# K061846: Combi SCAN100

- Pathway: 510(k) (Traditional)
- Applicant: Analyticon Biotechnologies AG
- Decided: Apr 6, 2007 after 284 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 K960546 (1996). 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)
- K960546: Clinitek 50 Urine Chemistry Analyzer, Bayer Corp. (1996) Summary page 1.

## Indications for use
The Combi Scan 100 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!

Source page: https://510kreport.com/device/K061846
Methodology: https://510kreport.com/methodology