Search Results

CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids is a rapid test for the qualitative detection of Oxycodone and Cannabinoids in human urine at a cutoff concentration of 100 ng/mL and 50 ng/mL, respectively. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained. The test is intended for over-the-counter and for prescription use.

The test may yield preliminary positive results even when the prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only.

The CR3 Keyless Split Sample Cup Oxycodone -Cannabinoids test uses immunochromatographic assays for Oxycodone and Cannabinoids. The test is a lateral flow system for the qualitative detection of oxycodone and cannabinoids in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CR3 Keyless Split Sample Cup Oxycodone-Cannabinoids device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for overall device performance in a pass/fail manner. Instead, it presents various performance characteristics intended to demonstrate substantial equivalence to a predicate device. I will infer performance goals from the reported data.

2. Sample Sizes and Data Provenance

• Precision Study Test Set: For each concentration of Oxycodone and Cannabinoids (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), tests were performed for 25 days, with 2 runs per day, by 3 operators. This means for each concentration level, there were 25 days * 2 runs/day * 1 detection/run = 50 detections per lot. With 3 lots tested, the total number of detections at each concentration level could be inferred as 50 * 3 = 150. The data provenance is not explicitly stated beyond "performed in-house".

• Cut-off Study Test Set: 125 Oxycodone samples and 125 Cannabinoids samples. The samples were distributed equally at concentrations of -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs. The data provenance is not explicitly stated beyond "conducted".

• Interference Study Test Set: Not explicitly stated as a number of samples, but samples were prepared with target drugs at 25% below and 25% above the cut-off (for both drug types) and tested with three batches by three operators. For the list of non-interfering substances, the concentration was 100µg/mL.

• Specificity Study Test Set: Samples prepared with target drugs, drug metabolites, and related compounds at various concentrations. Tested using three batches by three operators.

• Specific Gravity and pH Study Test Set: 12 urine samples covering normal, high, and low specific gravity ranges (1.000 to 1.035). Aliquots of negative urine were adjusted to pH ranges of 4.00 to 9.00. These were spiked with drugs at 25% below and 25% above the cut-off. Samples were tested using three batches by three operators.

• Method Comparison Test Set (Professional User): 80 unaltered clinical samples (40 negative and 40 positive) for each drug (Oxycodone and Cannabinoids), totaling 160 samples. The data provenance is "clinical samples" and "performed in-house". This implies they were real-world urine samples.

• Lay-User Study Test Set: 260 lay persons tested samples.

  • 20 drug-free samples
  • 120 oxycodone samples (20 samples for each concentration: -75%, -50%, -25%, +25%, +50%, +75% of cut-off)
  • 120 cannabinoids samples (20 samples for each concentration: -75%, -50%, -25%, +25%, +50%, +75% of cut-off)
    The samples were "blind-labeled and randomized." The data provenance involved "three intended user sites".

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Method Comparison Study: The ground truth for the 80 clinical samples was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is considered the "preferred confirmatory method" and a gold standard for drug quantification in urine. No human experts were used to establish the ground truth for this test set as it was an objective analytical method.

• Lay-User Study: The ground truth for the lay-user study samples was established by GC/MS as well, which confirmed the concentrations of the prepared urine samples.

4. Adjudication Method for the Test Set

• Method Comparison Study: No adjudication method is described for the "Viewer" results (which appear to be the device results interpreted by the laboratory assistants). The individual results of Viewer A, B, and C are presented. The comparison is made against the GC/MS ground truth.

• Lay-User Study: Similarly, no adjudication method is described. Each participant (lay user) provided their own result, which was then compared to the GC/MS-confirmed concentration of the sample they received.

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

• No MRMC comparative effectiveness study was done to assess how human readers improve with AI vs. without AI assistance.
  The device is an in vitro diagnostic (IVD) device, specifically a rapid test cup for qualitative detection of drugs in urine. It does not involve AI assistance for human readers/interpretation. The "Viewers" in the method comparison study were likely laboratory assistants reading the visual result of the test strip, not clinical "readers" of complex images or data that AI might typically assist.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done in the sense that the device itself (the test cup) provides a qualitative result based on immunochromatographic assays, independent of human interpretation for its operational mechanism. The "Performance Characteristics" section (Precision, Cut-off, Interference, Specificity, Effect of Specific Gravity and pH) describes the analytical performance of the device itself.
• The "Method Comparison" and "Lay-user study" then evaluate how well the device's output (the visual line) correlates with the GC/MS ground truth, showing the device's standalone accuracy when read by both professional and lay users.

7. Type of Ground Truth Used

• GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for determining drug concentrations for the method comparison study and the lay-user study. This is an objective, analytical gold standard method.
• For the precision, cut-off, interference, and specificity studies, the ground truth was established by known spiked concentrations of the analytes (Oxycodone, Cannabinoids) or interfering substances.

8. Sample Size for the Training Set

• The document implies that prior predicate devices (K122904) might have contributed to the knowledge base, but it does not describe a specific "training set" in the context of an algorithm or AI model development. This is a traditional IVD immunoassay device, which does not typically undergo a "training" phase like machine learning models. Its performance is inherent to its biochemical design.

9. How the Ground Truth for the Training Set Was Established

• Since there's no traditional "training set" for an algorithm, this question is not directly applicable. The performance characteristics are based on laboratory experiments using samples with known, spiked concentrations of analytes.

Ask a specific question about this device