Cleared Traditional

K854978 - DIFCO STREP A LATEX TEST (FDA 510(k) Clearance)

Class I Microbiology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
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.