# K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Oct 9, 2009 after 165 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905396 (1991). 8 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031947: Bayer Clinitek Status Analyzer, Bayer Healthcare, LLC (2003) Summary page 1.
- K032563: Clinitest HCG Pregnancy Test, Bayer Healthcare, LLC (2003) Summary page 1.

## Most influential descendants
- 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
- K160372: Uritek TC-201 Urine Chemistry Test System (2016), 0 descendants of its own

## Recalls of this device
- Sep 19, 2014 · Class II · Z-0083-2015: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- Sep 19, 2014 · Class II · Z-0082-2015: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- Sep 19, 2014 · Class II · Z-0081-2015: The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
- Feb 26, 2013 · Class III · Z-1545-2014: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

## Indications for use
The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). These measurements are used to assist diagnosis in the following areas: Kidney Function Urinary tract infections Metabolic disorders (e.g. diabetes mellitus) Liver Function Pregnancy Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only. The Clinitek Status®+ Analyzer is intended for near patient (point-of-care). facilities and centralized laboratory locations.

Source page: https://510kreport.com/device/K091216
Methodology: https://510kreport.com/methodology