One Step Midstream Hcg Pregnancy Test

• 3 recalls, same reason

  • Ongoing Z-0055-2024 FDA Class II ·initiated 22 May 2023
  • Ongoing Z-0066-2024 FDA Class II ·initiated 22 May 2023
  • Ongoing Z-0049-2024 FDA Class II ·initiated 22 May 2023

  Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

510(k) Number

K974059 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Mini Strip/Serum Hcg Open recall

  Class II

  FDA 510(k) K963132 Active Cleared 18 Nov 1996

• Ps-Unit Cassette/Serum and Urine Combo Hcg

  Class II

  FDA 510(k) K974009 Active Cleared 13 Mar 1998

• Urinalysis Reagent Strips (10 Parameters) Open recall

  Class I

  FDA 510(k) K993850 Active Cleared 3 Jan 2000

• Ministrip/ Serum and Urine Combo Hcg Test

  Class II

  FDA 510(k) K974060 Active Cleared 9 Apr 1998

• Ps-Unit Cassette/Serum Hcg Open recall

  Class II

  FDA 510(k) K963133 Active Cleared 18 Nov 1996

• Hcg Controls

  Class I

  FDA 510(k) K970176 Active Cleared 6 Feb 1997

See all devices from International Newtech Development, Inc. →