# K203527: Immunalysis Tapentadol Urine HEIA

- Pathway: 510(k) (Traditional)
- Applicant: Lmmunalysis Corporation
- Decided: May 9, 2022 after 523 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 K983159 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay, Immunalysis Corporation (2015) Summary page 4.

## Indications for use
For in vitro diagnostic use. The Inmunalysis Tapentadol Urine HEIATM is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only. The Immunalysis Tapentadol Urine HEIATM 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-Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).

Source page: https://510kreport.com/device/K203527
Methodology: https://510kreport.com/methodology