510(k) · Cleared
Recalled · Class II · 2018Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Dec 1, 2004 as substantially equivalent to K002551 (Dade Behring, Inc., 2000) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 1, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- LEG
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K984288 (1999). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK984288 Vitros Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 1999 · Recalled
- This deviceK042476 Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK043384 Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK043386 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
- Descendant · cites it directly · 0 of its ownK042479 Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
- K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
- K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984288 | Vitros Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 1999 | 3 |
| 0 (this device) | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
| +1 | K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +1 | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | 3 |
| +1 | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr… | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 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 LEG? 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 |
|---|---|---|---|
| * | K002551 | Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109ULSummary page 3…2 and are substantially equivalent to the SYVA Emit 2000 Valproic Acid Assay and the SYVA Emit 2000 Valproic Acid Calibrators, which were cleared by FDA (K002551) for IVD use. The relationship between the VITROS VALP assay and the predicate device, determined by least squar… | 2000 |
| * | K984288 | Vitros Chemistry Products PHBR SlidesSummary page 3…age and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution (K984288). The only difference is the addition of one constituent to the controls. The labeling will be updated to add assigned valu… | 1999 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers… | 2005 | 0 |
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers… | 2005 | 0 |
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products… | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2018 | Class II | Z-0848-2019 | Process control | Negative bias results when using VITROS VALP Reagent, GEN 25. |
| May 10, 2011 | Not classified | Z-0984-2012 | Manufacturing material removal | Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue. |
| Apr 18, 2005 | Not classified | Z-0866-05 | Other | Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days. |
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, K043384 (Ortho-Clinical Diagnostics, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LEG devicesLEG Enzyme Immunoassay, Valproic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEG
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LEG
Too few LEG 510(k)s in any year since 2007 to give a median.
Recalls per year · LEG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEG
5in 2025
MAUDE reports naming product code LEG, 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 | — | 1 | 12 |
| 2008 | 0 | — | 0 | 38 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 38 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 24 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy. For in vitro diagnostic use only. VITROS Chemistry Products…
Read the full statement (119 words)
For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 12 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of valproic acid (VALP).
For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VALP on VITROS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042476: Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042476
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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