# K974059: One Step Midstream HCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: International Newtech Development, Inc.
- Decided: Apr 9, 1998 after 164 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K122907: Fastep at-Home Pregnancy, HCG, Over the Counter (2013), 1 descendant of its own
- K233174: FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (2024), 0 descendants of its own

## Recalls of this device
- May 22, 2023 · Class II · Z-0055-2024: 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-0066-2024: 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-0049-2024: 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
One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of HCG (Human Choronic Gonadotropin) concentration in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.

Source page: https://510kreport.com/device/K974059
Methodology: https://510kreport.com/methodology