Cleared Traditional

K011709 - UNI-GOLD STREP A TEST KIT

K011709 is an FDA 510(k) clearance for UNI-GOLD STREP A TEST KIT, manufactured by Trinity Biotech, Plc. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K011709 · Trinity Biotech, Plc · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K011709

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.

GTZ Device Classification - Class 1, General Controls

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 87
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K011709.
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521 · Binax, Inc. · Nov 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · Binax, Inc. · Mar 2001
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726 · Binax, Inc. · Aug 1999
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories · Mar 1998
STREPTOLEX-STAT
K962296 · Unipath , Ltd. · Dec 1996
CARDS Q.S. STREP A
K955108 · Quidel Corp. · Apr 1996