Cleared Traditional

K935667 - QTEST(R) STREP

K935667 is an FDA 510(k) clearance for QTEST STREP, manufactured by Becton Dickinson Advanced Diagnostics. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K935667 · Becton Dickinson Advanced Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
146d
Days
Class 1
Risk

K935667 is an FDA 510(k) clearance for the QTEST(R) STREP. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 146 days - within the typical 510(k) review window.

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 Becton Dickinson Advanced Diagnostics devices

FDA 510(k) Submission Details - K935667

510(k) Number K935667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date April 21, 1994
Days to Decision 146 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
44d slower than avg
Panel avg: 102d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

GTY Device Classification - Class 1, General Controls

Product Code GTY Antigens, 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 - GTY Antigens, All Groups, Streptococcus Spp.

All 38
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K935667.
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · Princeton BioMeditech Corp. · Nov 1998
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · Princeton BioMeditech Corp. · Jul 1997
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
K945080 · Quidel Corp. · Feb 1995
BIOSTARS STREP A OIA -- MODIFICATION
K922765 · Biosearch Medical Products, Inc. · Aug 1992
ABBOTT STREP A CONTROLS
K922490 · Abbott Laboratories · Jul 1992
SLIDEX STREPTO-KIT
K905020 · Vitek Systems, Inc. · Jan 1991