Cleared Traditional

K834582 - DETECT GROUP A STREP TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K834582 · Difco Laboratories, Inc. · Microbiology device
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Apr 1984
Decision
97d
Days
Class 1
Risk

K834582 is an FDA 510(k) clearance for the DETECT GROUP A STREP TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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.

View all Difco Laboratories, Inc. devices

Submission Details

510(k) Number K834582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date April 04, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 102d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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.