Cleared Traditional

K133343 - WONDFO RAPID STREP A TEST

K133343 is an FDA 510(k) clearance for WONDFO RAPID STREP A TEST, manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K133343 · Guangzhou Wondfo Biotech Co., Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
93d
Days
Class 1
Risk

K133343 is an FDA 510(k) clearance for the WONDFO RAPID STREP A TEST. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on January 31, 2014 after a review of 93 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 Guangzhou Wondfo Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K133343

510(k) Number K133343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2013
Decision Date January 31, 2014
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 37
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K133343.
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC · Mar 2022
Sofia Strep A+ FIA, Sofia 2 Analyzer
K171976 · Quidel Corporation · Dec 2017
SOFIA (R) STREP A+ FIA
K141775 · Quidel Corporation · Dec 2014
SOFIA STREP A FIA
K123793 · Quidel Corporation · Jun 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
K122718 · Becton, Dickinson and Company · Feb 2013
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · Binax, Inc. · Sep 2009