# K062285: Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 22, 2006 after 137 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993985 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL, Syva Co. (2000) Summary page 4.
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439, Bio-Rad (2002) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K062285
Methodology: https://510kreport.com/methodology