# K023885: Combi-Screen, Models 10SL and 11SL

- Pathway: 510(k) (Traditional)
- Applicant: Analyticon Biotechnologies AG
- Decided: Oct 21, 2003 after 334 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 K991927 (1999). 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)
- K991927: Medi-Test Combi 11, Macherey-Nagel-Duren (1999) Summary page 1.

## Indications for use
Combi-Screen Urine Test Strips Model 1OSL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine

Source page: https://510kreport.com/device/K023885
Methodology: https://510kreport.com/methodology