510(k) · Cleared
ClearedHCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Deepblue Medical Technology Co., Ltd. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Oct 11, 2024 as substantially equivalent to K200133 (Safecare Biotech (Hangzhou) Co., Ltd., 2020) after a 255-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Oct 11, 2024
- Review
- 255 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K941090 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 4 generations backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- 3 generations backK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- 2 generations backK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- 1 generation backK200133 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test…Safecare Biotech (Hangzhou) Co., Ltd. · 2020
- This deviceK240242 HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use…Anhui Deepblue Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −4 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| −3 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| −2 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| −1 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech (Hangzhou) Co., Ltd. | 2020 | — |
| 0 (this device) | K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy… | Anhui Deepblue Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamSummary page 6…e/Device Name: hCG Urine Test Strip hCG Urine Test Cassette hCG Urine Test Midstream 510(k) number: K200133 E. Device Description The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal G… | 2020 |
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 30 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
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. 2024, 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 HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when…
Read the full statement (249 words)
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
This device is intended for home use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240242: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240242
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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