# K023944: Bayer Diagnostics Clinitest Pregnancy Test

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Corp.
- Decided: Feb 11, 2003 after 77 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices 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) SureStepm hCG/Combo (11) Pregnancy Test: named in the summary without a submission number

## Most influential descendants
- K032563: Clinitest HCG Pregnancy Test (2003), 7 descendants of its own
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K141874: Uriscan Optima (2015), 2 descendants of its own
- K210069: Minuteful - kidney test (2022), 1 descendant of its own
- K222921: Minuteful-kidney test (2023), 0 descendants of its own

## Indications for use
The Bayer Diagnostics ClinitestG9 hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlUlml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.

Source page: https://510kreport.com/device/K023944
Methodology: https://510kreport.com/methodology