# K032563: Clinitest HCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 23, 2003 after 125 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020801 (2002). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023944: Bayer Diagnostics Clinitest Pregnancy Test, Bayer Corp. (2003) Summary page 1.
- K020801: Quickvue One-Step HCG-Combo, Quidel Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K171521: DUS R-50S (Urine Chemistry system) (2018), 0 descendants of its own

## Recalls of this device
- Dec 15, 2011 · Not classified · Z-0972-2012: A potential for false positive or increase in borderline results with patients and commercially available negative control material.
- Apr 4, 2008 · Not classified · Z-1715-2008: False negative hCG results due to decreased sensitivity

## Indications for use
The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. This test is used to obtain a Clinitek Status analyzer result of positive, borderline or negative and is intended for near patient (point-of-care) and centralized laboratory locations.

Source page: https://510kreport.com/device/K032563
Methodology: https://510kreport.com/methodology