AMEDITECH IMMUTEST DRUG SCREEN THC

• K Number: K011813
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN THC
• Manufacturer: AMEDITECH, INC.
• Date Cleared: 2001-10-22 ( 133 days)
• Product Code: LDJ
• Regulation Number: 862.3870
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Ameditech ImmuTest™ Drug Screen THC is an In Vitro screen test for the presence of 11-nor-Δ'-THC-9-carboxylic acid (THC) in human urine at cut-off concentration of 50 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ameditech ImmuTest™ Drug Screen THC" device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the FDA's substantial equivalence determination for marketing the device.

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based on this document.

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).