Cleared Traditional

K792480 - CHEM-STRATE TRIGLYCERIDE

K792480 is the FDA 510(k) clearance for CHEM-STRATE TRIGLYCERIDE by General Diagnostics. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792480 · General Diagnostics · Chemistry device
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Dec 1979
Decision
24d
Days
Class 1
Risk

K792480 is an FDA 510(k) clearance for the CHEM-STRATE TRIGLYCERIDE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 24 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 General Diagnostics devices

Submission Details

510(k) Number K792480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date December 27, 1979
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 112
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K792480.
TRIGLYCERIDES FOR SMA AND AAII
K801226 · Reagents Applications, Inc. · Jun 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · Reagents Applications, Inc. · May 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · Sigma Chemical Co. · Mar 1980
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
K792234 · Boehringer Mannheim Corp. · Nov 1979
COULTER ACCU-ZYME II ENZYMATIC REAGENT
K791640 · Coulter Electronics, Inc. · Sep 1979
ENZYMATIC TRIGLYCERIDES-S.V.R.
K790773 · Calbiochem-Behring Corp. · Jun 1979