Cleared Traditional

K761262 - TRIGLYCERIDES (LIPASE) REAGENT SET

K761262 is an FDA 510(k) clearance for TRIGLYCERIDES (LIPASE) REAGENT SET, manufactured by Worthington Biochemical Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K761262 · Worthington Biochemical Corp. · Chemistry device
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Dec 1976
Decision
13d
Days
Class 1
Risk

K761262 is an FDA 510(k) clearance for the TRIGLYCERIDES (LIPASE) REAGENT SET. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Worthington Biochemical Corp. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1976 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 Worthington Biochemical Corp. devices

FDA 510(k) Submission Details - K761262

510(k) Number K761262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1976
Decision Date December 29, 1976
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 136
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K761262.
TRIGLYCERIDE REAGENT SET
K770993 · Macomb Chemical Co. · Sep 1977
MULTISTAT III TRIGLYCERIDE TEST
K771472 · Instrumentation Laboratory CO · Sep 1977
TRIGLYCERIDE ENZYMATIC METHOD
K770841 · Union Carbide Corp. · Jul 1977
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200 · Beckman Instruments, Inc. · Dec 1976
TRIGLYCERIDES TEST
K760713 · Boehringer Mannheim Corp. · Nov 1976
ENZYMATIC TRIGLYCERIDE
K760029 · Harleco · Sep 1976