Cleared Traditional

K792479 - CHEM-STRATE AMYLASE

K792479 is the FDA 510(k) clearance for CHEM-STRATE AMYLASE by General Diagnostics. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792479 · General Diagnostics · Chemistry device
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Dec 1979
Decision
24d
Days
Class 2
Risk

K792479 is an FDA 510(k) clearance for the CHEM-STRATE AMYLASE. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special 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 862.1070 - 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.

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Submission Details

510(k) Number K792479 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. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIJ Saccharogenic, Amylase

All 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K792479.
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053 · Coulter Electronics, Inc. · Feb 1984
DADE COLORIMETRIC AMYLASE
K813529 · American Dade · Dec 1981
ULTRA ZYME PLUS AMYL #64982 & 65031
K812594 · Harleco · Oct 1981
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500
K780513 · Harleco · May 1978
ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.
K780141 · Harleco · Mar 1978
ENZYMATIC AMYLASE REAGENT KIT
K760415 · Beckman Instruments, Inc. · Nov 1976