510(k) · Cleared
ClearedChemtrue (R) HCG Pregnancy Urine Midstream Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Jul 26, 2013 as substantially equivalent to K990578 (Wyntek Diagnostics, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jul 26, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990578 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990578 Osom Card II HCG-Urine Test, Model 102Wyntek Diagnostics, Inc. · 1999
- This deviceK131931 Chemtrue (R) HCG Pregnancy Urine Midstream TestChemtron Biotech, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990578 | Osom Card II HCG-Urine Test, Model 102 | Wyntek Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K131931 | Chemtrue (R) HCG Pregnancy Urine Midstream Test | Chemtron Biotech, Inc. | 2013 | — |
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 LCX? 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 LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K990578 | Osom Card II HCG-Urine Test, Model 102Summary page 1…redicate Device Name 510(k) k number OSOMO Card 11 hCG-Urine Test K990578 D. Indications for Use: The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay fo… | 1999 |
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.
- 1 other device also cites its predicate K990578.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, 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 | 4 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chemtrueo IICG Pregnancy Urine Midstream Urine Test isa rapid lateral
flow qualitative immunoassay for early detection of human chorionic
gonadotropin (bCG) in human urine in midstream format. The test is designed to
aid early detection of pregnancy by home users. The device is intended for Over-
The-Counter (OTC) Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131931: Chemtrue (R) HCG Pregnancy Urine Midstream Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131931
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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