ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

• K Number: K983147
• Device Name: ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 1998-09-28 ( 20 days)
• Product Code: DKE , DIO , DIS , DJG , DKN , DKZ , LCM , LFI
• Regulation Number: 862.3870
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

Device Description

AccuSign® DOA 8 (THC/OPI/COC/AMP/BZO/BAR/TCA/PCP) Rapid One-Step Drugs of Abuse Panel Test

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the AccuSign® DOA 8 Rapid One-Step Drugs of Abuse Panel Test from September 28, 1998. It primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, study design, or performance metrics in the format requested.

Therefore, I cannot extract the information to fulfill your request. The document is a clearance letter, not a device performance study report.

To provide the requested information, I would need a document such as:

• A summary of safety and effectiveness (SSE) for the 510(k) submission.
• A clinical study report.
• A detailed technical review from the FDA's evaluation.

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).