# K150925: Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jun 29, 2015 after 84 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 K113751 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113751: Randox Cocaine Metabolite, Randox Laboratories, Ltd. (2012) Summary page 4.

## Indications for use
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay The Immunalysis Benzoylecgonine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 150ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzoylecgonine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Benzoylecgonine. This in-vitro device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Benzoylecgonine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/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. Immunalysis Benzoylecgonine Urine Calibrators The Immunalysis Benzoylecgonine Urine Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Immunalysis Benzoylecgonine Urine Control Set The Immunalysis Benzoylecgonine Urine Control Set is intended for in vitro diagnostic use to monitor the performance of assays for the analyte currently listed in the package insert: Benzoylecgonine. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers

Source page: https://510kreport.com/device/K150925
Methodology: https://510kreport.com/methodology