Cleared Traditional

K834582 - DETECT GROUP A STREP TEST

K834582 is the FDA 510(k) clearance for DETECT GROUP A STREP TEST by Difco Laboratories, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - GTZ Antisera, All Groups, Streptococcus Spp.

All 61
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K834582.
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · Pharmacia, Inc. · Nov 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · Diagnostic Products Corp. · Jul 1984
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
PHADEBACT STREP F TEST
K830445 · Pharmacia, Inc. · Apr 1983
ABBOTT LABORATORIES STREP A EIA
K823569 · Abbott Laboratories · Mar 1983