The Carbon Dioxide (CO2) 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 (HCO3 ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction, catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydorgenase (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 provided text describes a 510(k) submission for the Abbott Laboratories Carbon Dioxide (CO2) assay. The study presented is a comparative performance study against a predicate device, not a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The data is about an in-vitro diagnostic method, which does not involve human readers or AI in the traditional sense. Therefore, many of the requested sections about human performance, AI, and ground truth establishment from expert consensus are not applicable.

Here's the information that can be extracted and presented based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Correlation with Predicate Device:
Correlation Coefficient	0.9691
Slope	0.991
Y-intercept	2.779 mEq/L
Precision:
Total %CV (Level 1/Panel 111 control)	3.6%
Total %CV (Level 2/Panel 112 control)	3.9%
Linearity:	Up to 40.0 mEq/L
Limit of Quantitation (Sensitivity):	4.0 mEq/L

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the comparative performance study.
- Data Provenance: Not explicitly stated, however, the study was conducted using the ALCYON™ Analyzer and compared against the Roche Cobas Mira Plus Automated Chemistry System. The nature of in vitro diagnostic assays implies laboratory samples, typically from human serum or plasma. It is a prospective study as it was conducted to demonstrate performance for the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an in vitro diagnostic assay, the "ground truth" is typically established by reference methods or validated predicate devices rather than expert consensus on images or similar data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to expert review of ambiguous cases, which is not relevant for this type of analytical performance study.
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 study is for an in vitro diagnostic assay, not a device involving human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided study describes the performance of the Carbon Dioxide assay method itself, which operates as a standalone diagnostic test without human-in-the-loop performance in the AI context. The study is a standalone performance assessment of the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this study was established by comparison to a legally marketed predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Carbon Dioxide assay (K844987). This means the predicate device's results served as the reference for determining the substantial equivalence of the new device's performance.
The sample size for the training set: Not applicable. This is an analytical performance study for an in vitro diagnostic assay, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable. (See #7).

Summary

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K981231

MAY 1 2 1998

510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 02, 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:

Test Description:

Carbon Dioxide 510(k) April 1, 1998 CO2fE2.lwp

Section II Page 1

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Substantial Equivalence:

The Carbon Dioxide assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Carbon Dioxide assay (K844987).

Both assays vield similar Performance Characteristics.

Similarities:

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 ALCYON™ Analyzer. The Carbon Dioxide assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Carbon Dioxide assay. The correlation coefficient = 0.9691, slope = 0.991, and Y-intercept = 2.779 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 111 control is 3.6% and Level 2/Panel 112 control is 3.9%. The Carbon Dioxide assay is linear up to 40.0 mEq/L. The limit of quantitation (sensitivity) for the Carbon Dioxide assay is 4.0 mEq/L. These data demonstrate that the performance of the Carbon Dioxide assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Carbon Dioxide assay.

Carbon Dioxide 510(k) April 1, 1998 CO2fE2.lwp

Section II Page 2

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Conclusion:

The Carbon Dioxide assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Carbon Dioxide assay as demonstrated by results obtained in the studies.

Carbon Dioxide 510(k)
April 1, 1998
CO2E2.lwp

Section II
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 1998

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981231 Re : Carbon Dioxide Requlatory Class: II Product Code: KHS Dated: April 2, 1998 Received: April 3, 1998

Dear Mr. Littlefield:

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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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 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): K 981231

Carbon Dioxide Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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.

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

	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)

Veronica D. Calvin HoramatomescuDivision of Clinical Laboratory Devices
510(k) Number K981231

00000000

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.