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DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative 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 Phencyclidine 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 by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 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.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Oral Fluid Phencyclidine Assay (K093989):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific pass/fail acceptance criteria or a dedicated study section detailing the device's performance against such criteria. It largely focuses on the device's description, intended use, and substantial equivalence to a predicate device.

However, based on the context of an immunoassay for drug detection, the primary performance characteristic would be accuracy (sensitivity and specificity) relative to a confirmatory method like LC/MS/MS. The document mentions that the product calibrators and controls are verified by LC/MS/MS, indicating this as a reference standard.

Given the information provided, we can infer the relevant performance characteristic and its reference.

These statements indicate that the verification of calibrators and controls uses LC/MS/MS, which serves as the reference for ensuring the assay's ability to detect phencyclidine at specific concentrations, including the 6 ng/mL cutoff. However, the results of a comprehensive study (e.g., sensitivity, specificity, agreement rate with LC/MS/MS on actual patient samples) are not reported in this summary. |
| Cutoff | Accurate detection at the specified cutoff concentration of 6 ng/mL. | The device is designed for "detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid." Calibrators are spiked at concentrations including 4 ng/mL and 8 ng/mL, surrounding the cutoff. Controls are also ±50% of the cutoff. The verification mentioned above indicates the assay is calibrated for this specific cutoff. |

Study Information (Based on provided text)

The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing full study results. Therefore, many of the requested details about the study are not explicitly present in this document.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified, but given the context of in vitro diagnostic development, it would likely involve laboratory-prepared samples (spiked synthetic oral fluid) and potentially clinical samples (though no details are given). The use of NIST traceable materials suggests a controlled laboratory environment for preparation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of experts: Not applicable/not specified. The ground truth for this type of chemical assay is typically established through a highly accurate reference analytical method, not expert consensus.
   • Qualifications of experts: Not applicable.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading) where disagreement can occur. For chemical assays, the reference method (LC/MS/MS) provides an objective ground truth.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is an in vitro diagnostic assay for detecting a chemical substance (Phencyclidine) in oral fluid. It does not involve human readers interpreting images or complex data, nor does it incorporate AI assistance in the way clinical diagnostic AI tools do.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The "device" itself (Oral Fluid Phencyclidine Assay) is a standalone biochemical test performed on an automated clinical chemistry analyzer. It functions "without human-in-the-loop performance" for the analytical measurement, although human operators are required for sample collection and loading. The results are quantitative/semi-quantitative outputs based on the chemical reaction. The document does not detail a separate "standalone study" from its general performance evaluation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Highly accurate analytical method: The ground truth for phencyclidine concentrations in oral fluid is established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This is explicitly mentioned for verifying calibrators and controls, and also as the "preferred confirmatory method" for positive assay results.

7. The sample size for the training set:

   • Not specified. This document describes a chemical assay, not a machine learning algorithm that requires a "training set" in the typical sense. The "training" for such a device involves calibration using carefully prepared calibrators at known concentrations. The concentrations of these calibrators are listed (0, 1, 2, 4, 8, and 16 ng/mL).

8. How the ground truth for the training set was established:

   • As noted above, for chemical assays, there isn't a "training set" in the machine learning context. The equivalent would be the calibrator and control preparation.
   • The ground truth for the calibrators and controls was established gravimetrically (by precise weighing) by spiking phencyclidine into a synthetic oral fluid matrix, and then verified by LC/MS/MS. This ensures the known, accurate concentrations of the drug in these solutions.

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