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I-Stat Tests for Acid-Base Parameters

by I-Stat Corp. 510(k)

Active United States

510(k) K936081

Overview

I-STAT TESTS FOR ACID-BASE PARAMETERS is a device type classified as Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, used for the in vitro quantification of acid-base parameters in blood specimens. It is designed to measure pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and lactate in arterial, venous, or capillary whole blood.

The device is supplied as a cartridge for use with the i-STAT 1 System and received FDA 510(k) clearance (K936081) on February 24, 1994, under product code CHL and regulation number 862.1120. It is intended for use in clinical chemistry settings and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK936081 Date24 Feb 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0374-2008 FDA Unclassified (pre-2012) initiated 18 Oct 2007 via K936081, on the same 510(k)

    Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
CHL
Device Class
Class II
Regulation
21 CFR Part 862.1120
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the I-STAT TESTS FOR ACID-BASE PARAMETERS used for?

    It is used for the in vitro quantification of acid-base parameters in blood specimens, specifically measuring pH, partial pressure of oxygen (PO2), partial pressure of carbon dioxide (PCO2), and lactate in arterial, venous, or capillary whole blood.

  • How is the I-STAT TESTS FOR ACID-BASE PARAMETERS supplied and used?

    The device is supplied as a cartridge designed for use with the i-STAT 1 System, enabling point-of-care testing of blood samples in clinical chemistry settings.

  • Is the I-STAT TESTS FOR ACID-BASE PARAMETERS sterile or single-use?

    The provided data does not describe the device as sterile, single-use, reusable, or MRI-safe; therefore, no claims about sterility or reuse can be made based on the available information.