# K063164: Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, Iii, IV

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 28, 2006 after 71 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 K993984 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011300: Emit II Plus Cannabinoid Assay, Model OSR9N229, Syva Co., Dade Behring, Inc. (2001)
- K993984: Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129UL, 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.

## Recalls of this device
- May 12, 2014 · Class II · Z-1805-2014: Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process 

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products THC Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose. The VITROS Chemistry Products THC 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 30 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of cannabinoids (THC). 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/K063164
Methodology: https://510kreport.com/methodology