Cleared Traditional

K760713 - TRIGLYCERIDES TEST

K760713 is an FDA 510(k) clearance for TRIGLYCERIDES TEST, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K760713 · Boehringer Mannheim Corp. · Chemistry device
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Nov 1976
Decision
66d
Days
Class 1
Risk

K760713 is an FDA 510(k) clearance for the TRIGLYCERIDES TEST. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1976 after a review of 66 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K760713

510(k) Number K760713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1976
Decision Date November 29, 1976
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
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 116
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K760713.
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
ENZYMATIC TRIGLYCERIDE
K760029 · Harleco · Sep 1976
REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1
K760195 · Coulter Electronics, Inc. · Aug 1976