510(k) · Cleared
ClearedScripps Laboratories HCG One-Step
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scripps Laboratories, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Aug 23, 1996 as substantially equivalent to K925435 (Quidel Corp., 1992) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 23, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925435 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK925435 Quickvue One-Step HCG TestQuidel Corp. · 1992
- This deviceK962906 Scripps Laboratories HCG One-StepScripps Laboratories, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925435 | Quickvue One-Step HCG Test | Quidel Corp. | 1992 | — |
| 0 (this device) | K962906 | Scripps Laboratories HCG One-Step | Scripps Laboratories, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K925435 | Quickvue One-Step HCG TestSummary page 2…uman Chorionic Gonadotropin (hCG) Test System. C. Legally Marketed Devices to Which Substantial Equivalence is Claimed 1. Quidel® QuickVue® One-Step hCG Urine Test (ref. K925435) 2. Wyntek Diagnostics OSOM™ hCG-Urine Test (ref. K953383) 6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: 619-546… | 1992 |
| * | K953383 | Wyntek Osom HCG-Urine TestSummary page 2…arketed Devices to Which Substantial Equivalence is Claimed 1. Quidel® QuickVue® One-Step hCG Urine Test (ref. K925435) 2. Wyntek Diagnostics OSOM™ hCG-Urine Test (ref. K953383) 6838 Flanders Drive, San Diego, CA 92121-2904 USA Telephone: 619-546-5800 FAX: 619-546-5812 Primary Manufucturer of Diagnostic… | 1995 |
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?
- None of the 2 ancestors has a recall.
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?
Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use.
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/K962906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962906: Scripps Laboratories HCG One-Step.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962906
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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