# K961375: Dia Screen 10 Way Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Labs, Inc.
- Decided: Jun 18, 1996 after 70 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940043 (1994). 2 ancestors in all.
5 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.
- K952971: Dia Screen Reagent Strips, Genesis Labs, Inc. (1995) Summary page 2.
- (no number) Ames 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 system: named in the summary without a submission number

## Most influential descendants
- K971976: Diascreen Reagent Strips (1997), 3 descendants of its own
- 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
- K981555: Diascreen Reagent Strips (1998), 0 descendants of its own

## Indications for use
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiquantitatively for patient urine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen by visual comparison with a color chart.

Source page: https://510kreport.com/device/K961375
Methodology: https://510kreport.com/methodology