# K960546: Clinitek 50 Urine Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 12, 1996 after 125 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 6 cite it directly.
0 of 23 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) MULTISTIX 10-SG Reagent Strips for Urinalysis (visual readout): named in the summary without a submission number
- (no number) CLINITEK 200+ Urine Chemistry Analyzer: named in the summary without a submission number
- (no number) CLINITEK ATLAS Urine Chemistry Analyzer: named in the summary without a submission number

## Most influential descendants
- K031947: Bayer Clinitek Status Analyzer (2003), 16 descendants of its own
- 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

## Recalls of this device
- Mar 12, 2004 · Not classified · Z-1051-04: Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.
- Jun 19, 2003 · Not classified · Z-0911-03: Analyzer will produce erroneous results due to missing grounding strap.

## Indications for use
The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.

Source page: https://510kreport.com/device/K960546
Methodology: https://510kreport.com/methodology