510(k) · Cleared
ClearedVitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Apr 14, 1997 after a 34-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Apr 14, 1997
- Review
- 34 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK970894 Vitros Immunodiagnostics Products Total B-HCG Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK063720 Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack…Ortho-Clinical Diagnostics · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970894 | Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| +1 | K063720 | Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators… | Ortho-Clinical Diagnostics | 2007 | 1 |
| +2 | K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063720 | Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers | 2007 | 1 |
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, K063720 (Ortho-Clinical Diagnostics, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970894
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026