Cleared Traditional

K790578 - GAMMA SMAC REAGENTS

K790578 is the FDA 510(k) clearance for GAMMA SMAC REAGENTS by Gamma Enterprises, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K790578 · Gamma Enterprises, Inc. · Chemistry device
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May 1979
Decision
49d
Days
Class 2
Risk

K790578 is an FDA 510(k) clearance for the GAMMA SMAC REAGENTS. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K790578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date May 15, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 177
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K790578.
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · American Monitor Corp. · Nov 1980
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · Volu Sol Medical Industries · Dec 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · Volu Sol Medical Industries · Dec 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · Fisher Scientific Co., LLC · Oct 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
K780524 · Harleco · May 1978