Cleared Traditional

K133343 - WONDFO RAPID STREP A TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K133343 · Guangzhou Wondfo Biotech Co., Ltd. · Microbiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.