# K061457: Ucp Rapid Drug Screening Tricyclic Antidepressant, Propoxyphene Tests

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Aug 21, 2006 after 88 days
- Product code: LFG (Radioimmunoassay, 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.
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. The FDA summary names its predicate without a number.
- (no number) ACON TCA One Step Tricyclic Antidepressant Test: named in the summary without a submission number
- (no number) Instant-View® Propoxyphene (PPX) Urine Test: named in the summary without a submission number

## Indications for use
The UCP RapidTM Drug Screening Tricyclic Antidepressant Test and UCP Rapid Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels: Test Calibrator Cut-off Tricyclic Antidepressant Nortriptyline 1000 ng/mL Propoxyphene Propoxyphene 300 ng/mL The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

Source page: https://510kreport.com/device/K061457
Methodology: https://510kreport.com/methodology