# K972835: 50NG/ML Cocaine Metabolite Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Aug 28, 1997 after 28 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine - metabolite enzyme immunoassay for qualitative and semu quantltatlve determination of cocaine and its metabolites in human urine. The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/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 preliminary positive results are used.

Source page: https://510kreport.com/device/K972835
Methodology: https://510kreport.com/methodology