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Rapid Response STR-15S25

by BTNX Inc

Rapid Response STR-15S25 is a Class I device made by BTNX Inc, cleared under FDA 510(k) K010582 on 7 May 2001 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066000014), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K010582

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00722066000014 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010582 Date7 May 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010582 decided 7 May 2001 Active
  • FDA GUDID UDI-DI 00722066000014 listed 25 Oct 2016 Listed

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-2337-2025 FDA Class II initiated 30 Jul 2025

    Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.

    • Ongoing Z-3185-2024 FDA Class II initiated 20 Aug 2024

    Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

    • Ongoing Z-1598-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Timeline

5 dated events

  1. Cleared FDA 510(k) K010582
  2. Listed FDA GUDID 00722066000014
  3. Recall initiated FDA recalls Z-1598-2022
  4. Recall initiated FDA recalls Z-3185-2024
  5. Recall initiated FDA recalls Z-2337-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rapid Response
Generic name
Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
STR-15S25
Primary DI / UDI-DI
00722066000014
510(k) Number
FDA product code
GTY
GMDN term
Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.3740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

Similar devices

Other devices filed under FDA product code GTY (Antigens, All Groups, Streptococcus Spp.).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)