Cleared Traditional

QUIKPAC STREP A TEST (K924007) - FDA 510(k) Clearance

Class I Microbiology device.

K924007 · Syntron Bioresearch, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
239d
Days
Class 1
Risk

K924007 is an FDA 510(k) clearance for the QUIKPAC STREP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Syntron Bioresearch, Inc. (Vista, US). The FDA issued a Cleared decision on April 6, 1993 after a review of 239 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K924007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date April 06, 1993
Days to Decision 239 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
137d slower than avg
Panel avg: 102d · This submission: 239d
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
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K924007.
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories · Mar 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · Abbott Laboratories · Jan 1996
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
ABBOTT TEST PACK STREP A TEST
K945571 · Abbott Laboratories · Aug 1995
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories · Jul 1992
BBL STREP GROUPING KIT
K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1992