# K022386: Pocketchem UA Aution Sticks 10TA

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Sep 17, 2002 after 57 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 K960546 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960546: Clinitek 50 Urine Chemistry Analyzer, Bayer Corp. (1996) Summary page 1.

## Indications for use
The PocketChemTMUA is a urine chemistry analyzer and is intended for use with the AUTION Sticks lOTA for the determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine. The tests provided by the use of the PocketChemTWJA and the AUTION Sticks 1OTA are considered routine urinalysis at the following levels of detection: For professional use only.

Source page: https://510kreport.com/device/K022386
Methodology: https://510kreport.com/methodology