FDA 510(k) clearance · back to tracker

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

ACON Laboratories, Inc. cleared K251697 on 2025-11-26, decision: substantially equivalent

K-number

K251697

Sponsor

ACON Laboratories, Inc.

Device

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-11-26

Product code

GTY

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3740

Official FDA record

Open K251697on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K251697 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.