(99 days)
The DRI® Oxycodone Assay is intended for the qualitative and semi-quantitative detection of oxycodone in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone in human urine.
The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.
The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.
The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
The provided text describes the DRI® Oxycodone Assay, its intended use, and its comparison to a predicate device for substantial equivalence. However, it does not contain a formal study, acceptance criteria, or performance data in the structured format requested. The document is primarily a 510(k) summary, which outlines the device's characteristics and its proposed equivalence to a legally marketed predicate device, rather than a detailed report of internal validation studies with explicit acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets and training sets, data provenance, or details on ground truth establishment for these sets.
- Information on experts, adjudication methods, or MRMC studies.
Here's what can be extracted based on the provided text, outlining why the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific performance thresholds for the new device and then proving it meets them.
- Reported Device Performance: Performance metrics such as sensitivity, specificity, accuracy, or other diagnostic performance indicators are not provided in this 510(k) summary. The comparison focuses on device characteristics (intended use, analyte, matrix, calibrator form/levels, storage, stability) to show similarity with the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable as no specific test set or expert-established ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable as no specific test set or ground truth adjudication process is described.
5. 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
- MRMC Study: Not mentioned. This device is an immunoassay for drug detection, not an imaging device typically evaluated with MRMC studies or human reader performance.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The device is described as a "homogeneous enzyme immunoassay" and its performance is evaluated in comparison to a predicate device and confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). The document implies a "standalone" analytical performance being assessed, but specific metrics like accuracy against GC/MS are not quantified in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For establishing substantial equivalence and confirming performance, the document states, "...as confirmed by gas chromatography/mass spectrometry, an independent analytical method." Therefore, Gas Chromatography / Mass Spectrometry (GC/MS) is explicitly identified as the preferred confirmatory method and the basis for comparison.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. This document relates to a 510(k) submission, not a study design detail for model training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: As no training set is described, the method for establishing its ground truth is not provided.
In summary: The provided text is a 510(k) summary for a diagnostic device. Its purpose is to demonstrate substantial equivalence to a predicate device, as confirmed by an independent analytical method (GC/MS). It does not contain a detailed report of a study with explicit acceptance criteria, performance metrics, or specifics about test and training datasets typically found in a clinical or algorithm validation study report.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.