Cleared Traditional

K792478 - CHEM-STRATE CHOLESTEROL

K792478 is an FDA 510(k) clearance for CHEM-STRATE CHOLESTEROL, manufactured by General Diagnostics. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792478 · General Diagnostics · Chemistry device
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Dec 1979
Decision
24d
Days
Class 1
Risk

K792478 is an FDA 510(k) clearance for the CHEM-STRATE CHOLESTEROL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), 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 862.1175 - 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

FDA 510(k) Submission Details - K792478

510(k) Number K792478 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.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 186
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K792478.
LIQUID-STAT LIQUID REAGENT
K800457 · Beckman Instruments, Inc. · Mar 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
K800199 · Simmler, Inc. · Feb 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1980
ENZYMATIC REAGENT SET, 4X250 ML.
K791511 · Macomb Chemical Co. · Sep 1979
AUTO ENZYMATIC CHOLESTEROL
K790947 · Macomb Chemical Co. · Jun 1979
ENZYMATIC DETERMINATION
K790724 · Sigma Chemical Co. · May 1979