510(k) · Cleared
ClearedCombi-Screen, Models 10SL and 11SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analyticon Biotechnologies AG · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Oct 21, 2003 as substantially equivalent to K991927 (Macherey-Nagel-Duren, 1999) after a 334-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 21, 2003
- Review
- 334 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991927 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991927 Medi-Test Combi 11Macherey-Nagel-Duren · 1999 · Recalled
- This deviceK023885 Combi-Screen, Models 10SL and 11SLAnalyticon Biotechnologies AG · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991927 | Medi-Test Combi 11 | Macherey-Nagel-Duren | 1999 | 1 |
| 0 (this device) | K023885 | Combi-Screen, Models 10SL and 11SL | Analyticon Biotechnologies AG | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991927 | Medi-Test Combi 11Summary page 1…, JMT, J R , CDM, CEN Regulatory Class: 11 Product Code: JIN Common/Usual Name: Urine Test Strips 2. Equivalent legally marketed device: Medi-Test Combi 11, K991927, Macherey- Nagel-Duren 3. Indications for Use (intended use) . Model IOSL: For rapid determination of Bilirubin, Uro… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023885: Combi-Screen, Models 10SL and 11SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023885
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026