AssayClassification name: Enzymatic bicarbonate/carbon dioxide test system
Device description	The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 nm is proportional to the concentration of bicarbonate in the sample.
Intended use	In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers.
Predicate Device	We claim substantial equivalence to the currently marketed COBAS Integra Bicarbonate liquid Assay. (K031879).

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510(k) Summary - Roche/Hitachi Bicarbonate liquid, continued

Reagent	The following table describes the similarities and differences between the
Summary	Roche/Hitachi Bicarbonate liquid and the predicate device.

Topic	COBAS Integra Bicarbonate liquid (K031879)	Roche/Hitachi Bicarbonate liquid (Modified Device)
Intended Use	The cassette COBAS IntegraBicarbonate liquid (CO2-L) containsan in vitro diagnostic reagent systemintended for use on COBAS Integrasystems for the quantitativedetermination of the bicarbonate(HCO3-) concentration in humanserum and plasma.	In vitro test for the quantitativedetermination of bicarbonate (HCO3-)in human serum and plasma onRoche clinical chemistry analyzers.
Method	Enzymatic, colorimetric test	Same
Sample type	Human Serum and Plasma	Same
Measuring range	0.46 - 50 mmol/L	1.5 - 50 mmol/L
Expected values	22 - 29 mmol/L	Same

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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AUG 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250

Re: K032377

Trade/Device Name: Roche/Hitachi Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: July 30, 2003 Received: August 1, 2003

Dear Ms. Coenen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): N/A

032377

Device Name: Roche/Hitachi Bicarbonate liquid

Indications For Use:

In vitro test for the quantitative determination of bicarbonate (HCO3) in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Carol C Benson (G. Jean Cooper, DVM
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Division Sign-C

Office of In Vitro Diagnostic Devise Evaluation and Safety

510(k) K032377

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.