CARBON DIOXIDE LIQUID STABLE REAGENT

K070251 · Pointe Scientific, Inc., · KHS · Apr 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070251
• Device Name: CARBON DIOXIDE LIQUID STABLE REAGENT
• Applicant: Pointe Scientific, Inc.,
• Product Code: KHS · Clinical Chemistry
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.

Device Story

Carbon Dioxide Liquid Stable Reagent is an in vitro diagnostic reagent for clinical laboratory use. It utilizes spectrophotometric analysis to measure carbon dioxide levels in human serum samples. The reagent reacts with the sample to produce a measurable change in absorbance, which correlates to the concentration of carbon dioxide. This quantitative measurement assists clinicians in evaluating patient acid-base balance. The device is intended for professional use in clinical settings.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing. Method comparison study (n=136 samples, range 14-40 mmol/L) against predicate device yielded a correlation coefficient of 0.986 and linear regression y = 0.965x + 1.2. Precision evaluated on Hitachi 917 analyzer showed within-day CVs of 2.2-3.1% and day-to-day CVs of 2.9-3.1%. Analytical specificity testing showed no interference from bilirubin (up to 20 mg/dL), hemoglobin (up to 500 mg/dL), or lipemia (up to 1000 mg/dL).

Technological Characteristics

Quantitative enzymatic assay. Reagents: Phosphoenolpyruvate (8.0 mM), Magnesium Ions (20 mM), NADH analog (0.5 mM), PEPC (>200 U/L), MDH (>1200 U/L), buffer (pH 7.5). Form factor: liquid, ready-to-use. Energy source: spectrophotometric (405-415 nm). Performance demonstrated on Hitachi 917 chemistry analyzer. Stability: 15-month shelf life at 2-8°C.

Indications for Use

Indicated for quantitative determination of carbon dioxide in human serum to assess acid-base balance disturbances.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Pointe Scientific, Inc. c/o Mr. William F. Walters, Jr. V.P .- Technical Operations 5449 Research Drive Canton, MI 48188

APR 3 0 2007

Re: k070251

> Trade/Device Name: Carbon Dioxide Liquid Stable Reagent Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system. Regulatory Class: Class II Product Code: KHS Dated: January 22, 2007 Received: January 30, 2007

Dear Mr. Walters:

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, l'isting 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 Islang (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 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 [phone]. 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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): Unknown at this time

Device Name: Carbon Dioxide Liquid Stable Reagent

Indications For Use: This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.

Prescription Use X (Part 21 CFR 801 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 Diagnostic Devices (OIVD)

Carol Benson

Ision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K070251