# K140717: Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration Kit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 17, 2014 after 242 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 K932674 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932674: Clinitek Atlas Automated Urine Chemistry System, Miles Inc., Dental Products (1993) Summary page 5.

## Indications for use
The CLINITEK Novus® Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument. The CLINITEK Novus analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus Cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus 10 Urinalysis Cassette is intended for the semi-quantitative measurement of the following parameters in urine: bilirubin, blood (occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein, color, and urobilinogen. These measurements are used to assist diagnosis in the following areas: « Carbohydrate metabolism (such as diabetes mellitus) » Kidney function » Liver function * Metabolic disorders « Urinary tract infection For in vitro diagnostic use. The CLINITEK Novus® Calibration Kit is intended to be used with the CLINITEK Novus Urinalysis Cassette to calibrate the CLINITEK Novus Automated Urine Chemistry analyzer. This product is for professional in vitro diagnostic use.

Source page: https://510kreport.com/device/K140717
Methodology: https://510kreport.com/methodology