510(k) · Cleared
ClearedOne Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Cross Bio-Medical Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Dec 18, 2007 after a 158-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 158 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK071930 One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG…Blue Cross Bio-Medical Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK132085 One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG…Co-Innovation Biotech Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK213808 Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test…Co-Innovation Biotech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK203246 Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG…Atlas Link Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK183097 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test…Weihai Kangzhou Biotechnology Engineering Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK103487 Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy TestTaidoc Technology Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K132085One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test MidstreamCo-Innovation Biotech Co., Ltd. · 2013 · cites it directly2descendants
- K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…Co-Innovation Biotech Co., Ltd. · 2022 · 2 generations on0descendants
- K203246Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test…Atlas Link Technology Co., Ltd. · 2021 · cites it directly0descendants
- K183097Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step…Weihai Kangzhou Biotechnology Engineering Co., Ltd. · 2019 · 2 generations on0descendants
- K103487Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy TestTaidoc Technology Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine… | Blue Cross Bio-Medical Co., Ltd. | 2007 | — |
| +1 | K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream | Co-Innovation Biotech Co., Ltd. | 2013 | — |
| +2 | K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip… | Co-Innovation Biotech Co., Ltd. | 2022 | — |
| +1 | K203246 | Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine… | Atlas Link Technology Co., Ltd. | 2021 | — |
| +2 | K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette… | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019 | — |
| +1 | K103487 | Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test | Taidoc Technology Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K132085 (Co-Innovation Biotech Co., Ltd., 2013) has gone furthest, with 2 descendants of its own.
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. 2007, 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 | — |
https://510kreport.com/device/K071930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071930: One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy Test (Cassette) , Model B01C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071930
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026