Cleared Traditional

LACTEST I (K971944) - FDA 510(k) Clearance

Class I Chemistry device.

K971944 · Jwt, Inc. · Chemistry device
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Dec 1997
Decision
204d
Days
Class 1
Risk

K971944 is an FDA 510(k) clearance for the LACTEST I. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Jwt, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Jwt, Inc. devices

Submission Details

510(k) Number K971944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date December 17, 1997
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
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 K971944.
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