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Rapid Response AMP-1S2-100

by BTNX Inc

Rapid Response AMP-1S2-100 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K161044 on 6 Jul 2016 (1 earlier submission) and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00722066000458), 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 found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00722066000458 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161044 Date6 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161044 decided 6 Jul 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00722066000458 listed 25 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121065
  2. Cleared FDA 510(k) K161044
  3. Listed FDA GUDID 00722066000458

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  • Withdrawn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
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
AMP-1S2-100
Primary DI / UDI-DI
00722066000458
510(k) Number
FDA product code
DIT
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Cleared under the same submission (K121065)

and 8 more cleared under K121065

Cleared under the same submission (K161044)

and 8 more cleared under K161044

Similar devices

Other devices filed under FDA product code DIT (Thin Layer Chromatography, Amphetamine).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)