Cleared Traditional

K760034 - TEST

K760034 is the FDA 510(k) clearance for TEST by Gamma Biologicals, Inc.. It is a Class 2 Microbiology device (product code DEM) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K760034 · Gamma Biologicals, Inc. · Microbiology device
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Aug 1976
Decision
58d
Days
Class 2
Risk

K760034 is an FDA 510(k) clearance for the TEST, STREP, LATEX SLIDE. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Gamma Biologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1976 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5130 - the FDA microbiology device 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 Biologicals, Inc. devices

Submission Details

510(k) Number K760034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date August 11, 1976
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
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 Microbiology devices follow this clearance model.