# K971976: Diascreen Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Dia-Screen Corp.
- Decided: Jun 17, 1997 after 19 days
- Product code: LJX (Test, Urine Leukocyte)
- Device class: 1
- Regulation: 21 CFR 864.7675
- Recalls of this device: none
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940043: Bioscan Reagent Strips, Bioscan Instruments, Inc. (1994) Summary page 2.
- K943008: Bioscan Reagent Strips, Genesis Labs, Inc. (1994) Summary page 2.
- K952971: Dia Screen Reagent Strips, Genesis Labs, Inc. (1995) Summary page 2.
- K961375: Dia Screen 10 Way Reagent Strips, Genesis Labs, Inc. (1996) Summary page 2.
- (no number) Bayer Multistix 10 SG: named in the summary without a submission number
- (no number) Behring Rapignost: named in the summary without a submission number
- (no number) Boehringer Mannheim Chemstrip urine test strip systems: named in the summary without a submission number

## Most influential descendants
- K083184: Tearlab Osmolarity System (2009), 1 descendant of its own
- K132066: Inflamma Dry (2013), 0 descendants of its own
- K030650: Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions (2003), 0 descendants of its own

## 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/K971976
Methodology: https://510kreport.com/methodology