The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and plasma. 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 COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 409 nm is proportional to the concentration of bicarbonate in the sample.

AI/ML Overview

This document describes the COBAS Integra Bicarbonate liquid, an in vitro diagnostic reagent system. The information provided focuses on the regulatory aspects and intended use of the device, rather than a detailed study proving its performance against specific acceptance criteria in the format requested.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

Focus on Substantial Equivalence: The document is primarily a 510(k) summary, aiming to establish "substantial equivalence" to a predicate device (COBAS Integra Carbon Dioxide Assay). This means the focus is on demonstrating that the new device is as safe and effective as a legally marketed one, rather than presenting a comprehensive study with pre-defined acceptance criteria and raw performance data.
Lack of Performance Data: The summary emphasizes similarities in intended use, method, sample type, and measuring range. While it mentions "Expected values," these are clinical reference ranges, not performance metrics.
No Details on Study Design: There's no information about specific studies, sample sizes, ground truth establishment, expert involvement, or adjudication methods for this device.

Therefore, many of the requested fields cannot be accurately populated from the provided text.

However, based on the context of a 510(k) submission for an in vitro diagnostic (IVD) reagent, we can infer some general acceptance criteria and potential study types, though specific numbers are absent.

Inferred Acceptance Criteria (Typical for IVDs) and Reported Device Performance (as much as can be extracted/inferred):

Acceptance Criteria Category (Inferred for IVD Reagents)	Inferred/Reported Device Performance
Reproducibility/Precision: (e.g., CV% within limits)	Not explicitly stated in terms of a specific study or numeric criteria. The claim of "substantial equivalence" to the predicate device (COBAS Integra Carbon Dioxide Assay, K980996) implies that the new device's precision characteristics are comparable and acceptable.
Accuracy/Bias: (e.g., agreement with a reference method)	Not explicitly stated in terms of a specific study or numeric criteria. Again, "substantial equivalence" suggests comparable accuracy to the predicate. The method is enzymatic and colorimetric, implying that its fundamental mechanism aims for accurate measurement.
Measuring Range:	Reported Performance: 0 - 50 mmol/L. This is stated as "Same" as the predicate device, indicating it meets the established range.
Applicable Sample Types:	Reported Performance: Human Serum and Plasma. This is stated as "Same" as the predicate device, confirming it meets this criteria.
Stability (Reagent and Calibrator):	Not explicitly stated. For an IVD reagent system, stability (onboard, open vial, shelf life) would be critical acceptance criteria, though no specific data is presented here. Substantial equivalence would imply similar or improved stability profile compared to the predicate.
Interferences: (e.g., from common substances)	Not explicitly stated. IVDs typically have acceptance criteria for known interferents (e.g., hemolysis, lipemia, icterus, common medications). Substantial equivalence would suggest the interference profile is acceptable and comparable to the predicate.
Expected/Reference Values:	Reported Performance: 22 - 29 mmol/L for anaerobic venous plasma or serum. The predicate device's expected range was 23 - 29 mmol/L. This slight difference might be due to updated reference populations or method equivalency, but it falls within a clinically acceptable range for bicarbonate, implying it meets the expectation for normal physiological values.
Intended Use:	Reported Performance: "The cassette COBAS Integra Bicarbonate liquid (CO2-L) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate ($HCO_3^-$) concentration in human serum and plasma." This aligns with the specified intended use and is demonstrated through the substantial equivalence argument, assuming the performance (accuracy, precision, range) supports this claim. The FDA's clearance confirms this intended use is supported.

Information Not Available in the Provided Text:

Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an IVD reagent summary. The "ground truth" for chemical measurements typically relies on reference methods or gravimetric/volumetric standards, not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an IVD reagent summary.
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 is an IVD reagent, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biochemical assay. Its "performance" is inherently standalone.
The type of ground truth used: For an IVD reagent measuring a chemical concentration, the ground truth would typically be established by a primary reference measurement procedure or certified reference materials traceable to higher-order standards. The document does not specify which reference method was used for validation.
The sample size for the training set: Not applicable in the context of an IVD reagent assay. There is no AI model being trained here.
How the ground truth for the training set was established: Not applicable.

Summary of what can be extracted/inferred:

Device Type: In Vitro Diagnostic (IVD) Reagent System
Purpose: Quantitative determination of bicarbonate ($HCO_3^-$) concentration in human serum and plasma.
Method: Enzymatic, colorimetric test.
Predicate Device: COBAS Integra Carbon Dioxide Assay (K980996).
Key "Performance" similarities to predicate (implying acceptance): Same method, sample type (Human Serum and Plasma), and measuring range (0-50 mmol/L).
Minor difference (but within clinical acceptance): Expected values for anaerobic venous plasma or serum - 22-29 mmol/L for the new device vs. 23-29 mmol/L for the predicate.
Study Type: The document is a 510(k) summary, which relies on demonstrating substantial equivalence. It implies that performance studies (accuracy, precision, interference, linearity, stability) were conducted to support this claim, but the details of these studies are not provided in this specific excerpt.

Summary

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510(k) Summary - COBAS Integra Bicarbonate liquid

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence
Submittername, address,contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 521-3831
	Contact person: Sherri L. Coenen
	Date prepared: June 13, 2003
Device Name	Proprietary name: Roche Diagnostics COBAS Integra Bicarbonate liquid
	Common name: Enzymatic Bicarbonate Assay
	Classification name: enzymatic bicarbonate/carbon dioxide test system
Devicedescription	The COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymaticassay with phosphenolpyruvate carboxylase and malate dehydrogenase. Adecrease in absorbance at 409 nm is proportional to the concentration ofbicarbonate in the sample.
Intended use	The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitrodiagnostic reagent system intended for use on COBAS Integra systems for thequantitative determination of the bicarbonate ( $HCO_3^-$ ) concentration in humanserum and plasma.
PredicateDevice	We claim substantial equivalence to the currently marketed COBAS IntegraCarbon Dioxide Assay. (K980996).

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510(k) Summary - COBAS Integra Creatinine plus ver.2, continued

Reagent Summary The following table describes the similarities and differences between the COBAS Integra Bicarbonate liquid and the predicate device.

Topic	COBAS Integra Carbon Dioxide(K980996)	COBAS Integra Bicarbonate liquid(Modified Device)
Intended Use	The cassette COBAS Integra CarbonDioxide (CO2-S) contains an in vitrodiagnostic reagent system intendedfor use on COBAS Integra systemsfor the quantitative determination ofthe carbon dioxide concentration inserum and plasma.	The cassette COBAS IntegraBicarbonate liquid (CO2-L) containsan in vitro diagnostic reagent systemintended for use on COBAS Integrasystems for the quantitativedetermination of the bicarbonate$(HCO_3^-)$ concentration in humanserum and plasma.
Method	Enzymatic, colorimetric test	Same
Sample type	Human Serum and Plasma	Same
Measuringrange	0 - 50 mmol/L	Same
Expectedvalues	Anaerobic venous plasma or serum:23 - 29 mmol/L	22 - 29 mmol/L

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 17 2003

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 46250-0457

Re: K031879

Trade/Device Name: COBAS Integra Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: June 13, 2003 Received: June 18, 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. Iisting 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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Page 2 -

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 Sutman

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

Device Name: COBAS Integra Bicarbonate liquid

Indications For Use:

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031875

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrentee 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.