# K150275: Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Mar 9, 2015 after 33 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010496 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102779: Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C, Siemens Healthcare Diagnostics, Inc. (2011) Summary page 4.

## Indications for use
The Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 10ng/mL. The assay is intended for use in laboratories for the qualitative analysis of 6-Acetylmorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against 6-Acetylmorphine. This in-vitro diagnostic device is for prescription use only. The Immunalysis 6-Acetylmorphine 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 6-Acetylmorphine Urine Controls: The Immunalysis 6-Acetylmorphine Urine Controls are used as control materials in Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay. Immunalysis 6-Acetylmorphine Urine Calibrator: The Immunalysis 6-Acetylmorphine Urine Calibrator is used as a calibrator in the Immunalysis Urine Enzyme Immunoassay for the qualitative determination of 6-Acetylmorphine in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K150275
Methodology: https://510kreport.com/methodology