510(k) · Cleared
Recalled · Class II · 2025Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Dec 15, 2006 as substantially equivalent to K011289 (Syva Co., Dade Behring, Inc., 2001) and 1 other predicate after a 114-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- Dec 15, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011289 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011289 Emit II Plus Opiate Assay, Model OSR9B229Syva Co., Dade Behring, Inc. · 2001
- This deviceK062460 Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and 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 | K011289 | Emit II Plus Opiate Assay, Model OSR9B229 | Syva Co., Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K062460 | Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K011289 | Emit II Plus Opiate Assay, Model OSR9B229 | 2001 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 3…rformance Verifiers are substantially equivalent to the EMIT® II Plus Opiate assay devices: (KO1 1289) and Bio-Rad Liquicheck Tm Urine Toxicology Controls (K022707) predicate devices which were cleared by the FDA for IVD 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2025 | Class II | Z-2073-2025 | Under Investigation by firm | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to… |
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 DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose. The VITROS Chemistry Products OP assay is intended for use by professional laboratory…
Read the full statement (190 words)
For in vitro diagnostic use only. VITROS Chemistry Products OP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of opiates (OP) in human urine using a cutoff of either 300 ng/mL or 2000 ng/mL. Measurements obtained with the VITROS OP method are used in the diagnosis and treatment of opiate use or overdose.
The VITROS Chemistry Products OP 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/K062460 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062460: Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062460
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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