510(k) · Cleared
ClearedCLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Clongene Biotech Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Dec 11, 2019 as substantially equivalent to K123050 (Nantong Biotechnology Co., Ltd., 2013) after a 29-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Dec 11, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993317 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993317 Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. · 1999 · Recalled
- 1 generation backK123050 Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette…Nantong Biotechnology Co., Ltd. · 2013
- This deviceK193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy…Hangzhou Clongene Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK212447 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993317 | Acon HCG One Step Pregnancy Test Device (Urine) | ACON Laboratories, Inc. | 1999 | 2 |
| −1 | K123050 | Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I… | Nantong Biotechnology Co., Ltd. | 2013 | — |
| 0 (this device) | K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test… | Hangzhou Clongene Biotech Co., Ltd. | 2019 | — |
| +1 | K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test… | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K123050 | Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and…Summary page 4…Clinical (hCG) Test System Chemistry (75) 5. Predicate Devices: EGENS One Step HCG Urine Pregnancy Test (K123050) 6. Intended Use CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of huma… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette… | 2022 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K212447 (Hangzhou Sejoy Electronics & Instruments Co., Ltd., 2022) has gone furthest, with 0 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. 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 CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193132: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid 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/K193132
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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