# K031947: Bayer Clinitek Status Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 19, 2003 after 178 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905396 (1991). 4 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960546: Clinitek 50 Urine Chemistry Analyzer, Bayer Corp. (1996) Summary page 1.
- K992257: New Multiples Reagent Strips, Bayer Corp. (1999) Summary page 1.
- K905396: Hemastix Reagent Strips, Heraeus Kulzer, Inc. (1991) Summary page 1.
- K972706: Clinitek Microalbumin Reagent Strips, Bayer Corp. (1997) Summary page 1.

## Most influential descendants
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), 6 descendants of its own
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), 3 descendants of its own
- K070929: Acon U120 Urine Analyzer, Model U111-101 (2007), 3 descendants of its own
- K141874: Uriscan Optima (2015), 2 descendants of its own
- K210069: Minuteful - kidney test (2022), 1 descendant of its own

## Indications for use
The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix® brand reagent strips), for testing in the clinical laboratory. The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.

Source page: https://510kreport.com/device/K031947
Methodology: https://510kreport.com/methodology