Cleared Traditional

QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY (K935554) - FDA 510(k) Clearance

Class I Microbiology device.

K935554 · Syntron Bioresearch, Inc. · Microbiology device
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Aug 1995
Decision
651d
Days
Class 1
Risk

K935554 is an FDA 510(k) clearance for the QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY. 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 651 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 K935554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date August 30, 1995
Days to Decision 651 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
549d slower than avg
Panel avg: 102d · This submission: 651d
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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