Cleared Traditional

K982071 - I-STAT LACTATE TEST

K982071 is an FDA 510(k) clearance for I-STAT LACTATE TEST, manufactured by I-Stat Corp.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K982071 · I-Stat Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K982071

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

KHP Device Classification - Class 1, General Controls

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.
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · Diametrics Medical, Inc. · Jan 2002
I-STAT SYSTEM
K011478 · I-Stat Corp. · Jul 2001
LACTATE PRO SYSTEM
K980908 · Kdk Corp. · Sep 1998
LACTEST I
K971944 · Jwt, Inc. · Dec 1997
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · Boehringer Mannheim Corp. · Aug 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · Nova Biomedical Corp. · Mar 1995
K982071 · I-STAT LACTATE TEST
Download PDF FDA Summary I-Stat Corp.