510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Aug 30, 2001 as substantially equivalent to K984303 (Ortho-Clinical Diagnostics, Inc., 1999) after a 20-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 2001
- Review
- 20 days
- Class
- Class I
- Product code
- LBR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984303 (1999). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK984303 Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc. · 1999
- This deviceK012593 Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros…Ortho-Clinical Diagnostics, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- Descendant · 5 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc. · 2007 · cites it directly4descendants
- K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · 2 generations on3descendants
- K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2008 · 3 generations on2descendants
- K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 4 generations on1descendant
- K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984303 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| 0 (this device) | K012593 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2001 | — |
| +1 | K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| +2 | K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| +3 | K081411 | Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2008 | 4 |
| +4 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| +5 | K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 LBR? 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? (2)
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 |
|---|---|---|---|
| * | K984303 | Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentSummary page 2…ntially equivalent to VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides for use with human serum and plasma which was cleared by the FDA (K984303 January 28, 1999) for in vitro diagnostic use. Table 1 lists the characteristics of the tests performed using the VITROS Magnet… | 1999 |
| * | — | VITROS Chemistry Products Calibrator Kit 2 Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659 | 2007 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0304-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K071801 (Ortho-Clinical Diagnostics, Inc., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only.
The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma.
For in vitro diagnostic use only.
VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.
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/K012593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012593: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012593
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026