510(k) · Cleared
ClearedContrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Diagnostics · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Nov 25, 1996 as substantially equivalent to K952319 (Medix Biotech, Inc., 1995) after a 40-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 25, 1996
- Review
- 40 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952319 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952319 Contrast & Rapid HCG Urine/Serum TSTMedix Biotech, Inc. · 1995
- This deviceK964155 Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum TestGenzyme Diagnostics · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952319 | Contrast & Rapid HCG Urine/Serum TST | Medix Biotech, Inc. | 1995 | — |
| 0 (this device) | K964155 | Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test | Genzyme Diagnostics | 1996 | — |
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? (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 |
|---|---|---|---|
| * | K952319 | Contrast & Rapid HCG Urine/Serum TSTSummary page 1…San Carlos, CA 94070 Delia R. Bethell, Ph.D. Director of Research and Development Phone: (415) 594-0513 Fax: (415) 594-0571 Rapid hCG™ Urine/Serum Test 510(k) Number: K952319 Cleared June 20, 1995 Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K952319.
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 qualitative detection of human chorionic gonadotropin (hCQG) in urine or serum for the early determination of pregnancy for use in the physician’s office and clinical laboratories.
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/K964155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964155: Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964155
Report an extraction error
Are you the manufacturer?
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