# K052525: Cybow 11 Series Reagent Strips for Urinalysis

- Pathway: 510(k) (Traditional)
- Applicant: DFI Co., Ltd.
- Decided: Mar 29, 2006 after 196 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Reagent Strips for Urinalysis (qualitative and semi-quantitative) of Urobilinogen, Glucose, Bilirubin, Ketone (acetoacetic acid), Specific Gravity, Blood, pH, Protein, Nitrite, Leukocytes, and Ascorbic Acid in human urine. CYBOW 11 Reagent Strips are for single use in professional near-patient (point- of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: • Kidney function * Urinary tract infections : Carbohydrate metabolism (e.g. diabetes mellitus) * Liver function * Acid-base balance : Urine concentration The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually.

Source page: https://510kreport.com/device/K052525
Methodology: https://510kreport.com/methodology