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The Snap-Top Split Key Cup for use with the GenPrime Drugs of Abuse (DOA) Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test cannot be read visually and must be used with the GenPrime DOA Reader. The Snap-Top Split Key Cup qualitatively detects drug classes in human urine at the cutoff concentrations shown below:

• Test/ Calibrated to /Cutoff Amphetamines/ d-Amphetamine/ 500 ng/mL Barbiturates/ Secobarbital/ 300 ng/mL Benzodiazepines/ Oxazapam/ 300 ng/mL Cocaine/ Benzoylecgonine/ 150 ng/mL Methamphetamine/ d-Methamphetamine/ 500 ng/mL Methadone/ Methadone/ 300 ng/mL Morphine/ Morphine/ 300 ng/mL Morphine 2000/ Morphine/ 2000 ng/mL Oxycodone/ Oxycodone/ 100 ng/mL Phencyclidine/ Phencyclidine/ 25 ng/mL Marijuana/ Delta-9-THC-COOH/ 50 ng/mL
  Configurations of the Snap-Top Split Key Cup may consist of any combination of the above listed drug analytes. The Snap-Top Split Key Cup provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flatbed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is intended for use with the Snap-Top Split Key Cup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine (K130082). This description is limited to the Snap-Top Split Key Cup (SK Cup), with 3 additional drugs being added, giving 11 total drugs.

The Snap-Top SK cup contains up to five (5) test strips embedded in a urine sample cup, containing a total of up to 11 drug test lines (between one and four drug test lines per test strip). Different drug configurations may be used. Each test strip has an internal control line to confirm validity of the test results.

The Snap-Top SK Cup Drugs of Abuse Test devices are run in the GenPrime DOA Reader System according to their specific instructions for use. At the conclusion of the test (5 minutes) an image is captured and the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually.

All analytes on the Snap-Top SK Cup for use with the GenPrime DOA Reader System were previously cleared (K130082) except for the drug tests for benzodiazepines, cocaine and barbiturates.

Here's a summary of the acceptance criteria and study details for the Snap-Top Split Key Cup, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision studies, which show the percentage of correct classifications at various concentrations relative to the cutoff. For accuracy, the agreement with reference methods is presented.

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

• Test Set Sample Size (Precision Study):
  • For each drug (BAR, BZO, COC) at specific % of cutoff concentrations (0%, 25%, 50%, 75%, 125%, 150%, 175%, 200%), the number of tests (N) ranged from 45 to 50 samples.
  • For the "All Drugs" summary in the precision studies, the total N at each % of cutoff ranged from 135 to 142.
• Test Set Sample Size (Clinical Accuracy Study):
  • For each drug (BAR, BZO, COC), a minimum of 40 unaltered positive and 40 unaltered negative clinical samples were assessed.
• Data Provenance:
  • The precision studies were performed at three sites representative of laboratory, workplace, and point-of-care (POC) settings, suggesting prospective data collection in a controlled environment.
  • The clinical accuracy studies used "blind coded clinical urine samples," implying prospective or retrospectively collected clinical samples with unknown status to the test operators.
  • The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the USA or adhering to international standards acceptable to the FDA.

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

• Precision Studies Ground Truth: The ground truth for the precision studies was established chemically. "GC/MS and/or LC/MS/MS were performed to confirm the concentration of calibrator drug in each test solution." No human experts were involved in establishing this ground truth directly.
• Clinical Accuracy Study Ground Truth: The ground truth for clinical samples was determined by "GC/MS or LC/MS/MS." Negative samples were initially screened by EIA, with 10% also confirmed by GC/MS or LC/MS/MS. Again, this points to instrumental analysis rather than human expert consensus for ground truth.

4. Adjudication Method for the Test Set

• No specific adjudication method by human experts (like 2+1 or 3+1) is mentioned in the document. The determination of "positive" or "negative" from the reference methods (GC/MS or LC/MS/MS) serves as the definitive ground truth for both precision and clinical studies. Discrepancies between the device and the reference standard were simply reported as "discordant results."

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

• No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The device is for in vitro diagnostic use, and the "Reader System" refers to an automated instrument that interprets the results, not human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The document explicitly states: "The test devices cannot be read visually." and "the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result." This indicates that the GenPrime DOA Reader System (which includes the software algorithm) operates as a standalone device to interpret the results without human interpretation of the test lines.

7. Type of Ground Truth Used

• Chemical/Instrumental Analysis (Gold Standard): The primary ground truth for both precision and clinical studies was established using highly accurate chemical analysis methods: Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC/MS/MS). These are considered gold standard methods for drug concentration confirmation.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" for the device's algorithm. The precision and clinical studies described appear to be validation studies rather than data used for initial algorithm development or training. Immunochromatographic tests typically rely on pre-defined thresholds and chemical reactions rather than machine learning algorithms that require explicit training sets. The "software algorithm" likely operates on fixed parameters derived from extensive research and development rather than a dynamic training process described for AI.

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

• As a training set is not explicitly mentioned or implied for a machine learning-based algorithm, how its ground truth was established is not detailed. For typical immunochromatographic tests with an automated reader, the 'training' process involves calibrating the reader to accurately detect the visual signal (colored lines) produced by known concentrations of analytes, which would have been established through controlled experimental protocols using chemically verified samples (similar to how the test set ground truth was established by GC/MS/LC/MS/MS).

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The GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, GenPrime DOA Windows compatible software and compatible qualitative immunochromatographic, OS Cup and Split Key Cup (SK Cup) test devices. The GenPrime DOA Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. The GenPrime DOA Reader and compatible DOA test devices qualitatively detect drug classes in human urine at the cutoff concentrations shown below:

OS Cun

SK Cup

Configurations of the OS Cup and SK Cup may consist of any combination of the above listed drug analytes associated with the respective cup.

The GenPrime DOA reader system provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GCMS), high performance liquid chromatography (HPLC) or liquid chromatography / mass spectronetry (LCMS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flat bed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is currently intended for use with two test devices, the OS Cup and the Split Key Cup, both of which are rapid, single use, disposable immunochromatographic tests for the qualitative detection of drugs of abuse in human urine.

An image of a compatible test device is captured and the software algorithm determines from the image whether the presence or absence of colored test lines is associated with a positive or negative result for each analyte on a test format. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use.

Acceptance Criteria and Device Performance Study for GenPrime Drugs of Abuse Reader System

This report details the acceptance criteria and the study that demonstrates the GenPrime Drugs of Abuse (DOA) Reader System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by the reported "Agreement with Reference" values in the clinical method comparison study. These represent the percentage of cases where the GenPrime DOA Reader System's result matched the reference method (GC/MS or LC/MS/MS). The target for this "Agreement with Reference" is not explicitly stated as a numerical acceptance criterion, but the reported values demonstrate high agreement, indicating successful performance in the context of a preliminary screening device.

Table: GenPrime DOA Reader System Performance (Agreement with Reference)

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

The clinical method comparison study, which serves as the primary performance evaluation, utilized the following sample sizes:

• For each drug analyte: A minimum of 40 unaltered positive and 40 unaltered negative clinical urine samples were assessed.
  • For the OS Cup, with 5 drug analytes, this translates to a minimum of 400 samples (200 positive, 200 negative) being tested. The "All Drugs" summary in Table 7 shows 240 negative and 259 positive GenPrime tests, suggesting a total of 499 samples for OS Cup.
  • For the SK Cup, with 8 drug analytes, this translates to a minimum of 640 samples (320 positive, 320 negative) being tested. The "All Drugs" summary in Table 8 shows 360 negative and 379 positive GenPrime tests, suggesting a total of 739 samples for SK Cup.
• Data Provenance: The study used clinical urine samples. The country of origin is not explicitly stated, but the context of an FDA submission implies data relevant to the US market. The samples were retrospective in the sense that they were "blind coded clinical urine samples that contained varying concentrations of drugs as determined by GC/MS or LC/MS/MS" prior to testing with the GenPrime device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The ground truth for the test set was established using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS/MS). These are highly accurate reference methods for drug detection. The submission does not specify the number of experts (e.g., laboratory personnel, toxicologists) or their qualifications beyond stating these methods were used to determine the drug concentrations. However, these methods are typically performed by highly trained laboratory professionals.

4. Adjudication Method for the Test Set

The ground truth was established by GC/MS or LC/MS/MS, which are considered definitive chemical confirmation methods. There is no mention of a human adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth from these analytical methods, as they themselves serve as the gold standard. For negative samples, some were screened by EIA and 10% of those were confirmed by GC/MS or LC/MS/MS, suggesting a tiered approach to confirming negative results.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is an automated reader system for lateral flow tests, and the study focuses on its standalone analytical accuracy compared to reference laboratory methods, not on how human readers' performance improves with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire clinical method comparison outlined in Tables 7, 8, 9, and 10 evaluates the performance of the GenPrime DOA Reader System (which includes the software algorithm) without human interpretation of the test lines. The system itself reads the image of the test and outputs a result ("presumptive positive" or "negative"). The critical characteristic, as stated in the device description, is that "The GenPrime DOA Reader System test devices cannot be read visually," highlighting that the algorithm's interpretation is essential.

7. Type of Ground Truth Used

The type of ground truth used was analytical confirmation by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS/MS). For negative samples, EIA screening was initially used, with a subset (10%) confirmed by GC/MS or LC/MS/MS. This is considered a high-fidelity ground truth for drug identification and quantification in toxicology.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set of the GenPrime DOA Reader's algorithm. The provided information focuses solely on the performance evaluation using a distinct test set.

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

The document does not provide details on how the ground truth for the training set was established. Given the nature of medical device development, it is typically established through similar highly accurate analytical methods as the test set (GC/MS, LC/MS/MS) during the development and optimization phases of the device and its algorithms. However, this information is not explicitly included in the provided 510(k) summary.

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