Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. 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 Oxazepam 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 oxazepam 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.

Healgen Morphine Test is an immunochromatographic assay for the qualitative determination of morphine (a drug in the opiate class) in human urine at a Cut-Off concentration of 2000 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 presult is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Description

Healgen Oxazepam Test and Healgen Morphine Test are immunochromatographic assays for Oxazepam and Morphine. Each assay test is a lateral flow system for the qualitative detection of Oxazepam and Morphine (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

This document describes the performance characteristics and acceptance criteria for the "Healgen Oxazepam Test" and "Healgen Morphine Test," which are immunochromatographic assays for the qualitative determination of Oxazepam and Morphine in human urine.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds in a dedicated table format. Instead, it presents performance data that implicitly serves as the proof of meeting intended performance. The key performance metrics evaluated are precision and method comparison (clinical sample testing) near the cut-off concentrations, and lay-user study accuracy.

I've extracted the relevant performance values. For "acceptance criteria," I'll interpret this as the implied high accuracy expected from such diagnostic tests.

Performance Metric	Specific Test and Concentration	Implied Acceptance Criteria (e.g., high agreement with GC/MS, low false rates)	Reported Device Performance (Oxazepam)	Reported Device Performance (Morphine)
Precision	Samples at -100% to -25% of cut-off	100% agreement with expected negative result	50-/0+ (50 negative, 0 positive) across all concentrations (-100%, -75%, -50%, -25%) and all formats (Strip, Cassette, Dip Card, CUP) for all 3 lots tested.	50-/0+ across all concentrations (-100%, -75%, -50%, -25%) and all formats (Strip, Cassette, Dip Card, CUP) for all 3 lots tested.
Precision	Samples at +25% to +100% of cut-off	100% agreement with expected positive result	50+/0- (50 positive, 0 negative) across all concentrations (+25%, +50%, +75%, +100%) and all formats (Strip, Cassette, Dip Card, CUP) for all 3 lots tested.	50+/0- across all concentrations (+25%, +50%, +75%, +100%) and all formats (Strip, Cassette, Dip Card, CUP) for all 3 lots tested.
Precision	Samples at Cut-off concentration	High percentage of correct classifications (mix of positive/negative expected)	Oxazepam Strip: 22-/28+ (22 negative, 28 positive); Cassette: 24-/26+; Dip Card: 18-/32+; CUP: 20-/30+ (across 3 lots each). This indicates expected variability near the cutoff.	Morphine Strip: 18-/32+; Cassette: 22-/28+; Dip Card: 22-/28+; CUP: 20-/30+ (across 3 lots each). This indicates expected variability near the cutoff.
Method Comparison (Clinical Samples)	Agreement with GC/MS for negative samples (Negative, Low Negative, Near Cutoff Negative)	Very high agreement with GC/MS	Oxazepam (all formats, all 3 viewers): All samples in these categories (10 + 15 + 15 = 40 samples per viewer) were correctly identified as negative (e.g., "10", "15", "15" in negative rows).	Morphine (all formats, all 3 viewers): All samples in these categories (10 + 16 + 14 = 40 samples per viewer) were correctly identified as negative (e.g., "10", "16", "14" in negative rows).
Method Comparison (Clinical Samples)	Agreement with GC/MS for positive samples (Near Cutoff Positive, High Positive)	Very high agreement with GC/MS	Oxazepam (all formats, all 3 viewers): Generally high agreement, with some discordant results near cutoff. For example, Strip format: 14/16 positive in "Near Cutoff Positive", 24/24 positive in "High Positive." See detailed discordant rows for exceptions.	Morphine (all formats, all 3 viewers): Generally high agreement, with some discordant results near cutoff. For example, Strip format: 13/17 positive in "Near Cutoff Positive", 23/23 positive in "High Positive." See detailed discordant rows for exceptions.
Lay-user Study (Accuracy)	Overall correct results for each concentration level tested (-100% Cutoff to +75% Cutoff)	≥ 90% correct for all concentrations	Generally 90-100% correct results across all concentration levels and all formats. For example, -25% Cutoff: 90-95% correct; +25% Cutoff: 90-95% correct. Others 100%.	Generally 90-100% correct results across all concentration levels and all formats. For example, -25% Cutoff: 90% correct; +25% Cutoff: 90-95% correct. Others 100%.
Lay-user Study (Instructions)	Ease of understanding instructions	Easily understood by lay users	All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid Grade Level: 7.	All lay users indicated that the device instructions can be easily followed. Flesch-Kincaid Grade Level: 7.

2. Sample sizes used for the test set and the data provenance:

Precision Studies (Analytical Performance):
- Test Set Size: For each drug (Oxazepam and Morphine), for each format (Strip, Cassette, Dip Card, CUP), and for each of the 3 lots, 50 samples were tested at each of 9 concentrations (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of cut-off).
  - Total precision samples per drug: (9 concentrations * 50 samples/conc * 4 formats * 3 lots) = 5400 samples
  - Total precision samples (Oxazepam + Morphine): 10,800 samples.
- Data Provenance: The document states "samples were prepared by spiking drug in negative samples." "These samples were tested using three batches of each device." The provenance (country of origin), whether retrospective or prospective, is not explicitly stated for these analytical samples, but they appear to be experimentally prepared rather than naturally occurring clinical samples.
Method Comparison Studies (Clinical Samples):
- Test Set Size: For each drug (Oxazepam and Morphine), and for each format (Strip, Cassette, Dip Card, CUP), 80 "unaltered clinical samples" (40 negative and 40 positive) were tested.
  - Total method comparison samples per drug: (80 samples * 4 formats) = 320 samples.
  - Total method comparison samples (Oxazepam + Morphine): 640 samples.
- Data Provenance: "unaltered clinical samples." The geographic origin of these clinical samples is not specified. They appear to be retrospective as they were collected and then blind labeled for testing.
Lay-user Study:
- Test Set Size: 140 lay persons for Oxazepam devices, and 140 lay persons for Morphine devices. Each participant was given 1 blind-labeled sample.
  - For Oxazepam and Morphine, each lay person tested one sample at one of 7 concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75%, of cut-off).
  - For each concentration level, 20 samples were tested. So, 20 * 7 = 140 samples were tested per drug.
- Data Provenance: The study was "performed at three intended user sites." The geographic origin is not specified. The samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." This indicates a prospective experimental design using prepared urine samples, not naturally occurring clinical samples.

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

For Precision Studies & Lay-user Studies: The document states that drug concentrations in the prepared samples were "confirmed by GC/MS." GC/MS (Gas Chromatography/Mass Spectrometry) is a highly reliable analytical chemistry method, and its results are considered the gold standard for confirming drug concentrations. The "experts" here are the calibrated GC/MS instrument and the analytical chemists operating and interpreting it. Specific expert qualifications are not detailed, but it's implied they adhere to standard laboratory practices for GC/MS.
For Method Comparison Studies (Clinical Samples): The ground truth was established by "GC/MS results." Similar to above, GC/MS is the reference method, implying that the ground truth was derived from this analytical technique rather than human expert interpretation of the test device itself.

4. Adjudication method for the test set:

Precision Studies & Lay-user Studies: No explicit adjudication method is mentioned. The ground truth (GC/MS confirmation) is considered definitive for these prepared samples.
Method Comparison Studies: The comparison was directly against "GC/MS results," which serves as the independent truth. The results from each of the three "laboratory assistants" (viewers) were compared individually to the GC/MS result. There was no listed adjudication process among the viewers; their individual agreement/disagreement with GC/MS is reported.

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 done. This document describes a traditional in-vitro diagnostic device (lateral flow immunoassay for drugs of abuse) and its validation. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data with and without AI assistance. The "viewers" in the method comparison study are "laboratory assistants" performing the test and visually reading the results, not interpreting complex medical images.

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

Not applicable in the context of AI/algorithms. This device is a rapid, visual immunochromatographic assay. Its "performance" is inherently linked to human observation of the test lines. There is no underlying algorithm separate from the chemical reaction displayed visually. The "standalone" performance is essentially the listed "Precision" and "Method Comparison" results, where the device itself (the chemical immunoassay) is assessed for its ability to correctly manifest positive/negative results under various conditions, which are then read by a human.

7. The type of ground truth used:

GC/MS (Gas Chromatography/Mass Spectrometry) results were used as the gold standard ground truth for both the precision studies (prepared samples) and the method comparison studies (clinical samples). This is a highly accurate and quantitative analytical method for drug concentration determination.

8. The sample size for the training set:

Not applicable. This document describes a traditional immunochromatographic assay, not a machine learning or artificial intelligence model. Therefore, there is no "training set" in the computational sense. The device's "training" is inherent in its chemical design and manufacturing process, optimized through R&D and quality control, not through data-driven learning.

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

Not applicable. As established in point 8, there is no "training set" for an AI model. For the development and verification of such an immunoassay, the "ground truth" would be established through established chemical and biological assays, often using purified standards and reference methods like GC/MS (as seen in the performance validation), during the manufacturing and R&D phases to ensure the reagents and test strip components function as intended. However, this is part of the product development and quality control, not a "training set" for an algorithm.

Summary

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

October 16, 2014

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

Re: K142280

Trade/Device Name: Healgen Oxazepam Test (Strip, Cassette, Cup, Dio Card): Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DJG Dated: August 12, 2014 Received: August 15, 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 (OS) 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,

Courtney

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

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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) K142280

Device Name

Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card) Healgen Morphine 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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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510(k) SUMMARY

1. Date:	October 6, 2014
2. Submitter:	HEALGEN SCIENTIFIC LLC5213 Maple StBellaire, TX77401
3. Contact person:	Jianqiu FangHEALGEN SCIENTIFIC LLC5213 Maple StBellaire, TX77401Telephone: 713-733-8088

Telephone: 713-733-8088 Fax: 713-733-8088 Email: bryan@healgen.com

1. Device Name: Healgen Oxazepam Test (Strip, Cassette. Cup, Dip Card) Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

Classification:

ProductCode	CFR #	Panel
JXM	21 CFR, 862.3170 Benzodiazepine 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
  Healgen Oxazepam Test is an immunochromatographic assay for the qualitative determination of Oxazepam (a drug in the benzodiazepine class) in human urine at a Cut-Off concentration of 300 ng/m L. 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 Oxazepam 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 oxazepam 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

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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.

7. Device Description

8. Substantial Equivalence Information

A summary comparison of features of the Healgen Oxazepam Test and Healgen Morphine 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	Oxazepam	BenzodiazepineDrug Class
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same

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

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Item	Device	Predicate -K052115
IntendedPopulation	For over-the-counter and prescriptionuses.	Forover-the-counteruse.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

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

Item	Device	Predicate - K052115
Intended Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Drug Analyte	Morphine	Opiate Drug Class
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	2000 ng/mL	Same
IntendedFor over-the-counter and prescription		For over-the-counter
Population	uses.	use.
Configurations	Strip, Cassette, Cup, Dip Card	Cup

9. Test Principle

Healgen Oxazepam Test and Healgen Morphine Test are rapid tests for the qualitative detection of Oxazepam and Morphine 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.

10. Performance Characteristics

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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, +50% 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. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

Oxazepam

	-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: 1201001	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1201002	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1201003	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

Strip Format

Cassette Format

	Result -100%	-50%		+25% +50% +75% +100%
Drug	Cut-off Cut-off Cut-off Cut-off		Cut-off	Cut-off Cut-off Cut-off Cut-off
Lot: 1201004	50-10+	50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0-
Lot: 1201005	50-10+	50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0-
Lot: 1201006		50-/0+ 50-/0+ 50-/0+ 50-/0+ 24-/26+ 50+/0- 50+/0- 50+/0- 50+/0-

Dip Card 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: 1201007	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: 1201008	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: 1201009	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	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: 1201010	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1201011	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1201012	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

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Morphine

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: 1112001	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: 1112002	50-/0+	50-/0+	50-/0+	50-/0+	18-/32+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: 1112003	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: 1112004	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot:1112005	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
	Lot: 1112006	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: 1112007	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1112008	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1112009	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	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: 1112010	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1112011	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot: 1112012	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	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℃.

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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 Oxazepam and Morphine. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off(ng/mL)
Oxazepam Test	Oxazepam	300
Morphine Test	Morphine	2000

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.

4-Acetamidophenol	Doxylamine	Oxolinic acid
Acetophenetidin	Ecaonine dydrochloride	Pentobarbital
N-Acetylprocainamide	Ecgonine methylester	Perphenazine
Acetylsalicylic acid	(-)-Ψ-Ephedrine	Phencyclidine
Aminoprine	Fenoprofen	Phenelzine
Amitriptyline	Furosemide	Phenobarbital
Amorbarbital	Gentisic acid	Phentermine
Amoxicillin	Hemoglobin	L-Phenylephrine
Ampicillin	Hydrocortisone	Phenylethylamine
1-Ascorbic Acid	O-Hydroxyhippuric acid	Phenylpropanotamine
D.L-Amphetamine	p-Hydroxy-methamphetamine	Prednisone
Aporphine	3-Hydroxytyramine	D.L-Propanolol

Oxazepam

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

Aspartame	Ibuprofen	D-Propoxyphene
Atropine	Imipramine	D-Pseudoephedrine
Benzillic acid	Iproniazid	Quinine
Benzoic acid	(±)Isoproterenol	Ranitidine
Benzoylecaonine	Isoxsuprine	Salicylic acid
Benzphetamine	Ketamine	Secobarbital
Bilirubin	Ketoprofen	Serotonin(5-Hydroxytyramine)
(±) Chlorpheniramine	Labetalol	Sertraline
Caffeine	Loperamide	Sulfamethazine
Cannabidiol	Maprotiline	Sulindac
Chloralhydrate	Meperidine	Tetrahydrocortisone,3 Acetate
Chloramphenicol	Meprobamate	Tetrahydrocortisone,(β-Dglucuronide)
Chlorothiazide	Methadone	Tetrahydrozoline
(±)Chlorpheniramine	Methoxyphenamine	Thiamine
Chlorpromazine	(+) 3,4-Methylenedioxy-amphetamine	Thioridazine
Chlorquine	(+)3,4-Methylenedioxy-methamphetamine	D.L-Tyrosine
Cholesterol	Nalidixic acid	Tolbutamide
Clomipramine	Nalorphine	Triamterene
Clonidine	Naloxone	Trifluoperazine
Cocaine hydrochloride	Naltrexone	Trimethoprim
Cortisone	Naproxen	Tryptamine
(-)cotinine	Niacinamide	D.L-Tryptophan
Creatinine	Nifedipine	Tyramine
Dextromethlorphan	Norethindrone	Uric acid
Diclolrfenac	D-Norpropoxyphene	Verapamil
Diflunisal	Noscapine	Zomepirac
Diaoxin	D.L-Octopamine
Diphenhydramine	Oxalic acid

Morphine

4-Acetamidophenol	Ecgonine methylester	Oxolinic acid
Acetophenetidin	(-) -Y -Ephedrine	Oxymetazoline
N-Acetylprocainamide	Erythromycin	Papaverine
Acetylsalicylic acid	β-Estradiol	Penicillin-G
Aminopyrine	Estrone-3-sulfate	Pentazocine
Amitryptyline	Ethyl-p-aminobenzoate	Pentobarbital
Amobarbital	Fenoprofen	Perphenazine
Amoxicillin	Furosemide	Phencyclidine
Ampicillin	Gentisic acid	Phenelzine
Ascorbic acid	Hemoglobin	Phenobarbital
D,L-Amphetamine	Hydralazine	Phentermine
Apomorphine	Hydrochlorothiazide	L-Phenylephrine
Aspartame	Hydrocortisone	β-Phenylethylamine
Atropine	O-Hydroxyhippuric acid	Phenylpropanolamine
Benzilic acid	p-Hydroxy methamphetamine	Prednisone
Benzoic acid	3-Hydroxytyramine	D,L-Propanolol
Benzoylecgonine	Ibuprofen	D-Propoxyphene
Benzphetamine	Imipramine	D-Pseudoephedrine
Bilirubin (±)	Iproniazid	Quinidine
Brompheniramine	Isoproterenol	Quinine
Caffeine	Isoxsuprine	Ranitidine
Cannabidiol	Ketamine	Salicylic acid
Chloralhydrate	Ketoprofen	Secobarbital
Chloramphenicol	Labetalol	Serotonin (5-Hydroxytyramine)
Chlordiazepoxide	Loperamide	Sulfamethazine
Chlorothiazide	Maprotiline	Sulindac
(±) Chlorpheniramine	Meperidine	Temazepam
Chlorpromazine	Meprobamate	Tetracycline
Chlorquine	Methadone	Tetrahydrocortisone, 3Acetate
Cholesterol	Methoxyphenamine	Tetrahydrocortisone3 (ß-Dglucuronide)
Clomipramine	(+) 3,4-Methylenedioxy-amphetamine	Tetrahydrozoline
Clonidine	(+)3,4-Methylenedioxy-methamphetamine	Thiamine
Cocaine hydrochloride	Nalidixic acid	Thioridazine
Cortisone	Nalorphine	D, L-Tyrosine
(-) Cotinine	Naloxone	Tolbutamide
Creatinine	Naltrexone	Triamterene
Deoxycorticosterone	Naproxen	Trifluoperazine
Dextromethorphan	Niacinamide	Trimethoprim
Diazepam	Nifedipine	Trimipramine
Diclofenac	Norethindrone	Tryptamine
Diflunisal	D-Norpropoxyphene	D, L-Tryptophan
Digoxin	Noscapine	Tyramine
Diphenhydramine	D,L-Octopamine	Uric acid
Doxylamine	Oxalic acid	Verapamil
Ecgonine hydrochloride	Oxazepam	Zomepirac

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

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

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.

	Result	%Cross-Reactivity
Oxazepam(Cut-off=300 ng/mL)	Positive at 300 ng/mL	100%
Alprazolam	Positive at 200 ng/mL	150%
Bromazepam	Positive at 1560 ng/mL	19%
Chlordiazepoxide HCL	Positive at 1560 ng/mL	19%
Clobazam	Positive at 100 ng/mL	300%
Clonazepam	Positive at 780 ng/mL	38%
Clorazepate Dipotassium	Positive at 200 ng/mL	150%
Delorazepam	Positive at 1560 ng/mL	19%
Desalkylflurazepam	Positive at 400 ng/mL	75%
Diazepam	Positive at 200 ng/mL	150%
Estazolam	Positive at 2500 ng/mL	12%
Flunitrazepam	Positive at 400 ng/mL	75%
a-Hydroxyalprazolam	Positive at 1260 ng/mL	24%
(±) Lorazepam	Positive at 1560 ng/mL	19%
RS-Lorazepam glucuronide	Positive at 160 ng/mL	188%
Midazolam	Positive at 12500 ng/mL	2.4%
Nitrazepam	Positive at 100 ng/mL	300%
Norchlordiazepoxide	Positive at 200 ng/mL	150%
Nordiazepam	Positive at 400 ng/mL	75%
Temazepam	Positive at 100 ng/mL	300%
Triazolam	Positive at 2500 ng/mL	12%

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

	Result	% Cross-Reactivity
Morphine(Cut-off=2000 ng/mL)	Positive at 2000 ng/mL	100%
O6-Acetylmorphine	Positive at 2500 ng/mL	80%
Codeine	Positive at 1000 ng/mL	200%
EthylMorphine	Positive at 250 ng/mL	800%
Heroin	Positive at 5000 ng/mL	40%
Hydromorphone	Positive at 2500 ng/mL	80%
Hydrocodone	Positive at 5000 ng/mL	40%
Oxycodone	Positive at 75000 ng/mL	3%
Thebaine	Positive at 13,000 ng/mL	15%

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

2. Comparison Studies

The method comparison studies for the Oxazepam Test, and the Morphine 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:

Oxazepam
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	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	14	24
	Negative	10	15	15	2	0

Oxazepam

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

Viewer	Sample Number	GC/MS Result	Strip FormatViewer Results
Viewer A	549	306	Negative
Viewer A	523	303	Negative
Viewer B	549	306	Negative
Viewer B	523	303	Negative
Viewer B	579	312	Negative
Viewer C	549	306	Negative
Viewer C	523	303	Negative

Discordant Results of Oxazepam Strip

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%)
	Positive	0	0	0	13	24
Viewer A	Negative	10	ાં ર	ાં ર	3	0
Viewer B	Positive	0	0	0	13	24
	Negative	10	ા ર	ા ર	3	0
Viewer C	Positive	0	0	0	13	24
	Negative	10	ા ર	ા ર	3	0

Discordant Results of Oxazepam Cassette

Viewer	Sample Number	GC/MS Result	Cassette FormatViewer Results
Viewer A	549	306	Negative
Viewer A	523	303	Negative
Viewer A	579	312	Negative
Viewer B	549	306	Negative
Viewer B	523	303	Negative
Viewer B	579	312	Negative
Viewer C	549	306	Negative
Viewer C	523	303	Negative
Viewer C	579	312	Negative

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

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	14	24
	Negative	10	15	15	2	0
Viewer B	Positive	0	0	0	14	24
	Negative	10	15	15	2	0
Viewer C	Positive	0	0	0	14	24
	Negative	10	15	15	2	0

Discordant Results of Oxazepam Cup

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	549	306	Negative
Viewer A	523	303	Negative
Viewer B	523	303	Negative
Viewer B	579	312	Negative
Viewer C	549	306	Negative
Viewer C	523	303	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	12	24
	Negative	10	15	15	4	0
Viewer B	Positive	0	0	0	12	24
	Negative	10	15	15	4	0
Viewer C	Positive	0	0	0	14	24
	Negative	10	15	15	2	0

Discordant Results of OxazepamDip Card

Discordant Results of OxazepamDip Card
Viewer	Sample Number		Dip Card FormatGC/MS ResultViewer Results
Viewer A	રે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ	315	Negative
Viewer A	549	306	Negative

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

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	523	303	Negative
Viewer A	579	312	Negative
Viewer B	505	315	Negative
Viewer B	549	306	Negative
Viewer B	523	303	Negative
Viewer B	579	312	Negative
Viewer C	549	306	Negative
Viewer C	523	303	Negative

Morphine

Stripformat		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	23
	Negative	10	16	14	4	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

Discordant Results of Morphine Strip

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer A	468	2036	Negative
Viewer A	466	2019	Negative
Viewer A	453	2066	Negative
Viewer A	449	2005	Negative
Viewer B	468	2036	Negative
Viewer B	466	2019	Negative
Viewer B	453	2066	Negative
Viewer B	449	2005	Negative
Viewer C	466	2019	Negative

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

Viewer	Sample Number	GC/MS Result	Strip Format Viewer Results
Viewer C	449	2005	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	14	23
	Negative	10	16	14	3	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 Morphine Cassette

Viewer	Sample Number	GC/MS Result	Cassette Format Viewer Results
Viewer A	468	2036	Negative
Viewer A	466	2019	Negative
Viewer A	449	2005	Negative
Viewer B	405	2053	Negative
Viewer B	468	2036	Negative
Viewer B	466	2019	Negative
Viewer B	449	2005	Negative
Viewer C	405	2053	Negative
Viewer C	468	2036	Negative
Viewer C	466	2019	Negative
Viewer C	449	2005	Negative

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

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	23
Viewer A	Negative	10	16	14	4	0
Viewer B	Positive	0	0	0	12	23
Viewer B	Negative	10	16	14	5	0
Viewer C	Positive	0	0	0	12	23
Viewer C	Negative	10	16	14	5	0

Discordant Results of Morphine Dip Card

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	405	2053	Negative
Viewer A	468	2036	Negative
Viewer A	466	2019	Negative
Viewer A	449	2005	Negative
Viewer B	405	2053	Negative
Viewer B	468	2036	Negative
Viewer B	466	2019	Negative
Viewer B	449	2005	Negative
Viewer B	429	2067	Negative
Viewer C	405	2053	Negative
Viewer C	468	2036	Negative
Viewer C	466	2019	Negative
Viewer C	449	2005	Negative
Viewer C	429	2067	Negative

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

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	15	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	13	23
	Negative	10	16	14	4	0

Discordant Results of Morphine Cup

Viewer	Sample Number	GC/MS Result	Cup Format Viewer Results
Viewer A	466	2019	Negative
Viewer A	449	2005	Negative
Viewer B	468	2036	Negative
Viewer B	466	2019	Negative
Viewer B	449	2005	Negative
Viewer C	405	2053	Negative
Viewer C	468	2036	Negative
Viewer C	466	2019	Negative
Viewer C	449	2005	Negative

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons testing the Oxazepam devices and another set of 140 persons testing the morphine devices. A total of 44 females and 96 males tested the Oxazepam samples, and 41 females and 99 males tested the Morphine 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.

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

% of Cutoff	Number of samples	Oxazepam Concentration by GC/MS (ng/mL)	Lay person results No. of Positive	Lay person results No. of Negative	The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	1	19	95%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

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

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

	Number	Oxazepam Concentration	Lay person results		The
% of Cutoff	ofsamples	by GC/MS(ng/mL)	No. ofPositive	No. ofNegative	percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

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

	Numberofsamples	Oxazepam Concentrationby 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	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	1	19	95%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

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

	Numberofsamples	Oxazepam Concentrationby 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	75	0	20	100%
-50% Cutoff	20	150	0	20	100%
-25% Cutoff	20	225	2	18	90%
+25% Cutoff	20	375	19	1	95%
+50% Cutoff	20	450	20	0	100%
+75% Cutoff	20	525	20	0	100%

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

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

% of Cutoff	Number of samples	MOP Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	500	0	20	100%
-50% Cutoff	20	1000	0	20	100%
-25% Cutoff	20	1500	2	18	90%
+25% Cutoff	20	2500	19	1	95%
+50% Cutoff	20	3000	20	0	100%
+75% Cutoff	20	3500	20	0	100%

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

	Numberofsamples	MOP 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	500	0	20	100%
-50% Cutoff	20	1000	0	20	100%
-25% Cutoff	20	1500	1	19	95%
+25% Cutoff	20	2500	19	1	95%
+50% Cutoff	20	3000	20	0	100%
+75% Cutoff	20	3500	20	0	100%

{21}------------------------------------------------

% of Cutoff	Numberofsamples	MOP Concentration byGC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	500	0	20	100%
-50% Cutoff	20	1000	0	20	100%
-25% Cutoff	20	1500	2	18	90%
+25% Cutoff	20	2500	18	2	90%
+50% Cutoff	20	3000	20	0	100%
+75% Cutoff	20	3500	20	0	100%

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

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

% of Cutoff	Numberofsamples	MOP Concentration byGC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100%
-75% Cutoff	20	500	0	20	100%
-50% Cutoff	20	1000	0	20	100%
-25% Cutoff	20	1500	2	18	90%
+25% Cutoff	20	2500	19	1	95%
+50% Cutoff	20	3000	20	0	100%
+75% Cutoff	20	3500	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 Oxazepam Test, and Healgen Morphine 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).