The Carbon Dioxide test system, reagent and calibrator, is a device intended to measurc bicarbonate/carbon dioxide in plasma, and serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentia!ly serious disorders associated with changes in body acid-base balance.

Device Description

Carbon Dioxide is an in vitro diagnostic assay for the quantitative analysis of CO2 in human serum or plasma. Carbon dioxide, as bicarbonate (HCO3), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH) analog. The resulting decrease in absorbance at 404 nm is proportional to the CO2 content in the sample.

AI/ML Overview

Here's a summary of the acceptance criteria and study detailed in the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Abbott Carbon Dioxide Assay)
Method Comparison (vs. Hitachi 717 CO2L)
AEROSET System	Correlation Coefficient: "similar"	0.994
	Slope: "similar"	0.99
	Y-intercept: "similar"	-0.20 mEq/L
ARCHITECT c8000 System	Correlation Coefficient: "similar"	0.9893
	Slope: "similar"	0.98
	Y-intercept: "similar"	-0.75 mEq/L
Method Comparison (AEROSET vs. ARCHITECT c8000)
ARCHITECT c8000 System	Correlation Coefficient: "similar"	0.995
	Slope: "similar"	0.98
	Y-intercept: "similar"	-0.55 mEq/L
Precision (%CV)
AEROSET System	Level 1: Not specified, but comparable to predicate	Level 1: 2.0%
	Level 2: Not specified, but comparable to predicate	Level 2: 2.4%
ARCHITECT c8000 System	Level 1: Not specified, but comparable to predicate	Level 1: 2.1%
	Level 2: Not specified, but comparable to predicate	Level 2: 2.5%
Linearity Range	Not specified, but comparable to predicate	5 to 50 mEq/L
Functional Sensitivity (Limit of Quantitation)	Not specified, but comparable to predicate	4 mg/dL
Limit of Detection (LOD)	Not specified, but comparable to predicate	2 mEq/L

Note: The acceptance criteria for this 510(k) submission are implied by the claim of "substantial equivalence" to the predicate device (Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer) and the phrasing "Both assays yield similar Performance Characteristics." Specific numerical thresholds for "similar" are not explicitly stated for all parameters, but the presented results are considered acceptable for demonstrating substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the method comparison or precision studies. It mentions "Comparative performance studies were conducted" but does not provide the number of samples or subjects included.

Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission is for an in vitro diagnostic assay, which measures a quantifiable analyte (carbon dioxide) in human serum or plasma. Therefore, the concept of "experts" establishing ground truth as typically seen in image analysis or diagnostic interpretation studies (e.g., radiologists, pathologists) does not directly apply here. The "ground truth" for method comparison is established by the performance of the legally marketed predicate device (Hitachi 717 Analyzer).

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay, adjudication in the sense of reconciling differing expert opinions on a diagnostic image or case is not relevant. The "truth" is based on the measurement provided by the reference method (predicate device).

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 is typically associated with diagnostic imaging or interpretation where human readers are involved. This submission is for an automated in vitro diagnostic assay.

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

Yes, the performance data presented is for the standalone performance of the Abbott Carbon Dioxide assay on the AEROSET and ARCHITECT c8000 Systems. These are automated systems, and the performance characteristics reported (correlation, precision, linearity, limits) are intrinsic to the device's measurement capabilities without direct human intervention in the analysis process beyond sample loading and general operation.

7. The Type of Ground Truth Used

The ground truth for the comparative performance studies was established by the legally marketed predicate device, the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the new device's measurements are compared against an already approved and accepted method.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. For an in vitro diagnostic chemical assay, the development process typically involves reagent formulation, optimization, and validation, rather than machine learning model "training" with a distinct dataset. The performance data presented are for the validation of the final device.

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

Not applicable. As noted above, information on a "training set" for a machine learning model is not provided, nor is it typically relevant for this type of in vitro diagnostic assay. The ground truth for the validation and substantial equivalence assessment was the predicate device's performance.

Summary

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510(k) Summary

MAY - 4 2006

Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 2-11 Regulatory Affairs (972) 518-6711 Fax (972) 518-7479

Date of Preparation of this Summary:	February 3, 2006
Device Trade or Proprietary Name:	Carbon Dioxide
Device Common/Usual Name orClassification Name:	Carbon Dioxide
Classification Number/Class:	KHS/Class II

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: K 060 295 .

Test Description:

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Substantial Equivalence:

The Carbon Dioxide assay is substantially equivalent to the Carbon Dioxide (CO2L) assay (K032377) on the Hitachi 717 Analyzer. Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro enzymatic assays. .
Both assays can be used for the quantitative analysis of carbon dioxide. .
Both assays yield similar results. .
Both assays are based on the PEP Carboxylase methodology. *

Differences:

None

Intended Use:

The Carbon Dioxide assay is used for the quantitation of carbon dioxide (CO2) in human serum or plasma.

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Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® and ARCHITECT® c8000 Systems. The Carbon Dioxide assay method comparison yielded acceptable correlation with the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer. The AEROSET System showed a correlation coefficient of 0.994, slope of 0.99, and Y-intercept of - 0.20 mEq/L when compared to the Hitachi 717 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9893, slope of 0.98, and Y-intercept of -- 0.75 mEq/L when compared to the Hitachi 717 Analyzer. The Carbon Dioxide assay method comparison yielded acceptable correlation between the AEROSET System and ARCHITECT c8000 System. The ARCHITECT c8000 System showed a correlation coefficient of 0.995, slope of 0.98 and Y-intercept of -0.55 mEq/L when compared to the AEROSET System. Precision studies were conducted using the Carbon Dioxide assay. On the AEROSET System, the total %CV for Level 1 is 2.0%, and Level 2 is 2.4%. On the ARCHITECT c8000 System, the total %CV for Level 1 is 2.1%, and Level 2 is 2.5%. The Carbon Dioxide assay is linear from 5 to 50 mEg/L. The functional sensitivity (limit of quantitation) of the Carbon Dioxide assay is 4 mg/dL and the limit of detection (LOD) 2 mEq/L. These data demonstrate that the performance of the Carbon Dioxide assay is substantially equivalent to the performance of the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer.

Conclusion:

The Carbon Dioxide assay is substantially equivalent to the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

CO2 - Conc. 510(k) February 3, 2006

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist Regulatory Affairs Abbott Laboratories 1921 Hurd Drive Irvine, TX 75038

MAY - 4 2006

K060295 Re: Trade/Device Name: Carbon Dioxide Regulation Number: 21 CFR§862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: February 3, 2006 Received: February 15, 2006

Dear Ms. Morris:

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 your device 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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to prematies 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 the mediation in (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Albert G. A

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: _______Carbon Dioxide

Indications For Use:

Prescription Use X (Part 21 CFR 80 l Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

Division/Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Office of and Safety

510(k) K060295

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.