510(k) · Cleared
ClearedQuik-Check Home Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 7, 2001 after a 22-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Aug 7, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK012215 Quik-Check Home Pregnancy TestACON Laboratories, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK210341 One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
- Descendant · cites it directly · 0 of its ownK131236 Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette…Ucp Biosciences, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK032661 Acon Quick-Check II Home Pregnancy Test Device (Cassette)ACON Laboratories, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K210341One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022 · cites it directly0descendants
- K131236Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream…Ucp Biosciences, Inc. · 2013 · cites it directly0descendants
- K032661Acon Quick-Check II Home Pregnancy Test Device (Cassette)ACON Laboratories, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012215 | Quik-Check Home Pregnancy Test | ACON Laboratories, Inc. | 2001 | — |
| +1 | K210341 | One Step Pregnancy Test | Spd Swiss Precision Diagnostics GmbH | 2022 | — |
| +1 | K131236 | Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test… | Ucp Biosciences, Inc. | 2013 | — |
| +1 | K032661 | Acon Quick-Check II Home Pregnancy Test Device (Cassette) | ACON Laboratories, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K210341 (Spd Swiss Precision Diagnostics GmbH, 2022) has gone furthest, with 0 descendants of its own.
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?
Quik-Check™ Home Pregnancy is intended for non-professional/Over-The Counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
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/K012215 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012215: Quik-Check Home Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012215
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026