The Carbon Dioxide assay is used for the quantitation of carbon dioxide in human serum or 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

Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which carbon dioxide, as bicarbonate (HCO2 - ), 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). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.

AI/ML Overview

The document describes the Abbott Laboratories Carbon Dioxide (CO2) assay and its substantial equivalence to the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it demonstrates substantial equivalence by showing that the performance characteristics of the new device are "similar" to or "acceptable" in comparison to the predicate device. For the purpose of this analysis, the performance of the predicate device (Boehringer Mannheim Carbon Dioxide assay) serves as the implicit acceptance criteria, and the reported device performance is that of the Abbott Carbon Dioxide assay.

Performance Metric	Implicit Acceptance Criteria (Predicate Device K933461)	Reported Device Performance (Abbott CO2 Assay)
Method Comparison (Correlation)	Acceptable correlation to predicate	Correlation coefficient = 0.9906
Method Comparison (Slope)	Similar to predicate	Slope = 0.909
Method Comparison (Y-intercept)	Similar to predicate	Y-intercept = 0.088 mEq/L
Precision (Within-run, Between-run, Between-day)	Acceptable precision for clinical use	Total %CV for Level 1 = 10.2%, Total %CV for Level 2 = 9.6%
Linearity	Linear up to a clinically relevant range	Linear up to 44.8 mEq/L
Limit of Quantitation (Sensitivity)	Clinically relevant sensitivity	2.80 mEq/L

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

The document briefly mentions "Comparative performance studies were conducted" and "Precision studies were conducted using the Carbon Dioxide assay," but it does not specify the sample size used for these test sets.

The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). However, the nature of a clinical chemistry assay comparison generally implies prospective data collection in a laboratory setting using human serum or plasma samples.

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

This information is not provided in the document. For an in vitro diagnostic (IVD) device like this, the "ground truth" is typically the measurement obtained from the predicate device or a reference method. It's not usually established by human expert consensus in the same way it might be for an image-based diagnostic.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in image interpretation studies where human experts disagree. For a quantitative chemical assay, the "ground truth" (or reference measurement) is established by the method itself.

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:

This is not applicable as the device is a clinical chemistry assay (an in vitro diagnostic), not an AI-powered diagnostic that assists human readers. Therefore, an MRMC study and
the concept of human reader improvement with AI are not relevant to this submission.

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

Yes, the studies conducted were standalone performance evaluations of the Abbott Carbon Dioxide assay.
The performance characteristics (correlation, precision, linearity, sensitivity) were determined for the assay system itself, without human intervention in the measurement process (beyond sample handling).

7. The Type of Ground Truth Used:

The ground truth used for comparison was the measurements obtained from the predicate device, the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer (K933461). This falls under the category of a well-established reference method or predicate device performance.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. This device is a traditional chemical assay, not an AI/machine learning algorithm, so there is no "training set" in the context of machine learning. The assay's parameters would have been optimized during its development, but this is a different concept than a machine learning training set.

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

This information is not applicable as there is no training set for this type of device.

Summary

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KC981840

JUN - 8 1998

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Sr. Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 22, 1998
Device Trade or Proprietary Name:	CO2
Device Common/Usual Name or Classification Name:	Carbon Dioxide
Classification Number/Class:	75CHS/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: 1981840

Test Description:

Carbon Dioxide 510(k) May 21, 1998 CQ2.Jwp

Section II Page 1

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Substantial Equivalence:

The Carbon Dioxide assay is substantially equivalent to the Boehringer Mannheim® Carbon Dioxide assay (K933461) on the Hitachi® 717 Analyzer.

Both assays vield similar Performance Characteristics.

Similarities to Boehringer Mannheim:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of carbon dioxide. .
Both assays yield similar clinical results. .

Intended Use:

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

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Carbon Dioxide assay method comparison yielded acceptable correlation with the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9906, slope = 0.909, and Y-intercept = 0.088 mEq/L. Precision studies were conducted using the Carbon Dioxide assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 control is 10.2% and Level 2/Panel 102 control is 9.6%. The Carbon Dioxide assay is linear up to 44.8 mEq/L. The limit of quantitation (sensitivity) for the Carbon Dioxide assay is 2.80 mEq/L. These data demonstrate that the performance of the Carbon Dioxide assay is substantially equivalent to the performance of the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer.

Section II Page 2

Comments of the comments of the comments of

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Conclusion:

. . . .

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

Carbon Dioxide 510(k) May 21, 1998 CO2.lwp

Section II Page 3

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Public Health Service

JUN 8 1008 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Linda Morris · Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K981840 Carbon Dioxide Requlatory Class: II Product Code: KHS Dated: May 22, 1998 Received: May 26, 1998

Dear Ms. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K98184C)

Device Name: _________________________________________________________________________________________________________________________________________________________________ Carbon Dioxide

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number R981840

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

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

(Optional Format 1-2-96)

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510(k) Number (if known): K98184C)

Carbon Dioxide Device Name:

Indications For Use:

(Division Sign-Off)
Division of Clínical Laboratory Devices
510(k) Number K981840

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use 11 OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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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.