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The Status DSTM OXY is an immunochromatograhic test for the qualitative detection of Oxycodone in urine samples. The decetion cut-off concentration of Oxycodone is 100 ng/ml. The test may be read visually or by using a DX press™ Reader. It is intended for clinical laboratory use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (CCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to the test result, particularly when preliminary positive results are obtained.

The Status DSTM OXY test device is a simple immuno-chromatographic test for the rapid, qualitative detection of oxycodone and/or their metabolites in human urine. The test may be read visually or by using a DXpress™ Reader. The DXpress reader captures an image of an inserted compatible test device and uses a software algorithm to calculate the intensity of the test line. The DXpress reader interprets test result automatically by comparing the intensity of the test line to the preset cutoff value. In addition, the software will use the presence of the control line to determine whether or not the test result is valid.

The Status DS™ OXY device is an immunochromatographic test for the rapid, qualitative detection of oxycodone and/or its metabolites in human urine. The test can be read visually or with a DXpress™ Reader which automatically interprets the results by comparing test line intensity to a preset cutoff.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "In the performance study," without specifying the number of samples used.
• Data Provenance: Not explicitly stated. However, given that this is a 510(k) submission to the FDA, it is highly likely that the study was conducted within a clinical laboratory setting, potentially in the US, but the specific country of origin is not mentioned. The nature of the study (retrospective or prospective) is also not stated.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable. The ground truth in this study was established using a legally marketed predicate device (MedTox Oxycodone, K060351) as the reference, not expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. The study compares the performance of the Status DS™ OXY test directly against a predicate device. There is no mention of human readers or an adjudication process for discrepancy resolution in the context of establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The study described is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the Status DS™ OXY test performance was evaluated independently against a legally marketed predicate device. The DXpress™ Reader component itself includes a "software algorithm to calculate the intensity of the test line" and "interprets test result automatically," indicating a standalone algorithmic interpretation capability. The comparison of "98% agreement for positive samples and 96% for negative samples" directly reflects this standalone device performance.

7. Type of Ground Truth Used

• Ground Truth Type: A legally marketed predicate device (MedTox Oxycodone, K060351) served as the reference standard. The text states: "Status DS OXY test showed 98% agreement for positive samples and 96% for negative samples compared to the reference test, while MedTox Oxycodone showed 96% and 97% agreement, respectively, indicating the two test devices are substantially equivalent." While the predicate device itself is for "qualitative detection," the ultimate confirmatory method mentioned for clinical use is Gas chromatography/mass spectrometry (GC/MS). However, for the purpose of demonstrating substantial equivalence to the FDA, the predicate device served as the comparison standard.

8. Sample Size for the Training Set

• Not explicitly mentioned. The provided text describes a performance study for demonstrating substantial equivalence. It does not detail the development or training of any underlying algorithms, only the performance of the final device against a predicate.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as details about a training set are not provided. The information focuses on the performance of the final product in comparison to a predicate device. If there was an internal training process for the DXpress™ Reader's algorithm, the method for establishing ground truth for that training is not described in this document.

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