Cleared Traditional

K852841 - RAPID DIRECT STREP A LATEX AGGLUTINATIO...

K852841 is the FDA 510(k) clearance for RAPID DIRECT STREP A LATEX AGGLUTINATIO... by Smithkline Diagnostics, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K852841 · Smithkline Diagnostics, Inc. · Microbiology device
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Jul 1985
Decision
19d
Days
Class 1
Risk

K852841 is an FDA 510(k) clearance for the RAPID DIRECT STREP A LATEX AGGLUTINATION TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Smithkline Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 24, 1985 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K852841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1985
Decision Date July 24, 1985
Days to Decision 19 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
83d faster than avg
Panel avg: 102d · This submission: 19d
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 K852841.
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