510(k) · Cleared
ClearedQuickvue One-Step HCG-Combo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on May 17, 2002 after a 66-day review. The FDA summary names no predicate by number. 13 later devices descend from it.
- Decided
- May 17, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK020801 Quickvue One-Step HCG-ComboQuidel Corp. · 2002
- Descendant · cites it directly · 7 of its ownK032563 Clinitest HCG Pregnancy TestBayer Healthcare, LLC · 2003 · Recalled
- Descendant · 2 generations on · 6 of its ownK091216 Clinitek Status+Analyzer and Clinitek Status Connect System, Models…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · cites it directly · 3 of its ownK132834 Fastep S10 HCG Serum/Urine Combo TestPolymed Therapeutics, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK203272 Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK141874 Uriscan OptimaYd Diagnostics Corp. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K032563Clinitest HCG Pregnancy TestBayer Healthcare, LLC · 2003 · cites it directly7descendants
- K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics · 2009 · 2 generations on6descendants
- K132834Fastep S10 HCG Serum/Urine Combo TestPolymed Therapeutics, Inc. · 2014 · cites it directly3descendants
- K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd. · 2022 · 2 generations on2descendants
- K141874Uriscan OptimaYd Diagnostics Corp. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020801 | Quickvue One-Step HCG-Combo | Quidel Corp. | 2002 | — |
| +1 | K032563 | Clinitest HCG Pregnancy Test | Bayer Healthcare, LLC | 2003 | 2 |
| +2 | K091216 | Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 | Siemens Healthcare Diagnostics | 2009 | 4 |
| +1 | K132834 | Fastep S10 HCG Serum/Urine Combo Test | Polymed Therapeutics, Inc. | 2014 | — |
| +2 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022 | — |
| +3 | K141874 | Uriscan Optima | Yd Diagnostics Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 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? (13)
See all 133 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, K032563 (Bayer Healthcare, LLC, 2003) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy. The test is intended for use by health care professionals.
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/K020801 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020801: Quickvue One-Step HCG-Combo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020801
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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