# K960733: Ministick Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Biomedical Corp.
- Decided: May 1, 1996 after 69 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914253 (1991). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914253: Proclinic One Step Pregnancy Test, Vanguard Biomedical Corp. (1991) Summary page 4.
- (no number) ANSWER 1-Step Pregnancy Test: named in the summary without a submission number
- (no number) 1 Step ADVANCE Pregnancy Test: named in the summary without a submission number
- (no number) Conceive Pregnancy Test: named in the summary without a submission number

## Most influential descendants
- K172512: ACRO HCG Pregnancy Rapid Test (2018), 1 descendant of its own
- K180771: Acro HCG Pregnancy Rapid Test (2018), 0 descendants of its own

## Indications for use
The MiniStick Pregnancy Test is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy.

Source page: https://510kreport.com/device/K960733
Methodology: https://510kreport.com/methodology