Cleared Traditional

K791454 - AGGLUTINOTEST-PERTUSSIS (FDA 510(k) Clearance)

Class I Microbiology device.

K791454 · Volu Sol Medical Industries · Microbiology device
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Sep 1979
Decision
49d
Days
Class 1
Risk

K791454 is an FDA 510(k) clearance for the AGGLUTINOTEST-PERTUSSIS. Classified as Antigen, B. Pertussis (product code GOX), Class I - General Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3065 - 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 Volu Sol Medical Industries devices

Submission Details

510(k) Number K791454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date September 24, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GOX Antigen, B. Pertussis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3065
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.