Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Marijuana (THC)	50 ng/mL

Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC)	50 ng/mL

Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Description

The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The Wisdiag Multi-Drug Urine Test Cup is intended for over-the-counter use and the Wisdiag Multi-Drug Urine Test Cup Rx is intended for prescription use.

AI/ML Overview

The document describes the performance characteristics of the Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx. The device is a rapid, single-use in-vitro diagnostic test for qualitative drug detection in human urine.

Here's an analysis of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" through a numerical threshold for accuracy metrics (e.g., "sensitivity must be >95%"). However, the precision studies and comparative studies demonstrate the device's performance against defined cut-off values. The "acceptance" can be inferred from the consistently high percentages of correct results at various concentrations relative to the cutoff, and the successful classification of samples below and above the cutoff.

Here's a table summarizing the performance based on the precision study and lay-user study for each drug at its respective cutoff concentrations. The "Reported Device Performance" here refers to the percentage of correct results for samples at the cutoff or near the cutoff values, as these are the most critical for determining accuracy. For "acceptance criteria," the expectation is generally high accuracy around the cutoff.

Table 1: Acceptance Criteria (Inferred) and Reported Device Performance

Drug (Identifier)	Cut-off Level	Inferred Acceptance Criteria (Precision Study)	Reported Device Performance (Precision Study - Cutoff)	Reported Device Performance (Lay-User Study - Cutoff / closest concentrations)
AMP 500	500 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive (≥95% correct classification at these points, and good differentiation at cutoff).	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-27 Negative / 23-27 Positive (e.g., Lot I: 23-/27+)	Configuration 1 (AMP 500): 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive). (Percentages represent classification according to expected outcome relative to actual value, not test result matches LC/MS).
BUP 10	10 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-27 Negative / 23-27 Positive (e.g., Lot I: 23-/27+)	Configuration 1: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 90% correct for +25% cutoff (2/20 negative, 18/20 positive).
BAR 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-28 Negative / 22-28 Positive (e.g., Lot I: 23-/27+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
BZO 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 24-27 Negative / 23-26 Positive (e.g., Lot I: 24-/26+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
COC 150	150 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-28 Negative / 22-27 Positive (e.g., Lot I: 28-/22+)	Configuration 1: 90% correct for -25% cutoff (18/20 negative, 2/20 positive). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
EDDP 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 25-28 Negative / 22-25 Positive (e.g., Lot I: 25-/25+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
MET 500	500 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-26 Negative / 24-27 Positive (e.g., Lot I: 25-/25+)	Configuration 1: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
MDMA 500	500 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-25 Negative / 25-28 Positive (e.g., Lot I: 24-/26+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
MOP 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-26 Negative / 24-28 Positive (e.g., Lot I: 25-/25+)	Configuration 1: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
MTD 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-27 Negative / 23-28 Positive (e.g., Lot I: 24-/26+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
OXY 100	100 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-27 Negative / 23-27 Positive (e.g., Lot I: 27-/23+)	Configuration 1: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
PCP 25	25 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-26 Negative / 24-28 Positive (e.g., Lot I: 26-/24+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
PPX 300	300 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 25-28 Negative / 22-25 Positive (e.g., Lot I: 25-/25+)	Configuration 1: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
TCA 1000	1000 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 22-27 Negative / 23-28 Positive (e.g., Lot I: 27-/23+)	Configuration 1: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
THC 50	50 ng/mL	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-27 Negative / 23-27 Positive (e.g., Lot I: 23-/27+)	Configuration 1: 90% correct for -25% cutoff (18/20 negative, 2/20 positive). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
AMP 1000	1000 ng/mL (Config 2)	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 24-27 Negative / 23-26 Positive (e.g., Lot I: 25-/25+)	Configuration 2: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
COC 300	300 ng/mL (Config 2)	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 24-27 Negative / 23-26 Positive (e.g., Lot I: 27-/23+)	Configuration 2: 100% correct for -25% cutoff (20/20 negative). 95% correct for +25% cutoff (1/20 negative, 19/20 positive).
MET 1000	1000 ng/mL (Config 2)	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-26 Negative / 24-27 Positive (e.g., Lot I: 26-/24+)	Configuration 2: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).
OPI 2000	2000 ng/mL (Config 2)	Consistent classification of -25% Cutoff samples as negative and +25% Cutoff samples as positive.	Negative: 49-50/50, Positive: 0-1/50 for -25% cutoff. Negative: 0-1/50, Positive: 49-50/50 for +25% cutoff. At Cutoff: 23-27 Negative / 23-27 Positive (e.g., Lot I: 23-/27+)	Configuration 2: 95% correct for -25% cutoff (19/20 negative, 1/20 positive). 100% correct for +25% cutoff (0/20 negative, 20/20 positive).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Precision Studies (Analytical Performance):
- Sample Size: For each drug and each concentration point (-100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, +100% cutoff), 50 tests were performed per lot across 3 lots (2 runs/day for 25 days). This means 3 lots x 50 tests = 150 tests per concentration per drug. With 9 concentration points, it is 1350 tests per drug. With 15 drugs, roughly 20,250 tests in total.
- Data Provenance: The samples were prepared by spiking target drugs into drug-free urine samples. Drug-free urine samples were used for the -100% cutoff. The document does not specify the country of origin of the "drug-free urine samples" or the location where the samples were collected. It is retrospective in the sense that samples were prepared in a lab setting rather than collected prospectively from patients.
Comparison Studies (Standalone Performance):
- Sample Size: For each drug, 80 unaltered urine samples (40 negative and 40 positive) were used. These were then tested by 3 operators.
- Data Provenance: "Unaltered urine samples" were used. The document does not specify the country of origin. This appears to be retrospective as the samples were pre-collected and blinded.
Lay-User Study:
- Sample Size: 280 participants were recruited.
  - 140 participants (66 males, 74 females) for Configuration 1 (AMP 500, MET 500, MOP 300, COC 150, BAR 300, BZO 300, BUP 10, EDDP 300, MDMA 500, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50).
  - 140 participants (72 males, 68 females) for Configuration 2 (AMP 1000, MET 1000, OPI 2000 (MOP 2000), COC 300, BAR 300, BZO 300, BUP 10, EDDP 300, MDMA 500, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50).
  - Each participant tested "one blind labeled test solution, and one test device." The concentration points tested were -100%, +/-75%, +/-50%, +/-25% of the cutoff. Given there are 15 assays per cup, and 8 concentration points, and 20 tests per concentration point, this implies a total of 15 * 8 * 20 = 2400 individual assay results per configuration (which aligns roughly with 140 participants given each participant runs multiple assays/drugs).
- Data Provenance: Samples were "prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens." It doesn't state the source of the "drug free-pooled urine specimens" or the country of origin. This is a retrospective study based on prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Ground Truth Method: LC/MS or LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) was used to confirm sample concentrations and establish the ground truth for all studies (Precision, Comparison, Lay-User).
Number/Qualifications of Experts: The document does not specify human experts for establishing ground truth. The LC/MS data is considered the analytical "gold standard" or ground truth for drug concentrations in urine.

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

No human adjudication method is described. The ground truth in all studies is based on LC/MS results. The device results (positive/negative) are compared directly to the quantitative LC/MS measurements relative to the specified cutoff.

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

There was no MRMC comparative effectiveness study involving human readers with/without AI assistance. The device is a lateral flow immunoassay intended for direct interpretation of visual lines, not an AI-assisted diagnostic tool.

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

Yes, standalone performance was done.
- Precision Studies: This directly assesses the device's ability to correctly classify samples based on LC/MS confirmed concentrations, without human interpretation variability being the primary focus. The results "-/+" notation at each concentration reflects the count of negative and positive results from the device, which are then compared to the known concentration.
- Comparison Studies: These studies explicitly compare the "Wisdiag Multi-Drug Urine Test Cup" results (interpreted by three operators) directly against LC/MS results. While operators are involved in reading, the intent is to show the device's inherent performance when read, validating its accuracy against the gold standard. The "discordant results" further confirm areas where the device's output (even if read by a human) deviates from clinical truth (LC/MS).

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

Analytical Ground Truth: LC/MS or LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) was used as the ground truth method to confirm the concentrations of all samples. This is a highly accurate and quantitative chemical analysis method.

8. The sample size for the training set

This device is a lateral flow immunoassay, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device's performance is determined by its inherent biochemical design (antigen-antibody reactions) and manufacturing consistency, not by learning from a dataset.

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

As stated in point 8, there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 10, 2022

Vivachek Biotech (Hangzhou) Co., Ltd % Joe Shia Director LSI International 540 E Diamond Avenue, Suite I Gaithersburg, MD 20877

Re: K222667

Trade/Device Name: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, OBF, QAW, NFW, LCM Dated: September 2, 2022 Received: September 6, 2022

Dear 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula
Digitally signed by
Paula Caposino -S
Caposino -S Date: 2022.11.10
14:59:10 -05'00'

Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222667

Device Name

Wisdiag Multi-Drug Urine Test Cup

Indications for Use (Describe)

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known) K222667

Device Name

Wisdiag Multi-Drug Urine Test Cup Rx

Indications for Use (Describe)

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC)	50 ng/mL

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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."

FORM FDA 3881 (6/20)

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EF PSC Publishing Services (301) 443-6740

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510(k) SUMMARY

	510(k) Number	K222667
1	Date	November 7, 2022
2	Submitter	VivaChek Biotech (Hangzhou) Co., Ltd.
		Level 2, Block 2, 146 East Chaofeng Rd.
		Hangzhou, China
3	Contact Person	Joe Shia
		LSI International Inc.
		504 East Diamond Ave., Suite I
		Gaithersburg, MD 20877
		Telephone: 240-505-7880
		Fax: 301-916-6213
		Email: shiajl@yahoo.com

4 Device Name Wisdiag Multi-Drug Urine Test Cup Wisdiag Multi-Drug Urine Test Cup Rx
5 Classification

Class II
Product CodeTarget Drug	Regulation Section	Cup
NFTAmphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
NGLBuprenorphine (BUP)	862.3650, Opiate Test System	Toxicology
PTHSecobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
NFVOxazepam (BZO)	862.3170,Benzodiazepine Test System	Toxicology
NFYCocaine (COC)	862.3250, Cocaine Test System	Toxicology
PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine(EDDP)	862.3620, Methadone Test System	Toxicology
NGGMethamphetamine(MET)	862.3610,Methamphetamine Test System	Toxicology
NGGMethylenedioxymethamphetamine (MDMA)	862.3610,Methamphetamine Test System	Toxicology
NGL	862.3650, Opiate Test System	Toxicology

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

Morphine (MOP/OPI)
PTG	862.3620, Methadone Test System	Toxicology
Methadone (MTD)
NGL	862.3650, Opiate Test System	Toxicology
Oxycodone (OXY)
LCM	Unclassified	Toxicology
Phencyclidine (PCP)
QBF	862.3700 Propoxyphene test system.	Toxicology
Propoxyphene (PPX)
QAW	862.3910 Tricyclic antidepressant drugs test system	Toxicology
Nortriptyline (TCA)
NFW	862.3870, Cannabinoids Test System	Toxicology
Cannabinoids (THC 50)

Predicate Device 6. K182701

Wondfo T-Cup® Multi-Drug Urine Test Cup

7. Intended Use

Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

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

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC)	50 ng/mL

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

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

8. Device Description

Item	Proposed Device	Predicate(K182701)
Indication(s) for use	For the qualitative determination of Amphetamine,Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,Methylenedioxymethamphetamine, Morphine, Methadone,Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline andCannabinoids in human urine.	Same
Methodology	Competitive binding, lateral flow immunochromatographic assaybased on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drug andCut Off Values	Target Drug	Cutoff (ng/mL)
	Amphetamine (AMP)	1000 or 500
	Buprenorphine (BUP)	10
	Secobarbital (BAR)	300
	Oxazepam (BZO)	300
	Cocaine (COC)	300 or 150

9. Substantial Equivalence Information

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

2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300
Methamphetamine (MET)	1000 or 500
Methylenedioxymethamphetamine (MDMA)	500
Morphine (MOP 300/OPI 2000)	2000 or 300
Methadone (MTD)	300
Oxycodone (OXY)	100
Phencyclidine (PCP)	25
Propoxyphene (PPX)	300
Nortriptyline (TCA)	1000
Cannabinoids (THC 50)	50
Configurations	Test Cup	Cup
Intended Use	Prescription Use and over-the-counter use	For over-the-counter use

10. Test Principle

Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.

A band should be formed on the control line region regardless of target drug or metabolite in the sample to indicate that the tests have been performed properly.

11. Performance Characteristics

1. Analytical Performance

a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test Cups. The results obtained are summarized in the following tables:

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

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
20.0	17.1	13.6	11.8	10.2	6.9	5.4	2.7	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup BUP 10

Wisdiag Multi-Drug Urine Test Cup PCP 25

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	52.1	43.1	37.3	29.4	25.2	17.7	12.2	6.5	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup THC 50

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	96.5	84.3	75.7	60.1	52.5	35.9	24.1	12.1	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup OXY 100

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	200.3	177.1	158.9	131.7	108.5	78.0	51.6	27.6	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

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

Wisdiag Multi-Drug Urine Test Cup BAR 300

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	588.4	525.8	457.6	383.8	301.6	228.3	157.1	80.2	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup BZO 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	596.1	536.5	470.4	370.3	290.4	219.8	157.3	78.5	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup EDDP 300

Concentration byLC/MS(ng/mL)	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	646.2	545.3	455.1	371.0	290.7	229.5	148.8	77.0	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	28-/22+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MTD 300

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	620.5	547.0	469.9	380.9	328.6	240.2	143.9	71.4	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

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

Wisdiag Multi-Drug Urine Test Cup MOP 300

Concentration byLC/MS(ng/mL)Lot Number	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
	622.4	530.2	468.8	381.8	322.8	220.8	159.0	75.4	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup PPX 300

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	622.3	562.7	451.3	383.3	297.7	218.3	152.5	75.8	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	28-/22+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup COC 150

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	298.2	246.1	237.0	193.6	157.7	106.5	76.2	36.0	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	28-/22+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MDMA 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	1048.5	861.5	740.8	614.9	522.8	342.0	250.6	128.4	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+

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

Wisdiag Multi-Drug Urine Test Cup TCA 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	2175.2	1841.2	1597.5	1261.6	1081.5	708.2	493.1	251.5	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	22-/28+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup AMP 500

	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
Lot Number	1011.8	846.4	772.7	646.8	544.3	357.6	225.0	120.9	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MET 500

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)	1072.7	873.9	731.7	633.1	477.8	386.1	249.2	122.5	0
Lot Number
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup OPI 2000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
(ng/mL)Lot Number	4208.2	3672.9	3119.0	2590.5	2050.0	1460.4	1007.5	493.0	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+

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

Wisdiag Multi-Drug Urine Test Cup COC 300

Concentration byLC/MS(ng/mL)Lot Number	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
	610.6	558.5	461.6	373.4	329.9	235.6	156.7	74.5	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup AMP 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS(ng/mL)	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
Lot Number	1933.3	1805.2	1562.7	1262.0	1051.1	812.0	540.9	271.9	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	25-/25+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	27-/23+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+

Wisdiag Multi-Drug Urine Test Cup MET 1000

Concentration by	+100%	+75%	+50%	+25%	Cutoff	-25%	-50%	-75%	-100%
LC/MS(ng/mL)Lot Number	cutoff	cutoff	cutoff	cutoff		cutoff	cutoff	cutoff	cut-off
1954.6	1824.2	1593.1	1304.9	1003.4	736.7	464.8	251.1	0
Lot I	0-/50+	0-/50+	0-/50+	0-/50+	26-/24+	50-/0+	50-/0+	50-/0+	50-/0+
Lot II	0-/50+	0-/50+	0-/50+	0-/50+	24-/26+	50-/0+	50-/0+	50-/0+	50-/0+
Lot III	0-/50+	0-/50+	0-/50+	0-/50+	23-/27+	50-/0+	50-/0+	50-/0+	50-/0+

The following cutoff values are verified:

Target Drug	Cut-off level
Amphetamine (AMP)	1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	300 ng/mL or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL

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

Methamphetamine (MET)	1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300/OPI 2000)	2000 ng/mL or 300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC 50)	50 ng/mL

b. Linearity

Not applicable

c. Stability

The devices are stable at 2-30℃ for 24 months based on accelerated stability studies at 55℃.

d. Interference

Potential interfering substances were added to drug-free urine samples with target drugs of -25% cutoff and +25% cutoff level.

Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.

Acetaminophen	Acetophenetidin	Acetylsalicylic Acid
Acyclovir	Amiodarone Hydrochloride	Apomorphine
Afrin	Albumin (100mg/dL)	Amlodipine Mesylate
Aminophylline	Amoxicillin	Aripiprazole
Aminopyrine	Ampicillin	Aspartame
Benzilic Acid	Atropine	Atomoxetine
Benzoic Acid	Carbamazepine	Atorvastatin Calcium
Bilirubin	Cefradine	Chloramphenicol
Bupropion	Cephalexin	Chlorothiazide
Captopril	Chloral Hydrate	Chloroquine
Ciprofloxacin Hydrochloride	Clonidine	Cholesterol
Citalopram	Clopidogrel Hydrogen Sulphate	(-) Cotinine
Clarithromycin	Clozapine	chlorpheniramine
Deoxy- corticosterone	D,L-Tyrosine	D,L-Octopamine
Dextromethorphan	Digoxin	D,L-Propranolol
Diclofenac	Diphenhydramine	D-Norpropoxy- phene
Diflunisal	Dirithromycin	Domperidone

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

D-Pseudo- ephedrine	Ecgonine Methyl Ester	Doxylamine
Duloxetine	Effexor	Epinephrine Hydrochloride
Dicyclomine	Enalapril Maleate	Erythromycin
β-Estradiol	Fentanyl Citrate	Esomeprazole Magnesium
Ethanol (1%)	Fluoxetine Hydrochloride	Furosemide
Fenofibrate	Fluvoxamine	Gabapentin
Fenoprofen	Glucose	Gentisic Acid
Glibenclamide	Haloperidol	3-Hydroxy- tyramine
Gliclazide	Hemoglobin	Isosorbide Dinitrate
Glipizide	Ketamine	Isoxsuprine
Ibuprofen	Kratom powder	Lamotrigine
Ketoconazole	Labetalol	Levofloxacin Hydrochloride
Ketoprofen	Liverite	Levonorgestrel
Lidocaine Hydrochloride	Loperamide	Levothyroxine Sodium
Lisinopril	Loratadine	Minocycline
Lithium Carbonate	Naproxen	Nalidixic Acid
Metoprolol Tartrate	Mifepristone	Niacinamide
Magnesium	Mirtazapine	Nifedipine
Meperidine	Montelukast Sodium	Nikethamide
Meprobamate	Phenelzine	Sulfamethazine
Mosapride Citrate	Pioglitazone Hydrochloride	Sulindac
Maprotiline	Piracetam	Tetrahydrocortisone 3 -acetate
Nimodipine	Pravastatin Sodium	Tetrahydrocortisone 3-(β-D-glucuronide)
Norethindrone	Prednisone	Tetrahydrozoline
N-Acetylprocain-amide	Propylthiouracil	Tetracycline
O-Hydroxyhippu-ric Acid	Promethazine	Thiamine
Olanzapine	Quetiapine Fumarate	Thioridazine
Omeprazole	Quinine	Topiramate
Oxalic Acid	Ranitidine	Tramadol Hydrochloride
Oxolinic Acid	Rifampicin	Trazodone Hydrochloride
Oxymetazoline	Risperidone	Triamterene
Ondansetran	Salicylic Acid	Trifluoperazine
Paliperidone	Serotonin	Trimethoprim
Pantoprazole	Sertraline Hydrochloride	Uric Acid
Papaverine	Sildenafil Citrate	Valproate
Paroxetine Hydrochloride	Simvastatin	Verapamil
Penfluridol	Sodium Valproate	Vitamin B2
PenicillinV Potassium	Spironolactone	Vitamin C

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

Specificity e.
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of each device.

Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:

BUP 10 (Buprenorphine,Cutoff=10 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Buprenorphine -3-D-Glucuronide	15	66.67%
Norbuprenorphine	20	50%
Norbuprenorphine-3-D-Glucuronide	200	5%
Morphine	>100000	-
Oxymorphone	>100000	-
Hydromorphone	>100000	-

PCP (Phencyclidine)(Phencyclidine,Cutoff=25 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
4-Hydroxyphencyclidine	12500	0.2%

THC 50(11-nor-Δ9-THC-9-COOH,Cutoff=50 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
(-)-11-nor-9-carboxy-Δ9-THC	50	100%
11-nor-Δ8-THC-9-COOH	50	100%
11-nor-Δ9-THC-carboxy glucuronide	100	50%
Cannabidiol	100,000	--
Cannabinol	100,000	--
Δ8- Tetrahydrocannabinol	15,000	0.5%
Δ9- Tetrahydrocannabinol	15,000	0.5%
11-hydroxy-Δ9-Tetrahydrocannabinol	5,000	1%

OXY 100(Oxycodone, Cutoff=100 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Dihydrocodeine	20,000	0.5%
Hydrocodone	80	125%
Oxymorphone	1,000	10%

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

Codeine	100,000	--
Hydromorphone	36,000	0.278%
Morphine	100,000	--
Acetylmorphine	100,000	--
Buprenorphine	100,000	--
Ethylmorphine	100,000	--
Thebaine	100,000	--

COC 150(Benzoylecgonine, Cutoff=150 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Cocaine	375	40%
Cocaethylene	6,250	2.4%
Ecgonine	16,000	<1%
Ecgonine methyl ester	100,000	--
Norcocaine	100,000	--

BAR 300(Secobarbital, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Amobarbital	300	100%
Alphenol	600	50%
Aprobarbital	200	150%
Butabarbital	100	300%
Butethal	200	150%
Butalbital	2,000	15%
Cyclopentobarbital	400	75%
Pentobarbital	200	150%
Phenobarbital	200	150%

BZO 300(Oxazepam, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Alprazolam	190	63.3%
a-Hydroxyalprazolam	300	100%
Bromazepam	500	60%
Chlordiazepoxide	1,500	20%
Clobazam	110	272.7%
Clonazepam	100,000	--
Clorazepate dipotassium	300	100%
Delorazepam	100,000	--
Desalkylflurazepam	200	150%

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

Diazepam	190	157.9%
Estazolam	5,000	6%
Flunitrazepam	400	75%
Midazolam	2,200	13.6%
Nitrazepam	200	150%
Norchlordiazepoxide	800	37.5%
Nordiazepam	150	200%
Temazepam	100	300%
Triazolam	6,000	5%
Demoxepam	2,000	15%
Flurazepam	100,000	--
D,L-Lorazepam	75,000	4%

EDDP 300(2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Cutoff = 300 ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Methadone	>100000	-
EMDP	>100000	-
Doxylamine	>100000	-
Disopyramide	>100000	-
LAAM (Levo-alpha-acetylmethadol) HCl	>100000	-
Alpha Methadol	>100000	-

MTD 300(Methadone, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Doxylamine	>100000	-
EDDP	>100000	-
EMDP	>100000	-
LAAM	>100000	-
Alpha Methadol	>100000	-

MOP 300(Morphine, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Normorphine	300	100%
Codeine	300	100%
s-Monoacetylmorphine	300	100%
Ethyl Morphine	200	150%
Heroin	300	100%
Hydrocodone	700	42.8%
Hydromorphone	200	150%

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

Morphinie-3-β-d-glucuronide	1,000	30%
Oxycodone	100,000	--
Oxymorphone	100,000	--
Thebaine	20,000	1.5%
Levorphanol	10,000	3%
6-Monoacetylmorphine (6-MAM)	300	100%
Norcodeine	6,250	4.8%
Procaine	100,000	--

PPX 300(d-Propoxyphene, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
d-Norpropoxyphene	300	100%

MDMA 500(3,4-Methylenedioxymethamphetamine HCl,Cutoff=500ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
3,4-Methylenedioxyamphetamine HCl (MDA)	4,000	12.5%
3,4-Methylenedioxyethylamphetamine (MDE)	400	125%
d-methamphetamine	>100000	-
d-amphetamine	>100000	-
l-methamphetamine	>100000	-
l-amphetamine	>100000	-

AMP (Amphetamine) (Amphetamine,Cutoff=500ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
l-Amphetamine	>100000	-
dl- Amphetamine	1,500	33.3%
(+/-) 3,4-Methylenedioxyamphetamine (MDA)	500	100%
Phentermine	6,000	8.3%
Hydroxyamphetamine	>100000	-
d-Methamphetamine	>100000	-
l-Methamphetamine	>100000	-
(+/-) 3,4-Methylenedioxyethylamphetamine (MDE)	>100000	-
(+/-)3,4-Methylenedioxymethamphetamine (MDMA)	>100000	-
β-Phenylethylamine	>100000	-
Tyramine	>100000	-
p-Hydroxynorephedrine	>100000	-
Phenylpropanolamine	>100000	-

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

(±)Phenylpropanolamine	>100000	-
p-Hydroxyamphetamine	>100000	-
d/l-Norephedrine	>100000	-
Benzphetamine	>100000	-
l-Ephedrine	>100000	-
l-Epinephrine	>100000	-
d/l-Epinephrine	>100000	-
Ephedrine	>100000	-

MET 500(D(+)-Methamphetamine, Cutoff=500ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDE)	12,500	4%
D/L-Methamphetamine	500	100%
p-Hydroxymethamphetamine	15,000	3.3%
D-Amphetamine	>100000	-
L-Amphetamine	>100000	-
Chloroquine	50,000	1%
(+/-)-Ephedrine	100,000	-
(-)-Methamphetamine	65,000	0.8%
(+/-)3,4-Methylenedioxyamphetamine (MDA)	>100000	-
(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	4,000	12.5%
β-Phenylethylamine	25,000	2%
Trimethobenzamide	10,000	5%
d,l-Amphetamine	>100000	-
Mephentermine	25,000	2%
(1R,2S)-(-)-Ephedrine	>100000	-
1-phenylephrine	>100000	-
L-Methamphetamine	65,000	0.8%

TCA 1000(Nortriptyline, Cutoff=1000ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Nordoxepine	1,000	100%
Trimipramine	3,000	33.3%
Amitriptyline	450	222.2%
Promazine	1,500	66.7%
Desipramine	200	500%
Imipramine	80	1250%

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

Clomipramine	1,200	83.3%
Doxepin	2,000	50%
Maprotiline	2,000	50%
Promethazine	>100,000	--
Cyclobenzaprine	800	125%
Norclomipramine	12,500	8%

COC 300(Benzoylecgonine, Cutoff=300ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Cocaine	780	38.5%
Cocaethylene	12,500	2.4%
Ecgonine	32,000	0.9%
Ecgonine methyl ester	100,000	0.3%
Norcocaine	100,000	0.3%

AMP 1000(d-Amphetamine, Cutoff=1000ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
l-Amphetamine	>100000	-
dl- Amphetamine	3,000	33.3%
(+/-)3,4-Methylenedioxyamphetamine (MDA)	1,000	100%,
Phentermine	6,000	16.7%
Hydroxyamphetamine	>100000	-
d-Methamphetamine	>100000	-
l-Methamphetamine	>100000	-
(+/-)3,4-Methylenedioxyethylamphetamine(MDE)	>100000	-
(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	>100000	-
β-Phenylethylamine	>100000	-
Tyramine	>100000	-
p-Hydroxynorephedrine	>100000	-
Phenylpropanolamine	>100000	-
(±)Phenylpropanolamine	>100000	-
p-Hydroxyamphetamine	>100000	-
d/l-Norephedrine	>100000	-
Benzphetamine	>100000	-
l-Ephedrine	>100000	-
l-Epinephrine	>100000	-
d/l-Epinephrine	>100000	-
Ephedrine	>100000	-

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

MET 1000(D(+)-Methamphetamine, Cutoff=1000ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDE)	25,000	4%
D/L-Methamphetamine	1,000	100%
p-Hydroxymethamphetamine	30,000	0.3%
D-Amphetamine	>100000	-
L-Amphetamine	>100000	-
Chloroquine	50,000	2%
(+/-)-Ephedrine	>100000	-
(-)-Methamphetamine	>100000	-
(+/-)3,4-Methylenedioxyamphetamine (MDA)	>100000	-
(+/-)3,4-Methylenedioxymethamphetamine(MDMA)	8,000	12.5%
β-Phenylethylamine	50,000	2%
Trimethobenzamide	20,000	5%
d,l-Amphetamine	>100000	-
Mephetermine	50,000	2%
(1R,2S)-(-)-Ephedrine	>100000	-
1-phenylephrine	>100000	-
L-Methamphetamine	>100000	-

OPI 2000(Morphine, Cutoff=2000ng/mL)	Minimum concentrationrequired to obtain apositive result (ng/mL)	% Cross-Reactivity
Normorphine	50,000	4%
Codeine	2,000	100%
s-Monoacetylmorphine	2,000	100%
Ethyl Morphine	1,500	133.3%
Heroin	2,000	100%
Hydrocodone	12,500	16%
Hydromorphone	3,500	57.1%
Morphinie-3-β-d-glucuronide	2,000	100%
Oxycodone	25,000	8%
Oxymorphone	25,000	8%
Thebaine	50,000	4%
Levorphanol	75,000	2.7%
6-Monoacetylmorphine (6-MAM)	2,000	100%
Norcodeine	12,500	16%

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

Procaine	>100,000	--
----------	----------	----

f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +25% cutoff and -25% cutoff levels. Three Operators tested each sample using test devices from three different lots. The results were all positive for samples at +25% cutoff and all negative for samples at -25% cutoff, indicating that urine specific gravity between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.

To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with target drugs at +25% cutoff and -25% cutoff levels. Three Operators tested each sample using test devices from three different lots. The results were all positive for samples at +25% cutoff and all negative for samples at -25% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.

1. Comparison Studies
  The method comparison studies for Wisdiag Multi-Drug Urine Test Cup were performed in-house with three operators.

Operators ran 80 (40 negative and 40 positive) unaltered urine samples were blind labeled and compared to LC/MS results. The results are presented in the table below:

For Wisdiag Multi-Drug Urine Test Cup:

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
OperatorA	Positive	0	0	1	20	20
	Negative	10	12	17	0	0
OperatorB	Positive	0	0	1	20	20
	Negative	10	12	17	0	0
OperatorC	Positive	0	0	1	20	20
	Negative	10	12	17	0	0

AMP 500

Discordant Results for AMP 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	AMP136	499.0	+
Operator B	AMP028	477.4	+
Operator C	AMP136	499.0	+

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

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	1	18	20
A	Negative	10	15	14	2	0
Operator	Positive	0	0	2	20	20
B	Negative	10	15	13	0	0
Operator	Positive	0	0	0	18	20
C	Negative	10	15	15	2	0

Discordant Results for BUP 10:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BUP029	10.2	-
Operator C	BUP029	10.2	-
Operator A	BUP055	10.8	-
Operator C	BUP055	10.8	-
Operator A	BUP058	9.8	+
Operator B	BUP058	9.8	+
Operator B	BUP070	9.9	+

BAR 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	17	20
A	Negative	10	16	14	3	0
Operator	Positive	0	0	0	18	20
B	Negative	10	16	14	2	0
Operator	Positive	0	0	0	19	20
C	Negative	10	16	14	1	0

Discordant Results for BAR 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BAR011	303.8	-
Operator B	BAR011	303.8	-
Operator C	BAR011	303.8	-
Operator A	BAR017	300.9	-

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

Operator B	BAR017	300.9	-
Operator A	BAR033	312.2	-

BZO 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	16	23
A	Negative	10	15	15	1	0
Operator	Positive	0	0	0	15	23
B	Negative	10	15	15	2	0
Operator	Positive	0	0	0	17	23
C	Negative	10	15	15	0	0

Discordant Results for BZO 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	BZO018	303.6	-
Operator B	BZO018	303.6	-
Operator B	BZO058	307.2	-

COC 150

WisdiagCup		Drug-Free	LowNegative byLC/MS(less than -50%)	Near CutoffNegative byLC/MS(Between -50% and theCutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	HighPositive byLC/MS(greaterthan +50%)
Operator A	Positive	0	0	1	18	22
	Negative	10	16	13	0	0
Operator B	Positive	0	0	1	18	22
	Negative	10	16	13	0	0
Operator C	Positive	0	0	0	17	22
	Negative	10	16	14	1	0

Discordant Results for COC 150:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	COC046	144.8	+
Operator B	COC146	148.9	+
Operator C	COC128	162.8	-

{28}------------------------------------------------

EDDP 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50% and theCutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)

Operator A	Positive	0	0	0	17	21
	Negative	10	15	15	2	0
Operator B	Positive	0	0	1	19	21
	Negative	10	15	14	0	0
Operator C	Positive	0	0	1	19	21
	Negative	10	15	14	0	0

Discordant Results for EDDP 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	EDDP075	290.6	+
Operator C	EDDP075	290.6	+
Operator A	EDDP010	318.6	-
Operator A	EDDP061	318.5	-

MET 500

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	18	20
A	Negative	10	15	15	2	0
Operator	Positive	0	0	0	19	20
B	Negative	10	15	15	1	0
Operator	Positive	0	0	0	20	20
C	Negative	10	15	15	0	0

Discordant Results for MET 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	MET062	519.5	-
Operator A	MET102	521.1	-
Operator B	MET102	521.1	-

MDMA 500

{29}------------------------------------------------

WisdiagCup	Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
OperatorA	Positive	0	0	2	20	20
A	Negative	10	17	11	0	0
OperatorB	Positive	0	0	0	20	20
B	Negative	10	17	13	0	0
OperatorC	Positive	0	0	1	20	20
C	Negative	10	17	12	0	0

Discordant Results for MDMA 500:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	MDMA026	488.3	+
Operator C	MDMA026	488.3	+
Operator A	MDMA060	492.0	+

MOP 300

WisdiagCup			LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
		Drug-Free
Operator	Positive	0	0	0	18	22
A	Negative	10	14	16	0	0
Operator	Positive	0	0	2	18	22
B	Negative	10	14	14	0	0
Operator	Positive	0	0	0	18	22
C	Negative	10	14	16	0	0

Discordant Results for MOP 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	MOP057	293.2	+
Operator B	MOP150	282.8	+

MTD 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS	High Positiveby LC/MS(greater than+50%)
----------------	--	-----------	-------------------------------------------------	-------------------------------------------------------------------------	-------------------------------------	-----------------------------------------------------

{30}------------------------------------------------

					(Between thecutoff and+50%)
Operator	Positive	0	0	0	18	20
A	Negative	10	16	14	2	0
Operator	Positive	0	0	2	20	20
B	Negative	10	16	12	0	0
Operator	Positive	0	0	1	20	20
C	Negative	10	16	13	0	0

Discordant Results for MTD 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	MTD022	298.2	+
Operator B	MTD049	289.2	+
Operator C	MTD049	289.2	+
Operator A	MTD003	309.1	-
Operator A	MTD045	301.7	-

OXY 100

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
OperatorA	Positive	0	0	2	19	21
	Negative	10	14	14	0	0
OperatorB	Positive	0	0	0	18	21
	Negative	10	14	16	1	0
OperatorC	Positive	0	0	0	17	21
	Negative	10	14	16	2	0

Discordant Results for OXY 100:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	OXY012	96.3	+
Operator A	OXY071	95.2	+
Operator B	OXY002	101.4	-
Operator C	OXY002	101.4	-
Operator C	OXY006	111.0	-

PCP 25

WisdiagCup	Drug-Free	LowNegative by	Near CutoffNegative byLC/MS	Near CutoffPositive byLC/MS	High Positiveby LC/MS
----------------	-----------	--------------------	-------------------------------------	-------------------------------------	---------------------------

{31}------------------------------------------------

			LC/MS (lessthan -50%)	(Between -50%and the Cutoff)	(Between thecutoff and+50%)	(greater than+50%)
Operator	Positive	0	0	1	21	18
A	Negative	10	18	11	1	0
Operator	Positive	0	0	1	21	18
B	Negative	10	18	11	1	0
Operator	Positive	0	0	1	22	18
C	Negative	10	18	11	0	0

Discordant Results for PCP 25:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	PCP003	22.4	+
Operator B	PCP060	22.7	+
Operator C	PCP060	22.7	+
Operator A	PCP023	25.5	-
Operator B	PCP023	25.5	-

PPX 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	2	19	21
A	Negative	10	16	12	0	0
Operator	Positive	0	0	0	16	21
B	Negative	10	16	14	3	0
Operator	Positive	0	0	1	18	21
C	Negative	10	16	13	1	0

Discordant Results for PPX 300:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	PPX024	292.5	+
Operator A	PPX029	291.4	+
Operator C	PPX024	292.5	+
Operator B	PPX043	300.7	-
Operator B	PPX053	300.8	-
Operator B	PPX073	303.4	-
Operator C	PPX043	300.7	-

TCA 1000

{32}------------------------------------------------

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	16	22
A	Negative	10	15	15	2	0
Operator	Positive	0	0	1	18	22
B	Negative	10	15	14	0	0
Operator	Positive	0	0	2	18	22
C	Negative	10	15	13	0	0

Discordant Results for TCA 1000:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	TCA005	991.3	+
Operator C	TCA005	991.3	+
Operator C	TCA043	969.0	+
Operator A	TCA010	1015.1	-
Operator A	TCA052	1015.9	-

THC 50

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
OperatorA	Positive	0	0	1	16	22
A	Negative	10	16	13	2	0
OperatorB	Positive	0	0	1	17	22
B	Negative	10	16	13	1	0
OperatorC	Positive	0	0	0	15	22
C	Negative	10	16	14	3	0

Discordant Results for THC 50:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator A	THC014	47.8	+
Operator B	THC054	46.8	+
Operator A	THC062	50.9	-
Operator A	THC069	53.5	-
Operator B	THC076	53.9	-

{33}------------------------------------------------

Operator C	THC036	50.5	-
Operator C	THC062	50.9	-
Operator C	THC069	53.5	-

AMP 1000

WisdiagCup			LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
		Drug-Free
OperatorA	Positive	0	0	0	17	21
	Negative	10	15	15	2	0
OperatorB	Positive	0	0	1	19	21
	Negative	10	15	14	0	0
OperatorC	Positive	0	0	0	18	21
	Negative	10	15	15	1	0

Discordant Results for AMP 1000:

Operator	Sample Number	LC/MS Result (ng/mL)	Hightop Result
Operator B	AMP116	998.8	+
Operator A	AMP095	1035.1	-
Operator A	AMP102	1048.4	-
Operator C	AMP102	1048.4	-

COC 300

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
OperatorA	Positive	0	0	2	17	23
	Negative	10	14	14	0	0
OperatorB	Positive	0	0	0	15	23
	Negative	10	14	16	2	0
OperatorC	Positive	0	0	1	17	23
	Negative	10	14	15	0	0

Discordant Results for COC 300:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator A	COC028	296.4	+
Operator A	COC143	283.8	+

{34}------------------------------------------------

Operator C	COC143	283.8	+
Operator B	COC033	317.7	-
Operator B	COC138	318.7	-

MET 1000

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	21	19
A	Negative	10	13	17	0	0
Operator	Positive	0	0	0	19	19
B	Negative	10	13	17	2	0
Operator	Positive	0	0	0	20	19
C	Negative	10	13	17	1	0

Discordant Results for MET 1000:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator B	MET123	1049.5	-
Operator B	MET138	1068.2	-
Operator C	MET138	1068.2	-

OPI 2000

WisdiagCup		Drug-Free	LowNegative byLC/MS (lessthan -50%)	Near CutoffNegative byLC/MS(Between -50%and the Cutoff)	Near CutoffPositive byLC/MS(Between thecutoff and +50%)	High Positiveby LC/MS(greater than+50%)
Operator	Positive	0	0	0	16	22
A	Negative	10	16	14	2	0
Operator	Positive	0	0	1	18	22
B	Negative	10	16	13	0	0
Operator	Positive	0	0	0	18	22
C	Negative	10	16	14	0	0

Discordant Results for OPI 2000:

Operator	Sample Number	LC/MS Result	Hightop Result
Operator B	MOP076	1943.3	+
Operator A	MOP089	2070.0	-
Operator A	MOP139	2105.7	-

{35}------------------------------------------------

Lay-user study:

A lay user study was performed using urine samples prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS or LC/MS. Each sample was aliquoted into individual containers and blind-labeled. A total of 280 participants with diverse educational and professional backgrounds aged 20 years and older were recruited from three sites. Sixty-six males and 74 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 72 male and 68 females tested Wisdiag Multi-Drug Urine Test Cup Configuration 2 (including AMP 1000, MET 1000, MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one blind labeled test solution, and one test device. The results are summarized below:

Lay-User Study Results for Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500,
MET 500, MOP 300, COC 150):

Assay	Results	Concentration
		-100% cutoff	-75% cutoff	-50% cutoff	-25% cutoff	+25% cutoff	+50% cutoff	+75% cutoff
AMP 500	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
BAR 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
BZO 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
BUP 10	Negative	20	20	20	19	2	0	0
	Positive	0	0	0	1	18	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	90%	100%	100%
COC 150	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	90%	95%	100%	100%
EDDP 300	Negative	20	20	20	20	0	0	0
	Positive	0	0	0	0	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	100%	100%	100%
MDMA 500	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
MET 500	Negative	20	20	20	19	1	0	0
	Positive	0	0	0	1	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	95%	100%	100%
MOP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
MTD 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
OXY 100	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
PCP 25	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
PPX 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
TCA 1000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો	100%	100%	100%
THC 50	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	90%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલત	100%	100%

{36}------------------------------------------------

{37}------------------------------------------------

Lay-User Study Results for Wisdiag Multi-Drug Urine Test Cup Configuration 2 (AMP 1000, MET 1000, MOP 2000 (OPI), COC 300):

Assay	Results	Concentration
		-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	+25%cutoff	+50%cutoff	+75%cutoff
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
AMP 1000	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
BAR 300	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
BZO 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
BUP 10	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%
COC 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	100%	95%	100%	100%

EDDP 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
MDMA 500	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
MET 1000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
OPI 2000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
MTD 300	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
OXY 100	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
PCP 25	Negative	20	20	20	20	1	0	0
	Positive	0	0	0	0	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	100%	95%	100%	100%
PPX 300	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage of correct results (%)	100%	100%	100%	95%	100%	100%	100%
TCA 1000	Negative	20	20	20	19	0	0	0
	Positive	0	0	0	1	20	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	તે તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના	100%	100%	100%
THC 50	Negative	20	20	20	18	1	0	0
	Positive	0	0	0	2	19	20	20
	Total	20	20	20	20	20	20	20
	Percentage ofcorrect results (%)	100%	100%	100%	90%	તે જેન્જી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો	100%	100%

{38}------------------------------------------------

{39}------------------------------------------------

Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Clinical Studies:

Not applicable.

12. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).