# K043167: Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195X

- Pathway: 510(k) (Special)
- Applicant: Phamatech, Inc.
- Decided: Dec 29, 2004 after 43 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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) ABMC RapidOne BZD test: named in the summary without a submission number

## Indications for use
The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a preliminary result for the detection/presence of benzodiazepines in urine. It is intended for professional use only. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only. An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Source page: https://510kreport.com/device/K043167
Methodology: https://510kreport.com/methodology