# DEN190028: MyCare Psychiatry Clozapine Assay Kit

- Pathway: De Novo (Direct)
- Applicant: Saladax Biomedical, Inc.
- Decided: Apr 16, 2020 after 328 days
- Product code: QKT (Clozapine Test System)
- Device class: 2
- Regulation: 21 CFR 862.3245
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in adult human serum using automated clinical chemistry analyzers. Measurements obtained can be used to aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia. This assay should be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make treatment decisions.

Source page: https://510kreport.com/device/DEN190028
Methodology: https://510kreport.com/methodology