510(k) · Cleared
ClearedVitros Immunodiagnostic Products Anti-HBS Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 27, 2004 as substantially equivalent to K003112 (Ortho-Clinical Diagnostics, Inc., 2000) after a 33-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Sep 27, 2004
- Review
- 33 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003112 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003112 Vitros Immunodiagnostic Products Anti-HBS ControlsOrtho-Clinical Diagnostics, Inc. · 2000
- This deviceK042303 Vitros Immunodiagnostic Products Anti-HBS ControlsOrtho-Clinical Diagnostics · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003112 | Vitros Immunodiagnostic Products Anti-HBS Controls | Ortho-Clinical Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K042303 | Vitros Immunodiagnostic Products Anti-HBS Controls | Ortho-Clinical Diagnostics | 2004 | — |
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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K003112 | Vitros Immunodiagnostic Products Anti-HBS ControlsSummary page 1…Anti-HBs Controls are substantially equivalent to the current VITROS Immunodiagnostic Products Anti-HBs Controls (K003112). Ortho-Clinical Diagnostics, Inc. VITROS Anti-HBs Controls Page 4 of 53 === Page 2 =… | 2000 |
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.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042303: Vitros Immunodiagnostic Products Anti-HBS Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042303
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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