510(k) · Cleared
ClearedOne Step hCG Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coretests, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Oct 2, 2015 as substantially equivalent to K043443 (Guangzhou Wondfo Biotech Co., Ltd., 2005) after a 262-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Oct 2, 2015
- Review
- 262 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K941090 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK941090 Unistep HCG Pregnancy Test StripBiotech Atlantic, Inc. · 1994
- 3 generations backK960174 Unimark Midstream Pregnancy Test StickBiotech Atlantic, Inc. · 1996
- 2 generations backK032992 Unimark Home Pregnancy Test DeviceBiotech Atlantic, Inc. · 2003
- 1 generation backK043443 One Step HCG Urine Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. · 2005
- This deviceK150063 One Step hCG Pregnancy TestCoretests, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK230741 Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230741Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941090 | Unistep HCG Pregnancy Test Strip | Biotech Atlantic, Inc. | 1994 | — |
| −3 | K960174 | Unimark Midstream Pregnancy Test Stick | Biotech Atlantic, Inc. | 1996 | — |
| −2 | K032992 | Unimark Home Pregnancy Test Device | Biotech Atlantic, Inc. | 2003 | — |
| −1 | K043443 | One Step HCG Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | 2005 | — |
| 0 (this device) | K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | 2015 | — |
| +1 | K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K043443 | One Step HCG Urine Pregnancy TestSummary page 4…n: Class II Regulation Number: 21 CFR 862.1155 Human chorionic gonadotropin test system Product code: LCX Panel: Clinical Chemistry (75) C. Predicate device K043443 Wondfo One Step HCG Urine Pregnancy Test D. Device description ACCU NEWSTM One Step hCG Pregnancy Test is a qualitative later… | 2005 |
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 |
|---|---|---|---|
| K230741 | Macro & Micro-Test HCG Pregnancy Test Midstream | 2023 | 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 21 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K230741 (Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K043443.
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?
ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human…
Read the full statement (141 words)
ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
ACCU NEWS One Step Pregnancy Test Midstream: The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150063: One Step hCG 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/K150063
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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