# K150502: DRI Hydrocodone Assay, DRI Hydrocodone Calibrators,  DRI Hydrocodone Controls

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Oct 9, 2015 after 225 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: 5 generations back to K014101 (2002). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141055: Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML), Lin-Zhi International, Inc. (2014) Summary page 5.

## Most influential descendants
- K231752: ARK Hydrocodone Assay (2023), 0 descendants of its own
- K173195: DRI Hydrocodone Assay (2018), 0 descendants of its own

## Indications for use
DRI® Hydrocodone Assay The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confirmation by a confirmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures. This assay provides a preliminary analytical test result. A more specific alternative chemical method must be used in order to confirm an analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. DRI® Hydrocodone Calibrators The DRI® Hydrocodone Assay Calibrators are intended for the calibration of the DRI® Hydrocodone Assay. For In Vitro Diagnostic Use Only. DRI® Hydrocodone Controls The DRI® Hydrocodone Controls are unassayed quality control material intended for use in the DRI Hydrocodone Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. For In Vitro Diagnostics Use Only

Source page: https://510kreport.com/device/K150502
Methodology: https://510kreport.com/methodology