510(k) · Cleared
ClearedVITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · DHA System, Test, Human Chorionic Gonadotropin
Cleared on May 8, 2024 as substantially equivalent to K063720 (Ortho-Clinical Diagnostics, 2007) after a 183-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- May 8, 2024
- Review
- 183 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970894 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK970894 Vitros Immunodiagnostics Products Total B-HCG Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
- 1 generation backK063720 Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack…Ortho-Clinical Diagnostics · 2007 · Recalled
- This deviceK233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 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 K230937 Alinity i Total ß-hCG Reagent Kit, GLP systems…score 7.3 · 7 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 |
|---|---|---|---|
| * | K063720 | Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersSummary page 4…Predicate Device FDA 510(k) Number VITROS Immunodiagnostic Products Total β-hCG II K063720 Reagent Pack Device Description The VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack (t… | 2007 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2024, this device’s year, is highlighted.
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 | — |
What is it indicated for?
For in vitro diagnostic use only.
For the quantitative measurement of human chorionic gonadotropin (hCG) and its β-subunit in human serum and plasma (heparin and EDTA) using the VITROS 5600 Integrated System to aid in the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233581
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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