# K031048: Carestart HCG Combo One-Step Pregnancy Test and Carestart Plus HCG Combo One-Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Access Bio Incorporate
- Decided: Jun 16, 2003 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CareStartTMhCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Source page: https://510kreport.com/device/K031048
Methodology: https://510kreport.com/methodology