510(k) · Cleared
Recalled · Class II · 2017Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace
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 Oct 28, 2004 as substantially equivalent to K032798 (Dade Behring, Inc., 2003) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 28, 2004
- Review
- 94 days
- Class
- Class I
- Product code
- LBS
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983849 (1999). 3 ancestors in all, the oldest K904768 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK983849 Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex…Dade Behring, Inc. · 1999
- 1 generation backK032798 Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge…Dade Behring, Inc. · 2003
- This deviceK042006 Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK120609 Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK052867 Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983849 | Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… | Dade Behring, Inc. | 1999 | — |
| −1 | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A)… | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K120609 | Vitros Chemistry Products DHDL Slides | Ortho-Clinical Diagnostics, Inc. | 2012 | 1 |
| +1 | K052867 | Vitros Chemistry Products Dtibc Reagent | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ASummary page 3…tially equivalent to the AHDL Flex reagent cartridge assay on the Dimension system (predicate device) which was cleared by the FDA (K032798) for IVD use. The relationship between the VITROS dHDL Slides assay and the predicate device,… | 2003 |
| * | K904768 | Kodatrol I and II Control and Diluent SetSummary page 5…bstantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use. Table 2 Table 2 lists the similarities and differences of the device characteristics between the… | 1990 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2017 | Class III | Z-0807-2018 | Unknown/Undetermined by firm | VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months. |
| 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. |
| Feb 2, 2012 | Not classified | Z-1316-2012 | Device Design | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K120609 (Ortho-Clinical Diagnostics, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032798.
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.
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 dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. 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. For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 25 is used to calibrate VITROS Chemistry Systems for the…
Read the full statement (105 words)
For in vitro diagnostic use only. VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. 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.
For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 25 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of HDL cholesterol using VITROS Chemistry Products dHDL Slides.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042006 · printed Nov 3, 2026
Cite this page
510(k) Report. “K042006: Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042006
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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