(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.
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II. 510(k) Summary
-
- APPLICANT'S INFORMATION: GenPrime, Inc 502 W. Riverside Avenue, #101 Spokane, WA 99201 PH: 866-624-9855 FX: 509-462-2847 E-mail: dmclean@genprime.com Internet: www.genprime.com Establishment Registration No .: Not yet assigned.
- SUBMITTER'S INFORMATION Maureen Garner President New World Regulatory Solutions, Inc. P.O. Box 5374 Toms River, NJ 08754 PH: 732-779-7422 Fax: 732-270-4829 E-mail: NWRSinc@gmail.com Internet: www.newworldreg.com
-
- DATE PREPARED: December 16, 2013
4. DEVICE INFORMATION
DEVICE NAME: GenPrime Drugs of Abuse Reader System
Common Name: Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use
Classification Panel: Clinical Toxicology (91) and Clinical Chemistry (75)
Classification Names: Regulatory information applicable to the test system is provided below:
| CFR Section | Product Code |
|---|---|
| Densitometer/scanner (integrating, reflectance, TLC, orradiochromatogram) for clinical use | JQT |
| 862.3100, Amphetamine Test System | DKZ |
| 862.3150, Barbiturate Test System | DIS |
| 862.3250, Cocaine and cocaine metabolite Test System | DIO |
| 862.3620, Methadone Test System | DJR |
| 862.3610, Methamphetamine Test System | DJC |
| 862.3640, Morphine Test System | DNK |
| 862.3650, Opiate Test System | DJG |
| Unclassified, Phencyclidine Test System | LCM |
| 862.3870, Cannabinoid Test System | LDJ |
DEVICE CLASSIFICATION: Class II
PREDICATE DEVICE: PROFILE®-V MEDTOXScan® Drugs of Abuse Test System,(K080635) ഗ്
DEC 2 0 2013
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DEVICE DESCRIPTION:
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.
OS Cup device
The GenPrime DOA Reader System detects drug classes at the following cutoff concentrations for the OS Cup device:
| 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 |
Configurations of the OS Cup may consist of any combination of the above listed drug analytes. Refer to specific product labeling for the combination of drug tests included in that test device.
Split Key Cup device
The GenPrime DOA Reader System detects drug classes at the following cutoff concentrations for the Split Key Cup device:
| AMP | Amphetamine (d-Amphetamine) | 500 ng/mL |
|---|---|---|
| MTD | Methadone (Methadone) | 300 ng/mL |
| MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL |
| MOP300 | Morphine | 300 ng/mL |
| MOP2000 | 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 Split Key Cup may consist of any combination of the above listed drug analytes. Refer to specific product labeling for the combination of drug tests included in that test device.
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INDICATIONS FOR USE:
The GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, Windows -compatible Software GenPrime DOA compatible 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 thecounter 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 Cup | ||
|---|---|---|
| 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 |
| MOP300 | Morphine | 300 ng/mL |
| MOP2000 | 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 (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 DOA Reader compatible test devices are identified using barcodes and/or label(s) on the panel housing. The GenPrime DOA Reader and Software use characteristics from this labeling to measure the quality of each image as it is generated. This ensures that each test result obtained and interpreted by the System has been first checked for its quality.
Special conditions for use statement(s):
The device is for in vitro diagnostic prescription use.
The GenPrime DOA Reader System test devices cannot be read visually.
The GenPrime DOA Reader System only provides 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 test is not intended for over-the-counter use.
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Special instrument requirements:
- . The GenPrime DOA Reader is required.
- The GenPrime DOA Reader Software must be loaded onto a PC, laptop computer or . Windows compatible device meeting the following minimum requirements:
GenPrime DOA Reader Software System Requirements
Operating System
MS Windows® XP with Service Pack 3, MS Windows® Vista, or MS Windows® 7
PC
Minimum Processor: Intel® Pentium® 4 1.5 GHz or equivalent
Minimum RAM: 1 GB
Free hard disc space: minimum of 50 MB at Installation, needs additional disc space while operating; an additional 850 MB necessary for installation of MS .NET Framework 4.0
Mouse for optimal interaction with user interface (e.g. IntelliMouse® / Microsoft®)
Standard keyboard with cursor keys, Num-Pad and Insert-, Delete-, Page up/down keys. Recommended with cable.
Minimum: 1 USB 2.0-compatible port
External Software
PDF-Compatible viewing application, i.e. Adobe Reader
8. DISCUSSION OF TECHNOLOGICAL CHARACTERISTICS:
प Similarities and differences to predicate device
Both the applicant and the predicate test systems are used to detect the presence of drugs of abuse and their metabolites in human urine. In both systems, a urine sample is added to the test device and allowed to react for a specified period of time, after which an instrument is used to read the test device and interpret and display the test result. Both the applicant and predicate test device are rapid single use disposable devices that use established immunochromatographic lateral flow technology. Both the applicant and predicate test utilize gold-conjugated reagents to generate reddish-purple test and control lines, which are read by the instrument. Both devices are competitive assays where concentration of drug is inversely related to the signal detected by the instrument. The applicant device measures line intensities using image analysis algorithms and then performs the analysis and outputs the results via a Windows compatible compatible compatible computer. The predicate device uses a CIS (contact imaging sensor) to measure line intensity and performs the analysis and outputs results using an embedded operating system and display. The applicant device requires that the operator manually time test development (5 minutes) and then operate the instrument, while the predicate instrument internally times test strip development (10 minutes) and then scans the test cassette. The overall performance and characteristics of the GenPrime DOA Reader System and the predicate device, the MEDTOXScan® are summarized in Table 1 below:
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| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Determines qualitative positive or negative resultfrom drugs of abuse immunoassay screens | Determines qualitative positiveor negative result from drugs ofabuse immunoassay screens |
| Single-UseTest Device | Produces colored lines on device. | Same |
| Assay Type | Competitive assay where concentration of drug isinversely related to the visible signal detected bythe instrument. | Same |
| SystemProcedure | Sample is added to a single use test device, whichis then read by instrument. Instrument is designedto read multiple single use test devices, one at atime. | Same |
| MeasurementMethod | Scans the single-use test device to detect a signal. | Same |
| Differences | ||
| Item | Device | Predicate |
| Test DeviceFormat | Reads multiple formats of single-use test devicesin different cup formats. | Reads a single-use testcassette. |
| Test Time andTiming Method | Operator manually times test development for 5minutes and then operates the instrument. | Instrument internally times teststrip development for 10minutes and then scans the testcassette. |
| DetectionMethod | Measures density of visible lines againstbackground on single-use test device. | Measures reflectance of visiblelines on single use testcassette. |
| Output | Outputs "presumptive positive", "negative", and"invalid" test results on a graphic user interfacedisplayed on a computer screen and automaticallystores results along with test information. Operatorhas ability to print and/or export results. | Outputs "positive," "negative,”and "invalid" test results onpaper printout or LCD screen:stores and uploads results. |
| Cutoff values | BAR cutoff is 300ngMTD cutoff is 300ng | BAR cutoff is 200ngMTD cutoff is 200ng |
| PowerRequirements | AC power only | AC or battery power |
| AdditionalRequirements | Windows®-based computer and cable accessories | None. |
Table 1. Comparison of Similarities and Difference for the GenPrime DOA Reader System and predicate system.
GenPrime believes that the technological characteristics of the GenPrime DOA Reader System are substantially similar to those of the predicate device.
9. DISCUSSION OF NON-CLINICAL TESTS PERFORMED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
Laboratory performance studies were conducted to determine the substantial equivalence of the GenPrime Drugs of Abuse Reader System to the predicate system. These studies are as follows:
Sensitivity/Precision/Distribution of Random Error
The precision studies were performed in the hands of the intended users at at three sites representative of laboratory, workplace, and POC settings. The studies were performed with a minimum of two skilled intended use operators per site. The operators performed the ten a following the instructions for use, which are included with the GenPrime DOA Reader and with each test device intended for use with the GenPrime DOA Reader System.
The clinical protocols and details for the POC sites and the operators where the studies were conducted are provided in Section XVII, Performance Testing, Clinical, below.
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Precision studies were performed with the target analytes at 0%, 25%, 50%, 150%, 175%, and 200% of the cutoff during a 20 working day period. The identity of the samples was masked from the operator. Each urine specimen was labeled with a unique alpha-numeric sample ID prior to delivery to the POC sites.
Performance of the GenPrime DOA Reader was evaluated for each drug analyte by testing each drug at the stated concentration using a minimum of 10 tests per operator. Each of the operators used a different GenPrime DOA Reader. Results for this study are summarized in Tables 2a and 2b below:
| OS Cup, AMP (500 ng/mL) | |||||
|---|---|---|---|---|---|
| % ofCutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 65 | 65 | 0 | 100% |
| 25% | 100 | 57 | 57 | 0 | 100% |
| 50% | 250 | 57 | 57 | 0 | 100% |
| 75% | 375 | 57 | 19 | 38 | 33.3% |
| 125% | 625 | 58 | 2 | 56 | 96.6% |
| 150% | 750 | 58 | 0 | 58 | 100% |
| 175% | 875 | 57 | 0 | 57 | 100% |
| 200% | 1000 | 57 | 0 | 57 | 100% |
| OS Cup, BAR (300 ng/mL) | |||||
| % ofCutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 65 | 65 | 0 | 100% |
| 25% | 75 | 57 | 57 | 0 | 100% |
| 50% | 150 | 57 | 57 | 0 | 100% |
| 75% | 225 | 57 | 22 | 35 | 38.6% |
| 125% | 375 | 58 | 3 | 55 | 94.8% |
| 150% | 450 | 58 | 0 | 58 | 100% |
| 175% | 525 | 57 | 0 | 57 | 100% |
| 200% | 600 | 57 | 0 | 57 | 100% |
| OS Cup, COC (150 ng/mL) | |||||
| % ofCutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 65 | 65 | 0 | 100% |
| 25% | 37.5 | 57 | 57 | 0 | 100% |
| 50% | 75 | 57 | 57 | 0 | 100% |
| 75% | 112.5 | 57 | 14 | 43 | 24.6% |
| 125% | 187.5 | 58 | 1 | 57 | 98.3% |
| 150% | 225 | 58 | 0 | 58 | 100% |
| 175% | 262.5 | 57 | 0 | 57 | 100% |
| 200% | 300 | 57 | 0 | 57 | 100% |
| OS Cup, MET (500 ng/mL) | |||||
| % ofCutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 65 | 65 | 0 | 100% |
| 25% | 100 | 57 | 57 | 0 | 100% |
| 50% | 250 | 57 | 57 | 0 | 100% |
| 75% | 375 | 57 | 18 | 39 | 31.6% |
| 125% | 625 | 58 | 0 | 58 | 100% |
| 150% | 750 | 58 | 0 | 58 | 100% |
| 175% | 875 | 57 | 0 | 57 | 100% |
| 200% | 1000 | 57 | 0 | 57 | 100% |
| OS Cup, THC (50 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 65 | 65 | 0 | 100% |
| 25% | 12.5 | 57 | 57 | 0 | 100% |
| 50% | 25 | 57 | 57 | 0 | 100% |
| 75% | 37 | 57 | 46 | 11 | 80.7% |
| 125% | 62 | 58 | 7 | 51 | 87.9% |
| 150% | 75 | 58 | 0 | 58 | 100% |
| 175% | 87.5 | 57 | 0 | 57 | 100% |
| 200% | 100 | 57 | 0 | 57 | 100% |
Table 2a. Sensitivity/Precision/Distribution of Random Error for the OS Cup
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Table 2a. Sensitivity/Precision/Distribution of Random Error for the OS Cup, continued
Table 2b. Sensitivity/Precision/Distribution of Random Error for the SK Cup
SK Cup. AMP (500 ng/ml)
r
| SK Cup, AMP (500 ng/mL) | |||||
|---|---|---|---|---|---|
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 100 | 88 | 88 | 0 | 100% |
| 50% | 250 | 84 | 84 | 0 | 100% |
| 75% | 375 | 85 | 47 | 38 | 55.3% |
| 125% | 625 | 84 | 3 | 81 | 96.4% |
| 150% | 750 | 85 | 0 | 85 | 100% |
| 175% | 875 | 87 | 0 | 87 | 100% |
| 200% | 1000 | 89 | 0 | 89 | 100% |
| SK Cup, MET (500 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 100 | 88 | 88 | 0 | 100% |
| 50% | 250 | 84 | 84 | 0 | 100% |
| 75% | 375 | 85 | 57 | 28 | 67.1% |
| 125% | 625 | 84 | 4 | 80 | 95.2% |
| 150% | 750 | 85 | 0 | 85 | 100% |
| 175% | 875 | 87 | 0 | 87 | 100% |
| 200% | 1000 | 89 | 0 | 89 | 100% |
| SK Cup, MTD (300 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 75 | 88 | 88 | 0 | 100% |
| 50% | 150 | 84 | 84 | 0 | 100% |
| 75% | 225 | 85 | 72 | 13 | 84.7% |
| 125% | 375 | 84 | 10 | 74 | 88.1% |
| 150% | 450 | 85 | 0 | 85 | 100% |
| 175% | 525 | 87 | 0 | 87 | 100% |
| 200% | 600 | 89 | 0 | 89 | 100% |
| SK Cup, MOP (300 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 75 | 45 | 45 | 0 | 100% |
| 50% | 150 | 45 | 43 | 2 | 96% |
| 75% | 225 | 46 | 29 | 17 | 63.0% |
| 125% | 375 | 45 | 4 | 41 | 91.1% |
| 150% | 450 | 45 | 1 | 44 | 98% |
| 175% | 525 | 45 | 0 | 45 | 100% |
| 200% | 600 | 46 | 0 | 46 | 100% |
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| SK Cup, MOP (2000 ng/mL) | |||||
|---|---|---|---|---|---|
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 500 | 88 | 88 | 0 | 100% |
| 50% | 1000 | 84 | 84 | 0 | 100% |
| 75% | 1500 | 85 | 63 | 22 | 74.1% |
| 125% | 2500 | 84 | 11 | 73 | 86.9% |
| 150% | 3000 | 85 | 0 | 85 | 100% |
| 175% | 3500 | 87 | 0 | 87 | 100% |
| 200% | 4000 | 89 | 0 | 89 | 100% |
| SK Cup, OXY (100 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 25 | 88 | 88 | 0 | 100% |
| 50% | 50 | 84 | 84 | 0 | 100% |
| 75% | 75 | 85 | 57 | 28 | 67.1% |
| 125% | 125 | 84 | 15 | 69 | 82.1% |
| 150% | 150 | 85 | 0 | 85 | 100% |
| 175% | 175 | 87 | 0 | 87 | 100% |
| 200% | 200 | 89 | 0 | 89 | 100% |
| SK Cup, PCP (25 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 6.25 | 88 | 88 | 0 | 100% |
| 50% | 12.5 | 84 | 84 | 0 | 100% |
| 75% | 18.75 | 85 | 50 | 35 | 58.8% |
| 125% | 31.25 | 84 | 6 | 78 | 92.9% |
| 150% | 37.5 | 85 | 0 | 85 | 100% |
| 175% | 43.75 | 87 | 0 | 87 | 100% |
| 200% | 50 | 89 | 0 | 89 | 100% |
| SK Cup, THC (50 ng/mL) | |||||
| % of Cutoff | ng/mL | N | # NEG | # POS | Precision |
| NEG | 0 | 86 | 86 | 0 | 100% |
| 25% | 12.5 | 88 | 88 | 0 | 100% |
| 50% | 25 | 84 | 84 | 0 | 100% |
| 75% | 37 | 85 | 63 | 22 | 74.1% |
| 125% | 62 | 84 | 14 | 70 | 83.3% |
| 150% | 75 | 85 | 0 | 85 | 100% |
| 175% | 87.5 | 87 | 0 | 87 | 100% |
| 200% | 100 | 89 | 0 | 89 | 100% |
Table 2b. Sensitivity/Precision/Distribution of Random Error for the SK Cup, continued
Related Compounds and Cross Reactants
Analytical specificity studies were performed to determine whether drugs and drug metabolites within the same class of drugs or with similar molecular structures cross-react in the test system. Results are expressed as the minimum concentration required to produce a positive result in the indicated assay.
Reference standards for the various metabolites and compounds were prepared at 100 µg/mL in pooled negative human urine samples. Compounds that tested positive were serially diluted until a negative result was observed. Resuits shown are expressed as the minimum concentration producing a positive result in the indicated assay. A list of these compounds and their level of cross reactivity is shown for the OS Cup in Table 3 below and for the Split Key Cup in Table 4 below.
{8}------------------------------------------------
| Related Compound or Cross-Reactant | Result | % Cross Reactive |
|---|---|---|
| Amphetamines (AMP)(d-Amphetamine) 500 ng/mL | ||
| 3,4-Methylendioxyamphetamine (MDA) | Positive at 500 ng/mL | 100% |
| Amphetamine (d,l) | Positive at 1000 ng/mL | 50% |
| Phentermine | Positive at 2250 ng/mL | 22% |
| b-Phenylethylamine (phenethylamine) | Positive at 50000 ng/mL | 1% |
| 3,4-methylenedioxy-N-ethylamphetamine-MDEA | Negative at 100000 ng/mL | N/A |
| Amphetamine (1) | Negative at 100000 ng/mL | N/A |
| (1R,2S)-(-)-Ephedrine | Negative at 100000 ng/mL | N/A |
| 3,4-Methylenedioxymethamphetamine (MDMA) | Negative at 100000 ng/mL | N/A |
| Fenfluramine | Negative at 100000 ng/mL | N/A |
| Methamphetamine (d) | Negative at 100000 ng/mL | N/A |
| Methamphetamine (1) | Negative at 100000 ng/mL | N/A |
| Tryptamine | Negative at 100000 ng/mL | N/A |
| Tyramine | Negative at 100000 ng/mL | N/A |
| Barbiturate (BAR) (Secobarbital) (300 ng/mL) | ||
| Butabarbital | Positive at 75 ng/mL | 400% |
| Butethal | Positive at 250 ng/mL | 120% |
| Pentobarbital | Positive at 250 ng/mL | 120% |
| Phenobarbital | Positive at 250 ng/mL | 120% |
| Aprobarbital | Positive at 400 ng/mL | 75% |
| Barbital | Positive at 500 ng/mL | 60% |
| Alphenal | Positive at 600 ng/mL | 50% |
| Amobarbital | Positive at 850 ng/mL | 35% |
| Cyclopentobarbital | Positive at 1500 ng/mL | 20% |
| Allobarbital | Positive at 3500 ng/mL | 9% |
| Butalbital | Positive at 11000 ng/mL | 3% |
| Mephobarbital | Positive at 100000 ng/mL | 0% |
| Barbituric Acid | Negative at 100000 ng/mL | N/A |
| Glutethimide | Negative at 100000 ng/mL | N/A |
| Hexobarbital | Negative at 100000 ng/mL | N/A |
| Phenytoin (diphenylhydantoin) | Negative at 100000 ng/mL | N/A |
| Thiopental | Negative at 100000 ng/mL | N/A |
| Cocaine (COC) (Benzoylecgonine) 150 ng/mL | ||
| Cocaethylene | Positive at 4000 ng/mL | 4% |
| Cocaine | Positive at 10000 ng/mL | 2% |
| Ecgonine | Positive at 10000 ng/mL | 2% |
| Ecgonine Methyl Ester | Negative at 100000 ng/mL | N/A |
| Methamphetamines (MET) (d-Methamphetamine) 500 ng/mL | ||
| 3,4-Methylenedioxymethamphetamine (MDMA) | Positive at 1250 ng/mL | 40% |
| Methamphetamine (1) | Positive at 6000 ng/mL | 8% |
| 3,4-methylenedioxy-N-ethylamphetamine-MDEA | Positive at 25000 ng/mL | 2% |
| b-Phenylethylamine (phenethylamine) | Positive at 25000 ng/mL | 2% |
| p-Hydroxymethamphetamine | Positive at 25000 ng/mL | 2% |
| Amphetamine (d) | Positive at 50000 ng/mL | 1% |
| Chloroquine | Positive at 50000 ng/mL | 1% |
| Mephentermine | Positive at 50000 ng/mL | 1% |
| 3,4-Methylendioxyamphetamine (MDA) | Negative at 100000 ng/mL | N/A |
| Amphetamine (d,l) | Negative at 100000 ng/mL | N/A |
| Amphetamine (1) | Negative at 100000 ng/mL | N/A |
| Ephedrine | Negative at 100000 ng/mL | N/A |
| Fenfluramine | Negative at 100000 ng/mL | N/A |
| Phenmetrazine | Negative at 100000 ng/mL | N/A |
| Phentermine | Negative at 100000 ng/mL | N/A |
| Phenylephrine (1) | Negative at 100000 ng/mL | N/A |
| Procaine | Negative at 100000 ng/mL | N/A |
| Table 3. US Cup Related Compounds and Cross-Reactants, continued | ||
| Related Compound or Cross-Reactant | Result | % Cross Reactive |
| Marijuana (THC) (11-nor-D9-THC-9 COOH) 50 ng/mL | ||
| 11-nor-D8-THC-9 COOH | Positive at 50 ng/mL | 100% |
| 11-Hydroxy- Δ9-THC | Positive at 5000 ng/mL | 1% |
| Cannabinol | Positive at 20000 ng/mL | 0% |
| Δ9-THC | Negative at 100000 ng/mL | N/A |
| Cannabidiol | Negative at 100000 ng/mL | N/A |
| Δ8-THC | Negative at 100000 ng/mL | N/A |
.
Table 3. OS Cup Related Compounds and Cross-Reactants
{9}------------------------------------------------
Table 3. OS Cup Related Compounds and Cro 0
Table 4. Split Key Cup Related Compounds and Cross-Reactants
| Related Compound or Cross-Reactant | Result | % Cross Reactive |
|---|---|---|
| Amphetamines (AMP) | (d-Amphetamine) 500 ng/mL | |
| Amphetamine (d,l) | Positive at 1000 ng/mL | 50% |
| 3,4-Methylendioxyamphetamine (MDA) | Positive at 4000 ng/mL | 13% |
| b-Phenylethylamine (phenethylamine) | Positive at 25000 ng/mL | 2% |
| 3,4-methylenedioxy-N-ethylamphetamine-MDEA | Negative at 100000 ng/mL | 1% |
| (1R,2S)-(-)-Ephedrine | Negative at 100000 ng/mL | N/A |
| 3,4-Methylenedioxymethamphetamine (MDMA) | Negative at 100000 ng/mL | N/A |
| Amphetamine (I) | Negative at 100000 ng/mL | N/A |
| Fenfluramine | Negative at 100000 ng/mL | N/A |
| Methamphetamine (d) | Negative at 100000 ng/mL | N/A |
| Methamphetamine (I) | Negative at 100000 ng/mL | N/A |
| Phentermine | Negative at 100000 ng/mL | N/A |
| Tryptamine | Negative at 100000 ng/mL | N/A |
| Tyramine | Negative at 100000 ng/mL | N/A |
| (d-Methamphetamine) 500 ng/mL | ||
| 3,4-Methylenedioxymethamphetamine (MDMA) | Positive at 1000 ng/mL | 50% |
| Methamphetamine (I) | Positive at 5000 ng/mL | 10% |
| p-Hydroxymethamphetamine | Positive at 15000 ng/mL | 3% |
| b-Phenylethylamine (phenethylamine) | Positive at 50000 ng/mL | 1% |
| Chloroquine | Positive at 50000 ng/mL | 1% |
| Mephentermine | Positive at 50000 ng/mL | 1% |
| 3,4-Methylendioxyamphetamine (MDA) | Negative at 100000 ng/mL | N/A |
| 3,4-methylenedioxy-N-ethylamphetamine-MDEA | Negative at 100000 ng/mL | N/A |
| Amphetamine (d,l) | Negative at 100000 ng/mL | N/A |
| Amphetamine (d) | Negative at 100000 ng/mL | N/A |
| Amphetamine (I) | Negative at 100000 ng/mL | N/A |
| Ephedrine | Negative at 100000 ng/mL | N/A |
| Fenfluramine | Negative at 100000 ng/mL | N/A |
| Methamphetamines (MET) (d-Methamphetamine) 500 ng/mL, continued | ||
| Phenmetrazine | Negative at 100000 ng/mL | N/A |
| Phentermine | Negative at 100000 ng/mL | N/A |
| Phenylephrine (I) | Negative at 100000 ng/mL | N/A |
| Procaine | Negative at 100000 ng/mL | N/A |
| Tyramine | Negative at 100000 ng/mL | N/A |
{10}------------------------------------------------
| Related Compound or Cross-Reactant | Result | % Cross Reactive |
|---|---|---|
| Morphine (MOP) (Morphine) 300 ng/mL | ||
| Morphine 6-β-D-Glucuronide | Positive at 250 ng/mL | 120% |
| 6-Monoacetylmorphine (6-MAM) | Positive at 300 ng/mL | 100% |
| Codeine | Positive at 300 ng/mL | 100% |
| Diacetyimorphine | Positive at 500 ng/mL | 60% |
| Dihydrocodeine | Positive at 2500 ng/mL | 12% |
| Morphine 3-β-D-Glucuronide | Positive at 3000 ng/mL | 10% |
| Ethylmorphine | Positive at 5000 ng/mL | 6% |
| Hydromorphone | Positive at 10000 ng/mL | 3% |
| Thebaine | Positive at 20000 ng/mL | 2% |
| Hydrocodone | Positive at 25000 ng/mL | 1% |
| Nalorphine | Positive at 50000 ng/mL | 1% |
| Apomorphine | Negative at 100000 ng/mL | N/A |
| Levorphanol (tartrate dihydrate) | Negative at 100000 ng/mL | 0% |
| Naloxone | Negative at 100000 ng/mL | N/A |
| Naltrexone | Negative at 100000 ng/mL | N/A |
| Norcodeine | Negative at 100000 ng/mL | N/A |
| Norhydrocodone | Negative at 100000 ng/mL | N/A |
| Normorphine | Negative at 100000 ng/mL | N/A |
| Noroxymorphone | Negative at 100000 ng/mL | N/A |
| Oxycodone | Negative at 100000 ng/mL | N/A |
| Oxymorphone | Negative at 100000 ng/mL | N/A |
| Procaine | Negative at 100000 ng/mL | N/A |
| Methadone (MTD) (Methadone) 300 ng/mL | ||
| Buprenorphine (MTD Replacement) | Negative at 100000 ng/mL | N/A |
| EDDP (Primary Metabolite) | Negative at 100000 ng/mL | N/A |
| EMDP (Secondary Metabolite) | Negative at 100000 ng/mL | N/A |
| Morphine (MOP) | (Morphine) 2000 ng/mL | |
| Morphine 6-β-D-Glucuronide | Positive at 2500 ng/mL | 80% |
| Nalorphine | Positive at 2500 ng/mL | 80% |
| Codeine | Positive at 3000 ng/mL | 67% |
| Hydromorphone | Positive at 4000 ng/mL | 50% |
| 6-MonoacetyImorphine (6-MAM) | Positive at 5000 ng/mL | 40% |
| Dihydrocodeine | Positive at 5000 ng/mL | 40% |
| Ethylmorphine | Positive at 5000 ng/mL | 40% |
| Morphine 3-β-D-Glucuronide | Positive at 5000 ng/mL | 40% |
| Normorphine | Positive at 10000 ng/mL | 20% |
| Hydrocodone | Positive at 12500 ng/mL | 16% |
| Diacetylmorphine | Positive at 15000 ng/mL | 13% |
| Norcodeine | Positive at 15625 ng/mL | 13% |
| Oxymorphone | Positive at 25000 ng/mL | 8% |
| Thebaine | Positive at 25000 ng/mL | 8% |
| Apomorphine | Negative at 100000 ng/mL | N/A |
| Levorphanol (tartrate dihydrate) | Negative at 100000 ng/mL | N/A |
| Naloxone | Negative at 100000 ng/mL | N/A |
| Naltrexone | Negative at 100000 ng/mL | N/A |
| Norhydrocodone | Negative at 100000 ng/mL | N/A |
| Noroxymorphone | Negative at 100000 ng/mL | N/A |
| Oxycodone | Negative at 100000 ng/mL | N/A |
| Procaine | Negative at 100000 ng/mL | N/A |
| Related Compound or Cross-Reactant | Result | % Cross Reactive |
| Oxycodone (OXY) (Oxycodone) 100 ng/mL | ||
| Oxymorphone | Positive at 400 ng/mL | 25% |
| Noroxymorphone | Positive at 2500 ng/mL | 4% |
| Hydrocodone | Positive at 12500 ng/mL | 1% |
| Naloxone | Positive at 37500 ng/mL | 0% |
| Hydromorphone | Positive at 50000 ng/mL | 0% |
| Levorphanol | Positive at 50000 ng/mL | 0% |
| Naltrexone | Positive at 50000 ng/mL | 0% |
| Norhydrocodone | Positive at 50000 ng/mL | 0% |
| 6-Monoacetylmorphine | Negative at 100000 ng/mL | N/A |
| Apomorphine | Negative at 100000 ng/mL | N/A |
| Codeine | Negative at 100000 ng/mL | N/A |
| Diacetylmorphine | Negative at 100000 ng/mL | N/A |
| Dihydrocodeine | Negative at 100000 ng/mL | N/A |
| Ethylmorphine | Negative at 100000 ng/mL | N/A |
| Morphine | Negative at 100000 ng/mL | N/A |
| Morphine 3-β-D-Glucuronide | Negative at 100000 ng/mL | N/A |
| Morphine 6-β-D-Glucuronide | Negative at 100000 ng/mL | N/A |
| Nalorphine | Negative at 100000 ng/mL | N/A |
| Norcodeine | Negative at 100000 ng/mL | N/A |
| Normorphine | Negative at 100000 ng/mL | N/A |
| Thebaine | Negative at 100000 ng/mL | N/A |
| Phencyclidine (PCP)(Phencyclidine) 25 ng/mL | ||
| 4-Hydroxyphencyclidine | Positive at 1500 ng/mL | 2% |
| Marijuana (THC) (11-Nor-9-carboxy-Δ9-THC) 50 ng/mL | ||
| 11-Hydroxy- Δ9-THC | Positive at 5000 ng/mL | 1% |
| 11-nor-D8-THC-9 COOH | Positive at 5000 ng/mL | 1% |
| Cannabinol | Positive at 20000 ng/mL | 0% |
| Cannabidiol | Negative at 100000 ng/mL | N/A |
| Δ8-THC | Negative at 100000 ng/mL | N/A |
| Δ9-THC | Negative at 100000 ng/mL | N/A |
Table 4. Split Key Cup Related Compounds and Cross-Reactants, continued
{11}------------------------------------------------
Table 4. Split Key Cup Related Compounds and Cross-Reactants, continued
Interference Data
pH and Specific Gravity
The GenPrime DOA Reader System was assayed with pH values of 3.0. 4.0. 7.0 and 9.0 ± 0.1. Each sample was assayed in triplicate. The pH samples were fortified with drug concentrations at 50% (negative) and 150% (positive) of cutoff. For both the OS and SK Cups, all four pH samples gave negative results in the 50% of cutoff level for each drug, and all gave positive results at the 150% of cutoff level for each drug.
The GenPrime DOA Reader System was assayed in triplicate with specific gravity values of 1.003, 1.015 and 1.030 ± 0.001. The specific gravity samples were fortified with drug concentrations as described above for pH to give strong negative and strong positive results. All three specific gravity samples gave negative results when fortified to the maximum strong negative level for each drug, and all gave positive results when fortified to the minimum strong positive level for each drug.
Common Drugs
Drug free urine samples were spiked with drug concentrations that were at 50% (negative) and 150% (positive) of cutoff. Concentrations of 100,000 ng/mL of the common drugs were then added to the preparation and assayed by the GenPrime DOA Reader System. If a common compound name is followed by the drug abbreviation (e.g., "BAR"), then it has expected reactivity in the specified drug test (see Related Compounds and Cross Reactants) and was not assayed for interference in that drug test. Samples were evaluated in triplicate by in-house operators. None of the common drugs listed in the following table affected the expected results for the OS Cup (Table 5) or the Split Key Cup (Table 6).
{12}------------------------------------------------
| Acetylsalicylic Acid | Chlorpheniramine | Phenobarbital - BAR |
|---|---|---|
| Acetaminophen | Cocaine - COC | Phenytoin (Diphenylhydantoin) - BAR |
| Brompheniramine maleate | Dextromethorphan | d-Pseudoephedrine |
| Caffeine | Doxylamine | Salicylic Acid |
| Carbamazepine | Ibuprofen |
Table 5. Common Drugs Evaluated with the OS Cup with the GenPrime DOA Reader System
Table 6. Common Drugs Evaluated with the Split Key Cup with the GenPrime DOA Reader System.
| Acetylsalicylic Acid | Chlorpheniramine | Ibuprofen |
|---|---|---|
| Acetaminophen | Cocaine | Morphine - MOP |
| Brompheniramine maleate | Dextromethorphan | d-Pseudoephedrine |
| Caffeine | Doxylamine | Salicylic Acid |
| Carbamazepine |
Discussion of Clinical Tests Performed for Determination of Substantial Equivalence
The accuracy of the GenPrime DOA Reader System was evaluated at three POC sites with blind coded clinical urine samples that contained varying concentrations of drugs as determined by GC/MS or LC/MS/MS. For each drug, a minimum of 40 unaltered positive and 40 unaltered negative clinical samples were assessed. Negative samples were screened negative by EIA, 10% of which were also confirmed by GC/MS or LC/MS/MS. No false positive results were found for the negative samples (0% of cutoff). Results were stratified to give values of 0%, 0% - 50%, 50% - 100%, 100% - 150% and > 150% of cutoff. At least 10% of the samples were in the near cutoff ranges of 50% - 100% and 100% - 150%. Results summaries are provided below in Table 7 for the OS Cup and Table 8 for the Split Key Cup, for all sites combined.
Discordant results and the drug levels detected by GC/MS or LC/MS/MS are provided in Table 9 for the OS Cup and Table 10 for the Split Key Cup.
| DRUG(cutoff) | GenPrimeTestSystemOS Cup | NoDrug | Negative(Lessthan -50% ofcutoff) | NearCutoffNegative(between-50%andcutoff) | NearCutoffPositive(Betweencutoffand+50%) | Positive(greaterthan+50% ofcutoff) | GenPrimeOS CupAgreementwithReference |
|---|---|---|---|---|---|---|---|
| AMP(500) | Positive | 0 | 0 | 3 | 5 | 36 | 100% |
| (500) | Negative | 40 | 1 | 4 | 0 | 0 | 94% |
| BAR(300) | Positive | 0 | 0 | 3 | 4 | 36 | 100% |
| (300) | Negative | 40 | 11 | 1 | 0 | 0 | 95% |
| COC(150) | Positive | 0 | 0 | 3 | 4 | 38 | 100% |
| (150) | Negative | 40 | 0 | 1 | 0 | 0 | 93% |
| MET(500) | Positive | 0 | 0 | 2 | 4 | 36 | 100% |
| (500) | Negative | 40 | 8 | 2 | 0 | 0 | 96% |
| THC(50) | Positive | 0 | 0 | 0 | 4 | 36 | 100% |
| (50) | Negative | 40 | 0 | 4 | 0 | 0 | 100% |
| AllDrugs | Positive | 0 | 0 | 12 | 25 | 222 | 100% |
| Drugs | Negative | 240 | 20 | 15 | 0 | 0 | 95.8% |
Table 7. Summary of method comparison data for the OS Cup (all sites combined)
{13}------------------------------------------------
| DRUG(cutoff) | GenPrime TestSystemSK Cup | NoDrug | Negative(Lessthan -50% ofcutoff) | NearCutoffNegative(between-50%andcutoff) | NearCutoffPositive(Betweencutoff and+50%) | Positive(greaterthan+50%) | GenPrimeSK CupAgreementwithReference |
|---|---|---|---|---|---|---|---|
| AMP(500) | Positive | 0 | 0 | 4 | 4 | 36 | 100% |
| (500) | Negative | 40 | 1 | 4 | 0 | 0 | 92% |
| MET(500) | Positive | 0 | 0 | 1 | 4 | 36 | 100% |
| (500) | Negative | 40 | 0 | 3 | 0 | 0 | 98% |
| MOP(300) | Positive | 0 | 0 | 1 | 3 | 36 | 98% |
| (300) | Negative | 40 | 0 | 3 | 1 | 0 | 98% |
| MTD(300) | Positive | 0 | 0 | 0 | 4 | 36 | 100% |
| (300) | Negative | 40 | 0 | 4 | 0 | 0 | 100% |
| MOP(2000) | Positive | 0 | 0 | 2 | 4 | 37 | 100% |
| (2000) | Negative | 40 | 1 | 3 | 0 | 0 | 96% |
| OXY(150) | Positive | 0 | 0 | 2 | 4 | 36 | 100% |
| (150) | Negative | 40 | 0 | 2 | 0 | 0 | 95% |
| PCP(25) | Positive | 0 | 0 | 0 | 4 | 39 | 100.0% |
| (25) | Negative | 40 | 0 | 4 | 0 | 0 | 100.0% |
| THC(50) | Positive | 0 | 0 | 0 | 3 | 38 | 97.6% |
| (50) | Negative | 40 | 33 | 7 | 1 | 0 | 100.0% |
| AllDrugs | Positive | 0 | 0 | 13 | 34 | 332 | 99.5% |
| Drugs | Negative | 360 | 51 | 31 | 2 | 0 | 97.1% |
Table 8. Summary of method comparison data for the Split Key Cup (all sites combined)
Table 9. Discordant Results for the OS Cup
| CutoffValue(ng/mL) | Drug | GenPrime DOAReader System | GC/MS or LC/MS/MS Value |
|---|---|---|---|
| 500 | AMP | Presumptive Positive | Amphetamine at 306 ng/mL |
| 500 | AMP | Presumptive Positive | Amphetamine at 437 ng/mL |
| 500 | AMP | Presumptive Positive | Amphetamine at 370 ng/mL |
| 300 | BAR | Presumptive Positive | Phenobarbital at 210 ng/mL (=252 ng/mL BAR equiv) |
| 300 | BAR | Presumptive Positive | Butalbital at 6000 ng/mL (=240 ng/mL BAR equiv) |
| 300 | BAR | Presumptive Positive | Butalbital at 4644 ng/mL (=186 ng/mL BAR equiv) |
| 150 | COC | Presumptive Positive | Benzoylecgonine at 130 ng/mL |
| 150 | COC | Presumptive Positive | Benzoylecgonine at 110 ng/mL |
| 150 | COC | Presumptive Positive | Benzoylecgonine at 126 ng/mL |
| 500 | MET | Presumptive Positive | Methamphetamine at 264 ng/mL |
| 500 | MET | Presumptive Positive | Methamphetamine at 277 ng/mL |
Table 10. Discordant Results for the Split Key Cup
| Cutoff Value (ng/mL) | Drug | GenPrime DOA Reader System | GC/MS or LC/MS/MS Value |
|---|---|---|---|
| 500 | AMP | Presumptive Positive | Amphetamine at 250 ng/mL |
| AMP | Presumptive Positive | Amphetamine at 437 ng/mL | |
| AMP | Presumptive Positive | Amphetamine at 365 ng/mL | |
| AMP | Presumptive Positive | Amphetamine at 370 ng/mL | |
| 500 | MET | Presumptive Positive | Amphetamine at 307 ng/mL |
| 300 | MOP | Negative | Codeine at 333 ng/mL (=333 ng/mL MOP equiv) |
| MOP | Presumptive Positive | Codeine at 283 ng/mL (=283 ng/mL MOP equiv) |
{14}------------------------------------------------
| Cutoff Value (ng/mL) | Drug | GenPrime DOA Reader System | GC/MS or LC/MS/MS Value |
|---|---|---|---|
| 2000 | MOP | Presumptive Positive | Morphine at 377 ng/mL, Codeine at 2097 ng/mL(=1782 MOP equiv) |
| MOP | Presumptive Positive | Morphine at 962 ng/mL, Codeine at 1437 ng/mL(=1925 MOP equiv) | |
| 100 | OXY | Presumptive Positive | Oxycodone at 65 ng/mL |
| OXY | Presumptive Positive | Oxycodone at 50 ng/mL | |
| 50 | THC | Negative | 11-nor-9-carboxy-D9-THC at 59 ng/mL |
Table 10. Discordant Results for the Split Key Cup, continued
Conclusion
The GenPrime DOA Reader System has the same intended use, similar technological characteristics and equivalent precision, interference, cross-reactivity and clinical accuracy as the predicate device. The data demonstrate that any differences in technological characteristics do not raise any new issues of safety or effectiveness. GenPrime believes that the GenPrime DOA Reader System is substantially equivalent to the predicate device.
{15}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/15/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
GENPRIME, INC C/O MAUREEN GARNER, PRESIDENT NEW WORLD REGULATORY SOLUTIONS 1983 HAZELWOOD ROAD TOMS RIVER NJ 08753
Re: K130082
Trade/Device Name: GenPrime Drugs of Abuse Reader System Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIS, DIO, LDJ, DJR, DJC, DJG, LCM, DNK, JOT Dated: December 06, 2013 Received: December 09, 2013
Dear Ms. Garner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{16}------------------------------------------------
Page 2—Ms. Garner
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/delault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{17}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K130082
Device Name: GenPrime Drugs of Abuse Reader System
Indications for Use:
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The GanPrime 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 |
| MOP300 | Morphine | 300 ng/mL |
| MOP2000 | 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.
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 807 Subpart C) |
|---|---|---|
| --------------------------------------------------- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130082 510(k)
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§ 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).