510(k) · Cleared
ClearedKangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weihai Kangzhou Biotechnology Engineering Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Jan 10, 2019 as substantially equivalent to K132085 (Co-Innovation Biotech Co., Ltd., 2013) after a 64-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jan 10, 2019
- Review
- 64 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071930 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK071930 One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG…Blue Cross Bio-Medical Co., Ltd. · 2007
- 1 generation backK132085 One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG…Co-Innovation Biotech Co., Ltd. · 2013
- This deviceK183097 Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test…Weihai Kangzhou Biotechnology Engineering Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K183097 | Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette… | Weihai Kangzhou Biotechnology Engineering Co., Ltd. | 2019 | — |
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 |
|---|---|---|---|
| * | K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test MidstreamSummary page 4…cal Chemistry Regulation Number 862.1155 Product Code LCX Classification Class II C. Predicate device 510 (K) Number: K132085 Co-Innovation One Step hCG Test Strip Co-Innovation One Step hCG Test Cassette Co-Innovation One Step hCG Test Midstream Produced… | 2013 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K132085.
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. 2019, 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 Kangzhou 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 for over-the-counter (OTC) use. The Kangzhou One Step hCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic…
Read the full statement (129 words)
The Kangzhou 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 for over-the-counter (OTC) use.
The Kangzhou 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 Kangzhou One Step hCG Test Midstream 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183097: Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183097
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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