# K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech. Co., Ltd.
- Decided: Feb 24, 2016 after 153 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K973858 (1997). 1 ancestor in all.
1 later device descends 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)
- K973858: Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo, Quidel Corp. (1997) Summary page 4.

## Most influential descendants
- K250117: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (2025), 0 descendants of its own

## Indications for use
The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings. The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings.

Source page: https://510kreport.com/device/K152768
Methodology: https://510kreport.com/methodology