510(k) · Cleared
Recalled · Class II · 2013Vitros Chemistry Products DHDL Slides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Cleared on Sep 7, 2012 as substantially equivalent to K042006 (Ortho-Clinical Diagnostics, Inc., 2004) after a 191-day review. Its family tree reaches back 3 generations to 1999. It has been recalled once.
- Decided
- Sep 7, 2012
- Review
- 191 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983849 (1999). 4 ancestors in all, the oldest K904768 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- 2 generations backK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- 1 generation backK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- This deviceK120609 Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| −2 | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| −1 | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| 0 (this device) | K120609 | Vitros Chemistry Products DHDL Slides | Ortho-Clinical Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 LBS? 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 |
|---|---|---|---|
| * | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Summary page 1…are substantially equivalent to the VITROS Chemistry Products dHDL Slides (current slide). The FDA cleared the VITROS Chemistry Products dHDL Slides on October 26, 2004 (k042006). Reason for 510(k) submission A Special 510(k) for a modification to own device which does not include a change in intended us… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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-0311-2014 | 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K042006.
How does its category compare?
All LBS devicesLBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LBS
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · LBS
118in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBS
6in 2025
MAUDE reports naming product code LBS, 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 | 0 |
| 2008 | 3 | 129 | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 3 | 118 | 0 | 3 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS-Chemistry Products dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.
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/K120609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120609: Vitros Chemistry Products DHDL Slides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120609
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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