# K990325: Quikstrip Dipscan X Multidrug Screening Device

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Jun 24, 1999 after 142 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 no predicate by number.

## Indications for use
Syntron's QuikStrip DipScan X Multidrug Sereening Device (the X is replaced by 2, 3, 4, 5,or6)is a holder for up to six rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DipScan are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP).The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated®. Syntron’s QuikStrip DipScan X Multidrug Sereening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.

Source page: https://510kreport.com/device/K990325
Methodology: https://510kreport.com/methodology