510(k) · Cleared
Recalled · Class III · 2016Vitros Immunodiagnostic Products Hbsag Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · MJX Kit, Serological, Positive Control
Cleared on Jan 17, 2003 as substantially equivalent to K011250 (Ortho-Clinical Diagnostics, Inc., 2001) after a 10-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 17, 2003
- Review
- 10 days
- Class
- Class I
- Product code
- MJX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011250 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011250 Vitros Immunodiagnostic Products Hbsag ControlsOrtho-Clinical Diagnostics, Inc. · 2001
- This deviceK030067 Vitros Immunodiagnostic Products Hbsag ControlsOrtho-Clinical Diagnostics · 2003
- Descendant · cites it directly · 0 of its ownK150815 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto…Becton, Dickinson and Company · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011250 | Vitros Immunodiagnostic Products Hbsag Controls | Ortho-Clinical Diagnostics, Inc. | 2001 | — |
| 0 (this device) | K030067 | Vitros Immunodiagnostic Products Hbsag Controls | Ortho-Clinical Diagnostics | 2003 | — |
| +1 | K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb… | Becton, Dickinson and Company | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 MJX? 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 |
|---|---|---|---|
| * | K011250 | Vitros Immunodiagnostic Products Hbsag Controls | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2016 | Class III | Z-0313-2017 | Under Investigation by firm | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K150815 (Becton, Dickinson and Company, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MJX devicesMJX Kit, Serological, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MJX
Too few MJX 510(k)s in any year since 2007 to give a median.
Recalls per year · MJX
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJX
No MAUDE report names MJX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030067: Vitros Immunodiagnostic Products Hbsag Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030067
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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