# K141803: Immunalysis Tramadol Urine Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Feb 12, 2015 after 224 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: 3 generations back to K983159 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls, Lin-Zhi International, Inc. (2012) Summary page 4.

## Most influential descendants
- K203527: Immunalysis Tapentadol Urine HEIA (2022), 0 descendants of its own

## Indications for use
Immunalysis Tramadol Urine Enzyme Immunoassay: The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. This in-vitro diagnostic 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 test is not intended to differentiate between drugs of abuse and prescription use of Tramadol. There are no uniformly recognized drug levels for Tramadol in urine. The Immunalysis Tramadol 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 Spectroscopy (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 Tramadol Urine Controls: The Immunalysis Tramadol Urine Controls are used as control materials in the Immunalysis Tramadol Urine Enzyme Immunoassay. Immunalysis Tramadol Urine Calibrators: The Immunalysis Tramadol Urine Calibrators are used as calibrators in the Immunalysis Tramadol Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Tramadol in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K141803
Methodology: https://510kreport.com/methodology