# K061559: Acon Urinalysis Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Acon Laboratories Co.
- Decided: Aug 11, 2006 after 67 days
- Product code: CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1785
- 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: 1 generation back to K861255 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905396: Hemastix Reagent Strips, Heraeus Kulzer, Inc. (1991) Summary page 2.
- K861255: Behring Rapignost Total Screen L Urine Test Strips, Behring Diagnostics, Inc. (1986) Summary page 2.

## Recalls of this device
- Jun 22, 2018 · Class III · Z-2786-2018: Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.

## Indications for use
The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid. The ACON Urinalysis Reagent Strips (Urine) 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 track 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. It is intended for professional use only.

Source page: https://510kreport.com/device/K061559
Methodology: https://510kreport.com/methodology