Ind One Step Hcg Pregnancy Test - Cassette Format

• 2 recalls, same reason

  • Ongoing Z-0048-2024 FDA Class II ·initiated 22 May 2023
  • Ongoing Z-0064-2024 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.

• • Terminated Z-0897-2009 FDA Unclassified (pre-2012) ·initiated 13 Nov 2008 ·on shared 510(k) K050741

  Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

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

510(k) Number

K050741 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• One Step Drug Test - Amp/Met/Mor/Thc/Coc

  Class II

  FDA 510(k) K060810 Active Cleared 7 Aug 2006

• Ind One Step Fecal Occult Blood Test Model 440-10

  Class II

  FDA 510(k) K100031 Active Cleared 19 Jul 2010

• Ind Urinary Tract Infection (Uti) Test Strips Open recall

  Class I

  FDA 510(k) K103037 Active Cleared 17 Apr 2012

• Ind Drug Home Multi-Panel Test (2-5) Ind Morphine Home Test

  Class II

  FDA 510(k) K121231 Active Cleared 30 Jul 2012

• One Step Hcg Pregnancy Test - 2000 Miu/Ml, Model 100 Series.

  Class II

  FDA 510(k) K052694 Active Cleared 16 Dec 2005

• One Step Fsh Menopausal Test Open recall

  Class I

  FDA 510(k) K052662 Active Cleared 30 Nov 2005

See all devices from Ind Diagnostic, Inc. →