Cleared Traditional

CLEARVIEW STREP A (K893422) - FDA 510(k) Clearance

Class I Microbiology device.

K893422 · Unipath , Ltd. · Microbiology device
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Jun 1989
Decision
52d
Days
Class 1
Risk

K893422 is an FDA 510(k) clearance for the CLEARVIEW STREP A. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on June 23, 1989 after a review of 52 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 Unipath , Ltd. devices

Submission Details

510(k) Number K893422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date June 23, 1989
Days to Decision 52 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 102d · This submission: 52d
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 104
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