Cleared Traditional

I-STAT LACTATE TEST (K982071) - FDA 510(k) Clearance

Class I Chemistry device.

K982071 · I-Stat Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
17d
Days
Class 1
Risk

K982071 is an FDA 510(k) clearance for the I-STAT LACTATE TEST. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I-Stat Corp. devices

Submission Details

510(k) Number K982071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1998
Decision Date June 29, 1998
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KHP Acid, Lactic, Enzymatic Method

All 26
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K982071.
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · Boehringer Mannheim Corp. · Aug 1995
DIMENSION(R) LACTIC ACID METHOD
K914508 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · Eastman Kodak Company · Aug 1991
SYNCHRON LACTATE REAGENT
K910534 · Beckman Instruments, Inc. · Apr 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · Eastman Kodak Company · Jan 1989
TDX REA LACTIC ACID
K861741 · Abbott Laboratories · Jul 1986