# K143500: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Feb 6, 2015 after 58 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K993982 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062077: Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers, Ortho-Clinical Diagnostics, Inc. (2006) Summary page 5.

## Indications for use
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semi- quantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. 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 Amphetamine 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 Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Controls are used as control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay. Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators are used as calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K143500
Methodology: https://510kreport.com/methodology