Cleared Traditional

K854978 - DIFCO STREP A LATEX TEST

K854978 is an FDA 510(k) clearance for DIFCO STREP A LATEX TEST, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K854978 · Difco Laboratories, Inc. · Microbiology device
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Mar 1986
Decision
96d
Days
Class 1
Risk

K854978 is an FDA 510(k) clearance for the DIFCO STREP A LATEX TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on March 18, 1986 after a review of 96 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

FDA 510(k) Submission Details - K854978

510(k) Number K854978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date March 18, 1986
Days to Decision 96 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
6d faster than avg
Panel avg: 102d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

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 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K854978.
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TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · Hybritech, Inc. · Apr 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc. · Mar 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
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ABBOTT STREP A P.S.D.
K852266 · Abbott Laboratories · Dec 1985