510(k) · Cleared
ClearedPocketchem UA Aution Sticks 10TA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Sep 17, 2002 as substantially equivalent to K960546 (Bayer Corp., 1996) after a 57-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 17, 2002
- Review
- 57 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960546 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960546 Clinitek 50 Urine Chemistry AnalyzerBayer Corp. · 1996 · Recalled
- This deviceK022386 Pocketchem UA Aution Sticks 10TAArkray, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960546 | Clinitek 50 Urine Chemistry Analyzer | Bayer Corp. | 1996 | 2 |
| 0 (this device) | K022386 | Pocketchem UA Aution Sticks 10TA | Arkray, Inc. | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960546 | Clinitek 50 Urine Chemistry AnalyzerSummary page 1…et Beverly, MA 0 1915 Substantiah Equivalent Device: Product: Clinitek 50 / MULTISTIX lOSG Reagent Strips Manufactured by: Bayer Corp 510k Number: K960546 Product DescriDtion: Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K960546.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022386: Pocketchem UA Aution Sticks 10TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022386
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026