Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "software algorithm" for image analysis to determine the presence of lines, but there is no mention of AI, ML, or related concepts like training data, neural networks, or adaptive learning. The image analysis appears to be based on a deterministic algorithm rather than a learned model.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) device used to detect drugs of abuse in human urine, providing diagnostic information rather than directly treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The GenPrime DOA Reader System is for in vitro diagnostic use." The "Device Description" also confirms it qualitatively detects drug classes in human urine, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "small, portable high resolution flat bed scanner" in addition to the software and test devices. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The GenPrime DOA Reader System is for in vitro diagnostic use..."
Nature of the Test: The device is designed to qualitatively detect drug classes in human urine, which is a biological sample. This is a core characteristic of in vitro diagnostics.
Purpose: The test is used to provide a preliminary analytical result for the presence of drugs of abuse, which is a diagnostic purpose.
Setting: The intended use in laboratories, point-of-care, and workplaces aligns with typical settings for IVD use.
Regulatory Context: The mention of a predicate device (K080635) strongly suggests that this device is being submitted for regulatory review as an IVD.

Therefore, based on the provided information, the GenPrime Drugs of Abuse (DOA) Reader System is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
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 (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.

Product codes (comma separated list FDA assigned to the subject device)

JQT, DKZ, DIS, DIO, DJR, DJC, DJG, LCM, LDJ, DNK

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

laboratories, point-of-care sites and workplaces by minimally trained users.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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:
Precision studies were performed in the hands of the intended users 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 test 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.
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.

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%.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Laboratory performance studies, Analytical specificity studies (Related Compounds and Cross Reactants), Interference Data (pH and Specific Gravity, Common Drugs), Clinical Accuracy Studies.

Sample Size:

Precision Studies: For OS Cup, N ranges from 57 to 65 for each concentration level. For SK Cup, N ranges from 84 to 89 for each concentration level. A minimum of 10 tests per operator.
Clinical Accuracy Studies: For each drug, a minimum of 40 unaltered positive and 40 unaltered negative clinical samples for both OS Cup (total urine samples reported for all drugs and all sites combined: 494) and SK Cup (total urine samples reported for all drugs and all sites combined: 731).

Key Results:

Precision (Sensitivity/Precision/Distribution of Random Error): The tables (2a and 2b) show precision percentages for different concentration levels (% of Cutoff and ng/mL) for various drugs in both OS Cup and SK Cup devices. At 0%, 25%, 50% of cutoff (negative concentrations), precision is consistently 100% (0 positives, all negatives). At 150%, 175%, 200% of cutoff (positive concentrations), precision is consistently 100% (all positives, 0 negatives). In the near-cutoff range (75% and 125% of cutoff), precision varies but shows the expected distribution of positive and negative results.
Related Compounds and Cross Reactants: Tables 3 and 4 show the minimum concentration required to produce a positive result for various related compounds and cross-reactants, and their corresponding % Cross Reactive. Many compounds show cross-reactivity at varying concentrations, while others show no cross-reactivity even at very high concentrations.
Interference (pH and Specific Gravity): For both OS and SK Cups, all pH values (3.0, 4.0, 7.0, 9.0) and all specific gravity values (1.003, 1.015, 1.030) did not affect the expected results; negative samples remained negative, and positive samples remained positive.
Interference (Common Drugs): None of the common drugs listed in Tables 5 and 6 affected the expected results for the OS Cup or the Split Key Cup.
Clinical Accuracy (Method Comparison Data):
- OS Cup (Table 7): Agreement with reference (GC/MS or LC/MS/MS) for positive results was 100% across all drugs. Agreement for negative results ranged from 93% to 100%, with "All Drugs" agreement for negative at 95.8%.
- SK Cup (Table 8): Agreement with reference for positive results was 97.6% to 100%. Agreement for negative results ranged from 92% to 100%, with "All Drugs" agreement for negative at 97.1%.
Discordant Results: Tables 9 and 10 detail specific cases where the GenPrime DOA Reader System's result differed from the GC/MS or LC/MS/MS value, often occurring in the near-cutoff range for the drug.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision Data: Presented as % Precision, indicating the agreement of results at specific concentration levels (e.g., 100% at 0%, 25%, 50% of cutoff for negatives, and 100% at 150%, 175%, 200% of cutoff for positives).
Cross Reactivity: Expressed as a percentage of cross-reactivity (minimum concentration required to produce a positive result relative to the cutoff concentration).
Agreement with Reference:
- OS Cup: Positive Agreement: 100% for all individual drugs and "All Drugs". Negative Agreement: Ranged from 93% to 100% for individual drugs, and 95.8% for "All Drugs".
- SK Cup: Positive Agreement: Ranged from 97.6% to 100% for individual drugs, and 99.5% for "All Drugs". Negative Agreement: Ranged from 92% to 100% for individual drugs, and 97.1% for "All Drugs".

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

PROFILE®-V MEDTOXScan® Drugs of Abuse Test System,(K080635)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

II. 510(k) Summary

1. 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

1. 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, or
radiochromatogram) 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

1

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
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 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.

2

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
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 (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.

3

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:

4

Similarities
Item	Device	Predicate
Intended Use	Determines qualitative positive or negative result
from drugs of abuse immunoassay screens	Determines qualitative positive
or negative result from drugs of
abuse immunoassay screens
Single-Use
Test Device	Produces colored lines on device.	Same
Assay Type	Competitive assay where concentration of drug is
inversely related to the visible signal detected by
the instrument.	Same
System
Procedure	Sample is added to a single use test device, which
is then read by instrument. Instrument is designed
to read multiple single use test devices, one at a
time.	Same
Measurement
Method	Scans the single-use test device to detect a signal.	Same
Differences
Item	Device	Predicate
Test Device
Format	Reads multiple formats of single-use test devices
in different cup formats.	Reads a single-use test
cassette.
Test Time and
Timing Method	Operator manually times test development for 5
minutes and then operates the instrument.	Instrument internally times test
strip development for 10
minutes and then scans the test
cassette.
Detection
Method	Measures density of visible lines against
background on single-use test device.	Measures reflectance of visible
lines on single use test
cassette.
Output	Outputs "presumptive positive", "negative", and
"invalid" test results on a graphic user interface
displayed on a computer screen and automatically
stores results along with test information. Operator
has ability to print and/or export results.	Outputs "positive," "negative,”
and "invalid" test results on
paper printout or LCD screen:
stores and uploads results.
Cutoff values	BAR cutoff is 300ng
MTD cutoff is 300ng	BAR cutoff is 200ng
MTD cutoff is 200ng
Power
Requirements	AC power only	AC or battery power
Additional
Requirements	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.

5

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)
% of
Cutoff	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)
% of
Cutoff	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)
% of
Cutoff	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)
% of
Cutoff	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

6

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%

7

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) | GenPrime
Test
System
OS Cup | No
Drug | Negative
(Less
than -
50% of
cutoff) | Near
Cutoff
Negative
(between
-50%
and
cutoff) | Near
Cutoff
Positive
(Between
cutoff
and
+50%) | Positive
(greater
than
+50% of
cutoff) | GenPrime
OS Cup
Agreement
with
Reference |
|------------------|--------------------------------------|------------|--------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------|
| 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% |
| All
Drugs | 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) | GenPrim
e Test
System
SK Cup | No
Drug | Negative
(Less
than -
50% of
cutoff) | Near
Cutoff
Negative
(between
-50%
and
cutoff) | Near
Cutoff
Positive
(Between
cutoff and
+50%) | Positive
(greater
than
+50%) | GenPrime
SK Cup
Agreement
with
Reference |
|------------------|---------------------------------------|------------|--------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------|------------------------------------------------------|
| 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% |
| All
Drugs | 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

| Cutoff
Value
(ng/mL) | Drug | GenPrime DOA
Reader 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
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.

| 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)

Page 1 of _1 __