Cleared Traditional

STREPTACOCCUS CO-AGGLUTINATION KIT (K822799) - FDA 510(k) Clearance

Class I Microbiology device.

K822799 · American Scientific Products · Microbiology device
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Dec 1982
Decision
94d
Days
Class 1
Risk

K822799 is an FDA 510(k) clearance for the STREPTACOCCUS CO-AGGLUTINATION KIT. Classified as Exoenzymes, Multiple, Streptococcal (product code GTP), Class I - General Controls.

Submitted by American Scientific Products (Walker, US). The FDA issued a Cleared decision on December 19, 1982 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3720 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K822799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1982
Decision Date December 19, 1982
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTP Exoenzymes, Multiple, Streptococcal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
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.