Cleared Traditional

K971944 - LACTEST I

K971944 is an FDA 510(k) clearance for LACTEST I, manufactured by Jwt, Inc.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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

FDA 510(k) Submission Details - K971944

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
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 19
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K971944.
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STAT PROFILE PLUS 9 ANALYZER
K936066 · Nova Biomedical Corp. · Mar 1995
DIMENSION(R) LACTIC ACID METHOD
K914508 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991