(36 days)
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:
THC Tetrahydrocannabinol 50 ng/mL
COC Cocaine (Benzoylecgonine) 300 ng/mL
OPS Opiates (Codeine/Morphine) 300 ng/mL
AMP Amphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL
This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.
PROFILE-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine.
This document is a 510(k) clearance letter and an Indications for Use form for a rapid drug detection device called PROFILE-II. It does not contain the detailed study information regarding acceptance criteria and device performance that you requested.
The document states the device's indications for use: "PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine." It also lists the cut-off concentrations for each drug.
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, or details on prospective/retrospective studies.
- Information on the number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Results of standalone (algorithm-only) performance.
- The type of ground truth used (e.g., pathology, outcomes data, beyond the implied GC/MS confirmation).
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information is typically found in the full 510(k) submission, specifically in the performance data sections, which are not included in this letter. The letter is primarily an FDA clearance notification.
§ 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).