# K110889: Ind One Step HCG Urine Pregnancy Test (Strip)

- Pathway: 510(k) (Traditional)
- Applicant: Ind Diagnostics, Inc.
- Decided: Jun 20, 2011 after 82 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 22, 2023 · Class II · Z-0042-2024: 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" Ke
- May 22, 2023 · Class II · Z-0054-2024: 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" Ke
- May 22, 2023 · Class II · Z-0053-2024: 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" Ke

## Indications for use
IND One Step hOG Urine Pregnancy Tests Device is intended for the qualitative detection of human chorionic gonadotropin (hOG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use.

Source page: https://510kreport.com/device/K110889
Methodology: https://510kreport.com/methodology