510(k) · Cleared
ClearedSEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Sejoy Electronics & Instruments Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Feb 18, 2022 as substantially equivalent to K193132 (Hangzhou Clongene Biotech Co., Ltd., 2019) after a 197-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Feb 18, 2022
- Review
- 197 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993317 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK993317 Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. · 1999 · Recalled
- 2 generations backK123050 Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette…Nantong Biotechnology Co., Ltd. · 2013
- 1 generation backK193132 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy…Hangzhou Clongene Biotech Co., Ltd. · 2019
- This deviceK212447 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step…Hangzhou Sejoy Electronics & Instruments Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993317 | Acon HCG One Step Pregnancy Test Device (Urine) | ACON Laboratories, Inc. | 1999 | 2 |
| −2 | K123050 | Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I… | Nantong Biotechnology Co., Ltd. | 2013 | — |
| −1 | K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test… | Hangzhou Clongene Biotech Co., Ltd. | 2019 | — |
| 0 (this device) | K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test… | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Summary page 4…Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream 510(k) Number K193132 Product Code LCX Manufacturer Hangzhou Clongene Biotech Co.,Ltd. 4. Device Description Sejoy HCG One… | 2019 |
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 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2022, 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 SEJOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212447: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212447
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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