# K983268: Modification of Tricyclic Serum Tox Eia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Nov 18, 1998 after 62 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213875: DRI TM Tricyclics Serum Tox Assay (2022), 1 descendant of its own
- K231020: Alinity c Tricyclic Antidepressants Reagent Kit (2023), 0 descendants of its own

## Indications for use
This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.

Source page: https://510kreport.com/device/K983268
Methodology: https://510kreport.com/methodology