510(k) · Cleared
ClearedHealgen URS Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · LJX Test, Urine Leukocyte
Cleared on Jun 16, 2023 as substantially equivalent to K100024 (Teco Diagnostics, 2011) after a 65-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 16, 2023
- Review
- 65 days
- Class
- Class I
- Product code
- LJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905396 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK905396 Hemastix Reagent StripsHeraeus Kulzer, Inc. · 1991
- 1 generation backK100024 Teco Diagnostics Uti Detection StripsTeco Diagnostics · 2011
- This deviceK231045 Healgen URS Test StripsHealgen Scientific,, LLC · 2023
- Descendant · cites it directly · 0 of its ownK251800 Healgen® URS Test StripsHealgen Scientific,, LLC · 2025
- Descendant · cites it directly · 0 of its ownK252607 AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242767 Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K251800Healgen® URS Test StripsHealgen Scientific,, LLC · 2025 · cites it directly0descendants
- K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd. · 2025 · cites it directly0descendants
- K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905396 | Hemastix Reagent Strips | Heraeus Kulzer, Inc. | 1991 | — |
| −1 | K100024 | Teco Diagnostics Uti Detection Strips | Teco Diagnostics | 2011 | — |
| 0 (this device) | K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023 | — |
| +1 | K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025 | — |
| +1 | K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +1 | K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K100024 | Teco Diagnostics Uti Detection StripsSummary page 4…idase Test System Hematology JMT 21 CFR § 862.1510, Nitrite Test System Chemistry 5. Predicate Devices: K100024 Teco Diagnostics UTI Test Strips 6. Intended Use: The Healgen URS Test Strips are for the qualita… | 2011 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251800 (Healgen Scientific,, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LJX devicesLJX Test, Urine Leukocyte: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Healgen URS Test Strips are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a 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/K231045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231045: Healgen URS Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231045
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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