(340 days)
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
| AMP | Amphetamine (d-Amphetamine) | 500 ng/mL |
|---|---|---|
| BAR | Barbiturates (Secobarbital) | 300 ng/mL |
| COC | Cocaine (Benzoylecgonine) | 150 ng/mL |
| MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL |
| THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL |
SK Cup
| AMP | Amphetamine (d-Amphetamine) | 500 ng/mL |
|---|---|---|
| MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL |
| MTD | Methadone | 300 ng/mL |
| MOP 300 | Morphine | 300 ng/mL |
| MOP 2000 | Morphine | 2000 ng/mL |
| OXY | Oxycodone (Oxycodone) | 100 ng/mL |
| PCP | Phencyclidine (Phencyclidine) | 25 ng/mL |
| THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL |
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)
| Drug Analyte (Cutoff) | GenPrime OS Cup Agreement with Reference | GenPrime SK Cup Agreement with Reference |
|---|---|---|
| AMP (500 ng/mL) | 100% (Positive), 94% (Negative) | 100% (Positive), 92% (Negative) |
| BAR (300 ng/mL) | 100% (Positive), 95% (Negative) | N/A (Not in SK Cup) |
| COC (150 ng/mL) | 100% (Positive), 93% (Negative) | N/A (Not in SK Cup) |
| MET (500 ng/mL) | 100% (Positive), 96% (Negative) | 100% (Positive), 98% (Negative) |
| THC (50 ng/mL) | 100% (Positive), 100% (Negative) | 97.6% (Positive), 100.0% (Negative) |
| MTD (300 ng/mL) | N/A (Not in OS Cup) | 100% (Positive), 100% (Negative) |
| MOP (300 ng/mL) | N/A (Not in OS Cup) | 98% (Positive), 98% (Negative) |
| MOP (2000 ng/mL) | N/A (Not in OS Cup) | 100% (Positive), 96% (Negative) |
| OXY (150 ng/mL) | N/A (Not in OS Cup) | 100% (Positive), 95% (Negative) |
| PCP (25 ng/mL) | N/A (Not in OS Cup) | 100.0% (Positive), 100.0% (Negative) |
| All Drugs Combined | 100% (Positive), 95.8% (Negative) | 99.5% (Positive), 97.1% (Negative) |
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.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).