# K062460: Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 15, 2006 after 114 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011289 (2001). 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)
- K011289: Emit II Plus Opiate Assay, Model OSR9B229, Syva Co., Dade Behring, Inc. (2001)
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439, Bio-Rad (2002) Summary page 3.

## Recalls of this device
- Jun 12, 2025 · Class II · Z-2073-2025: 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, t

## Indications for use
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.

Source page: https://510kreport.com/device/K062460
Methodology: https://510kreport.com/methodology