CLINICAL BLOOD GAS MIXTURE

• K Number: K993789
• Device Name: CLINICAL BLOOD GAS MIXTURE
• Manufacturer: GENERAL AIR SERVICE AND SUPPLY
• Date Cleared: 2000-01-10 ( 62 days)
• Product Code: CHL
• Regulation Number: 862.1120
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Clinical Blood Gas Mixtures are intended for use as calibration gases for research and Blood Gas Analyzers.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K993789 letter and associated documents does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

This document is a notification from the FDA to General Air Service & Supply regarding their "Clinical Blood Gas Mixture." It primarily states that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, subject to general controls.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample size for a test set, data provenance, or ground truth establishment.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Stand-alone algorithm performance or training set details.

The letter focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific metrics and methodologies.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 0 2000

Mr. Michael Fisher Safety Coordinator General Air Service & Supply 6330 Colorado Boulevard Commerce City, Colorado 80022

Re: K993789

Trade Name: Clinical Blood Gas Mixture Regulatory Class: II Product Code: CHL Dated: October 26, 1999 Received: November 9, 1999

Dear Mr. Fisher:

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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug 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 [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 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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) : K993789

DEVICE NAME: Clinical Blood Gas Mixture

INDICATIONS FOR USE:

Clinical Blood Gas Mixtures are intended for use as calibration gases for research and Blood Gas Analyzers.

Stevin Cooper

ision Sign vices vision of Clinical Laboratory 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

BOULDER, CO 80301-2524 3750 WALNUT STREET [phone] FAX (B03) 440-7730

DENVER, CO 80204-3399 1105 ZUNI STREET [phone] FAX [phone]

FT. COLLINS, CO 80524-2723 1918 HEATH PKWY. [phone] FAX [phone]

GREELEY, CO 80631-5931 1700 1ST AVENUE [phone] FAX [phone]

LITTLETON, CO 80120 4901 RIO GRANDE [phone] FAX [phone]

Look us up on the World Wide Web: www.generalair.com

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.