# K213875: DRI TM Tricyclics Serum Tox Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Dec 21, 2022 after 373 days
- Product code: LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs)
- Device class: 2
- Regulation: 21 CFR 862.3910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983268 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983268: Modification of Tricyclic Serum Tox Eia Assay, Diagnostic Reagents, Inc. (1998) Summary page 4.

## Most influential descendants
- K231020: Alinity c Tricyclic Antidepressants Reagent Kit (2023), 0 descendants of its own

## Indications for use
The DRI™ Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of tricyclic antidepressants (TCAs) in human serum, plasma, or urine of patients at a cutoff concentration of 300 ng/mL in patients suspected of drug overdose. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K213875
Methodology: https://510kreport.com/methodology