510(k) · Cleared
ClearedOne Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Innovation Biotech Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Nov 12, 2013 as substantially equivalent to K071930 (Blue Cross Bio-Medical Co., Ltd., 2007) after a 130-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Nov 12, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071930 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK071930 One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG…Blue Cross Bio-Medical Co., Ltd. · 2007
- This deviceK132085 One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG…Co-Innovation Biotech Co., Ltd. · 2013
- Descendant · cites it directly · 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 ownK183097 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test…Weihai Kangzhou Biotechnology Engineering Co., Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See all- K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…Co-Innovation Biotech Co., Ltd. · 2022 · 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine… | Blue Cross Bio-Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream | Co-Innovation Biotech Co., Ltd. | 2013 | — |
| +1 | K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip… | Co-Innovation Biotech Co., Ltd. | 2022 | — |
| +1 | K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette… | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 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 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 |
|---|---|---|---|
| * | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy…Summary page 2…nic Gonadotropin (HCG) Test and the predicate devices is provided in the following Table: ItmDevice -- Predicate (K071930) Qualitative detection of human Indication for use chorionic gonadotropin ("HCG") i… | 2007 |
What descends from it? (2)
2 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?
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 Co-Innovation One Step HCG 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. It is intended far over-the-counter (OTC) use. The Co-Innovation One Step HCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human…
Read the full statement (130 words)
The Co-Innovation One Step HCG 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. It is intended far
over-the-counter (OTC) use.
The Co-Innovation One Step HCG 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. It is intended for
over-the-counter (OTC) use.
The Co-Innovation One Step HCG Test Midstream is an in vitro diagnostic visual qualitative
immunochromatographic assay designed for the mapid determination of human chorionic
gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for
over-the-counter (OTC) use .
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132085: One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132085
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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