510(k) · Cleared
ClearedAcon Uti Urinary Tract Infection Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · LJX Test, Urine Leukocyte
Cleared on Oct 12, 2007 as substantially equivalent to K905396 (Heraeus Kulzer, Inc., 1991) after a 345-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Oct 12, 2007
- Review
- 345 days
- Class
- Class I
- Product code
- LJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905396 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- This deviceK063295 Acon Uti Urinary Tract Infection Test StripsACON Laboratories, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| 0 (this device) | K063295 | Acon Uti Urinary Tract Infection Test Strips | ACON Laboratories, Inc. | 2007 | — |
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 LJX? 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 LJX device
- #1 K231045 Healgen URS Test Stripsscore 14.8 · 2 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 |
|---|---|---|---|
| * | K905396 | Hemastix Reagent StripsSummary page 2…Nitrite (urinary, non-quant.) test system Medical Specialty: Clinical Chemistry Predicate Device: Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA. Device Description: The ACON… | 1991 |
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 no recall.
- 3 other devices also cite its predicate K905396.
How does its category compare?
All LJX devicesLJX Test, Urine Leukocyte: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LJX
Too few LJX 510(k)s in any year since 2007 to give a median.
Recalls per year · LJX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJX
7in 2025
MAUDE reports naming product code LJX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ACON UTI Urinary Tract Infection Test Strips are for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063295 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063295: Acon Uti Urinary Tract Infection Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063295
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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