510(k) · Cleared
ClearedQuickstick One Step HCG Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamatech · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 1, 1997 after a 15-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 1, 1997
- Review
- 15 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (3)
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 |
|---|---|---|---|
| * | — | Unipath Clearview HCG Named without a submission number | |
| * | — | Abbott Laboratories’ Fact Plus Named without a submission number | |
| * | — | Syntron Bioresearch Be Sure Pregnancy Test Named without a submission number |
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.
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?
Over-the-Counter HCG (pregnancy) tests are for utlmgg“ipdividuals who, for any reason, beliave they may be pregnant. This tesLdetects‘hCG inurine. HCG is a hormone produced by the placenta shortly after implantation. Since HCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to…
Read the full statement (123 words)
Over-the-Counter HCG (pregnancy) tests are for utlmgg“ipdividuals who, for any reason, beliave they may be pregnant. This tesLdetects‘hCG inurine. HCG is a hormone produced by the placenta shortly after implantation. Since HCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointmeant scheduling difficuities. This device offers an altemative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confimation tests by trained clinicat technicians.
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/K972682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972682: Quickstick 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/K972682
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026