# K984077: Instant-View Pregnancy Combo Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Feb 16, 1999 after 92 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 K945951 (1995). 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)
- K945951: Quikpac II, One Step HCG Combo Kit, Syntron Bioresearch, Inc. (1995) Summary page 1.

## Indications for use
The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for laboratory and professional use only.

Source page: https://510kreport.com/device/K984077
Methodology: https://510kreport.com/methodology