# K132834: Fastep S10 HCG Serum/Urine Combo Test

- Pathway: 510(k) (Traditional)
- Applicant: Polymed Therapeutics, Inc.
- Decided: Jan 9, 2014 after 121 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 K020801 (2002). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020801: Quickvue One-Step HCG-Combo, Quidel Corp. (2002) Summary page 1.

## Most influential descendants
- K203272: Alltest Pregnancy Rapid Combo Test Cassette (2022), 2 descendants of its own
- K262299: Instant-View® hCG Combo II Cassette Test (2026), 0 descendants of its own
- K241919: Innovita HCG Pregnancy Rapid Combo Test (2024), 0 descendants of its own

## Indications for use
The Fastep SI10 hCG Serum/Urine Combo Test 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 isonly intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.

Source page: https://510kreport.com/device/K132834
Methodology: https://510kreport.com/methodology