# K992748: Drugcheck X Multidrug Screening Device

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Sep 2, 1999 after 17 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 DrugCheck X Multidrug Screening Device (the X may be replaced by 2,8, 4,5, 6,7, or 8) is a holder for up to eight 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 DrugCheck X 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 indicatedS. Syntron’s QuikStrip DrugCheck X Multidrug Screening 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/K992748
Methodology: https://510kreport.com/methodology