510(k) · Cleared
ClearedEmit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Oct 11, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 11, 2000
- Review
- 55 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK002551 Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators…Dade Behring, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK042476 Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK043384 Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK043386 Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK042479 Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros…Ortho-Clinical Diagnostics, Inc. · 2005 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K042476Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly3descendants
- K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
- K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
- K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002551 | Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model… | Dade Behring, Inc. | 2000 | — |
| +1 | K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2004 | 3 |
| +2 | K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | — |
| +2 | K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance… | Ortho-Clinical Diagnostics, Inc. | 2005 | 3 |
| +2 | K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr… | Ortho-Clinical Diagnostics, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12… | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042476 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K002551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002551: Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002551
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026