510(k) · Cleared
ClearedVitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I, II, Iii, IV & V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Nov 22, 2006 as substantially equivalent to K010962 (Syva Co., Dade Behring, Inc., 2001) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 22, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010962 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010962 Emit II Plus Methadone Assay, Model OSRE229Syva Co., Dade Behring, Inc. · 2001
- This deviceK062637 Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010962 | Emit II Plus Methadone Assay, Model OSRE229 | Syva Co., Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K062637 | Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 DJR? 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 |
|---|---|---|---|
| * | K010962 | Emit II Plus Methadone Assay, Model OSRE229Summary page 3…ROS Chemistry to predicate Products DAT Performance Verifiers are substantially equivalent to the devices EMIT® 11 Plus Methadone Assay (K010962) and BIO-RAD Liquichek TM Urine Toxicology Controls (K022707) (predicate devices) which were… | 2001 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 3…ially equivalent to the devices EMIT® 11 Plus Methadone Assay (K010962) and BIO-RAD Liquichek TM Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use.… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS Chemistry Products METD Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of methadone (METD) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS METD method are used in the diagnosis and treatment of methadone use or overdose. The VITROS Chemistry Products METD assay is intended for use by professional laboratory personnel. It provides only a…
Read the full statement (184 words)
VITROS Chemistry Products METD Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of methadone (METD) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS METD method are used in the diagnosis and treatment of methadone use or overdose.
The VITROS Chemistry Products METD assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062637: Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I, II, Iii, IV & V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062637
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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