510(k) · Cleared
Recalled · Class II · 2024Medi-Test Combi 11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Macherey-Nagel-Duren · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Sep 17, 1999 after a 101-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 17, 1999
- Review
- 101 days
- Class
- Class II
- Product code
- JIL
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991927 Medi-Test Combi 11Macherey-Nagel-Duren · 1999
- Descendant · cites it directly · 0 of its ownK023885 Combi-Screen, Models 10SL and 11SLAnalyticon Biotechnologies AG · 2003
Most influential descendants
Showing 1 of 1 · See all- K023885Combi-Screen, Models 10SL and 11SLAnalyticon Biotechnologies AG · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991927 | Medi-Test Combi 11 | Macherey-Nagel-Duren | 1999 | — |
| +1 | K023885 | Combi-Screen, Models 10SL and 11SL | Analyticon Biotechnologies AG | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | — | Bayer Multistix 10SG Named without a submission number | |
| * | — | Dia Strip System, Calif. Immuno Diagnostics Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023885 | Combi-Screen, Models 10SL and 11SL | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2024 | Class II | Z-1834-2024 | Under Investigation by firm | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023885 (Analyticon Biotechnologies AG, 2003) has gone furthest, with 0 descendants of its own.
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?
The Medi-Test Combi 11 Reagent Strip for Urinalysis is a dip-and-read test strip. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases, blllary and fiepatlc obstructions and diseases of the kidneys and urinary tract.
The strip provides qualitative and semi-quantitative tests for specific gravity, Ieucoéytéé, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen by visual comparison with a color chart for each concentration range.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991927 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991927: Medi-Test Combi 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991927
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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