(67 days)
TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations:
Cutoff Concentrations:
- Amphetamines: 1000 ng/mL
- Benzodiazepines: 200 ng/mL
- Cocaine metabolite: 300 ng/mL
- Methamphetamine: 500 ng/mL
- Methamphetamine: 300 ng/mL
- Morphine: 300 ng/mL
- Morphine (M2K): 2000 ng/mL
- Phencyclidine (PCP): 25 ng/mL
- Tetrahydrocannabinols: 50 ng/mL
TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use in the qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic acid 50 ng/mL).
The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.
Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.
When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative") result is the absence of a blue band.
An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.
I am sorry, but I am unable to extract the detailed information requested regarding the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) summary for a medical device (drug test cups) and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and performance study results.
The document states the intended use and cutoff concentrations for various drugs, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts used for ground truth, adjudication methods, or specific expert qualifications.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
- Results of a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
The text mentions that the assays are based on "microparticle capture inhibition" and describes the general principle of how the test works (formation/absence of a blue band). It also states that the modified devices "have the same intended use and incorporate the same fundamental scientific technology as the predicate devices."
To provide the requested information, a different type of document, such as a detailed study report or clinical trial summary, would be necessary.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).