510(k) · Cleared
ClearedOne Step HCG Urine Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Wondfo Biotech Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Apr 8, 2005 as substantially equivalent to K033658 (Unipath, Ltd., 2004) and 3 other predicates after a 115-day review. Its family tree reaches back 3 generations to 1994. 14 later devices descend from it.
- Decided
- Apr 8, 2005
- Review
- 115 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K941090 (1994). 7 ancestors in all. 14 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 2 generations backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- 1 generation backK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- This deviceK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK173229 Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK222305 MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK192123 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test…Qingdao Hightop Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK150063 One Step hCG Pregnancy TestCoretests, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2018 · cites it directly2descendants
- K222305MissLan™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., Ltd. · 2022 · 2 generations on1descendant
- K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd. · 2020 · cites it directly1descendant
- K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP…Qingdao Hightop Biotech Co., Ltd. · 2019 · cites it directly1descendant
- K150063One Step hCG Pregnancy TestCoretests, Inc. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −2 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| −1 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| 0 (this device) | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| +1 | K173229 | Preview Digital Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | — |
| +2 | K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co., Ltd. | 2022 | — |
| +1 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | 2020 | — |
| +1 | K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip… | Qingdao Hightop Biotech Co., Ltd. | 2019 | — |
| +1 | K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K033658 | E.P.T. Pregnancy TestSummary page 2…indications for use, device design, predicate device described herein with respect materials, and method of manufacture: Unipath, Ltd, E.P.T. Pregnancy Test - K033658 Test Device - K032992 Biotech Atlantic, Inc., Unimark Home Pre… | 2004 |
| * | K032992 | Unimark Home Pregnancy Test DeviceSummary page 2…ect materials, and method of manufacture: Unipath, Ltd, E.P.T. Pregnancy Test - K033658 Test Device - K032992 Biotech Atlantic, Inc., Unimark Home Pregnancy 1I Home Pregnancy… | 2003 |
| * | K033041 | Acon Quik-Check II Home Pregnancy Test StripSummary page 2…, Unimark Home Pregnancy 1I Home Pregnancy Test Strip - Acon Laboratories, Inc, Acon Quick-Check K033041 - K031798 Standard Diagnostics, Inc., Good Morning Test… | 2003 |
| * | K031798 | Good Morning TestSummary page 2…1I Home Pregnancy Test Strip - Acon Laboratories, Inc, Acon Quick-Check K033041 - K031798 Standard Diagnostics, Inc., Good Morning Test and marketed Class 11… | 2003 |
What descends from it? (14)
See all 149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173229 | Preview Digital Pregnancy Test | 2018 | 2 |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | 2020 | 1 |
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP… | 2019 | 1 |
| K150063 | One Step hCG Pregnancy Test | 2015 | 1 |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One… | 2024 | 0 |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | 2023 | 0 |
| K192843 | INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette… | 2019 | 0 |
| K172627 | David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette | 2018 | 0 |
| K081150 | Rapidan Optima Early Pregnancy Test and Toyo Pregnancy Test | 2009 | 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 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K173229 (Guangzhou Wondfo Biotech Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K033658.
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.
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 Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043443: One Step HCG Urine Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043443
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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