CO2

K981231 · Abbott Mfg., Inc. · KHS · May 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981231
• Device Name: CO2
• Applicant: Abbott Mfg., Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

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

Device Story

The Carbon Dioxide (CO2) assay is an in vitro diagnostic reagent used on the ALCYON™ Analyzer. It measures CO2 levels in human serum or plasma samples. The assay utilizes an enzymatic reaction where phospho(enol)pyruvate carboxylase (PEPC) converts bicarbonate and phospho(enol)pyruvate into oxalacetate and phosphate. Malate dehydrogenase (MDH) then reduces oxalacetate to malate, oxidizing NADH in the process. The resulting decrease in absorbance at 380 nm is measured by the analyzer and is directly proportional to the CO2 concentration in the sample. The device is intended for use by clinical laboratory professionals to provide quantitative data that aids healthcare providers in diagnosing and managing patients with acid-base imbalances.

Clinical Evidence

Bench testing only. Performance studies compared the subject assay to the Roche Cobas Mira Plus system. Results showed a correlation coefficient of 0.9691, slope of 0.991, and Y-intercept of 2.779 mEq/L. Precision studies (within-run, between-run, between-day) yielded total %CVs of 3.6% (Level 1) and 3.9% (Level 2). The assay is linear up to 40.0 mEq/L with a limit of quantitation of 4.0 mEq/L.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Principle: Enzymatic spectrophotometric measurement (NADH oxidation at 380 nm). Reagents: Phospho(enol)pyruvate carboxylase (PEPC) and Malate dehydrogenase (MDH). Form factor: Liquid reagent for use on automated clinical chemistry analyzers (ALCYON™).

Indications for Use

Indicated for the quantitative determination of carbon dioxide in human serum or plasma to assist in the diagnosis and treatment of disorders associated with acid-base balance changes.

Regulatory Classification

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.

Predicate Devices

• Roche Cobas Mira Plus Automated Chemistry System Carbon Dioxide assay (K844987)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

| 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 (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.

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
Page 3

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 | <div>✓</div> | 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

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