# K884968: TDX Methadone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 16, 1988 after 16 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 5, 2003 · Not classified · Z-0510-04: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Dec 5, 2003 · Not classified · Z-0511-04: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table

Source page: https://510kreport.com/device/K884968
Methodology: https://510kreport.com/methodology