# K112101: Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests

- Pathway: 510(k) (Traditional)
- Applicant: Polymed Therapeutics, Inc.
- Decided: Jul 17, 2012 after 361 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964461 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964461: One -Step Urine/Serum Combo Pregnancy Card Test, Teco Diagnostics (1997) Summary page 2.

## Recalls of this device
- Oct 20, 2016 · Class II · Z-2391-2018: Incorrect hCG results

## Indications for use
The Polymned Therapeutics' Fastep' hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professidnals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).

Source page: https://510kreport.com/device/K112101
Methodology: https://510kreport.com/methodology