510(k) · Cleared
Recalled · Class II · 2018Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · MRR System, Test, Low Density, Lipoprotein
Cleared on Aug 25, 2004 as substantially equivalent to K020852 (Polymedco, Inc., 2002) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it. It has been recalled once.
- Decided
- Aug 25, 2004
- Review
- 62 days
- Class
- Class I
- Product code
- MRR
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904768 (1990). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK904768 Kodatrol I and II Control and Diluent SetEastman Kodak Company · 1990 · Recalled
- This deviceK041720 Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK042477 Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK060940 Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 2006
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042477Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly4descendants
- K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on3descendants
- K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · 3 generations on1descendant
- K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 4 generations on0descendants
- K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | 1990 | 1 |
| 0 (this device) | K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +2 | K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +3 | K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2006 | 1 |
| +4 | K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance… | Ortho-Clinical Diagnostics, Inc. | 2013 | — |
| +3 | K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2013 | 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 MRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K020852 | Poly-Chem GlucoseSummary page 3…alibrator 1 are substantially equivalent to the Polymedco Lipi+Plus Direct LDL assay (predicate device) which was cleared by the FDA (K020852) for IVD use. The relationship between the VITROS dLDL and the predicate device,… | 2002 |
| * | K904768 | Kodatrol I and II Control and Diluent SetSummary page 4…tantially 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… | 1990 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20… | 2004 | 4 |
| K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I… | 2004 | 0 |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance… | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2018 | Class II | Z-0476-2019 | Under Investigation by firm | VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K042477 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with…
Read the full statement (119 words)
For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.
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/K041720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041720: Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and Performance Verifiers I and II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041720
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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