The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	300
Methamphetamine	MAMP	d-Methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Opiates	OPI	Morphine	2000
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

The multi test panels can consist of up to fourteen (14) of the above issed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Device Description

The Chemtrue® Drug Screen Tests are colloidal gold based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

AI/ML Overview

Acceptance Criteria and Device Performance for Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests

This document describes the acceptance criteria and the study that demonstrates the Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests meet these criteria. The device is a rapid lateral flow immunoassay for the qualitative detection of various drugs of abuse in human urine, intended for prescription and Over-The-Counter (OTC) use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly demonstrated through the performance characteristics presented in the 510(k) summary. These include:

Precision (Reproducibility): Consistent results at and around the cut-off concentrations across different operators and lots. The exact acceptance percentage for concordance at cut-off is not explicitly stated as a numerical criterion but is demonstrated by the reported distribution of positive/negative results.
Specificity (Cross-Reactivity): Detect the target analytes and related compounds at specified concentrations, while exhibiting minimal cross-reactivity with non-target substances. Acceptance is qualitative based on the reported cross-reactivity percentages.
Interference: No interference from common endogenous compounds or non-structurally related compounds. Acceptance is qualitative, showing "no interference" for a wide range of substances at tested concentrations.
Effect of Urine pH and Specific Gravity: Test performance should not be affected by variations in urine pH and specific gravity within specified ranges. Acceptance is demonstrated by stating these factors "do not affect the test performance."
Stability: Maintain performance over a specified shelf-life. Acceptance is a 2-year shelf life at 2°C to 30°C.
Accuracy (Method Comparison): High agreement with a confirmed reference method (GC/MS). The acceptance criterion for accuracy is ≥ 99% agreement between the Chemtrue® Drug Screen test device and GC/MS values.
Lay-user Accuracy and Usability (for OTC): High accuracy when performed by lay-users and ease of understanding instructions. The acceptance criterion is demonstrated by ≥ 99% agreement with GC/MS values for lay-user studies and ≥ 96% of lay users easily following instructions.

Below is a summary of the key performance criteria and the reported device performance. Note that for precision and cross-reactivity, specific numerical acceptance thresholds were not explicitly stated as distinct criteria, but the reported performance data in the tables indicate successful demonstration of these characteristics.

Table 1: Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criterion (Implicit where not numerical)	Reported Device Performance
Precision (Reproducibility)	Consistent qualitative results (+/-) at negative, 50%, 75%, cut-off, 125%, and 150% of cut-off across operators and lots.	At Cutoff (e.g., AMP 300 ng/mL Dip Card): 16 positive, 14 negative out of 30. At 125% & 150% of Cutoff: 30 positive out of 30. At 50% & 75% of Cutoff & Negative: 0 positive, 30 negative out of 30. Similar distributions for other analytes and formats, indicating consistent qualitative detection around the cutoff.
Specificity (Cross-Reactivity)	Detect target analytes and related compounds; minimal cross-reactivity with non-target substances.	Reported cross-reactivity percentages for various related compounds (e.g., d-Amphetamine 100% at 500 ng/mL, d,l-Amphetamine 62.5% at 800 ng/mL for AMP 500). Non-structurally related compounds found "not to cross-react" at 100 µg/mL.
Interference	No interference from 103 specified potential interferents (endogenous and non-structurally related compounds) at tested concentrations.	"It was found not to cross-react when tested at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations." Listed 103 compounds explicitly stated as "do not interfere."
Effect of Urine pH	Test performance unaffected within pH range of 2.0 to 9.0 at ±25% of the drug cut-off concentrations.	"The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance."
Effect of Specific Gravity	Test performance unaffected within SG ranges of 1.001, 1.015, 1.020, 1.025, and 1.030 at ±25% of the drug cut-off concentrations.	"The specific gravity (SG) ranges of 1.001, 1.015, 1.020, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results."
Stability (Shelf Life)	Support a 2-year shelf-life at 2℃ to 30℃.	"The stability study results support two (2) years shelf-life of the products at (2℃ to 30℃). The real time stability study is still on going."
Accuracy (Method Comparison)	≥ 99% agreement with GC/MS reference method.	Reported: ≥ 97.6% to 100% agreement with GC/MS for individual analytes in Method Comparison Study (Tables 6a & 6b). "The results demonstrate that the agreement between the Chemtrue® Drug Screen test device and GC/MS values is ≥ 99%." (This combines all analytes for both Dip Card and Cup).
OTC Lay-user Accuracy	≥ 99% agreement with GC/MS reference method when performed by lay-users.	Reported: 99% to 100% agreement with GC/MS for individual analytes in OTC Accuracy studies (Tables 7a & 7b). "The results demonstrate that the agreement between the Chemtrue® Drug Screen test device and GC/MS values is ≥ 99%." (This combines all analytes for both Dip Card and Cup).
OTC Lay-user Usability	≥ 96% of lay users can easily follow instructions to perform the test and interpret results, with a Flesch-Kincaid reading level of 7th grade.	"The results demonstrate that ≥ 96% of the lay users can easily follow the instructions to perform the test and interpret the results. A Flesch-Kincaid reading analysis supports a 7th grade reading level."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly delineate a "test set" in the context of the training/testing split common in AI/ML studies, as this device is a lateral flow immunoassay. Instead, it refers to various validation studies.

Precision (Reproducibility) Studies:
- Sample Size: 30 samples per concentration level (Negative, 50% of cutoff, 75% of cutoff, Cutoff, 125% of cutoff, 150% of cutoff) for each analyte and device format. This equates to 180 samples per analyte/format combination (e.g., AMP Dip Card Test: Cutoff: 300 ng/mL used 180 samples).
- Data Provenance: Not specified, but the samples were "GC/MS confirmed drug spiked urine controls." This implies controlled laboratory generation rather than real clinical samples. No country of origin is mentioned. These are prospective, controlled experiments due to the spiked nature.
Specificity Studies:
- Sample Size: Not explicitly stated as a number of "samples." Various related compounds were tested for cross-reactivity at different concentrations, and 103 potential interferents were tested at a concentration of 100 µg/mL at ±25% of the drug cut-off concentrations.
- Data Provenance: Not specified, likely laboratory-generated samples with controlled spiking of compounds. Prospective.
Interference Studies:
- Sample Size: 103 potential interferents tested. Each was tested with "one lot each of the test device format." The implied sample count would be (number of interferents) * (number of device formats).
- Data Provenance: Laboratory-generated, spiked samples. Prospective.
Effect of Urine pH and Specific Gravity Studies:
- Sample Size: Not explicitly stated, but tests were performed within specified pH and SG ranges at ±25% of the drug cut-off concentrations.
- Data Provenance: Laboratory-generated, controlled urine samples. Prospective.
Accuracy (Method Comparison) Studies:
- Sample Size: "On average of 85 clinical specimens for each drug test and a total of 685 samples were tested" for the analytes specifically included in this submission (AMP300/500, BAR200/BZO200, COC150, MET300/500 and PPX).
- Data Provenance: "blind-labeled clinical specimen correlation study." This indicates real human urine samples, but the country of origin is not specified. These are retrospective analyses as they compare the device's results to pre-existing or independently confirmed GC/MS values.
OTC Lay-user Accuracy Studies:
- Sample Size: "One hundred (130) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup)." The number of tests performed is much higher, as each lay-user was given "up to two (2) random blind labeled samples" with concentrations covering negative, 50%, 75%, 125%, 150%, and 200% of the cutoff.
- Data Provenance: "GC/MS confirmed urine samples," which were "spiking drugs into drug-free urine pool." This suggests laboratory-controlled, spiked samples rather than true "clinical" samples from drug users. Prospective experiment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For Precision, Specificity, Interference, pH/SG, OTC Lay-user Studies: The ground truth was established by GC/MS confirmation of drug-spiked urine samples. This method is considered the gold standard for drug detection and quantification in urine. Therefore, the "experts" are the technicians/analysts operating the GC/MS equipment, whose qualifications are implicitly high-level laboratory personnel but not explicitly stated (e.g., clinical chemists, toxicologists).
For Accuracy (Method Comparison) Studies: The ground truth was also established by GC/MS values. These were "blind-labeled clinical specimen" samples. Again, the experts are the GC/MS laboratory personnel. The document states, "Three operators performed the testing," but this refers to the Chemtrue device operators, not necessarily the GC/MS operators who established ground truth.

4. Adjudication Method for the Test Set

For Precision Studies: The ground truth for the spiked samples was known. Qualitative results (+/-) from the device were compared against the expected positive/negative based on the known concentration relative to the cutoff. Discordant results are implicitly handled by the quantitative reporting in the tables (e.g., at cutoff, some were positive, some negative, reflecting the expected variability around the cutoff).
For Accuracy (Method Comparison) Studies: The ground truth was the GC/MS value. This method serves as the definitive reference, so no adjudication among multiple experts for ground truth was performed; it was a direct comparison to the GC/MS result. The results describe "discordant results" where the device's reading didn't match the GC/MS, and these were "confirmed at the drug cutoff level with the GC/MS concentrations," which is a further verification against the gold standard.
For OTC Lay-user Accuracy Studies: Similar to the accuracy studies, the ground truth was the GC/MS values from the spiked samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to assess the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The Chemtrue device is a rapid diagnostic test (lateral flow immunoassay) that provides a direct qualitative result, not an AI system designed to assist human interpretation of complex data. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

Yes, the device essentially operates in a standalone manner. The Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests are standalone devices that generate a qualitative (positive/negative) result without human intervention in the result generation process itself. Humans are "in the loop" for running the test and interpreting the visual lines, but the device's chemical reactions provide the "algorithm's" output.

The validation studies (precision, specificity, interference, pH/SG, and the majority of the accuracy studies) demonstrate this standalone performance. The "OTC Lay-user Accuracy Studies" did involve human interpretation of the visual lines by lay-users, evaluating their ability to correctly use and interpret the standalone device.

7. The Type of Ground Truth Used

The primary ground truth used throughout the studies is Gas Chromatography / Mass Spectrometry (GC/MS). For all accuracy studies, spiked samples and clinical specimens were confirmed by GC/MS. This is explicitly stated: "GC/MS or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods." Given the context of drug screening devices, GC/MS is widely considered the definitive reference method for identifying and quantifying drugs and their metabolites in biological matrices.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to traditional lateral flow immunoassay devices like the Chemtrue Multi-Panel Drug Screen tests. These are not machine learning or AI models that require training data to develop their "algorithm." Their mechanism is based on specific antigen-antibody reactions. Therefore, there is no "training set" in the computational sense. The device's components (antibodies, drug-protein conjugates) are developed and optimized through laboratory research and development, but this is a different process than "training" a dataset.

9. How the Ground Truth for the Training Set was Established

As explained in point 8, there is no "training set" in the context of this device. The development of the assay relies on established biochemical principles and extensive R&D to select and optimize antibodies and reagents. The "ground truth" for the development and optimization of the assay components would involve controlled laboratory experiments using known concentrations of analytes and interferents, confirmed by reference methods like GC/MS, to ensure the assay's sensitivity and specificity are appropriate to achieve the desired cut-offs. This is part of the extensive biochemical and quality control processes inherent in developing such diagnostic tests.

Summary

{0}------------------------------------------------

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 image of three human profiles facing to the right, stacked on top of each other.

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

April 18, 2016

CHEMTRON BIOTECH, INC. JANE ZHANG DIRECTOR OF QA/RA 9245 BROWN DEER ROAD SAN DIEGO CA 92121

Re: K153192

Trade/Device Name: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests. Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, JXN, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR Dated: April 1, 2016 Received: April 4, 2016

Dear Ms. Zhang:

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.

{1}------------------------------------------------

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 H. Lias -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153192

Device Name

Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Tests

Indications for Use (Describe)

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	300
Methamphetamine	MAMP	d-Methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Opiates	OPI	Morphine	2000
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

{3}------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Indications for Use

510(k) Number (if known) K153192

Device Name

Chemtrue® Multi-Panel Drug Screen Dip Card Tests

Indications for Use (Describe)

Indications on Ose (Docking) Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxy methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	300
Methamphetamine	MAMP	d-Methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Morphine	MOR	Morphine	300
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
Tricyclic Antidepressants	TCA	Nortriptyline	1000

The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

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)

{5}------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{6}------------------------------------------------

Indications for Use

510(k) Number (if known) K153192

Device Name

Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests

Indications for Use (Describe)

The Chemtrue® Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	300
Methamphetamine	MAMP	d-Methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Opiates	OPI	Morphine	2000
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

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)

{7}------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Indications for Use

510(k) Number (if known) K153192

Device Name

Chemtrue® Multi-Panel Drug Screen Cup Tests

Indications for Use (Describe)

The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	300
Methamphetamine	MAMP	d-Methamphetamine	500
Methamphetamine	MAMP	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Morphine	MOR	Morphine	300
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

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

IX Prescription Use (Part 21 CFR 801 Subpart D)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

AS REQUIRED BY 21 CFR 807.92(c)

SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA 92121. A. TEL: 858-450-0044;

FAX: 858-450-0046

Contact Person: Jane Zhang, Director of QA/RA

Official FDA Correspondent 9245 Brown Deer Road, Suite B San Diego, CA 92121 Office: (858) 450-0044; FAX: (858) 450-0046 Email: jane@uschemtronbio.com

Date Prepared: April 12, 2016

DEVICE B.

Trade or Proprietary Name: Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests, Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests Common Name: Single/Multi-Drug Urine Test Panel

Regulatory Class: Class II

Regulatory Information:

Drug of Abuse	Product Code	Panel	Regulation Section
Amphetamine	DKZ	Toxicology 91	21CFR 862.3100, Amphetamine Test System
Benzodiazepines	JXM	Toxicology 91	21 CFR 862.3170, Benzodiazepines Test System
Barbiturates	DIS	Toxicology 91	21 CFR 862.3150, Barbiturates Test System
Cocaine	DIO	Toxicology 91	21 CFR 862.3250, Cocaine and metabolites Test System
Methamphetamine	LAF	Toxicology 91	21 CFR 862.3610, Methamphetamine Test System
Propoxyphene	JXN	Toxicology 91	21 CFR 862.3700 Propoxyphene test system

These devices also incorporate the assays previously cleared under 510(k) numbers K142396 and K143599, which consist of any combinations of the following drug tests:

Drug of Abuse	Product Code	Panel	Regulation Section
Buprenorphine (BUP)	DJG	Toxicology 91	21CFR 862.3650, Opiate Test System
Ecstasy (MDMA)	DJC	Toxicology 91	21 CFR 862.3610, Methamphetamine Test System
Methadone	DJR	Toxicology 91	21 CFR 862.3620, Methadone Test System
Morphine	DNK	Toxicology 91	21 CFR 862.3640, Morphine Test System
Opiates	DJG	Toxicology 91	21 CFR 862.3650, Opiate Test System
Oxycodone	DJG	Toxicology 91	21 CFR 862.3650, Opiate Test System
Phencyclidine	LCM	Toxicology 91	Unclassified, Enzyme immunoassay Phencyclidine
Marijuana	LDJ	Toxicology 91	21 CFR 862.3870, Cannabinoids Test System
Tricyclic Antidepressants (TCA)	LFG	Toxicology 91	21 CFR 862.3910, Tricyclic antidepressant drugs test system.

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

C. PREDICATE DEVICES

C-1. K061718: Innovacon Spectrum II Test Card with Integrated Cups, applicant: Innovacon Laboratories, Inc.

C-2. k10329: QuickScreen™ Test. The applicant: Phamatech. Inc.

C-3. K060896: ONSite CupKit™. The applicant: Variance, Inc.

D. INDICATIONS FOR USE:

Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Tests

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MET	d-Methamphetamine	300
Methamphetamine	MET	d-Methamphetamine	500
Methamphetamine	MET	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Opiates	OPI	Morphine	2000
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

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

Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Chemtrue® Multi-Panel Drug Screen Cup Tests

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MET	d-Methamphetamine	300
Methamphetamine	MET	d-Methamphetamine	500
Methamphetamine	MET	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Morphine	MOR	Morphine	300
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

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

Chemtrue® Multi-Panel Drug Screen Dip Card with OPI2000 Tests

The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MET	d-Methamphetamine	300
Methamphetamine	MET	d-Methamphetamine	500
Methamphetamine	MET	d-Methamphetamine	1000
Marijuana	THC	11-nor-Δ9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Opiates	OPI	Morphine	2000
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic

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

Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Chemtrue® Multi-Panel Drug Screen Dip Card Tests

Analyte	Abbreviation	Calibrator	Cutoff Concentration (ng/mL)
Amphetamine	AMP	d-Amphetamine	300
Amphetamine	AMP	d-Amphetamine	500
Amphetamine	AMP	d-Amphetamine	1000
Barbiturates	BAR	Secobarbital/Pentobarbital	200
Barbiturates	BAR	Secobarbital/Pentobarbital	300
Benzodiazepines	BZO	Oxazepam	200
Benzodiazepines	BZO	Oxazepam	300
Buprenorphine	BUP	Buprenorphine	10
Cocaine	COC	Benzoylecgonine	150
Cocaine	COC	Benzoylecgonine	300
Ecstasy	MDMA	d,l-Methylenedioxymethamphetamine	500
Methamphetamine	MET	d-Methamphetamine	300
Methamphetamine	MET	d-Methamphetamine	500
Methamphetamine	MET	d-Methamphetamine	1000
Marijuana	THC	11-nor-A9-THC-9-COOH	50
Methadone	MTD	Methadone	300
Morphine	MOR	Morphine	300
Oxycodone	OXY	Oxycodone	100
Phencyclidine	PCP	Phencyclidine	25
Propoxyphene	PPX	Propoxyphene	300
TricyclicAntidepressants	TCA	Nortriptyline	1000

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

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

E. DEVICE DESCRIPTION

F. SUBSTANTIAL EQUIVALENCE INFORMATION:

Comparison with the predicate devices is outlined below:

	Similarities and Differences
Item	Candidate Devices	Predicate Devices(K061718, K103295 and K060896)
Indication(s) for use	Same	For qualitative detection of drugs of abuse inhuman urine
Specimen Type	Same	Human urine
Methodology/TechnologicalCharacteristics	Same	Lateral flow, competitive binding immunoassaybased on the principle of antigen and antibodyimmunochemistry.
Results	Same	Qualitative
Cut Off	Propoxyphene – Same	K061718Propoxyphene – 300
	Cocaine – 150	Cocaine – 150 / 300
	Amphetamine – 500 / 300	Amphetamine – 300 / 1000
	Methamphetamine – 500 / 300	Methamphetamine – 500 / 1000
	Methamphetamine – SameBarbiturates - SameBenzodiazepines – SameMethamphetamine 300 – Same	K103295Methamphetamine – 500Barbiturates – 200Benzodiazepines – 200K060896Methamphetamine – 300
Configurations	Dip Card and Cup	K061718Dip Card and CupK103295Dipcard and CassetteK060896Cup Only
Intended Use	Same	Prescription / OTC Use

G. TEST PRINCIPLE

These devices are rapid lateral flow immunoassays in which chemically modified drugs (drugprotein conjugates) compete with drugs that may be present in urine. On each test strip, a drugprotein conjugate is striped on the test band of the membrane - known as the test region (T) and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the

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

membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.

A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.

Monoclonal anti-drug antibodies are used on the AMP/ BAR/COC/MET/PPX Test devices which are derived from mouse. The polyclonal and monoclonal anti-drug antibodies which are used on BZO Test devices are derived from sheep/mouse.

H. PERFORMANCE CHARACTERISTICS

Performance data is only provided for AMP300/500, BAR200/BZO200, COC150, MET300/500 and PPX as the new analytes in this submission. AMP1000, BAR3000, BZO300, BUP, COC300, MET1000, MOR, PCP, THC, MDMA, MTD, OPI2000, OXY and TCA analytes were previously cleared under K143599 and K142396.

1. Reproducibility (Precision) Studies:
  The precision study was conducted by three (3) Operators with three (3) lots in replicates of 10 devices/lot of each device format at each concentration level of Negative, 50%, 75%, cut-off, 125% and 150% of the cutoff which are GC/MS confirmed drug spiked urine controls. The study was conducted over a ten (10) nonconsecutive days. The samples were blind coded according to a random table and randomly distributed to three operators by the research coordinator. The data is analyzed and summarized in the tables below:

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	16	14
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1a. AMP Dip Card Test: Cutoff: 300 ng/mL

Table 1b. AMP Dip Card Test: Cutoff: 500 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30

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

50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	14	16
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1c. BAR Dip Card Test: Cutoff: 200 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	14	16
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1d. BZO Dip Card Test: Cutoff: 200 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	16	14
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1e. COC Dip Card Test: Cutoff: 150 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	16	14
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1f. MET Dip Card Test: Cutoff: 300 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	14	16
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1g. MET Dip Card Test: Cutoff: 500 ng/mL

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

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	14	16
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1h. Propoxyphene Dip Card Test: Cutoff: 300 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	15	15
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1i. AMP Cup Test: Cutoff: 300 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	13	17
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1j. AMP Cup Test: Cutoff: 500 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	14	16
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1k. BAR Cup Test: Cutoff: 200 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30

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

Cutoff	30	15	15
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 11. BZO Cup Test: Cutoff: 200 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	15	15
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1m. COC Cup Test: Cutoff: 150 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	17	13
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 1n. MET Cup Test: Cutoff: 300 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	15	15
125% of cutoff	30	30	0
150% of cutoff	30	30	0

Table 10. MET Cup Test: Cutoff: 500 ng/mL

Concentration Level	n	TOTAL
		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	17	13
125% of cutoff	30	30	0
150% of cutoff	30	30	0

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

		+	-
Negative	30	0	30
50% of cutoff	30	0	30
75% of cutoff	30	0	30
Cutoff	30	15	15
125% of cutoff	30	30	0
150% of cutoff	30	30	0

1. Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen.
  The following structurally-related compounds were tested for cross-reactivity and found to be positive if the levels were greater than the following listed concentrations:

Amphetamine 500 related compounds:

Substances	Concentration (ng/mL)	% Cross Reactivity
d-Amphetamine	500	100
d,l-Amphetamine	800	62.5
l-Amphetamine	>50,000	<1
d-Methamphetamine	>50,000	<1
l-Methamphetamine	>50,000	<1
d,l-Methamphetamine	>50,000	<1
d,l-MDMA	>50,000	<1
Ephedrine	>50,000	<1
Pseudoephedrine	50,000	<1
(d,l)-(MDA)	800	62.5
Phentermine	5,000	10
MDEA	>50,000	<1
d,l-Phenylpropanolamine	>50,000	<1
Phenylephrine	>50,000	<1
Phenylethlylamine	50,000	<1
Tyramine	>50,000	<1

Amphetamine 300 related compounds:

Substances	Concentration (ng/mL)	% Cross Reactivity
d-Amphetamine	300	100
d,l-Amphetamine	600	50
l-Amphetamine	>30,000	<1
d-Methamphetamine	>30,000	<1
l-Methamphetamine	>30,000	<1
d,l-Methamphetamine	>30,000	<1
d,l-MDMA	>30,000	<1
Ephedrine	>30,000	<1

Pseudoephedrine	>30,000	<1
(d,l)-(MDA)	300	100
Phentermine	4,000	7.5
MDEA	>30,000	<1
d,l-Phenylpropanolamine	>30,000	<1
Phenylephrine	>30,000	<1
Phenylethlylamine	>30,000	<1
Tyramine	>30,000	<1
Barbiturates 200 related compounds:
Substances	Concentration (ng/mL)	% Cross Reactivity
Secobarbital	200	100
Pentobarbital	200	100
Alphenal	300	67
Amobarbital	400	50
Aprobarbital	400	50
Barbital	6,000	3.3
Butabarbital Butisol	300	67
Butalbital	1,000	20
Cyclopentobarbital	240	83
Phenobarbital	1,200	16.7
Benzodiazepines 200 related compounds:
Substances	Concentration (ng/mL)	% Cross Reactivity
Oxazepam	200	100
Alprazolam	200	100
Alpha-Hydroxyalprazolam	200	100
Bromazepam	200	100
Chlordiazepoxide	400	50
Clobazam	600	33
Clonazepam	20,000	<1
Clorazepate	1,800	11
Desalkylflurazepam	800	25
Diazepam	300	67
Estazolam	200	100
Flunitrazepam	4,600	4.4
Flurazepam	200	100
Lorazepam	600	33.3
Lormetazepam	2,800	7
Midazolam	8,000	2.5
Nitrazepam	800	25
Nordiazepam	5,200	3.9
Temazepam	400	50
Triazolam	1,200	16.7
Cocaine 150 related compounds:
Substances	Concentration (ng/mL)	% Cross Reactivity

Benzoylecgonine	150	100
Cocaine	180	83
Cocaethylene	150	100
Ecgonine Hcl	>15,000	<1
Ecgonine Methylester	>15,000	<1

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

{22}------------------------------------------------

Methamphetamine 300 related compounds:

Substances	Concentration (ng/mL)	% Cross Reactivity
d-Methamphetamine	300	100
d,l-Methamphetamine	1,600	18.8
l-Methamphetamine	2,000	15
d-Amphetamine	>30,000	<1
d,l-Amphetamine	>30,000	<1
l-Amphetamine	>30,000	<1
Ephedrine	>30,000	<1
Phenylephrine	>30,000	<1
Phenylethylamine	>30,000	<1
Pseudoephedrine	>30,000	<1
d,l-(MDA)	>30,000	<1
d,1-MDEA	20,000	1.5
d,1-MDMA	2,000	15
Phentermine	>30,000	<1

Methamphetamine 500 related compounds:

Substances	Concentration (ng/mL)	% Cross Reactivity
d-Methamphetamine	500	100
d,l-Methamphetamine	2,000	25
l-Methamphetamine	2,500	20
d-Amphetamine	>50,000	<1
d,l-Amphetamine	>50,000	<1
l-Amphetamine	>50,000	<1
Ephedrine	>50,000	<1
Phenylephrine	>50,000	<1
Phenylethylamine	>50,000	<1
Pseudoephedrine	>50,000	<1
d,l-(MDA)	>50,000	<1
d,1-MDEA	25,000	2
d,l-MDMA	2,600	19
Phentermine	>50,000	<1

Propoxyphene 300 related compounds:

Substances	Concentration (ng/mL)	% Cross Reactivity
Propoxyphene	300	100
Norpropoxyphene	300	100

{23}------------------------------------------------

3. Interference:

One hundred and three (103) potential interferents were tested with one lot each of the test device format. It was found not to cross-react when tested at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations.

Table 3. The following compounds do not interfere with the tests:

Endogenous Compounds:
Albumin	Creatinine	Riboflavin
Bilirubin	Glucose	Sodium Chloride
Cholesterol	Hemoglobin	Uric Acid

Endogenous Compounds:

Non-structurally related compound:

Non-structurally related compound:
Acetaminophen	5, 5-Diphenylhydantoin	Octopamine
Acetone	Dopamine	Oxalic Acid
Acetylsalicylic Acid	1-Erythromycin,	Papaverine
Amoxicillin	Estradiol	Penicillin-G
Ampicillin	Estrone	Perphenazine
R-(-)-Apomorphine	Ethanol	Phenelzine
L-Ascorbic Acid	Fenofibrate	Phenylethylamine
Aspirin	Fentanyl	Prednisone
Aspartame	Fotemustine	Promazine
Atropine	Furosemide	Promethazine
Baclofen	Gemfibrozil	d-Propoxyphene
Benzocaine	Guaiacolglyceryl ether	d,l-Propranolol
Benzoic Acid	Gentisic acid	Pyridoxine
Carisoprodol	Hydralazine	Pyrilamine
Chloramphenicol	Hydrocortisone	Pyrogallol
Chlordiazepoxide	3-Hydroxytyramine	Quinidine
d-Chlorpheniramine	d,l-Isoproterenol	Quinine
Chlorpromazine	Ketamine	Quinolinic Acid
Clofibrate	Meprobamate	Ranitidine
Clonidine	Methapyrilene	Salicylic Acid
Cortisone	Methylphenidate	Sulfamethazine
1-Cotinine	Nalidixic Acid	Sulindac
Creatine Hydrate	Naloxone	Tetracycline
Cyclobenzaprine	Naltrexone	Tetrahydrozoline
Cyclodextrin-r	d-Naproxen	Thiamine
Cyproheptadine	Niacinamide	Thioridazine
Deoxycorticosterone	Nicotinic Acid	Tramadol
Dextromethorphan	Nifedipine	Trifluoperazine
Diclofenac	19-Norethindrone	Tryptamine
Diflunisal	Norpropoxyphene	Tyramine
4-Dimethyl-aminoantipyrine	Noscapine	Zomepirac sodium salt

{24}------------------------------------------------

Additional interference study: In addition to the cross-reactivity and interference studies presented in this submission, the drug tests were tested with each of all the drug analytes at 150% and 50% of the drug cut-off urine samples. The results confirmed that the no interference or crossreactivity among these drug tests and the Chemtrue® Drug Screen Tests are safe and equivalent to the similar test devices that were FDA cleared.

1. Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.001, 1.015, 1.020, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results.
1. Stability Study: To establish and support the shelf life and expiration date, stability studies were conducted under accelerated temperature (at 60°C and real time (2°C to 30°C) with three (3) lots of each device format. The stability study results support two (2) years shelf-life of the products at (2℃ to 30℃). The real time stability study is still on going.
1. Method Comparison (Accuracy) Studies:

Chemtrue® DOA Low Cutoff with PPX Drug Screen Tests were compared to the GC/MS Reference Method. The accuracy of the Chemtrue® Test devices were evaluated against the confirmed GC/MS values in this blind-labeled clinical specimen correlation study (On average of 85 clinical specimens for each drug test and a total of 685 samples were tested). Three operators performed the testing. Each blind-labeled sample was randomly distributed to each operator by the Clinical Research Cooperator. The results are summarized in the tables below:

	Concentration By GC/MS (ng/mL)
Chemtrue®		(-)	(+)		%
Drug Screen	No drug	Near cutoff	Near cutoff positive	GC/MS Positive	Agreement
Dip Card	present	negative	(Cutoff to 150% of the	(>150% of the cutoff)
		(50% of the C/O to cutoff)	C/O)
AMP300(+)	0	0	14	27	100%
(-)	31	11	0	0	100%
BAR200(+)	0	1	26	14	100%
(-)	34	9	0	0	98.2%
BZO200(+)	0	0	26	14	100%
(-)	31	16	0	0	100%
COC150(+)	0	0	15	28	100%
(-)	31	10	0	0	100%
MET300 (+)	0	1	14	34	100%
(-)	31	9	0	0	97.6%
PPX(+)	0	0	12	33	100%
(-)	31	10	0	0	100%
AMP500 (+)	0	0	12	31	100%
(-)	31	14	0	0	100%

6-1. Test Result Summary:

Table 6a. Method comparison study summary: Chemtrue® Drug Screen Dip Card Test results vs GC/MS

{25}------------------------------------------------

MET500	0	1	11	30	100%
(-)	31	11	0	0	97.8%

Table 6b. Method comparison study summary - Chemtrue® Drug Screen Cup Test results vs GC/MS

	Concentration By GC/MS (ng/mL)
Chemtrue®Drug ScreenCup	No drugpresent	Near cutoffnegative(75% of the C/O to cutoff)	Near cutoff positive(Cutoff to 125% of theC/O)	GC/MS Positive(≥150% of the cutoff)	%Agreement
AMP300 (+)	0	1	14	27	100%
AMP300 (-)	31	10	0	0	97.6%
BAR200 (+)	0	1	26	14	100%
BAR200 (-)	34	9	0	0	97.7%
BZO200 (+)	0	0	26	14	100%
BZO200 (-)	31	16	0	0	100%
COC150 (+)	0	0	15	28	100%
COC150 (-)	31	10	0	0	100%
MET300 (+)	0	1	14	34	100%
MET300 (-)	31	9	0	0	97.6%
PPX (+)	0	0	12	33	100%
PPX (-)	31	10	0	0	100%
AMP500 (+)	0	1	11	31	97.7%
AMP500 (-)	31	13	1	0	97.8%
MET500 (+)	0	0	11	30	100%
MET500 (-)	31	12	0	0	100%

6-2. DISCORDANT RESULTS: Table 6c. Dip Card Tests:

Cutoff Value (ng/mL)	Analyte assay(POS/NEG)	Drug/Metabolite GC/MS value (ng/mL)
		Drug Analyte	GC/MS Value (ng/mL)
Methamphetamine 300	+	Methamphetamine	296
Methamphetamine 500	+	Methamphetamine	494
Barbiturates 200	+	Pentobarbital	185

Table 6d. Cup Tests:

Cutoff Value (ng/mL)	Analyte assay(POS/NEG)	Drug/Metabolite GC/MS value (ng/mL)
		Drug Analyte	GC/MS Value (ng/mL)
Amphetamine 300	+	Amphetamine	229
Amphetamine 500	-	Amphetamine	510
Amphetamine 500	+	Amphetamine	441
Methamphetamine 300	+	Methamphetamine	296
Barbiturates 200	+	Pentobarbital	185

All these eight (8) discordant results were confirmed at the drug cutoff level with the GC/MS concentrations.

1. OTC Lay-user Accuracy Studies:
  One hundred (130) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup) for OTC accuracy and usability study from three (3) intended user sites with

{26}------------------------------------------------

GC/MS confirmed urine samples. The sample concentrations are consisted of negative (0), 50%, 75%, 125%, 150% and 200% of the cutoff by spiking drugs into drug-free urine pool. Each sample was aliquot into an individual blind-labeled container. Each lay-user was provided with a package insert in English only and up to two (2) random blind labeled samples with the tests of each device format. The results are summarized below:

	Concentrations By GC/MS (mL)
Chemtrue®Drug Screen DipCard Test	(-)		(+)		%Agreement
	< 50% ofthe C/O	GC/MSNegative(50% of the C/O)	Near cutoffnegative(75% of the C/O)	Near cutoffpositive(C/O to 125% of the C/O)	Positive(≥150% of theC/O)
AMP500 (+)	0	0	0	28	21	100%
(-)	54	39	41	0	0	100%
BAR200 (+)	0	0	0	43	22	100%
(-)	194	26	22	0	0	100%
BZO200 (+)	0	0	0	21	25	100%
(-)	184	37	40	0	0	100%
COC150 (+)	0	0	0	37	40	100%
(-)	183	25	22	0	0	100%
MET500 (+)	0	0	0	22	36	100%
(-)	55	44	26	0	0	100%
PPX (+)	0	0	0	38	40	100%
(-)	185	22	22	0	0	100%
AMP 300 (+)	0	0	1	24	46	100%
(-)	53	21	23	0	0	99%
MET 300 (+)	0	0	1	24	43	100%
(-)	57	20	23	0	0	99%

Table 7a. OTC Accuracy study summary between the Chemtrue® Dip Card Tests and the GC/MS values

Table 7b. OTC Accuracy study summary between the Chemtrue® Cup Tests and the GC/MS values

	Concentrations By GC/MS (mL)
Chemtrue®	(-)		(+)		%
Drug Screen Cup	< 50% of	GC/MS	Near cutoff	Near cutoff	Positive	Agreement
Test	the C/O	Negative	negative	positive	(≥150% of the
		(50% of the C/O)	(75% of the C/O)	(C/O to 125% of the C/O)	C/O)
AMP500(+)	0	0	0	26	21	100%
(-)	60	23	39	0	0	100%
BAR200(+)	0	0	0	43	22	100%
(-)	194	26	22	0	0	100%
BZO200(+)	0	0	0	22	24	100%
(-)	184	37	40	0	0	100%
COC150 (+)	0	0	0	37	41	100%
(-)	182	25	22	0	0	100%
MET500 (+)	0	0	0	26	22	100%

{27}------------------------------------------------

(-)	55	41	25	0	0	100%
PPX (+)	0	0	1	38	40	100%
(-)	185	22	21	0	0	99.6%
AMP 300 (+)	0	0	0	23	48	100%
(-)	51	21	25	0	0	100%
MET 300 (+)	0	0	0	23	42	100%
(-)	56	22	25	0	0	100%

The results demonstrate that the agreement between the Chemtrue® Drug Screen test device and GC/MS values is ≥ 99%.

These lay-users were also given surveys on the ease of understanding the package insert instructions. The results demonstrate that ≥ 96% of the lay users can easily follow the instructions to perform the test and interpret the results. A Flesch-Kincaid reading analysis supports a 7th grade reading level.

I. CONCLUSION:

Based on the test principle and performance characteristics of the proposed device, it is concluded that the candidate devices are substantially equivalent to the predicate device.

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).