510(k) · Cleared
Recalled · Class II · 2023Healgen HCG One Step Pregnancy Test (Strip), Healgen HCG One Step Pregnancy Test (Cassette)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Apr 10, 2013 after a 128-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.
- Decided
- Apr 10, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- LCX
- Recalls
- 3
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2023 | Class II | Z-0264-2024 | Storage | Products were stored outside of labeled temperature requirements. |
| Jun 23, 2022 | Class II | Z-1528-2022 | Storage | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| Jun 23, 2022 | Class II | Z-1527-2022 | Storage | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
No ancestor or descendant has a Class I recall.
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 Healgen hCG One Step Pregnancy Test Strip is an in vitro diagnostic visual
qualitative immunochromatographic assay designed for the rapid determination of human
chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine
sample collected with cup only. For Over-The-Counter self-testing use.
The Healgen hCG One Step Pregnancy Test Cassette is an in vitro diagnostic visual
qualitative immunochromatographic assay designed for the rapid determination of human
chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine
sample collected with cup only. For Over-The-Counter self-testing use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123703: Healgen HCG One Step Pregnancy Test (Strip), Healgen HCG One Step Pregnancy Test (Cassette).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123703
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026