510(k) · Cleared
ClearedWondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
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 Aug 7, 2015 as substantially equivalent to K123436 (Church & Dwight Co., Inc., 2013) after a 213-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Aug 7, 2015
- Review
- 213 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992232 (1999). 5 ancestors in all. 6 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK992232 First Response 1-Step PregnancyArmkel, LLC · 1999
- 3 generations backK030258 First Response Pregnancy TestArmkel, LLC · 2003
- 2 generations backK083716 First Response Early Result Pregnancy Test (Otc)Church & Dwight Co., Inc. · 2009 · Recalled
- 1 generation backK123436 First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 2013 · Recalled
- This deviceK150022 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG…Guangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK251040 MissLan® Early Detection Digital Pregnancy Test; MissLan® Early…Guangzhou Decheng Biotechnology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251053 Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy…Assure Tech., LLC · 2025
- Descendant · cites it directly · 0 of its ownK240643 MissLan® Early Detection Pregnancy Test Strip; MissLan® Early…Guangzhou Decheng Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK234152 ACESO Early Pregnancy TestAceso Laboratories, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…Guangzhou Decheng Biotechnology Co., Ltd. · 2025 · cites it directly0descendants
- K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd. · 2025 · cites it directly0descendants
- K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…Assure Tech., LLC · 2025 · cites it directly0descendants
- K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…Guangzhou Decheng Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K234152ACESO Early Pregnancy TestAceso Laboratories, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992232 | First Response 1-Step Pregnancy | Armkel, LLC | 1999 | — |
| −3 | K030258 | First Response Pregnancy Test | Armkel, LLC | 2003 | — |
| −2 | K083716 | First Response Early Result Pregnancy Test (Otc) | Church & Dwight Co., Inc. | 2009 | 1 |
| −1 | K123436 | First Response Early Result Pregnancy Test | Church & Dwight Co., Inc. | 2013 | 2 |
| 0 (this device) | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine… | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +1 | K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | — |
| +1 | K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025 | — |
| +1 | K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test… | Assure Tech., LLC | 2025 | — |
| +1 | K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection… | Guangzhou Decheng Biotechnology Co., Ltd. | 2024 | — |
| +1 | K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K123436 | First Response Early Result Pregnancy TestSummary page 5…Test System 5. Predicate Device: Church & Dwight Co., Inc. FIRST RESPONSETM Early Result Pregnancy Test (K123436) 6. Intended Use Wondfo One Step HCG Urine Pregnancy Test Strip is a rapid chromatographic immunoassay for the qualitative detec… | 2013 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy… | 2025 | 0 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | 2025 | 0 |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette… | 2025 | 0 |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test… | 2024 | 0 |
| K234152 | ACESO Early Pregnancy Test | 2024 | 0 |
| K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | 2024 | 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 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K251040 (Guangzhou Decheng Biotechnology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K123436.
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. 2015, 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?
Wondfo One Step HCG Urine Pregnancy Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. Important note regarding negative results: Some pregnant women will not be able to detect hCG in their urine 5 days…
Read the full statement (545 words)
Wondfo One Step HCG Urine Pregnancy Test Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This product is intended for both prescription use and over-the-counter use.
Wondfo One Step HCG Urine Pregnancy Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This product is intended for both prescription use and over-the-counter use.
Wondfo One Step HCG Urine Pregnancy Test Midstream is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
Important note regarding negative results:
Some pregnant women will not be able to detect hCG in their urine 5 days before the expected period. If you test negative before your missed period, but think you may still be pregnant, you should test again a few days after your missed period.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.
All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This product is intended for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150022: Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy 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/K150022
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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