# K981555: Diascreen Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Chronimed, Inc.
- Decided: Jun 1, 1998 after 31 days
- Product code: LJX (Test, Urine Leukocyte)
- Device class: 1
- Regulation: 21 CFR 864.7675
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940043 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943008: Bioscan Reagent Strips, Genesis Labs, Inc. (1994) Summary page 2.
- K961375: Dia Screen 10 Way Reagent Strips, Genesis Labs, Inc. (1996) Summary page 2.
- (no number) Bayer Multistix 10 SG Reagent Strips for Urinalysis: named in the summary without a submission number

## Recalls of this device
- Mar 24, 2010 · Not classified · Z-2634-2010: This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four

## Indications for use
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format. The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.

Source page: https://510kreport.com/device/K981555
Methodology: https://510kreport.com/methodology