Wondfo Amphetamine Urine Test AMP 500 Cup is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test AMP 500 DipCard is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 Cup is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Cocaine Urine Test COC 150 DipCard is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. This test is callbrated to Benzoylecgonine (calibrator).

Wondfo Methamphetamine Urine Test MET 500 Cup is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Wondfo Amphetamine Urine Test MET 500 DipCard is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Device Description

WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

AI/ML Overview

The document provides information on the acceptance criteria and performance of the Wondfo Amphetamine/Cocaine/Methamphetamine Urine Tests.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with a direct comparison to performance against those criteria. Instead, it presents performance characteristics (precision, cut-off verification, interference, specificity, effects of specific gravity and pH, agreement with GC/MS, and lay-user performance) which implicitly define the device's acceptable performance. The performance demonstrated is the acceptance criteria met.

Implicit Acceptance Criteria and Reported Device Performance (Summary derived from the text):

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Consistent results across concentrations and lots.	Amphetamine (AMP) Dip Card & Cup: For all three lots and both formats: -100%, -75%, -50%, -25% Cut-off: 50-/0+ (Negative) observed for all tests.+25%, +50%, +75%, +100% Cut-off: 50+/0- (Positive) observed for all tests.At Cut-off: 43+/7- or 44+/6- (Mix of Positive/Negative) observed, indicating expected behavior around the cut-off. Cocaine (COC) Dip Card & Cup: Similar results to AMP for all three lots and both formats, demonstrating expected performance across the concentration range and at the cut-off. (Methamphetamine (MET) precision data reported in K122961, not detailed here.)
Cut-off Verification	Accurate classification at and around defined cut-off levels.	All samples at and above +50% cut-off were positive. All samples at and below -50% cut-off were negative for Amphetamine, Cocaine, and Methamphetamine.
Interference	No interference from common physiological/pathological substances.	Numerous common substances (listed in the document, pages 10-12) showed no interference at 100 µg/mL. Targeted drugs at 25% above cut-off levels were correctly detected in the presence of these substances.
Specificity	Proper reactivity to target analytes and appropriate cross-reactivity.	AMP: D-Amphetamine: 100% reactivity at 500 ng/mL. Cross-reactivity observed with L-Amphetamine (2%), D,L-Amphetamine (33%), Phentermine (33%), Hydroxyamphetamine (6%), MDA (20%). No reaction with D/L-Methamphetamine, Ephedrine, MDE, MDMA at 100,000 ng/mL.COC: Benzoylecgonine: 100% reactivity at 150 ng/mL. Cross-reactivity with Cocaine HCl (40%), Cocaethylene (2.4%), Ecgonine (0.9%), Norcocaine (0.3%). MET: D-Methamphetamine: 100% reactivity at 500 ng/mL. 100% reactivity with MDEA, MDA, D/L-Methamphetamine. Cross-reactivity with L-Methamphetamine (5%), L-Amphetamine (1.3%).
Urine Specific Gravity & pH Effects	Consistent results across a range of urine specific gravity and pH.	Urine samples with specific gravity 1.000-1.035 and pH 4-9 spiked at +/- 25% cut-off levels showed all positive results for samples at and above +25% cut-off and all negative results for samples at and below -25% cut-off. No differences were observed across formats.
Agreement with GC/MS (Method Comparison)	High agreement with GC/MS for both negative and positive samples.	AMP (Dip Card & Cup): Across 3 viewers, 0 false positives for negative and low negative samples. For near cut-off negative, 1-2 false positives were reported by viewers. For near cut-off positive and high positive samples, viewers consistently reported positive results with minimal discordance (e.g., 2 samples with GC/MS at 480 or 481 ng/mL were called positive by some viewers, demonstrating sensitivity close to cut-off). COC (Dip Card & Cup): Similar to AMP, with 0 false positives for negative and low negative. Few false positives for near cut-off negative (1-2). High agreement for near cut-off positive and high positive. Discordant results mainly around the cut-off (e.g., GC/MS 145 or 146 ng/mL called positive by viewers).(Methamphetamine (MET) data reported in K122961, not detailed here.)
Lay-User Performance	High percentage of correct results by untrained users.	AMP (Cup & Dip Card): 100% correct for -100%, -75%, -50%, +50%, +75% cut-off concentrations. 90-95% correct for -25% and +25% cut-off concentrations (expected variability around cut-off). COC (Cup & Dip Card): 100% correct for -100%, -75%, -50%, +50%, +75% cut-off concentrations. 90% correct for -25% and +25% cut-off concentrations. MET (Cup & Dip Card): 100% correct for -100%, -75%, -50%, +50%, +75% cut-off concentrations. 90% correct for -25% and +25% cut-off concentrations. All lay users found instructions easy to follow, with a Flesch-Kincaid Grade Level of 7.

The study demonstrates that the Wondfo Urine Test devices perform as expected for qualitative drug detection around specified cut-off levels, show appropriate specificity, are not significantly affected by common interfering substances or urine properties, and can be used accurately by lay-users. This collective performance data indicates that the devices meet the implied acceptance criteria for their intended use as preliminary, over-the-counter drug screening tests.

Study Details:

2. Sample Size and Data Provenance

Test Set Sample Size:
- Precision Studies: For each drug concentration, three lots of devices were tested, with two runs per day for 25 days. The number of individual tests per concentration point for each lot is not explicitly stated as a single total, but 50 measurements (e.g., 50-/0+ or 50+/0-) are reported for each concentration for each lot. This implies 50 tests per concentration per lot for each of "Lot 1, Lot 2, Lot 3". Given 9 concentration points per drug, that's 9 * 50 = 450 tests per lot, and 3 lots means 1350 tests per drug for each device format (Cup/DipCard).
- Cut-off Verification: 150 samples were used in total, equally distributed across 5 concentrations (-50%, -25%, cut-off, +25%, +50%). Tested using three different lots of each device by three different operators. (This means 150 samples * 3 lots * 3 operators = 1350 individual test results reported for this section across all drugs and device formats).
- Interference & Specificity Studies: Not explicitly stated as a total N, but substances were added to drug-free urine and target-drug urine (25% above cut-off) and tested using "three batches of each device for all formats."
- Method Comparison (Agreement with GC/MS): 80 unaltered clinical samples (40 negative, 40 positive) were used for each drug (Amphetamine, Cocaine, Methamphetamine) for each device format (Cup/DipCard).
- Lay-user Study: 280 lay persons for Amphetamine devices, 280 for Cocaine devices, and 280 for Methamphetamine devices. Each lay person tested one blind-labeled sample. For each drug, 7 distinct concentration levels with 20 samples per level were used. This means 7 * 20 = 140 samples were prepared for each drug per device format (e.g., AMP Cup), and these samples were then distributed to the 280 lay users (presumably 140 for the Cup and 140 for the DipCard, but this is not explicitly stated for all, though AMP and COC show 140 samples in total distributed across the 7 concentrations for both Cup and DipCard results tables).
Data Provenance:
- Country of Origin: Wondfo Biotech Co., Ltd. is located in Guangzhou, P.R. China (page 4). The studies were likely conducted internally or by associated labs.
- Retrospective or Prospective: Not explicitly stated, but the "clinical samples" for the method comparison were "unaltered," which often implies prospectively collected real-world samples. The precision and cut-off studies involved "spiking drug in negative samples" which are laboratory-prepared. The lay-user study used prepared samples and was a controlled prospective study.

3. Number of Experts and Qualifications for Ground Truth

Method Comparison (Agreement with GC/MS):
- The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug testing, considered the "gold standard."
- No human "experts" were listed as establishing ground truth for the test set; the GC/MS analytical results served as the objective gold standard.
- Three "laboratory assistants" were involved in running the Wondfo devices, not in establishing the ground truth. Their qualifications are not provided.
Precision, Cut-off, Interference, Specificity, Specific Gravity/pH: The ground truth for these studies was established by the precise preparation of samples with known drug concentrations (confirmed by GC/MS where relevant) and the analytical methods used to prepare and characterize the samples.
Lay-user Study: The ground truth for the lay-user study was established by GC/MS for the prepared urine samples.

4. Adjudication Method for the Test Set

Method Comparison: No formal "adjudication method" among human readers is described for the test sets. The Wondfo device results (read by the laboratory assistants/viewers) were directly compared to the GC/MS ground truth. Discordant results are noted individually for each viewer against the GC/MS result.
Precision/Cut-off: Not applicable, as results were based on predefined expectations for concentrations.
Lay-user Study: Not applicable, as each lay person read their assigned sample independently against the GC/MS-confirmed concentration.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was explicitly performed or reported in this document to assess how much human readers improve with AI (or rather, with the device) versus without assistance.
The studies were designed to evaluate the performance of the device itself and the ability of lay users to correctly interpret device results compared to a gold standard (GC/MS).
The "Method Comparison" section involved three "viewers" (laboratory assistants) independently reading the device results and comparing them to GC/MS. This is a multi-reader study, but it's evaluating the device's accuracy when read by trained personnel, not necessarily the improvement of those readers.
The "Lay-user study" is also a multi-reader study (280 lay persons), but it's assessing the device's ease of use and accuracy in untrained hands, not an improvement over unassisted human performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The core of the document describes the standalone performance of the Wondfo Urine Test device itself.
- The "Precision," "Cut-off," "Interference," and "Specificity" sections evaluate the analytical performance of the device in a laboratory setting when operated by laboratory personnel, without explicit human-in-the-loop decision-making beyond visual interpretation of a test line.
- The "Method Comparison" study explicitly compares the device's qualitative results (interpreted visually by laboratory assistants) against the GC/MS gold standard. This is a direct measure of the device's standalone performance in a simulated clinical context.

7. Type of Ground Truth Used

The primary ground truth used for all performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) for drug concentrations was GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is a highly accurate analytical chemistry technique considered the definitive "confirmatory method" for drug identification and quantification in urine.
For the lay-user study, the ground truth for ease of use was collected via user surveys.

8. Sample Size for the Training Set

Not Applicable. This device is an immunochromatographic assay (lateral flow immunoassay), not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The device's performance is based on its chemical and biological design, not a trained algorithm.

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

Not Applicable, as there is no "training set" for this type of device. The ground truth for the validation/test samples was established via GC/MS.

Summary

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

June 27, 2016

GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K161214

Trade/Device Name: Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup. Dipcard). Wondfo Methamphetamine Urine Test MET 500 (Cup. Dipcard) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DKZ, DJC Dated: April 21, 2016 Received: April 29, 2016

Dear Mr. Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney 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

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Indications for Use

510(k) Number (if known) K161214

Device Name Wondfo Amphetamine Urine Test AMP 500 (Cup, DipCard) Wondfo Cocaine Urine Test COC 150 (Cup, DipCard)

Wondfo Methamphetamine Urine Test MET 500 (Cup, DipCard)

Indications for Use (Describe)

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

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The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a twostep process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

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)

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1. Date: June 8, 2016

Submitter: Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641

1. 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
1. Device Name: WONDFO Urine Test Amphetamine (Cup, DipCard) WONDFO Urine Test Cocaine (Cup, DipCard) WONDFO Urine Test Methamphetamine (Cup, DipCard)

Classification. Class II
ProductCode	CFR #	Panel
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
DJC	21 CFR, 862.3610 Methamphetamine Test System	Toxicology

Classification: Class II

1. Predicate Devices:
  K122809 Advin Multi-Drug Screen Test
1. Intended Use
  WONDFO Urine Test Amphetamine Cup is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

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

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For in vitro diagnostic use only. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

WONDFO Urine Test Amphetamine DipCard is a rapid test for the qualitative detection of Amphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Amphetamine (calibrator).

WONDFO Urine Test Cocaine Cup is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 150 ng/ml. This test is calibrated to Benzoylecgonine (calibrator).

WONDFO Urine Test Cocaine DipCard is a rapid test for the qualitative detection of Benzoylecgonine in human urine at a cutoff concentration of 150 ng/ml. This test is calibrated to Benzoylecgonine (calibrator).

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WONDFO Urine Test Methamphetamine Cup is a rapid test for the qualitative detection of Methamphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

WONDFO Urine Test Methamphetamine DipCard is a rapid test for the qualitative detection of Methamphetamine in human urine at a cutoff concentration of 500 ng/mL. This test is calibrated to d-Methamphetamine (calibrator).

1. Device Description
  WONDFO Urine Test devices are immunochromatographic assays for cocaine, amphetamine and Methamphetamine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine, or D-amphetamine or D-methamphetamine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: DipCards, or Cups. It contains a Test Device (in one of the two formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.
1. Substantial Equivalence Information
  A summary comparison of features of the WONDFO Urine Test and the predicate device is provided in Table 1, Table 2 & Table 3.

Table 1: Features Comparison of WONDFO Cocaine Test and the Predicate Device

Item	Device	Predicate -K122809
Indication(s)for Use	For the qualitative determination ofBenzoylecgonine in human urine.	Same

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Item	Device	Predicate -K122809
Calibrator	Benzoylecgonine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	150 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Same
Configurations	Cup, Dip Card	Cup, Dip Card,Cassette

Table 2: Features Comparison of WONDFO Amphetamine Test and the Predicate Device

Item	Device	Predicate - K122809
Indication(s)for Use	For the qualitative determination ofD-amphetamine in human urine.	Same
Calibrator	D-amphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	500 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Same
Configurations	Cup, Dip Card	Cup, Dip Card,Cassette

Table 3: Features Comparison of WONDFO Methamphetamine Test and the Predicate Device

Item	Device	Predicate - K122809
Indication(s)for Use	For the qualitative determination ofD-methamphetamine in human urine.	Same
Calibrator	D-methamphetamine	Same

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Item	Device	Predicate - K122809
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	500 ng/mL	Same
IntendedPopulation	For over-the-counter and prescriptionuses.	Same
Configurations	Cup, Dip Card	Cup, Dip Card,Cassette

9. Test Principle

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

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

Drug	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Lot 1		50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-

Amphetamine (AMP) Dip Card Format

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	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug	Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
Drug	Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
Amphetamine (AMP) Cup Format
	Result	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Drug	Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
Drug	Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-
Drug	Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-

Cocaine (COC) Dip Card Format

Drug	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
	Lot 1		50-/0+	50-/0+		50-/0+	50-/0+	43+/7-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-

COC Cup Format

Drug	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off

Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-

The Methamphetamine precision data was reported in K122961.

b. Linearity
Not applicable, these are visually read devices.
c. Stability

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

The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C. Control materials are not provided with the device. The labeling provides information on how to obtain control materials.

d. Cut-off
A total of 150 samples equally distributed at concentrations of -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested using three different lots of each device by three different operators. Results were all positive at and above +50% cut-off and all negative at and below -50% cut-off for Amphetamine, Cocaine and Methamphetamine (K122961). The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
WONDFO Urine Test AmphetamineCup (DipCard)	D-amphetamine	500
WONDFO Urine Test Cocaine Cup(DipCard)	Benzoylecogonine	150
WONDFO Urine TestMethamphetamine Cup (DipCard)	D-methamphetamine	500

e. Interference

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

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

4-Acetamidophenol	L-Ephedrine	Oxycodone
Acetophenetidin	(-) Y Ephedrine	Oxymetazoline
N-Acetylprocainamide	Erythromycin	Papaverine
Acetylsalicylic acid	ß-Estradiol	Penicillin-G
Aminopyrine	Estrone-3-sulfate	Pentazocaine
Amitryptyline	Ethyl aminobenzoate	Pentobarbital
Amobarbital	Fenfluramine	Perphenazine
Amoxicillin	Fenoprofen	Phencyclidine
Ampicillin	Furosemide	Phenelzine
Ascorbic acid	Gentisic acid	Phenobarbital
Aspartame	Hemoglobin	Phetoin
Atropine	Hydralazine	L-Phenylephrine
Benzilic acid	Hydrochlorothiazide	Phenylpropanolamine

AMP

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

Benzoic acid	Hydrocodone	Prednisolone
Benzoylecgonine	Hydrocortisone	Prednisone
Bilirubin	O-Hydroxyhippuric acid	Procaine
Brompheniramine	3-Hydroxytyramine	Promazine
Caffeine	Ibuprofen	Promethazine
Cannabidiol	Imipramine	D,L-Propanolol
Cannabinol	(-) Isoproterenol	D-Propoxyphene
Chloralhydrate	Isoxsuprine	Quinidine
Chloramphenicol	Ketamine	Quinine
Chlordiazepoxide	Ketoprofen	Ranitidine
Chlorothiazide	Labetalol	Salicylic acid
(±)-Chlorpheniramine	Levorphanol	Secobarbital
Chlorpromazine	Loperamide	Sulfamethazine
Chloroquine	Maprotiline	Sulindac
Cholesterol	Meperidine	Temazepam
Clomipramine	Meprobamate	Tetracycline
Clonidine	Methadone	Tetrahydrocortisone
Cocaine hydrochloride	Methylphenidate	Tetrahydrozoline
Codeine	Morphine-3-Dglucuronide	Δ9-THC-COOH
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	D,L-Thyroxine
Dextromethorphan	Niacinamide	Tolbutamide
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine
Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	D,L-Octopamine	D, L-Tyrosine
Ecgonine hydrochloride	Oxalic acid	Uric acid
Ecgonine methylester	Oxazepam	Verapamil
(1R,2S)-(-)-Ephedrine	Oxolinic acid	Zomepirac

COC

Acetaminophen	Estrone-3-sulfate	Oxymetazoline
Acetophenetidin	Ethyl-p-aminobenzoate	Papaverine
N-Acetylprocainamide	Fenoprofen	Penicillin-G
Acetylsalicylic acid	Furosemide	Pentobarbital
Aminopyrine	Gentisic acid	Perphenazine
Amitryptyline	Hemoglobin	Phencyclidine
Amobarbital	Hydralazine	Phenelzine
Amoxicillin	Hydrochlorothiazide	Phenobarbital
Ampicillin	Hydrocodone	Phentermine
L-Ascorbic acid	Hydrocortisone	L-Phenylephrine
DL-Amphetamine Sulfate	O-Hydroxyhippuric acid	β-Phenylethylamine
Apomorphine	p-Hydroxymethamphetamine	Phenylpropanolamine
Aspartame	3-Hydroxytyramine	Prednisolone
Atropine	Ibuprofen	Prednisone
Benzilic acid	Imipramine	Procaine
Benzoic acid	Iproniazid	Promazine
Benzphetamine	(±) - Isoproterenol	Promethazine
(±) -Brompheniramine	Isoxsuprine	DL-Propranolol
Caffeine	Ketamine	D-Propoxyphene
Cannabidiol	Ketoprofen	D-Pseudoephedrine
Cannabinol	Labetalol	Quinidine
Chloralhydrate	Levorphanol	Quinine
Chloramphenicol	Loperamide	Ranitidine
Chlordiazepoxide	Maprotiline	Salicylic acid
Chlorothiazide	Meperidine	Secobarbital
(±) -Chlorpheniramine	Meprobamate	Serotonin
Chlorpromazine	Methadone	Sulfamethazine
Chloroquine	Methoxyphenamine	Sulindac
Cholesterol	(±) -3,4-Methylenedioxyamphetamine	Temazepam
Clomipramine	Methylene-dioxymethamphetamine	Tetracycline
Clonidine	Morphine-3-B-D glucuronide	Tetrahydrocortisone3-(β-D glucuronide)
Codeine	Morphine Sulfate	Tetrahydrozoline
Cortisone	Nalidixic acid	Thebaine
(-) Cotinine	Naloxone	Thiamine
Creatinine	Naltrexone	Thioridazine
Deoxycorticosterone	Naproxen	DL-Tyrosine
Dextromethorphan	Niacinamide	Tolbutamide
Diazepam	Nifedipine	Triamterene
Diclofenac	Norcodein	Trifluoperazine
Diflunisal	Norethindrone	Trimethoprim
Digoxin	D-Norpropoxyphene	Trimipramine
Diphenhydramine	Noscapine	Tryptamine
Doxylamine	DL-Octopamine	DL-Tryptophan
Ecgonine methylester	Oxalic acid	Tyramine
(-) - Ψ-Ephedrine	Oxazepam	Uric acid
Erythromycin	Oxolinic acid	Verapamil
ß-Estradiol	Oxycodone	Zomepirac

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

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

MET: The MET interference data was reported in K122961.

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

AMP	Result	Reactivity
(D- Amphetamine, Cut-off=500 ng/mL)	Positive at 500 ng/mL	100%
L - Amphetamine	25000	2%
D,L - Amphetamine	1500	33%
Phentermine	1500	33%
Hydroxyamphetamine	8000	6%
Methylenedioxyamphetamine (MDA)	2500	20%
d-Methamphetamine	Negative at 100000	<1%
1-Methamphetamine	Negative at 100000	<1%
ephedrine	Negative at 100000	<1%
Methylenedioxyethylamphetamine (MDE)	Negative at 100000	<1%
3,4-methylenedioxy-methamphetamine(MDMA)	Negative at 100000	<1%

COC	Result	Reactivity
(Benzoylecogonine, Cut-off=150 ng/mL)	Positive at 150 ng/mL	100%
Cocaine HCl	Positive at 375 ng/mL	40%
Cocaethylene	Positive at 6250 ng/mL	2.4%
Ecgonine	Positive at 16000 ng/mL	0.9%
Norcocaine	Positive at 50000 ng/mL	0.3%

MET	Result	Reactivity
(D- Methamphetamine, Cut-off=500 ng/mL)	Positive at 500 ng/mL	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	Positive at 500 ng/mL	100%
(+/-) 3,4-Methylenedioxyamphetamine (MDA)	Positive at 500 ng/mL	100%
d/l-Methamphetamine	Positive at 500 ng/mL	100%

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

l-Methamphetamine	Positive at10,000 ng/mL	5%
l-Amphetamine	Positive at 37,500 ng/mL	1.3%

MET: Additional MET interference data was reported in K122961.

g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.
1. Comparison Studies
  The method comparison studies for the WONDFO Urine Test (Amphetamine, Cocaine and Methamphetamine) were performed in-house with three different laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

AMP
Dip Cardformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	30	10
	Negative	10	17	11	0	0
Viewer B	Positive	0	0	2	30	10
	Negative	10	17	11	0	0
Viewer C	Positive	0	0	1	30	10
	Negative	10	17	12	0	0

Discordant Results of AMP Dip Card

Viewer	Sample Number	GC/MS Result	Dipcard FormatViewer Results
Viewer A	AMP5062	480	Positive
Viewer A	AMP5065	481	Positive
Viewer B	AMP5062	480	Positive
Viewer C	AMP5062	480	Positive

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

Viewer	Sample Number	GC/MS Result	Dipcard FormatViewer Results
Viewer B	AMP5218	365	Positive

AMP

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	30	10
	Negative	10	17	11	0	0
Viewer B	Positive	0	0	1	30	10
	Negative	10	17	12	0	0
Viewer C	Positive	0	0	2	30	10
	Negative	10	17	11	0	0

Discordant Results of AMP Cup

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	AMP5062	480	Positive
Viewer A	AMP5065	481	Positive
Viewer B	AMP5062	480	Positive
Viewer C	AMP5062	480	Positive
Viewer C	AMP5065	481	Positive

COC

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

Dip Cardformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	30	10
	Negative	10	18	10	0	0
Viewer B	Positive	0	0	2	30	10
	Negative	10	18	10	0	0
Viewer C	Positive	0	0	1	29	11
	Negative	10	18	11	0	0

Discordant Results of COC DipCard

Viewer	Sample Number	GC/MS Result	DipCard FormatViewer Results
Viewer A	COC1215	145	Positive
Viewer A	COC1217	146	Positive
Viewer B	COC1215	145	Positive
Viewer B	COC1217	146	Positive
Viewer C	COC1217	146	Positive

COC

Cupformat		Negative	LowNegativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcut-off)	NearCutoffPositive byGC/MS(Betweenthe cut-offand +50%)	HighPositive byGC/MS(greaterthan +50%)
Viewer A	Positive	0	0	2	30	10
	Negative	10	18	10	0	0
Viewer B	Positive	0	0	1	30	10
	Negative	10	18	11	0	0
Viewer C	Positive	0	0	2	30	10
	Negative	10	18	10	0	0

Discordant Results of COC Cup

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

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Results
Viewer A	COC1215	145	Positive
Viewer B	COC1215	145	Positive
Viewer C	COC1215	145	Positive
Viewer C	COC1217	146	Positive
Viewer A	COC1217	146	Negative

The Methamphetamine method comparison data was reported in K122961.

Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons testing the amphetamine devices, 280 lay persons testing the cocaine devices and 280 lay persons testing the Methamphetamine devices. They had diverse educational and professional backgrounds and ranged in age from 21 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.

% of Cutoff	Numberofsamples	d-AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	126.3	0	20	100
-50% Cutoff	20	248.6	0	20	100
-25% Cutoff	20	377.1	1	19	95.0
+25% Cutoff	20	625.8	18	2	90.0
+50% Cutoff	20	753.2	20	0	100
+75% Cutoff	20	874.3	20	0	100

Comparison between GC/MS and Lay Person Results AMP Cup

Comparison between GC/MS and Lay Person Results AMP Dip Card

% of Cutoff	Numberofsamples	d-AmphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results
			No. of	No. of

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

			Positive	Negative	(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	126.3	0	20	100
-50% Cutoff	20	248.6	0	20	100
-25% Cutoff	20	377.1	2	18	90.0
+25% Cutoff	20	625.8	18	2	90.0
+50% Cutoff	20	753.2	20	0	100
+75% Cutoff	20	874.3	20	0	100

Comparison between GC/MS and Lay Person Results COC Cup

	Numberofsamples	BenzoylecgonineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
% of Cutoff			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	38.1	0	20	100
-50% Cutoff	20	75.6	0	20	100
-25% Cutoff	20	113.4	2	18	90.0
+25% Cutoff	20	186.7	18	2	90.0
+50% Cutoff	20	226.3	20	0	100
+75% Cutoff	20	259.8	20	0	100

Comparison between GC/MS and Lay Person Results COC Dip Card

% of Cutoff	Numberofsamples	BenzoylecgonineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	38.1	0	20	100
-50% Cutoff	20	75.6	0	20	100
-25% Cutoff	20	113.4	2	18	90.0
+25% Cutoff	20	186.7	18	2	90.0
+50% Cutoff	20	226.3	20	0	100
+75% Cutoff	20	259.8	20	0	100

Comparison between GC/MS and Lay Person Results MET Cup

% of Cutoff	Numberofsamples	MethamphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative

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

-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	124.8	0	20	100
-50% Cutoff	20	251.3	0	20	100
-25% Cutoff	20	377.6	2	18	90.0
+25% Cutoff	20	625.9	18	2	90.0
+50% Cutoff	20	748.3	20	0	100
+75% Cutoff	20	878.1	20	0	100

Comparison between GC/MS and Lay Person Results MET Dip Card

% of Cutoff	Numberofsamples	MethamphetamineConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	124.8	0	20	100
-50% Cutoff	20	251.3	0	20	100
-25% Cutoff	20	377.6	2	18	90.0
+25% Cutoff	20	625.9	18	2	90.0
+50% Cutoff	20	748.3	20	0	100
+75% Cutoff	20	878.1	20	0	100

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

1. Clinical Studies
  Not applicable.

11.Conclusion

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

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

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