# K033851: Diascreen Reagent Strips for Urinalysis, Models D122OO (2GK), D12100 (1K), D11100 (1G)

- Pathway: 510(k) (Traditional)
- Applicant: Hypoguard USA, Inc.
- Decided: Mar 2, 2004 after 82 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) DiaScreen® Reagent Strips for Urinalysis: named in the summary without a submission number

## Indications for use
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucosuria (glucose in urine). These measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the diagnosis and treatment of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes. Testing can be done by dipping the Reagent Strips into a specimen container or holding them directly in the urine stream. The glucose and ketone strips are intended for both professional and over-the-counter use.

Source page: https://510kreport.com/device/K033851
Methodology: https://510kreport.com/methodology