QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131

• K Number: K980865
• Device Name: QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
• Manufacturer: PHAMATECH
• Date Cleared: 1998-04-01 ( 26 days)
• Product Code: DKZ , DIO , DJG , LAF , LCM , LDJ
• Regulation Number: 862.3100
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.

Device Description

QuickScreen™ Pro Multi Drug Screening Test

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (QuickScreen™ Pro Multi Drug Screening Test). It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

However, this document does not contain the detailed acceptance criteria for the device's performance, nor does it include a description of the specific study that proves the device meets those criteria. It's a regulatory approval document, not a scientific study report or a summary of performance data.

Therefore, I cannot extract the information you requested about acceptance criteria and study details from this document.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).