Search Results

DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiguantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.

DAT Oral Fluid Methamphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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.

The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.

No specific acceptance criteria or details of a study proving the device meets these criteria are mentioned in the provided text. The document is a 510(k) summary for a medical device (Oral Fluid Methamphetamine Assay), which primarily focuses on establishing substantial equivalence to a predicate device.

The provided text details:

• Device Name: Oral Fluid Methamphetamine Assay
• Intended Use: Qualitative and semiquantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL.
• Methodology: KIMS (Kinetic interaction of microparticles in solution)
• Comparison to Predicate Device: The document compares the new device to the Methamphetamine Intercept® MICRO-PLATE EIA (K993208) based on methodology, sample type, intended use, cutoff, controls, and calibrator.
• Regulatory Information: It includes the FDA's letter of substantial equivalence determination.

However, the document does not contain:

1. A table of acceptance criteria and reported device performance against those criteria.
2. Information on the sample size used for a test set or data provenance.
3. Details on the number or qualifications of experts used to establish ground truth.
4. Information on any adjudication method.
5. References to a multi-reader, multi-case (MRMC) comparative effectiveness study.
6. Details of a standalone performance study.
7. The type of ground truth used in any studies.
8. The sample size for a training set.
9. How ground truth for a training set was established.

The 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to an existing legally marketed device, not on presenting novel performance data against pre-defined acceptance criteria from a new study. While it mentions the technology and the cutoff concentration, it lacks the detailed study information typically associated with proving a device meets specific acceptance criteria based on new performance data.

Ask a specific question about this device