# K063276: Clinitek Advantus, Model 1420

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 28, 2006 after 59 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- 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 K926359 (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)
- K926359: Clinitek 200+ Urine Chemistry Analyzer, Heraeus Kulzer, Inc. (1993) Summary page 1.
- (no number) Clinitek 500: named in the summary without a submission number

## Indications for use
The CLINITEK AdvantusTM Urinalysis analyzer is a semi-automated, benchtop analyzer. It is designed to read Bayer® Reagent Strips for Urinalysis, such as, MULTISTIX® 10 SG and MULTISTIX PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Specific Gravity, and Urobilinogen. These measurements are used to assist diagnosis in the following areas: * Kidney Function * Urinary tract infections * Metabolic disorders (e.g. diabetes mellitus) * Liver Function Tests performed using the CLINITEK AdvantusTM are intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K063276
Methodology: https://510kreport.com/methodology