# K972619: Quickscreen One Step Opiate Screening Test (9080)

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Aug 20, 1997 after 40 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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) ABI SureStep: named in the summary without a submission number
- (no number) Syntron Bioresearch Opiates Test: named in the summary without a submission number

## Indications for use
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians’ offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of any addictive narcotic pain relieving opiate drug, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmacological actions. The opiates include drugs such as morphine, heroin, codeine, nalorphine,meperidine and morphine glucuronide. Measurements that are obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Source page: https://510kreport.com/device/K972619
Methodology: https://510kreport.com/methodology