Cleared Traditional

AllTest Strep A Rapid Test (K260342) - FDA 510(k) Clearance

Class I Microbiology device.

K260342 · Hangzhou AllTest Biotech Co., Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
87d
Days
Class 1
Risk

K260342 is an FDA 510(k) clearance for the AllTest Strep A Rapid Test. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 30, 2026 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hangzhou AllTest Biotech Co., Ltd. devices

Submission Details

510(k) Number K260342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2026
Decision Date April 30, 2026
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
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.

Regulatory Consultant

LSI International, Inc.
Jenny Xia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GTY Antigens, All Groups, Streptococcus Spp.

All 43
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K260342.
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · ACON Laboratories, Inc. · Nov 2025
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC · Mar 2022
ABBOTT STREP A CONTROLS
K922490 · Abbott Laboratories · Jul 1992
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · Eastman Kodak Company · Jan 1991
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories · Feb 1987
BBL DIRECTIGEN TEST KIT
K812808 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981