# K991927: Medi-Test Combi 11

- Pathway: 510(k) (Traditional)
- Applicant: Macherey-Nagel-Duren
- Decided: Sep 17, 1999 after 101 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bayer Multistix 10SG: named in the summary without a submission number
- (no number) Dia Strip System, Calif. Immuno Diagnostics: named in the summary without a submission number

## Most influential descendants
- K023885: Combi-Screen, Models 10SL and 11SL (2003), 0 descendants of its own

## Recalls of this device
- Apr 4, 2024 · Class II · Z-1834-2024: 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) cust

## Indications for use
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.

Source page: https://510kreport.com/device/K991927
Methodology: https://510kreport.com/methodology