Cleared Traditional

K781607 - STREP-TEX (FDA 510(k) Clearance)

Class I Immunology device.

K781607 · Burroughs Wellcome Co. · Immunology device
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Oct 1978
Decision
29d
Days
Class 1
Risk

K781607 is an FDA 510(k) clearance for the STREP-TEX. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Burroughs Wellcome Co. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3740 - the FDA immunology 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 Burroughs Wellcome Co. devices

Submission Details

510(k) Number K781607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date October 17, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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.