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

Intended Use

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

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of such technologies.

Therapeutic

No
The device is described as "calibration gases for research and Blood Gas Analyzers" and intended for "research and Blood Gas Analyzers," indicating a diagnostic or laboratory utility rather than direct therapeutic application to a patient.

Diagnostic

No

Explanation: The device is described as "Clinical Blood Gas Mixtures" intended as "calibration gases for research and Blood Gas Analyzers." It is a calibration substance, not a device that directly diagnoses. The Blood Gas Analyzers that use these mixtures would be the diagnostic devices.

SaMD (Software as a Medical Device)

No

The device is described as "Clinical Blood Gas Mixtures," which are physical substances (gases) used for calibration. This is a hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states "calibration gases for research and Blood Gas Analyzers." Blood Gas Analyzers are devices used to measure parameters in blood samples (which are in vitro). Calibration gases are essential for ensuring the accuracy of these in vitro measurements.

While the description is brief and lacks details about the device itself, the intended use strongly aligns with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Calibration materials used with IVD instruments fall under the scope of IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

CHL

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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)

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