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K Number
K980836
Device Name
GENIE CUP INTEGRATED SCREENING DEVICE
Manufacturer
APPLIED TECHNOLOGY VENTURES, L.L.C.
Date Cleared
1998-06-29

(117 days)

Product Code
LDJ,DIO,DJG,DKZ,LCM
Regulation Number
862.3870
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is a 510(k) clearance letter from the FDA for the "Genie Cup™ Integrated Screening Device."

While it mentions the intended use and cutoff concentrations for certain substances, it does not include:

  • A table of acceptance criteria and reported device performance. It lists cutoff concentrations but not the performance metrics against those cutoffs (e.g., sensitivity, specificity).
  • Sample size and data provenance for a test set.
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication method.
  • Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Details about standalone algorithm performance.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • Sample size and ground truth establishment for the training set.

The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It refers to "established economics of the major metabolites of Sep" and SAMHSA specified cutoff concentrations, suggesting that the device's design aligns with existing standards, but it doesn't present the specific rigorous study data you're asking for.

§ 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).