Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette 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 prescription and for over-the-counter use.

Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 ng/mL. The test is available in a Strip format, a Cassette 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 prescription and for over-the-counter use.

Device Description

Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (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 Each test device is sealed with a desiccant in an aluminum pouch. insert.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single section as pass/fail thresholds. Instead, the performance characteristics studies demonstrate the device's accuracy and reliability against the established cut-off values as compared to GC/MS, which serves as the gold standard.

Healgen MDMA (Ecstasy) Test Performance Summary (Across all formats: Strip, Cassette, Cup, Dip Card)

Acceptance Criteria (Implied)	Reported Device Performance (Summary from tables)
Precision: - Samples < -25% Cut-off: Negative result - Samples > +25% Cut-off: Positive result- Samples at Cut-off: Expected mix of positive/negative	MDMA (Ecstasy):- Samples at -100%, -75%, -50%, -25% Cut-off: 50-/0+ (All negative)- Samples at +25%, +50%, +75%, +100% Cut-off: 50+/0- (All positive)- Samples at Cut-off: Varied (e.g., Strip, Cassette: 22-/28+; Dip Card: 24-/26+; Cup: 30-/20+) - Indicates appropriate sensitivity around the cut-off.
Cut-off Verification: - All samples at and above +25% cut-off: Positive- All samples at and below -25% cut-off: Negative	MDMA (Ecstasy): Verified (all positive at/above +25% cut-off, all negative at/below -25% cut-off).Phencyclidine: Verified (all positive at/above +25% cut-off, all negative at/below -25% cut-off).
Interference: No clinically significant interference from common substances at 100 µg/mL.	No differences observed for different formats. Numerous compounds listed showed no interference at 100 µg/mL.
Specificity: Cross-reactivity analysis as expected.	MDMA (Ecstasy): 3,4-Methylenedioxyamphetamine HCl (MDA) 17% cross-reactivity, 3,4-Methylenedioxyethylamphetamine (MDEA) 167% cross-reactivity. d-methamphetamine 20% cross-reactivity. d-, l-amphetamine, l-methamphetamine not detected at >100,000 ng/mL.Phencyclidine: 4-Hydroxy Phencyclidine 28% cross-reactivity.
Effect of Urine Specific Gravity and pH: Accurate results across a range of specific gravities (1.000-1.035) and pH (4-9).	Results all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. No differences observed for different formats.
Method Comparison (Professional User): High agreement with GC/MS.	Each format across MDMA and Phencyclidine tests showed high agreement with GC/MS, with discordant results primarily near the cut-off concentrations (as expected for qualitative tests). Example for MDMA Strip, Viewer A: 13/16 (81.25%) agreement at Near Cutoff Positive, 24/24 (100%) at High Positive. 10/10 (100%) at Negative, 15/15 (100%) at Low Negative.
Lay-User Performance: High percentage of correct results, easy-to-follow instructions.	MDMA (Ecstasy): - Samples at -100%, -75%, -50% Cut-off: 100% correct negative.- Samples at -25% Cut-off: 95% correct negative.- Samples at +50%, +75% Cut-off: 100% correct positive.- Samples at +25% Cut-off: 95% correct positive.Similar results for Phencyclidine with some formats showing 90% at -25% and +25% Cut-off. All lay users indicated device instructions can be easily followed (Flesch-Kincaid Grade Level 7).

Healgen Phencyclidine Test Performance Summary (Across all formats: Strip, Cassette, Cup, Dip Card)

Acceptance Criteria (Implied)	Reported Device Performance (Summary from tables)
Precision: - Samples < -25% Cut-off: Negative result - Samples > +25% Cut-off: Positive result- Samples at Cut-off: Expected mix of positive/negative	Phencyclidine:- Samples at -100%, -75%, -50%, -25% Cut-off: 50-/0+ (All negative)- Samples at +25%, +50%, +75%, +100% Cut-off: 50+/0- (All positive)- Samples at Cut-off: Varied (e.g., Strip: 20-/30+; Cassette: 18-/32+; Dip Card: 22-/28+; Cup: 16-/34+) - Indicates appropriate sensitivity around the cut-off.
Cut-off Verification: - All samples at and above +25% cut-off: Positive- All samples at and below -25% cut-off: Negative	MDMA (Ecstasy): Verified (all positive at/above +25% cut-off, all negative at/below -25% cut-off).Phencyclidine: Verified (all positive at/above +25% cut-off, all negative at/below -25% cut-off).
Interference: No clinically significant interference from common substances at 100 µg/mL.	No differences observed for different formats. Numerous compounds listed showed no interference at 100 µg/mL.
Specificity: Cross-reactivity analysis as expected.	MDMA (Ecstasy): 3,4-Methylenedioxyamphetamine HCl (MDA) 17% cross-reactivity, 3,4-Methylenedioxyethylamphetamine (MDEA) 167% cross-reactivity. d-methamphetamine 20% cross-reactivity. d-, l-amphetamine, l-methamphetamine not detected at >100,000 ng/mL.Phencyclidine: 4-Hydroxy Phencyclidine 28% cross-reactivity.
Effect of Urine Specific Gravity and pH: Accurate results across a range of specific gravities (1.000-1.035) and pH (4-9).	Results all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. No differences observed for different formats.
Method Comparison (Professional User): High agreement with GC/MS.	Each format across MDMA and Phencyclidine tests showed high agreement with GC/MS, with discordant results primarily near the cut-off concentrations (as expected for qualitative tests). Example for Phencyclidine Strip, Viewer A: 13/16 (81.25%) agreement at Near Cutoff Positive, 24/24 (100%) at High Positive. 10/10 (100%) at Negative, 15/15 (100%) at Low Negative.
Lay-User Performance: High percentage of correct results, easy-to-follow instructions.	MDMA (Ecstasy): - Samples at -100%, -75%, -50% Cut-off: 100% correct negative.- Samples at -25% Cut-off: 95% correct negative.- Samples at +50%, +75% Cut-off: 100% correct positive.- Samples at +25% Cut-off: 95% correct positive.Similar results for Phencyclidine with some formats showing 90% at -25% and +25% Cut-off. All lay users indicated device instructions can be easily followed (Flesch-Kincaid Grade Level 7).

2. Sample size used for the test set and the data provenance

Precision Study:
- Test set size: For each drug (MDMA/Phencyclidine) and each device format, 9 different concentration levels were tested. For each concentration level, 50 tests were performed (2 runs/day for 25 days). So, 9 concentrations * 50 tests/concentration = 450 tests per lot. Since there are 3 lots mentioned per format, this would be 3 lots * 450 tests/lot = 1350 tests per format for each drug.
- Data Provenance: Samples were prepared by spiking drug in negative urine samples, suggesting these are prospectively prepared, controlled samples. The text does not specify the country of origin, but the submission is to the FDA, implying studies likely conducted in or for the US market. The samples were confirmed by GC/MS.
Cut-off Verification Study:
- Test set size: 150 samples were tested for each drug, equally distributed at 5 concentrations (-50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off).
- Data Provenance: Samples were prepared by spiking drug in negative samples, indicating prospectively prepared, controlled samples.
Interference Study:
- Test set size: Not explicitly stated as a number of samples, but numerous potential interfering substances were added to drug-free urine and urine containing target drugs at 25% above cut-off levels. Each type of sample/interferent was tested using three batches of each device for all formats.
- Data Provenance: Prepared samples, suggesting prospectively prepared, controlled samples.
Specificity Study:
- Test set size: Not explicitly stated as a number of samples, but drug metabolites and other components were tested using three batches of each device for all formats.
- Data Provenance: Prepared samples, suggesting prospectively prepared, controlled samples.
Effect of Urine Specific Gravity and pH Study:
- Test set size: Urine samples across a range of specific gravities (1.000-1.035) and pH (4-9) were spiked with target drugs at 25% below and 25% above cut-off levels. These were tested using three batches of each device for all formats.
- Data Provenance: Prepared samples, suggesting prospectively prepared, controlled samples.
Comparison Studies (Professional Users):
- Test set size: For each drug (MDMA and Phencyclidine) and each format (Strip, Cassette, Cup, Dip Card), 80 unaltered clinical samples were used (40 negative and 40 positive). So, for MDMA, 4 formats * 80 samples/format = 320 samples. For Phencyclidine, 4 formats * 80 samples/format = 320 samples.
- Data Provenance: Unaltered clinical samples, which were blind labeled. The text does not specify the country of origin, but it is retrospective in nature given they are "unaltered clinical samples." (The samples were analyzed by GC/MS, meaning the true drug concentration was known retrospectively).
Lay-User Study:
- Test set size: 557 lay persons tested MDMA devices and 555 lay persons tested Phencyclidine devices. Total of 1112 individuals. For each drug, samples were prepared at 7 concentration levels (negative, +/-75%, +/-50%, +/-25% of cutoff). For each concentration, 19-20 samples were tested. Thus, for MDMA: (3 * 20 samples) + (1 * 19 samples for -50% cutoff) + (1 * 20 samples for -25% cutoff) + (1 * 20 samples for +25% cutoff) + (1 * 20 samples for +50% cutoff) + (1 * 19 samples for +75% cutoff) = ~139 unique samples tested across different concentrations for each format (though the table headers suggest 20 samples per concentration usually). The 557 and 555 refers to the number of users, implying each user got at least one sample.
- Data Provenance: Samples were prepared by spiking drugs into drug-free pooled urine specimens, making this a prospectively prepared, controlled sample study. The concentrations were confirmed by GC/MS. The study was performed at "three intended user sites," but country of origin is not specified.

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

Professional User Comparison Study:
- Ground Truth: Established by GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a highly accurate analytical method, considered the gold standard for drug confirmation.
- Experts for Ground Truth: Not applicable in the traditional sense of human readers. The ground truth is established by a diagnostic laboratory method (GC/MS).
- Human Readers of the Device: Three "laboratory assistants" were used for each format. Their specific qualifications are not detailed beyond "laboratory assistants."
Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH Studies:
- Ground Truth: Established primarily by GC/MS for confirmation of spiked drug concentrations.
- Experts for Ground Truth: Not applicable in the traditional sense.
Lay-User Study:
- Ground Truth: Established by GC/MS confirmation of the spiked urine sample concentrations.
- Experts for Ground Truth: Not applicable.

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

Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH Studies:
- No adjudication method is described for interpreting the results of the device itself (e.g., if there were conflicting results). However, for the precision study, three different operators performed the tests, suggesting individual readings were recorded. The summary tables aggregate these results. The ground truth (spiked concentration) was confirmed by GC/MS prior to testing.
Comparison Studies (Professional Users):
- For the discordant results in the comparison studies (Table: Discordant Results of MDMA (Ecstasy) Strip, etc.), it shows individual "Viewer" results (Viewer A, B, C) compared to the GC/MS result. This implies no adjudication method was applied to the device readings to establish a single device result. Instead, the individual results of the three viewers were compared directly to the GC/MS ground truth. They are presenting individual agreement/disagreement.
Lay-User Study:
- Each lay person individually performed the test and interpreted the results. There was no adjudication method among lay users. Each lay user's result was compared to the GC/MS ground truth.

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 involving AI assistance was NOT done.
- This device is an in vitro diagnostic (IVD) test (immunochromatographic assay for drug detection in urine), not an AI-powered image analysis or diagnostic support system for human readers.
- The "Viewers" mentioned in the comparison studies are human laboratory assistants interpreting the visual lines on the test strips/cassettes, not radiologists or clinicians integrating AI outputs. Their performance alone, both individually and in aggregate, is being evaluated against the GC/MS gold standard.

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

Yes, in essence, the "device" itself is a standalone test.
- For an IVD like this, the "algorithm" is the biochemical reaction and visual detection mechanism. The testing (precision, cut-off, interference, specificity, specific gravity/pH) directly evaluates the device's performance in detecting the target analytes in urine samples. The "professional user" comparison and "lay user" study involve human interpretation, but the core performance characteristics are intrinsic to the device's design. There isn't a separate "algorithm" being evaluated beyond the physical test kit itself.

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

The primary ground truth used for all performance studies (Precision, Cut-off, Interference, Specificity, Specific Gravity/pH Effect, Professional User Comparison, Lay-User Study) was Gas Chromatography/Mass Spectrometry (GC/MS).
- GC/MS is a highly reliable and recognized analytical method for confirming the presence and concentration of drugs in biological samples and is considered the gold standard for such applications.

8. The sample size for the training set

There is no stated training set for this device as it is an immunochromatographic assay, not a machine learning or AI algorithm in the context of typical software device development. The device's performance is based on its biochemical design and manufacturing, not a learned model from a dataset.

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

Not applicable, as there is no training set for this type of IVD device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

March 4, 2015

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

HEALGEN SCIENTIFIC LLC C/O JOE XIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K150096

Trade/Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, LCM Dated: January 12, 2015 Received: January 20, 2015

Dear Mr. Xia:

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 -A

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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Indications for Use

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

510(k) Number (if known) K150096

Device Name Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

Indications for Use (Describe)

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.This section applies only to requirements of the Paperwork Reduction Act of 1995.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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1. Date: February 26, 2015
1. Submitter: HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401
1. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX 77401 Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com
1. Device Name: Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card) Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

Classification:

Product Code	CFR #	Panel
LCM	This device has not been classified.
LAF	21 CFR, 862.3610 Methamphetamine 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 prescription and for over-the-counter use.

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

1. Device Description
  Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine Test are immunochromatographic assays for Methylenedioxymethamphetamine and Phencyclidine. Each assay test is a lateral flow system for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine (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 Each test device is sealed with a desiccant in an aluminum pouch. insert.

8. Substantial Equivalence Information

A summary comparison of features of the Healgen MDMA (Ecstasy) Test and Healgen Phencyclidine 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	Methylenedioxymethamphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	500 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Forover-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

Table 1: Features Comparison of Healgen MDMA (Ecstasy) Test and the Predicate Device

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

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Item	Device	Predicate - K052115
Intended Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Drug Analyte	Phencyclidine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	25 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 MDMA (Ecstasy) Test and Healgen Phencyclidine Test are rapid tests for the qualitative detection of Methylenedioxymethamphetamine and Phencyclidine 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 will not form in the test line region if the target drug level exceeds its cut-offconcentration 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

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind labeled and randomized by the person who prepared samples and did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days by three different operators for

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each format of devices. Different set of operators tested each format. The results obtained are summarized in the following tables:

MDMA (Ecstasy)

	Result					Cut-off
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:MDMA1201001	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201002	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201003	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

Cassette Format

Drug	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
Lot:MDMA1201004	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201005	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201006	50-/0+	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	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:MDMA1201007	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201008	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201009	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

CUP 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:MDMA1201010	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201011	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:MDMA1201012	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	50+/0-	50+/0-	50+/0-	50+/0-

Phencyclidine

Strip 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:PCP1111001	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:PCP1111002	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot:PCP1111003	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

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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:PCP1111004	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:PCP1111005	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:PCP1111006	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-

Dip Card Format

	Result -100% -75%		+50% +75% +100%
Drug	Cut-off Cut-off Cut-off Cut-off	Cut-off	Cut-off Cut-off Cut-off Cut-off
Lot:PCP1111007	50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0- 50+/0-
Lot:PCP1111008	50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 50+/0- 50+/0- 50+/0- 50+/0-
Lot:PCP1111009	50-/0+ 50-/0+ 50-/0+ 50-/0+ 22-/28+ 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:PCP1111010	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:PCP1111011	50-/0+	50-/0+	50-/0+	50-/0+	16-/34+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:PCP1111012	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℃ for 24 months based on the accelerated stability study at 45℃ 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.

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 Methylenedioxymethamphetamine and Phencyclidine. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off(ng/mL)

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

MDMA (Ecstasy) Test	Methylenedioxymethamphetamine	500
Phencyclidine Test	Phencyclidine	25

e. Interference
Potential interfering substances found in human urine of physiological or pathological 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	Ethyl Morphine	Phenelzine
N-Acetylprocainamide	Ethyl-p-aminobenzoate	Phenobarbital
Acetylsalicylic Acid(Aspirin)	Fenoprofen	Phentermine
Aminopyrine	Furosemide	Phenylephrine-L
Amitriptyline	Gentisic acid	Phenylethylamine
Amoxicillin	Hemoglobin	Phenylpropanolamine
Amobarbital	Hydralazine	Prednisolone Acetate
D-Amphetamine	(+/-)-4-HydroxyamphetamineHCL	Prednisone
L-Amphetamine	Hydrochlorothiazide	Procaine(Novocaine)
Amphetamine Sulfate	Hydrocodone	Promazine
Ampicinine(Ampicillin)	Hydrocortisone	Promethazine
Apomorphine	a -Hydroxyhippuric acid	Propoxyphene,d-
L-Ascorbic Acid	p-Hydroxymethamphetamine	Propranolol
Aspartame	Ibuprofen	Pseudoephedrine HCL
Atropine	Imipramine	Quinidine
Benzilic acid	Isoxsuprine	Quinine
Benzphetamine	Isoproterenol-(+/-)	Ranitidine(Zantac)
Bezoic Acid	Ketamine	Salicylic Acid
Bilirubin	Levorphanol	Secobarbital
Caffeine	Loperamide	Serotonin
Chloramphenicol	Maprotiline	Sulfamethazine
ChlordiazepoxideHCL	Meprobamate	Sulindac
Chloroquine	Methadone	Temazepam
Chlorothiazide	Methoxyphenamine	11-Nor-Δ9-Tetrahydrocannabinol

MDMA (Ecstasy)

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

Chlorpheniramine	Methylphenidate	Tetracycline
Chlorpromazine	Nalbuphine	Tetrahydrozoline
Cholesterol	Nalidixic acid	Thebaine
Clomipramine	Naloxone hydrochloride	Thiamine
Clonidine hydrochloride	Naltrexone hydrochloride	L-Thyroxine
Codeine	Naproxen	ThioridazineHydrochloride
Cortisone	Niacinamide	Triamterene
Cotinine(-)	Nifedipine	TriflupromazineHydrochloride
Creatinine	Norethindrone	Trimethoprim
Deoxyepinephrine	Norpropoxyphene	Trimipramine
Dextromethorphan	Noscapine	Tryptamine
Diazepam	Oxazepam	DL-Tryptophan
Diflunisal	Oxycodone	Tyramine
Digoxin	Oxymetazoline	D/L-Tyrosine
Doxylamine	Papaverine	Uric Acid
Ecgonine methylester	Penicillin	Verapamil
R(-)-Epinephrine	Pentobarbital	Zomepirac
Erythromycin	Perphenazine
Estrone-3-sulfate	Phencyclidine

Phencyclidine

Acetophenetidin	Ethyl-p-aminobenzoate	Phenelzine
N-Acetylprocainamide	Fenoprofen	Phenobarbital
Acetylsalicylic Acid(Aspirin)	Furosemide	Phentermine
Aminopyrine	Gentisic acid	Phenylephrine-L
Amitriptyline	Hemoglobin	Phenylethylamine
Amoxicillin	Hydralazine	Phenylpropanolamine
Amobarbital	(+/-)-4-HydroxyamphetamineHCL	Prednisolone Acetate
D-Amphetamine	Hydrochlorothiazide	Prednisone
L-Amphetamine	Hydrocodone	Procaine(Novocaine)
Amphetamine Sulfate	Hydrocortisone	Promazine
Ampicinine(Ampicillin)	a -Hydroxyhippuric acid	Promethazine
Apomorphine	p-Hydroxymethamphetamine	Propoxyphene,d-
L-Ascorbic Acid	Ibuprofen	Propranolol
Aspartame	Imipramine	Pseudoephedrine HCL
Atropine	Isoxsuprine	Quinidine
Benzilic acid	Isoproterenol-(+/-)	Quinine

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

Benzphetamine	Ketamine	Ranitidine(Zantac)
Bezoic Acid	Labetalol	Salicylic Acid
Bilirubin	Levorphanol	Secobarbital
Caffeine	Loperamide	Serotonin
Chloramphenicol	Maprotiline	Sulfamethazine
ChlordiazepoxideHCL	Meprobamate	Sulindac
Chloroquine	Methadone	Temazepam
Chlorothiazide	Methoxyphenamine	11-Nor-Δ9-Tetrahydrocannabinol
Chlorpheniramine	(+/-)-Methylenedioxyamphetamine(MDA)	Tetracycline
Chlorpromazine	Methylphenidate	Tetrahydrozoline
Cholesterol	Nalbuphine	Thebaine
Clomipramine	Nalidixic acid	Thiamine
Clonidine hydrochloride	Naloxone hydrochloride	L-Thyroxine
Codeine	Naltrexone hydrochloride	ThioridazineHydrochloride
Cortisone	Naproxen	Triamterene
Cotinine(-)	Niacinamide	TriflupromazineHydrochloride
Creatinine	Nifedipine	Trimethoprim
Deoxyepinephrine	Norethindrone	Trimipramine
Dextromethorphan	Norpropoxyphene	Tryptamine
Diazepam	Noscapine	DL-Tryptophan
Diflunisal	Oxazepam	Tyramine
Digoxin	Oxycodone	D/L-Tyrosine
Doxylamine	Oxymetazoline	Uric Acid
Ecgonine methylester	Papaverine	Verapamil
R(-)-Epinephrine	Penicillin	Zomepirac
Erythromycin	Pentobarbital
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.

MDMA	Result	%
------	--------	---

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

Methylenedioxymethamphetamine(Cut-off=500 ng/mL)		Cross-Reactivity
Methylenedioxymethamphetamine	Positive at 500 ng/mL	100%
3,4-Methylenedioxyamphetamine HCl(MDA)	Positive at 3000 ng/mL	17%
3,4-Methylenedioxyethylamphetamine(MDEA)	Positive at 300 ng/mL	167%
d-methamphetamine	Positive at 2500 ng/mL	20%
d-amphetamine	>100,000	Not detected
l-amphetamine	>100,000	Not detected
l-methamphetamine	>100,000	Not detected

Phencyclidine(Cut-off=25 ng/mL)	Result	% Cross-Reactivity
Phencyclidine	Positive at 25 ng/mL	100%
4-Hydroxy Phencyclidine	Positive at 90 ng/mL	28%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and 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 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 MDMA (Ecstasy) Test, and the Phencyclidine 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 were blind labeled and compared to GC/MS results. The results are presented in the tables below:

IVALLA VIZA LEZULO V
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	13	24

	MDMA (Ecstasy)
--	----------------

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

Viewer B	Negative	10	15	15	3	0
	Positive	0	0	0	12	24
Viewer C	Negative	10	15	15	4	0
	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of MDMA (Ecstasy) Strip

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	1008	ર૦તે	Negative
Viewer A	1033	ર૦ર	Negative
Viewer A	1076	507	Negative
Viewer B	1008	ર૦તે	Negative
Viewer B	1033	ર૦ર	Negative
Viewer B	1076	507	Negative
Viewer B	1037	211	Negative
Viewer C	1008	ર૦તે	Negative
Viewer C	1033	ર૦ર	Negative
Viewer C	1076	507	Negative

Cassette 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	14	24
	Negative	10	15	15	2	0

Discordant Results of MDMA (Ecstasy) Cassette

Cassette Format
Viewer	Sample Number	GC/MS Result	Viewer Results
Viewer A	1008	509	Negative
Viewer A	1033	505	Negative
Viewer A	1076	507	Negative
Viewer B	1033	505	Negative
Viewer B	1037	511	Negative

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

Viewer	Sample Number	GC/MS Result	Cassette FormatViewer Results
Viewer B	1076	507	Negative
Viewer C	1033	505	Negative
Viewer C	1076	507	Negative

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	12	24
	Negative	10	15	15	4	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of MDMA (Ecstasy) Cup

Viewer	Sample Number	GC/MS Result	Cup Format
			Viewer Results
Viewer A	1008	ર09	Negative
Viewer A	1033	ર૦ર	Negative
Viewer A	1076	507	Negative
Viewer B	1008	ર૦તે	Negative
Viewer B	1033	૨૦૨	Negative
Viewer B	1076	507	Negative
Viewer B	1037	211	Negative
Viewer C	1008	ર૦તે	Negative
Viewer C	1033	ર૦ર	Negative
Viewer C	1076	507	Negative

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	14	24

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

	Negative	10	15	15	2	0
Viewer B	Positive	0	0	0	15	24
	Negative	10	15	15	1	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	15	15	3	0

Discordant Results of MDMA (Ecstasy) Dip Card

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	1033	505	Negative
Viewer A	1076	507	Negative
Viewer B	1033	505	Negative
Viewer C	1008	509	Negative
Viewer C	1033	505	Negative
Viewer C	1076	507	Negative

Phencyclidine
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	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 Phencyclidine Strip

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	774	26	Negative
Viewer A	721	25	Negative
Viewer A	779	27	Negative
Viewer B	774	26	Negative
Viewer B	721	25	Negative
Viewer B	702	27	Negative
Viewer C	721	25	Negative
Viewer C	704	27	Negative

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

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer C	779	27	Negative

Cassette 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	14	24
	Negative	10	15	15	2	0
Viewer B	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer C	Positive	0	0	0	12	24
	Negative	10	15	15	4	0

Discordant Results of Phencyclidine Cassette

Viewer	Sample Number	GC/MS Result	Cassette Format Viewer Results
Viewer A	774	26	Negative
Viewer A	721	25	Negative
Viewer B	774	26	Negative
Viewer B	721	25	Negative
Viewer B	702	27	Negative
Viewer C	774	26	Negative
Viewer C	721	25	Negative
Viewer C	704	27	Negative
Viewer C	779	27	Negative

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	13	24
	Negative	10	15	15	3	0

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

Viewer B	Positive	0	0	0	13	24
	Negative	10	15	15	3	0
Viewer C	Positive	0	0	0	12	24
	Negative	10	15	15	4	0

Viewer	Sample Number	GC/MS Result	Dip Card Format Viewer Results
Viewer A	774	26	Negative
Viewer A	721	25	Negative
Viewer A	779	27	Negative
Viewer B	774	26	Negative
Viewer B	721	25	Negative
Viewer B	702	27	Negative
Viewer C	774	26	Negative
Viewer C	721	25	Negative
Viewer C	779	27	Negative
Viewer C	704	27	Negative

Discordant Results of Phencyclidine Dip Card

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	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 Phencyclidine Cup

Viewer	Sample Number	GC/MS Result	Cup Format Viewer Results
Viewer A	774	26	Negative
Viewer A	721	25	Negative
Viewer A	779	27	Negative
Viewer B	774	26	Negative
Viewer B	721	25	Negative

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

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer B	702	27	Negative
Viewer C	721	25	Negative
Viewer C	779	27	Negative
Viewer C	704	27	Negative

Lay-user study

A lay user study was performed at three intended user sites with 557 lay persons testing the MDMA(Ecstasy) devices and another set of 555 persons testing the Phencyclidine devices. Total of 1112 individuals performed the study. A total of 230 females and 327 males tested the MDMA(Ecstasy) samples, and 226 females and 329 males tested the Phencyclidine 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.

	Numberofsamples	MDMA Concentration byGC/MS(ng/mL)	Lay person results		The
% of Cutoff			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	125	0	20	100%
-50% Cutoff	19	250	0	19	100%
-25% Cutoff	20	375	1	19	95%
+25% Cutoff	20	625	19	1	95%
+50% Cutoff	20	750	20	0	100%
+75% Cutoff	20	875	20	0	100%

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

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

	Number	MDMA Concentration byGC/MS(ng/mL)	Lay person results		The
% of Cutoff	ofsamples		No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	19	125	0	19	100%
-50% Cutoff	20	250	0	20	100%
-25% Cutoff	20	375	1	19	તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય
+25% Cutoff	20	ર્ભ (૧૯૮૮)	19	1	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત

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

+50% Cutoff	20	750	20	0	100%
+75% Cutoff	20	875	20	0	100%

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

	Number	MDMA Concentration by	Lay person results		The
% of Cutoff	ofsamples	GC/MS(ng/mL)	No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	125	0	20	100%
-50% Cutoff	20	250	0	20	100%
-25% Cutoff	20	375	1	19	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો
+25% Cutoff	20	ર્ભ (૧૯૮૮)	19	1	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો
+50% Cutoff	20	750	20	0	100%
+75% Cutoff	20	875	20	0	100%

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

% of Cutoff	Numberofsamples	MDMA Concentration byGC/MS(ng/mL)	Lay person results		The
			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	125	0	20	100%
-50% Cutoff	20	250	0	20	100%
-25% Cutoff	20	375	1	19	તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય
+25% Cutoff	20	ર્ભ (૧૯૮૮)	19	1	તે તે જે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય
+50% Cutoff	19	750	19	0	100%
+75% Cutoff	20	875	20	0	100%

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

	Number	PhencyclidineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
% of Cutoff	ofsamples		No. ofPositive	No. ofNegative
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	19	6	0	19	100%
-50% Cutoff	20	12.5	0	20	100%
-25% Cutoff	20	19	1	19	95%
+25% Cutoff	20	31	19	1	95%
+50% Cutoff	20	37.5	20	0	100%
+75% Cutoff	20	44	20	0	100%

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

	Numberofsamples	PhencyclidineConcentration by GC/MS(ng/mL)	Lay person results		The
% of Cutoff			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	6	0	20	100%
-50% Cutoff	19	12.5	0	19	100%
-25% Cutoff	20	19	1	19	95%
+25% Cutoff	20	31	19	1	95%
+50% Cutoff	20	37.5	20	0	100%
+75% Cutoff	20	44	20	0	100%

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

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

	Numberofsamples	PhencyclidineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
% of Cutoff	ofsamples	PhencyclidineConcentration by GC/MS(ng/mL)	No. ofPositive	No. ofNegative	Thepercentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	6	0	20	100%
-50% Cutoff	20	12.5	0	20	100%
-25% Cutoff	20	19	2	18	90%
+25% Cutoff	20	31	18	2	90%
+50% Cutoff	20	37.5	20	0	100%
+75% Cutoff	19	44	19	0	100%

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

% of Cutoff	Numberofsamples	PhencyclidineConcentration by GC/MS(ng/mL)	Lay person results		The
			No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100%Cutoff	20	0	0	20	100%
-75%Cutoff	20	6	0	20	100%
-50% Cutoff	19	12.5	0	19	100%
-25% Cutoff	20	19	2	18	90%
+25% Cutoff	20	31	19	1	95%
+50% Cutoff	20	37.5	20	0	100%
+75% Cutoff	19	44	19	0	100%

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

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 MDMA(Ecstasy) Test, and Healgen Phencyclidine Test are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).