Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen Oxycodone Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Description

Healgen Amphetamine Test and Healgen Oxycodone Test are immunochromatographic assays for Amphetamine and Oxycodone. Each assay test is a lateral flow system for the qualitative detection of Amphetamine and Oxycodone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The document describes the performance characteristics and studies for the Healgen Amphetamine Test and Healgen Oxycodone Test, which are immunochromatographic assays for the qualitative determination of Amphetamine and Oxycodone in human urine.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but presents performance data for several metrics. Based on the context of immunoassay device submission, the implicit acceptance criteria are that the device should accurately classify samples as positive or negative relative to the established cut-off concentrations, and demonstrate precision, specificity, and lack of significant interference from common substances.

Here's a table summarizing the performance:

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance and Results
Precision	Consistent and accurate detection of target analytes around the cut-off concentration. Expected to show 100% agreement far from the cut-off and some variability near the cut-off, as is typical for qualitative tests.	Amphetamine (Cut-off: 1000 ng/mL): For all formats (Strip, Cassette, Dip Card, Cup) across 3 lots, samples at -100%, -75%, -50% cut-off were 100% negative (50-/0+). Samples at +25%, +50%, +75%, +100% cut-off were 100% positive (50+/0-). At the cut-off, results varied: - Strip & Cup: 18-/32+ (36% Negative, 64% Positive) - Cassette & Dip Card: 20-/30+ (40% Negative, 60% Positive) Oxycodone (Cut-off: 100 ng/mL): For all formats (Strip, Cassette, Dip Card, Cup) across 3 lots, samples at -100%, -75%, -50% cut-off were 100% negative (50-/0+). Samples at +25%, +50%, +75%, +100% cut-off were 100% positive (50+/0-). At the cut-off, results varied: - Strip & Cassette: 20-/30+ (40% Negative, 60% Positive) - Dip Card: 24-/26+ (48% Negative, 52% Positive) - Cup: 16-/34+ (32% Negative, 68% Positive)
Cut-off Verification	Confirm that the device's functional cut-off aligns with the declared cut-off concentration. Samples well below the cut-off should be negative, and samples well above should be positive.	Amphetamine (1000 ng/mL) & Oxycodone (100 ng/mL): - All samples at and below -25% cut-off were negative. - All samples at and above +25% cut-off were positive. (Verified for 3 lots, 3 operators, for concentrations -50%, -25%, cut-off, +25%, +50%).
Interference	No significant interference from common exogenous and endogenous substances found in human urine at specified concentrations.	Numerous compounds (physiological conditions, drugs, metabolites) were tested at 100 µg/mL. No interference was observed for a comprehensive list of substances (listed in the document for both Amphetamine and Oxycodone tests) when target drugs were at 25% above cut-off levels.
Specificity (Cross-reactivity)	The device should primarily detect the target analyte and demonstrate acceptable cross-reactivity with structurally similar compounds or metabolites, where appropriate.	Amphetamine (Cut-off=1000 ng/mL): - D,L - Amphetamine: 100% - Phentermine: 80% - (+/-)-4-Hydroxyamphetamine HCL: 167% - L-Amphetamine: 5% - (+/-)-Methylenedioxyamphetamine(MDA): 67% - d-Methamphetamine, 1-Methamphetamine, ephedrine, 3,4-Methylenedioxyethylamphetamine (MDE), 3,4-methylenedioxy-methamphetamine (MDMA): <1% (at >100000 ng/mL) Oxycodone (Cut-off=100 ng/mL): - Oxycodone: 100% - Codeine: 0.2% - Ethyl Morphine: 0.1% - Thebaine: 0.2% - Oxymorphone: 13% - Dihydrocodeine: 0.8% - Hydromorphone, Hydrocodone, Morphine, Acetylmorphine, Buprenorphine, Ethylmorphine: <0.1% (at >100000 ng/mL)
Effect of Urine Specific Gravity and pH	Performance should be robust across a typical range of urine specific gravity and pH values.	Urine samples with specific gravity 1.000 to 1.035 and pH 4 to 9 were tested with target drugs at -25% and +25% cut-off levels. All samples at and below -25% cut-off were negative, and all samples at and above +25% cut-off were positive. No differences observed across formats.
Method Comparison	High agreement with a reference method (e.g., GC/MS) for clinical samples, especially those far from the cut-off. Some discordance is expected near the cut-off due to the inherent variability and qualitative nature of immunoassays.	Amphetamine: For each format, 80 clinical samples (40 negative, 40 positive) were compared to GC/MS. - Samples well below cut-off (Negative and Low Negative by GC/MS) showed 100% negative results by the device. - Samples well above cut-off (High Positive by GC/MS) showed 100% positive results by the device. - Near Cut-off Negative (GC/MS: between -50% and cut-off): 100% negative results by the device. - Near Cut-off Positive (GC/MS: between cut-off and +50%): Showed some discrepancies, e.g., for Amphetamine Strip, Viewer A, B, C detected 14, 14, and 13 positives out of 17 (3/4 negative discordances for Viewer A & B, 4/4 for Viewer C). Discordant samples were generally very close to the cut-off. Oxycodone: Similar pattern observed. For each format, 80 clinical samples (40 negative, 40 positive) were compared to GC/MS. - Samples well below cut-off (Negative and Low Negative by GC/MS) showed 100% negative results by the device. - Samples well above cut-off (High Positive by GC/MS) showed 100% positive results by the device. - Near Cut-off Negative (GC/MS: between -50% and cut-off): 100% negative results by the device. - Near Cut-off Positive (GC/MS: between cut-off and +50%): Showed some discrepancies, e.g., for Oxycodone Strip, Viewer A detected 13 positives out of 16 (3/3 negative discordances). Discordant samples were generally very close to the cut-off.
Lay-User Performance	High percentage of correct results by untrained laypersons, particularly far from the cut-off, and ease of understanding instructions.	Amphetamine (for each format - Strip, Cassette, Dip Card, Cup): - -100%, -75%, -50% Cutoff: 100% correct negative results. - -25% Cutoff (750 ng/mL, i.e., 250 ng/mL below 1000 ng/mL cut-off): 90-95% correct negative results (1-2 false positives out of 20 samples). - +25% Cutoff (1250 ng/mL, i.e., 250 ng/mL above 1000 ng/mL cut-off): 90-100% correct positive results (0-2 false negatives out of 20 samples). - +50%, +75% Cutoff: 100% correct positive results. Oxycodone (for each format - Strip, Cassette, Dip Card, Cup): - -100%, -75%, -50% Cutoff: 100% correct negative results. - -25% Cutoff (75 ng/mL, i.e., 25 ng/mL below 100 ng/mL cut-off): 90-95% correct negative results (1-2 false positives out of 20 samples). - +25% Cutoff (125 ng/mL, i.e., 25 ng/mL above 100 ng/mL cut-off): 90-95% correct positive results (1-2 false negatives out of 20 samples). - +50%, +75% Cutoff: 100% correct positive results. - Lay users indicated instructions were easy to follow (Flesch-Kincaid Grade Level 7).

2. Sample Sizes and Data Provenance

Precision Study (Test Set):
- For each drug (Amphetamine, Oxycodone), for each of 4 device formats (Strip, Cassette, Cup, Dip Card), and for each of 3 lots: 50 samples were analyzed per drug concentration level.
- Total samples for precision: 2 drugs * 4 formats * 3 lots * 9 concentration levels * 50 samples/level = 10,800 sample analyses (if each level was unique per lot).
- Data Provenance: The samples were "drug free urine samples" spiked with drugs or collected as "negative samples." The exact country of origin is not specified but implied to be in a laboratory setting for controlled spiking. This is a prospective study in a controlled lab environment.
- Ground Truth: Confirmed by GC/MS.
Cut-off Verification Study (Test Set):
- Total samples: 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% cut-off) for each drug using three different lots of each device format.
- This implies 2 drugs * 4 formats * 3 lots * 5 concentration levels * ~10 samples/level = Approximately 1200 sample analyses.
- Data Provenance: Not explicitly stated, but likely laboratory-prepared spiked samples. This is a prospective study.
- Ground Truth: Determined by preparation based on known cut-off concentrations.
Interference Study (Test Set):
- Various interfering substances added to drug-free urine and urine with target drugs at 25% above cut-off.
- Tested using three batches of each device for all formats.
- Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
- Ground Truth: Known concentrations of interfering substances and target analytes.
Specificity (Cross-reactivity) Study (Test Set):
- Drug metabolites and other components were tested using three batches of each device for all formats.
- Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
- Ground Truth: Known concentrations of cross-reactant compounds.
Effect of Urine Specific Gravity and pH Study (Test Set):
- Urine samples with varying specific gravity (1.000 to 1.035) or pH (4 to 9) were spiked with target drugs at -25% and +25% cut-off levels.
- Tested using three batches of each device for all formats.
- Data Provenance: Not specified, likely laboratory-prepared samples. Prospective.
- Ground Truth: Known specific gravity, pH, and drug concentrations.
Method Comparison Study (Clinical Samples - Test Set):
- For each drug (Amphetamine, Oxycodone) and each device format: 80 unaltered clinical samples (40 negative and 40 positive) were run.
- Total samples for method comparison: 2 drugs * 4 formats * 80 samples/format = 640 clinical samples.
- Data Provenance: "Unaltered clinical samples" - country of origin is not specified, but they are patient samples. This is a retrospective evaluation of collected samples.
- Ground Truth: Confirmed by GC/MS.
Lay-User Study (Test Set):
- Amphetamine: 140 lay persons tested each format of the device. This implies 140 individuals * 4 formats = 560 separate tests, each using one sample. (The text states "Total of 1120 individuals performed the study," which seems to imply 140 persons for Amphetamine and 140 for Oxycodone, each testing all 4 formats, or it means 140 unique individuals per format. The breakdown states "230 females and 330 males tested the Amphetamine samples," totaling 560 individuals specifically for Amphetamine, and similarly for Oxycodone. This suggests 560 individuals for Amphetamine and 560 for Oxycodone. If each person tested only ONE sample, then 560 samples for Amphetamine, 560 for Oxycodone).
- Each participant received one blind-labeled sample. Samples were prepared at 7 concentration levels (0, 250, 500, 750, 1250, 1500, 1750 ng/mL for Amphetamine; 0, 25, 50, 75, 125, 150, 175 ng/mL for Oxycodone). The tables show 20 samples per concentration level.
- Total samples evaluated by lay users: 2 drugs * 4 formats * 7 concentration levels * 20 samples/level = 1120 samples.
- So, most likely, 1120 unique individuals tested one sample each.
- Data Provenance: Laboratory-prepared spiked urine samples. Prospective.
- Ground Truth: Confirmed by GC/MS.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

GC/MS (Gas Chromatography/Mass Spectrometry) is repeatedly stated as the "preferred confirmatory method" and the method used to confirm drug concentrations. GC/MS is an objective analytical method and does not rely on expert interpretation in the same way clinical imaging or pathology might. Therefore, no "experts" in the subjective sense were used to establish the ground truth for the test set for the concentrations of the drugs. The validity of GC/MS results depends on the expertise and accreditation of the laboratory performing the tests.
For the Method Comparison Studies, three "laboratory assistants" performed the device readings. While they are readers, their classification (positive/negative) is compared to the objective GC/MS ground truth, not used to establish it.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe an adjudication method for the test set interpretations. The ground truth (GC/MS) is an objective analytical measurement, not a subjective interpretation requiring adjudication.
For the Precision studies, different operators evaluated the lots, but the results are presented as counts of positive/negative for a given concentration, not as a consensus interpretation.
For the Method Comparison Studies, three "laboratory assistants" read the devices. Their individual results are reported against the GC/MS. There is no mention of an adjudication process among these three readers.
For the Lay-User Study, each lay user's result on a single sample was compared directly to the GC/MS ground truth; no adjudication occurred.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not performed.
This device is a rapid, qualitative immunochromatographic assay (a "drug test strip/cassette/cup/dip card"), which requires visual interpretation of lines. It is not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable to this device.
The "readers" in the method comparison study were human (laboratory assistants), and in the lay-user study, they were laypersons. Their performance was evaluated in a standalone manner against a reference standard (GC/MS) for the device itself, not in an AI-assisted workflow.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in effect, a standalone performance was evaluated. The device itself (the immunochromatographic assay) is the "algorithm" here, and its performance is judged by the chemical reaction and visual line development. The precision, cut-off verification, interference, specificity, and specific gravity/pH studies evaluated the intrinsic performance of the device's chemical assay independent of human interpretation variability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for all performance characteristics (precision, cut-off verification, interference, specificity, method comparison, and lay-user study) was Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is an objective, highly accurate analytical method for quantifying drug concentrations, making it the gold standard for confirming drug presence and concentration in urine samples.

8. The sample size for the training set

This document describes a medical device (immunochromatographic assay) that does not use artificial intelligence or machine learning. Therefore, there is no training set in the context of AI/ML model development. The device's performance is based on its chemical and biological design, manufacturing, and intrinsic properties, which are optimized during product development (not "training").

9. How the ground truth for the training set was established

As there is no AI/ML component, there is no training set or corresponding ground truth establishment process in the AI/ML sense. The "ground truth" for evaluating the performance during development and validation phases (analogous to how a training set might be used in AI) would have been established through controlled experiments using known concentrations of analytes and reference methods like GC/MS to ensure the device's chemical reagents and design function as intended.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2015

HEALGEN SCIENTIFIC LLC JOE SHIA LSI INTERNATIONAL INC 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877

Re: K143187

Trade/Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DJG Dated: October 31, 2014 Received: November 5, 2014

Dear Mr. Joe Shia:

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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.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 Industry and Consumer Education 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,

Katherine Serrano -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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143187

Device Name

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)

Indications for Use (Describe)

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Amphetamine Test (Strip, Cassette, Cup, Dip Card) and Oxycodone Test (Strip, Cassette, Cup, Dip Card

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1. Date: January 21, 2014
1. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401
1. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
1. Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card) Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
- Classification:

ProductCode	CFR #	Panel
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
DJG	21 CFR, 862.3650 Opiate Test System	Toxicology

1. Predicate Devices: K052115 First Check Multi Drug Cup 12
1. Intended Use / Indications for Use

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

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The test may yield preliminary positive results even when prescription drug Oxycodone is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxycodone in urine. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

1. Device Description
  Healgen Amphetamine Test and Healgen Oxycodone Test are immunochromatographic assays for Amphetamine and Oxycodone. Each assay test is a lateral flow system for the qualitative detection of Amphetamine and Oxycodone (target analyte) in human urine. The products are in vitro diagnostic devices, which come in the form of: Strips, Cassettes, DipCards, or Cups. Each product contains a Test Device (in one of the four formats), and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
1. Substantial Equivalence Information
  A summary comparison of features of the Healgen Amphetamine Test and Healgen Oxycodone Test and the predicate device is provided in Table 1 & Table 2.

Item	Device	Predicate -K052115
Intended Use	For the qualitative determination of drugsof abuse in human urine.	Same
Drug Analyte	Amphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same

Table 1: Features Comparison of Healgen Amphetamine Test and the Predicate Device

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Intended UsePopulation	For over-the-counter andprescription uses.	Forover-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

Table 2: Features Comparison of Healgen Oxycodone Test and the Predicate Device

Item	Device	Predicate - K052115
Intended Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Drug Analyte	Oxycodone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	100 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	For over-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

9. Test Principle

Healgen Amphetamine Test and Healgen Oxycodone Test are rapid tests for the qualitative detection of Amphetamine and Oxycodone in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the test has been performed properly.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

The precision performance of the Healgen Amphetamine and Oxycodone tests was evaluated using 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device. Each lot was evaluated by a

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different operator. The testing consisted of analyzing samples in 2 runs per day for 25 days (n = 50 per lot) and by spiking drug free urine samples to achieve 100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off drug The samples were prepared by spiking drug into negative samples. All sample concentrations. aliquots were blind labeled and randomized and each drug concentration was confirmed by GC/MS. Results are summarized below for each lot and device.

Amphetamine

Strip Format

Drug	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-

Cassette Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug	Lot 4	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 5	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 6	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

Dip Card Format

	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 7	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 8	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 9	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

CUP Format

	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 10	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 11	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 12	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-

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Oxycodone

Strip Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug	Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

Cassette Format

Drug	-100% Cut-off	-75% Cut-off	-50% Cut-off	-25% Cut-off	Cut-off	+25% Cut-off	+50% Cut-off	+75% Cut-off	+100% Cut-off
Lot 4	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 5	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 6	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

Dip Card Format

	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug
Lot 7	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 8	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 9	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

CUP Format

	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug	Lot 10	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 11	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot 12	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable.

c. Stability
The devices are stable at 4-30°C for 24 months based on the accelerated stability study at 45°C and real time stability determination at both 4℃ and 30℃.

Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

{8}------------------------------------------------

d. Cut-off

A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% cut-off and all negative at and below -25% cut-off for both Amphetamine and Oxycodone. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off(ng/mL)
Amphetamine Test	Amphetamine	1000
Oxycodone Test	Oxycodone	100

e. Interference

Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of each device for all formats.

Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different formats.

Acetophenetidin	Fenoprofen	Phenelzine
N-Acetylprocainamide	Furosemide	Phenobarbital
Acetylsalicylic Acid(Aspirin)	Gentisic acid	Phenylephrine-L
Aminopyrine	Hemoglobin	Phenylethylamine
Amitriptyline	Hydralazine	Phenylpropanolamine
Amoxicillin	Hydrochlorothiazide	Prednisolone Acetate
Amobarbital	Hydrocodone	Prednisone
Ampicinine(Ampicillin)	Hydrocortisone	Procaine(Novocaine)
Apomorphine	a -Hydroxyhippuric acid	Promazine
L-Ascorbic Acid	p-Hydroxymethamphetamine	Promethazine
Aspartame	Ibuprofen	Propoxyphene,d-
Atropine	Imipramine	Propranolol
Benzilic acid	Isoxsuprine	Pseudoephedrine HCL
Benzphetamine	Isoproterenol-(+/-)	Quinidine
Bezoic Acid	Ketamine	Quinine
Bilirubin	Labetalol	Ranitidine(Zantac)
Caffeine	Levorphanol	Salicylic Acid
Chloramphenicol	Loperamide	Secobarbital

Amphetamine

{9}------------------------------------------------

ChlordiazepoxideHCL	Maprotiline	Serotonin
Chloroquine	Meprobamate	Sulfamethazine
Chlorothiazide	Methadone	Sulindac
Chlorpheniramine	Methoxyphenamine	Temazepam
Chlorpromazine	Methylphenidate	11-Nor-Δ9-Tetrahydrocannabinol
Cholesterol	Nalbuphine	Tetracycline
Clomipramine	Nalidixic acid	Tetrahydrozoline
Clonidine hydrochloride	Naloxone hydrochloride	Thebaine
Codeine	Naltrexone hydrochloride	Thiamine
Cortisone	Naproxen	L-Thyroxine
Cotinine(-)	Niacinamide	ThioridazineHydrochloride
Creatinine	Nifedipine	Triamterene
Deoxyepinephrine	Norethindrone	TriflupromazineHydrochloride
Dextromethorphan	Norpropoxyphene	Trimethoprim
Diazepam	Noscapine	Trimipramine
Diflunisal	Oxazepam	Tryptamine
Digoxin	Oxycodone	DL-Tryptophan
Doxylamine	Oxymetazoline	Tyramine
Ecgonine methylester	Papaverine	D/L-Tyrosine
R(-)-Epinephrine	Penicillin	Uric Acid
Erythromycin	Pentobarbital	Verapamil
Estrone-3-sulfate	Perphenazine	Zomepirac
Ethyl-p-aminobenzoate	Phencyclidine

Oxycodone

Acetophenetidin	Ethyl-p-aminobenzoate	Phencyclidine
N-Acetylprocainamide	Fenoprofen	Phenelzine
Acetylsalicylic Acid(Aspirin)	Furosemide	Phenobarbital
Aminopyrine	Gentisic acid	Phentermine
Amitriptyline	Hemoglobin	Phenylephrine-L
Amoxicillin	Hydralazine	Phenylethylamine
Amobarbital	(+/-)-4-HydroxyamphetamineHCL	Phenylpropanolamine
D-Amphetamine	Hydrochlorothiazide	Prednisolone Acetate
L-Amphetamine	Hydrocodone	Prednisone
Amphetamine Sulfate	Hydrocortisone	Procaine(Novocaine)
Ampicinine(Ampicillin)	a -Hydroxyhippuric acid	Promazine

{10}------------------------------------------------

Apomorphine	p-Hydroxymethamphetamine	Promethazine
L-Ascorbic Acid	Ibuprofen	Propoxyphene,d-
Aspartame	Imipramine	Propranolol
Atropine	Isoxsuprine	Pseudoephedrine HCL
Benzilic acid	Isoproterenol-(+/-)	Quinidine
Benzphetamine	Ketamine	Quinine
Benzoic Acid	Labetalol	Ranitidine(Zantac)
Bilirubin	Levorphanol	Salicylic Acid
Caffeine	Loperamide	Secobarbital
Chloramphenicol	Maprotiline	Serotonin
Chlordiazepoxide HCL	Meprobamate	Sulfamethazine
Chloroquine	Methadone	Sulindac
Chlorothiazide	Methoxyphenamine	Temazepam
Chlorpheniramine	(+/-)-Methylenedioxyamphetamine(MDA)	11-Nor-Δ9-Tetrahydrocannabinol
Chlorpromazine	Methylphenidate	Tetracycline
Cholesterol	Nalbuphine	Tetrahydrozoline
Clomipramine	Nalidixic acid	Thiamine
Clonidine hydrochloride	Naloxone hydrochloride	L-Thyroxine
Cortisone	Naltrexone hydrochloride	Thioridazine Hydrochloride
Cotinine(-)	Naproxen	Triamterene
Creatinine	Niacinamide	TriflupromazineHydrochloride
Deoxyepinephrine	Nifedipine	Trimethoprim
Dextromethorphan	Norethindrone	Trimipramine
Diazepam	Norpropoxyphene	Tryptamine
Diflunisal	Noscapine	DL-Tryptophan
Digoxin	Oxazepam	Tyramine
Doxylamine	Oxymetazoline	D/L-Tyrosine
Ecgonine methylester	Papaverine	Uric Acid
R(-)-Epinephrine	Penicillin	Verapamil
Erythromycin	Pentobarbital	Zomepirac
Estrone-3-sulfate	Perphenazine

f. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. The obtained lowest detectable concentration was used to calculate the cross-reactivity. There were no differences observed for different formats.

{11}------------------------------------------------

Amphetamine (Cut-off=1000 ng/mL)	Result	% Cross-Reactivity
D,L - Amphetamine(Amphetamine Sulfate)	Positive at 1000 ng/mL	100%
Phentermine	Positive at 1250 ng/mL	80%
(+/-)-4-Hydroxyamphetamine HCL	Positive at 600 ng/mL	167%
L-Amphetamine	Positive at 20000 ng/mL	5%
(+/-)-Methylenedioxyamphetamine(MDA)	Positive at 1500 ng/mL	67%
d-Methamphetamine	Positive at >100000 ng/mL	<1%
1-Methamphetamine	Positive at >100000 ng/mL	<1%
ephedrine	Positive at >100000 ng/mL	<1%
3,4-Methylenedioxyethylamphetamine (MDE)	Positive at >100000 ng/mL	<1%
3,4-methylenedioxy-methamphetamine (MDMA)	Positive at >100000 ng/mL	<1%

Oxycodone (Cut-off=100 ng/mL)	Result	% Cross-Reactivity
Oxycodone (Cut-off=100 ng/mL)	Positive at 100 ng/mL	100%
Codeine	Positive at 50000 ng/mL	0.2%
Ethyl Morphine	Positive at 75000 ng/mL	0.1%
Thebaine	Positive at 50000 ng/mL	0.2%
Oxymorphone	Positive at 750 ng/mL	13%
Dihydrocodeine	Positive at 12500 ng/mL	0.8%
Hydromorphone	Positive at >100000 ng/mL	<0.1%
Hydrocodone	Positive at >100000 ng/mL	<0.1%
Morphine	Positive at >100000 ng/mL	<0.1%
Acetylmorphine	Positive at >100000 ng/mL	<0.1%
Buprenorphine	Positive at >100000 ng/mL	<0.1%
Ethylmorphine	Positive at >100000 ng/mL	<0.1%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all

{12}------------------------------------------------

negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.

1. Comparison Studies
  The method comparison studies for the Amphetamine Test, and the Oxycodone Test were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

Amphetamine
Stripformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	0	14	23
	Negative	10	16	14	3	0
Viewer B	Positive	0	0	0	14	23
	Negative	10	16	14	3	0
Viewer C	Positive	0	0	0	13	23
	Negative	10	16	14	4	0

Amphetamine

Discordant Results of Amphetamine Strip

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	630	1006	Negative
Viewer A	604	1009	Negative
Viewer A	676	1010	Negative
Viewer B	630	1006	Negative
Viewer B	604	1009	Negative
Viewer B	663	1011	Negative
Viewer C	663	1011	Negative
Viewer C	630	1006	Negative
Viewer C	604	1009	Negative
Viewer C	676	1010	Negative

{13}------------------------------------------------

Cassetteformat		Negative	LowNegativeby GC/MS(less than-50% )	NearCutoffNegativeby GC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	0	ાર	23
	Negative	10	16	14	2	0
Viewer B	Positive	0	0	0	14	23
	Negative	10	16	14	3	0
Viewer C	Positive	0	0	0	14	23
	Negative	10	16	14	3	0

Discordant Results of Amphetamine Cassette

Viewer	Sample Number	GC/MS Result	Cassette FormatViewer Results
Viewer A	630	1006	Negative
Viewer A	604	1009	Negative
Viewer B	663	1011	Negative
Viewer B	630	1006	Negative
Viewer B	604	1009	Negative
Viewer C	630	1006	Negative
Viewer C	604	1009	Negative
Viewer C	676	1010	Negative

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
	Viewer A
Negative		10	16	14	2	0
Viewer B	Positive	0	0	0	13	23
	Negative	10	16	14	4	0
Viewer C	Positive	0	0	0	15	23
	Negative	10	16	14	2	0

{14}------------------------------------------------

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	630	1006	Negative
Viewer A	676	1010	Negative
Viewer B	663	1011	Negative
Viewer B	630	1006	Negative
Viewer B	604	1009	Negative
Viewer B	650	1015	Negative
Viewer C	630	1006	Negative
Viewer C	676	1010	Negative

Discordant Results of Amphetamine Cup

Dip Cardformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	0	15	23
	Negative	10	16	14	2	0
Viewer B	Positive	0	0	0	13	23
	Negative	10	16	14	4	0
Viewer C	Positive	0	0	0	13	23
	Negative	10	16	14	4	0

Discordant Results of Amphetamine Dip Card

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	630	1006	Negative
Viewer A	676	1010	Negative
Viewer B	630	1006	Negative
Viewer B	663	1011	Negative
Viewer B	604	1009	Negative
Viewer B	650	1015	Negative
Viewer C	630	1006	Negative
Viewer C	676	1010	Negative
Viewer C	663	1011	Negative
Viewer C	604	1009	Negative

{15}------------------------------------------------

Oxycodone

Strip format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer B	Positive	0	0	0	14	24
	Negative	10	15	15	2	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of Oxycodone Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	1256	101	Negative
Viewer A	1243	103	Negative
Viewer A	1211	105	Negative
Viewer B	1256	101	Negative
Viewer B	1211	105	Negative
Viewer C	1256	101	Negative
Viewer C	1243	103	Negative
Viewer C	1211	105	Negative

Cassetteformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	Near CutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan+50%)
Viewer A	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer B	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

{16}------------------------------------------------

Viewer	Sample Number	GC/MS Result	Cassette Format
			Viewer Results
Viewer A	1256	101	Negative
Viewer A	1243	103	Negative
Viewer A	1211	105	Negative
Viewer B	1256	101	Negative
Viewer B	1243	103	Negative
Viewer B	1211	105	Negative
Viewer C	1256	101	Negative
Viewer C	1243	103	Negative
Viewer C	1211	105	Negative

Discordant Results of Oxycodone Cassette

Dip Card format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer B	Positive	0	0	0	14	24
	Negative	10	15	15	2	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of Oxycodone Dip Card

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	1256	101	Negative
Viewer A	1243	103	Negative
Viewer A	1211	105	Negative
Viewer B	1211	105	Negative
Viewer B	1256	101	Negative
Viewer C	1256	101	Negative
Viewer C	1243	103	Negative
Viewer C	1211	105	Negative

{17}------------------------------------------------

Cup format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cut-off)	Near Cutoff Positive by GC/MS (Between the cut-off and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer B	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of Oxycodone Cup

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	1256	101	Negative
Viewer A	1243	103	Negative
Viewer A	1211	105	Negative
Viewer B	1256	101	Negative
Viewer B	1243	103	Negative
Viewer B	1211	105	Negative
Viewer C	1256	101	Negative
Viewer C	1243	103	Negative
Viewer C	1211	105	Negative

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons testing each format of the Amphetamine devices and another set of 140 persons testing each format of the Oxycodone devices. Total of 1120 individuals performed the study. A total of 230 females and 330 males tested the Amphetamine samples, and 226 females and 334 males tested the Oxycodone samples. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

{18}------------------------------------------------

Comparison between GC/MS and Lay Person Results (Amphetamine Strip)
% of Cutoff	Numberofsamples	AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	2	18	90%
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

Comparison between GC/MS and Lay Person Results (Amphetamine Strip)

Comparison between GC/MS and Lay Person Results (Amphetamine Cassette)

% of Cutoff	Number of samples	Amphetamine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	No. of Positive 0	No. of Negative 20	100%
-75% Cutoff	20	250	No. of Positive 0	No. of Negative 20	100%
-50% Cutoff	20	500	No. of Positive 0	No. of Negative 20	100%
-25% Cutoff	20	750	No. of Positive 1	No. of Negative 19	95%
+25% Cutoff	20	1250	No. of Positive 19	No. of Negative 1	95%
+50% Cutoff	20	1500	No. of Positive 20	No. of Negative 0	100%
+75% Cutoff	20	1750	No. of Positive 20	No. of Negative 0	100%

Comparison between GC/MS and Lay Person Results (Amphetamine DipCard)

% of Cutoff	Numberofsamples	AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	1	19	95%
+25% Cutoff	20	1250	18	2	90%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

{19}------------------------------------------------

% of Cutoff	Number of samples	AmphetamineConcentration by GC/MS(ng/mL)	Lay person resultsNo. of Positive	Lay person resultsNo. of Negative	Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	1	19	95%
+25% Cutoff	20	1250	20	0	100%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

Comparison between GC/MS and Lay Person Results (Amphetamine Cup)

Comparison between GC/MS and Lay Person Results (Oxycodone Strip)

% of Cutoff	Number of samples	Oxycodone Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	25	0	20	100%
-50% Cutoff	20	50	0	20	100%
-25% Cutoff	20	75	2	18	90%
+25% Cutoff	20	125	18	2	90%
+50% Cutoff	20	150	20	0	100%
+75% Cutoff	20	175	20	0	100%

Comparison between GC/MS and Lay Person Results (Oxycodone Cassette)

% of Cutoff	Number of samples	OxycodoneConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	No. of Positive	No. of Negative	100%
-75% Cutoff	20	25	0	20	100%
-50% Cutoff	20	50	0	20	100%
-25% Cutoff	20	75	1	19	95%
+25% Cutoff	20	125	19	1	95%
+50% Cutoff	20	150	20	0	100%
+75% Cutoff	20	175	20	0	100%

{20}------------------------------------------------

% of Cutoff	Number of samples	Oxycodone Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	25	0	20	100%
-50% Cutoff	20	50	0	20	100%
-25% Cutoff	20	75	2	18	90%
+25% Cutoff	20	125	18	2	90%
+50% Cutoff	20	150	20	0	100%
+75% Cutoff	20	175	20	0	100%

Comparison between GC/MS and Lav Person Results (Oxycodone DipCard)

Comparison between GC/MS and Lay Person Results (Oxycodone Cup)

% of Cutoff	Numberofsamples	OxycodoneConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	25	0	20	100%
-50% Cutoff	20	50	0	20	100%
-25% Cutoff	20	75	1	19	95%
+25% Cutoff	20	125	19	1	95%
+50% Cutoff	20	150	20	0	100%
+75% Cutoff	20	175	20	0	100%

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

1. Clinical Studies
  Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen Amphetamine Test, and Healgen Oxycodone Test are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).