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Rapid Response U5.3-1S100

by BTNX Inc

Rapid Response U5.3-1S100 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K061559 on 11 Aug 2006 and listed in FDA GUDID since 4 Nov 2016 (UDI-DI 00722066004364), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K061559

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 Number00722066004364 UDI-DI Date4 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061559 Date11 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061559 decided 11 Aug 2006 Active
  • FDA GUDID UDI-DI 00722066004364 listed 4 Nov 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2786-2018 FDA Class III initiated 22 Jun 2018 on shared 510(k) K061559

    Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K061559
  2. Listed FDA GUDID 00722066004364
  3. Recall initiated FDA recalls Z-2786-2018

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  • Withdrawn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
Urine pH IVD, kit, rapid colorimetric, clinical
Model / Ref / Catalog
U5.3-1S100
Primary DI / UDI-DI
00722066004364
510(k) Number
FDA product code
JIO, JIR, JIN, JIL, CEN
GMDN term
Urine pH IVD, kit, rapid colorimetric, clinical
Device class
Class II
Regulation number
864.6550, 862.1645, 862.1435, 862.1340, 862.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urine glucose IVD, kit, rapid colorimetric, clinicalUrine ketone IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinicalUrine blood IVD, kit, rapid colorimetric, clinical

Cleared under the same submission (K061559)

and 5 more cleared under K061559

Similar devices

Other devices filed under FDA product code JIO (Blood, Occult, Colorimetric, In Urine).

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)