Cleared Traditional

K910797 - STREPTEX ACID EXTRACTION KIT

K910797 is the FDA 510(k) clearance for STREPTEX ACID EXTRACTION KIT by Wellcome Diagnostics. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K910797 · Wellcome Diagnostics · Microbiology device
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Mar 1991
Decision
31d
Days
Class 1
Risk

K910797 is an FDA 510(k) clearance for the STREPTEX ACID EXTRACTION KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 31 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 Wellcome Diagnostics devices

Submission Details

510(k) Number K910797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date March 29, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
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 63
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K910797.
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PATHO DX STREP D
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K901274 · Abbott Laboratories · May 1990