Cleared Traditional

K971522 - ABBOTT TESTPACK PLUS STREP A WITH ON BO...

K971522 is an FDA 510(k) clearance for ABBOTT TESTPACK PLUS STREP A WITH ON BO..., manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K971522 · Abbott Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
312d
Days
Class 1
Risk

K971522 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 3, 1998 after a review of 312 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K971522

510(k) Number K971522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date March 03, 1998
Days to Decision 312 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 102d · This submission: 312d
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 81
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K971522.
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
STREPTOLEX-STAT
K962296 · Unipath , Ltd. · Dec 1996
CARDS Q.S. STREP A
K955108 · Quidel Corp. · Apr 1996
BINAX STREP A TEST
K960712 · Binax, Inc. · Mar 1996