NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM

K982928 · Radiometer America, Inc. · CHL · Jan 6, 1999 · Clinical Chemistry

Device Facts

• Record ID: K982928
• Device Name: NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
• Applicant: Radiometer America, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jan 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO2 pO2 ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.

Device Story

NPT7 Series is a stand-alone blood gas analyzer utilizing DRI-TEK cartridges for analysis of human whole blood (arterial, venous, capillary). Device measures pH, pCO2, pO2, and co-oximetry parameters. Designed for point-of-care and laboratory use by minimally trained personnel; supports operation in stationary, vehicle, and aircraft environments. Provides quantitative diagnostic data to clinicians to assist in patient management. System automates sample analysis, reducing complexity for non-specialized operators.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and device specifications.

Technological Characteristics

Stand-alone blood gas analyzer; utilizes DRI-TEK cartridges for sample analysis; measures pH, pCO2, pO2, and co-oximetry; designed for stationary, vehicle, and aircraft use.

Indications for Use

Indicated for use by minimally trained personnel for the measurement of pH, blood gases (pCO2, pO2), and co-oximetry parameters in human arterial, venous, and capillary whole blood samples in laboratory and point-of-care settings, including stationary, vehicle, and aircraft environments.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration Mr. Donald L. Baker JAN 6 1999 2098 Gaither Road Director of Customer Relations Rockville MD 20850 and Technical Support Medical Division Radiometer America Inc. 811 Sharon Drive Westlake, Ohio 44145-1598 K982928 Re: Trade Name: NPT7 Series Analyzer with DRI-TEK Cartridge CHL, JHP, CGA, CGZ, CEM, Product Code: Regulatory Class: II JGS, & GKF KHP Product Code: Regulatory Class: I

Dear Mr. Baker:

Received:

Dated: August 12, 1998

August 20, 1998

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 Requlations, 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 (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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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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 Boutman

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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## EXHIBIT V

| 510(k) NUMBER (IF KNOWN): | K982928 |
|---------------------------|-------------|
| DEVICE NAME: | NPT7 Series |

## INDICATIONS FOR USE:

NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO2 pO2 ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.

Cuan Cooper
(Division Sign-Off)

Division of Clinical La boratory I. svices 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)

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