Cleared Traditional

K935475 - QUIKSTRIP ONESTEP STREP A TEST IMMUNOCH...

K935475 is the FDA 510(k) clearance for QUIKSTRIP ONESTEP STREP A TEST IMMUNOCH... by Syntron Bioresearch, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 653-day FDA review.

K935475 · Syntron Bioresearch, Inc. · Microbiology device
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Aug 1995
Decision
653d
Days
Class 1
Risk

K935475 is an FDA 510(k) clearance for the QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Syntron Bioresearch, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 30, 1995 after a review of 653 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K935475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date August 30, 1995
Days to Decision 653 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
551d slower than avg
Panel avg: 102d · This submission: 653d
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.

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