510(k) · Cleared
ClearedVitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Dec 22, 2006 as substantially equivalent to K993985 (Syva Co., 2000) and 1 other predicate after a 137-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 22, 2006
- Review
- 137 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K993985 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993985 Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSyva Co. · 2000
- This deviceK062285 Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL | Syva Co. | 2000 | — |
| 0 (this device) | K062285 | Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and… | 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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 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 |
|---|---|---|---|
| * | K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULSummary page 4…erformance Verifiers are substantially equivalent to the devices DADE BEHRING Syva® EMIT® II Plus Benzodiazepine Assay (K993985) and BIO-RAD LiquichekT M Urine Toxicology Controls (K022707) (predicate devices) which were cleared… | 2000 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 4…BEHRING Syva® EMIT® II Plus Benzodiazepine Assay (K993985) and BIO-RAD LiquichekT M 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.
- 1 other device also cites its predicate K993985.
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS Chemistry Products BENZ Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It…
Read the full statement (213 words)
VITROS Chemistry Products BENZ Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ 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 FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
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/K062285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062285: Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062285
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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