# K971209: Clinitek HCG Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 4, 1997 after 2 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. The FDA summary names its predicate without a number.
- (no number) QuickVue® One-Step HCG Combo: named in the summary without a submission number
- (no number) Test Pack +Plus hCG Combo: named in the summary without a submission number

## Indications for use
CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.

Source page: https://510kreport.com/device/K971209
Methodology: https://510kreport.com/methodology