I-STAT SYSTEM

K973292 · I-Stat Corp. · CGL · Oct 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973292
• Device Name: I-STAT SYSTEM
• Applicant: I-Stat Corp.
• Product Code: CGL · Clinical Chemistry
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Story

The i-STAT Creatinine Test is an in vitro diagnostic test used with the i-STAT analyzer to measure creatinine levels in whole blood. The system is designed for use by healthcare professionals in clinical settings. The device processes whole blood samples to provide quantitative creatinine results, which assist clinicians in diagnosing and managing renal diseases and monitoring patients undergoing dialysis. The output provides objective data to inform clinical decision-making regarding kidney function and treatment efficacy.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic test cartridge for use with the i-STAT analyzer; quantitative electrochemical measurement of creatinine in whole blood.

Indications for Use

Indicated for quantitative determination of Creatinine in whole blood for patients requiring diagnosis and treatment of renal diseases or monitoring of renal dialysis.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

OCT 20 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Imants R. Lauks, Ph.D. . Executive VP & Chief Technology Officer i-STAT 303 College Road East Princeton, New Jersey 08540

Re: K973292 i-STAT® Creatinine Test Regulatory Class: II Product Code: CCL Dated: Auqust 29, 1997 September 2, 1997 Received:

Dear Dr. Lauks:

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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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. ਸ 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 requlation 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 requlations.

{1}------------------------------------------------

Paqe 2

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 requlation 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.qov/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 Radioloqical Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510(k) Number (if Known): K973692

Device Name: i-STAT Creatinine Test

Indications for Use:

an y 大安都哪个彩票 新疆彩票官网

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

?

స్త

ా విద్యాలయం గ్రామం నుండి 5 న

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------: 要

ﺔ ﺍﻟﻤﺘﺤﺪﺓ

ني ڀ , ,

For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

(Division Sign-Off) Division of Clinical Laboratory Do 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (OED)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)