(396 days)
The RapidFRET Oral Fluid Assay for Methamphetamine is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for methamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Methamine Calibrators and RapidFRET Oral Fluid Methamphetamine Controls are intended for use only with appropriate RapidFRET Oral Fluid Assay products and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive controls are used to monitor laboratory systems, operators, precision. accuracy and assay conditions. For In Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid Assay for Methamphetamine is an In Vitro Diagnostic competitive immunoassay used to detect methamphetamine in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
The provided text describes the RapidFRET Oral Fluid Assay for Methamphetamine. Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" through a defined table or specific performance thresholds for sensitivity, specificity, or accuracy that the device must meet. Instead, the performance characteristics are presented as results from various studies, which imply the expected performance for a successful premarket notification. The de facto acceptance criteria appear to be substantial equivalence to the predicate device (Lin-Zhi International, Inc., LZI Oral Fluid Methamphetamine Enzyme Immunoassay (K131652)) and demonstrating acceptable analytical performance.
However, based on the provided data, we can infer some performance expectations and list the reported outcomes:
| Performance Characteristic | Inferred Acceptance Criteria / Expectation (based on predicate equivalence and general assay performance) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity (D-Methamphetamine) | Accurate detection near the cutoff concentration (50 ng/mL) with high frequency for levels above cutoff and low frequency for levels below cutoff. Expected to be within 75% and 125% of cutoff. | Within 75% and 125% of cutoff (37.5 ng/mL to 62.5 ng/mL). Achieved 100% frequency of expected results in this range. |
| Precision | Repeatable and reproducible results across different lots and runs. | Three lots analyzed over 20+ days showed consistent results. At 100% of cutoff (50 ng/mL), 47 positive and 217 negative results out of 264 total were reported (implying some samples at this exact cutoff concentration might be interpreted as negative depending on minor fluctuation around the threshold). All samples at 125%, 150%, 175%, and 200% of cutoff were positive (264/264 P), and all samples at 0%, 25%, 50%, and 75% of cutoff were negative (264/264 N) except for the 100% cutoff samples. |
| Correlation with MS Quantitation (Accuracy) | High agreement with a gold standard confirmatory method (GC/MS or LC/MS/MS). | Overall Agreement for n=92 samples: |
- RapidFRET POS / Confirmed POS:
- ≥150% Cutoff: 39
- 100-150% Cutoff: 5
- 50-100% Cutoff: 2‡ (These would ideally be negative by the screening cutoff)
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§ 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).