Search Results

CR3 Keyless Split Sample Cup Morphine-Methamphetamine is a rapid test for the qualitative detection of Morphine and Methamphetamine in human urine at a cutoff concentration of 300 ng/mL and 1000 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 CR3 Keyless Split Sample Cup Morphine-Methamphetamine 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 Morphine-Methamphetamine test uses immunochromatographic assays for Morphine and Methamphetamine. The test is a lateral flow system for the qualitative detection of Morphine and Methamphetamine 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.

The acceptance criteria and the study proving the device meets these criteria are detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the overall device performance in a consolidated table. However, implied acceptance criteria can be derived from the precision and lay-user study results, particularly around the cutoff concentrations. For the purpose of this response, I will synthesize the observed performance from the precision and lay-user studies as the "reported device performance" against common expectations for such devices.

Implied Acceptance Criteria and Reported Device Performance for Morphine (MOP) and Methamphetamine (MET) Detection:

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study:

  • For each concentration level (-100% to +100% of cut-off), 50 tests were performed per lot. With 9 concentration levels and 3 lots, this implies a total of 450 tests per drug (Morphine and Methamphetamine).
  • Data Provenance: Not explicitly stated, but the study was "carried out" by the manufacturer. It is implied to be a prospective analytical study using spiked samples designed to test device precision. The samples were "masked and randomized."

• Cut-off Study:

  • A total of 125 morphine samples and 125 methamphetamine samples were used. These were distributed at -50%, -25%, at the cut-off, +25%, +50% of their respective cut-offs.
  • Data Provenance: Not explicitly stated, but "samples were tested using three different lots by three different operators." This is an analytical study.

• Interference Study:

  • Not specified, but likely in-house analytical testing using spiked urine samples.

• Specificity Study:

  • Not specified, but likely in-house analytical testing using spiked urine samples.

• Effect of Specific Gravity and Urine pH Study:

  • 12 urine samples (normal, high, low specific gravity) were spiked for each drug.
  • pH study: Aliquots of negative urine pool adjusted to pH 4.00-9.00 (6 increments) were spiked for each drug.
  • Data Provenance: In-house analytical testing.

• Comparison Studies (Algorithm Only / Standalone Study Implicit):

  • 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug (Morphine and Methamphetamine).
  • Data Provenance: "In-house with three laboratory assistants." The samples were "unaltered clinical samples," suggesting real human urine samples, and were "masked and randomized." The country of origin is not specified but implicitly where the manufacturing facility is located (Guangzhou, P.R. China) or where the testing was conducted. This study appears to be a standalone performance evaluation against a gold standard method.

• Lay-User Study:

  • 260 lay persons participated.
  • Sample distribution: 20 drug-free samples, 120 morphine samples, and 120 methamphetamine samples.
  • Sample concentrations: -100%, +/-75%, +/-50%, +/-25% of the cut-off.
  • Data Provenance: Clinical study performed "at three intended user sites" using spiked drug-free pooled urine specimens. The samples were "blind-labeled and randomized."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Studies: "Three operators" conducted these tests, but their qualifications are not specified beyond being "operators." The ground truth for these analytical studies was based on the precisely known concentrations of spiked drug analytes.

• Comparison Studies (Clinical Samples):

  • Ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing and considered a gold standard. No human experts are explicitly mentioned for establishing ground truth from GC/MS, as it is an objective analytical method.
  • Three "laboratory assistants" were the "operators" who read the device results. Their qualifications are not specified.

• Lay-User Study:

  • The ground truth for the spiked concentrations was "confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS.

4. Adjudication Method for the Test Set

The document does not describe a formal "adjudication method" involving multiple readers for reconciling discrepancies in the test results.

• Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Studies: The results are presented as counts (e.g., 50-/0+), implying individual test outcomes were recorded, not adjudicated.
• Comparison Studies: Three "Viewers" (A, B, C) individually read the results of the 80 clinical samples for each drug. Their individual results are reported, including discordant cases, but there's no mention of a consensus or adjudication process among them. Each viewer's performance is listed separately.
• Lay-User Study: Each participant (lay person) received one device and one blind-labeled sample. Their individual interpretation was recorded and compared to the GC/MS confirmed concentration. No adjudication among lay users is mentioned.

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

No, a formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly performed or reported.

The "Comparison Studies" involved three "laboratory assistants" (referred to as Viewers A, B, C) interpreting device results. This is a multi-reader study, and the cases were clinical samples. However, there's no "AI assistance" component mentioned to evaluate an improvement effect size over unassisted human reading. The device itself is an immunochromatographic rapid test, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was implicitly done.

The "Comparison Studies" section evaluates the performance of the CR3 Keyless Split Sample Cup Morphine - Methamphetamine device alone against GC/MS results for "unaltered clinical samples." The device itself is the "algorithm only" in this context, as it is a rapid diagnostic test providing a qualitative result (positive/negative line on the strip). The three laboratory assistants are merely "reading" the output of the device. The data provided in the tables for "Viewer A, B, C" in the Comparison Studies section actually reflect the performance of the device as interpreted by different individuals.

7. Type of Ground Truth Used

• For all analytical studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH): The ground truth was based on known spiked concentrations of the target analytes in urine.
• For Comparison Studies (Clinical Samples) and Lay-User Study: The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is considered a definitive analytical method for confirming drug presence and concentration.

8. Sample Size for the Training Set

The document describes premarket performance characteristics and refers to a "device" that is an immunochromatographic assay. This type of device does not typically involve a "training set" in the context of machine learning or AI models. Its performance is based on the chemical and biological properties of its reagents and manufacturing process, which are developed and validated through iterative R&D. Therefore, a specific "training set" as understood in AI/ML is not applicable to this device.

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

As noted above, a "training set" in the AI/ML sense is not applicable to this device. The development and optimization of such a rapid test involve extensive in-house analytical testing using known concentrations of analytes and interferents, which serve to refine the device design and manufacturing.

Ask a specific question about this device