Cleared Traditional

UNI-GOLD STREP A TEST KIT (K011709) - FDA 510(k) Clearance

Class I Microbiology device.

K011709 · Trinity Biotech, Plc · Microbiology device
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Nov 2001
Decision
157d
Days
Class 1
Risk

K011709 is an FDA 510(k) clearance for the UNI-GOLD STREP A TEST KIT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Trinity Biotech, Plc (Ballinasloe, IE). The FDA issued a Cleared decision on November 8, 2001 after a review of 157 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 Trinity Biotech, Plc devices

Submission Details

510(k) Number K011709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date November 08, 2001
Days to Decision 157 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
55d slower than avg
Panel avg: 102d · This submission: 157d
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 K011709.
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