(29 days)
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Secobarbital | 300 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Phencyclidine | 25 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methadone | 300 ng/mL |
| Notriptyline | 1000ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the above listed drug analytes.
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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Here's a breakdown of the acceptance criteria and study information for the Wondfo CR3 Keyless Split Sample Cup, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device as a qualitative test, meaning it determines the presence or absence of a substance, not its exact quantity. The performance is assessed against specific cut-off levels for each drug. The provided text, however, focuses on analytical performance being established in previous 510(k) submissions for individual drug tests and then verifying functionality in a multi-drug cup configuration. It explicitly states: "The test strips of the candidate device are the same as those cleared with the predicate devices. Drug cutoffs of the candidate device are also identical to the predicate devices. Analytical performance was established for each device in the submissions as stated below."
Therefore, the acceptance criteria are implicitly tied to the performance demonstrated in those predicate device submissions. The table below lists the drugs and their cut-off levels, which are the primary performance metric. The "Reported Device Performance" here refers to the device's ability to qualitatively detect these drugs at or above these cut-off levels, which was verified to be consistent with the predicate.
| Drug (Identifier) | Acceptance Criteria (Cut-off level) | Reported Device Performance (as stated in document) |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | Qualitatively detects at/above cut-off |
| Secobarbital (BAR) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Oxazepam (BZO) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Cocaine (COC) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Cannabinoids (THC) | 50 ng/mL | Qualitatively detects at/above cut-off |
| Methamphetamine (MET) | 1000 ng/mL | Qualitatively detects at/above cut-off |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Qualitatively detects at/above cut-off |
| Morphine (MOP) | 300 ng/mL or 2000 ng/mL | Qualitatively detects at/above cut-off |
| Phencyclidine (PCP) | 25 ng/mL | Qualitatively detects at/above cut-off |
| Oxycodone (OXY) | 100 ng/mL | Qualitatively detects at/above cut-off |
| Buprenorphine (BUP) | 10 ng/mL | Qualitatively detects at/above cut-off |
| Methadone (MTD) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Notriptyline (TCA) | 1000 ng/mL | Qualitatively detects at/above cut-off |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state a specific sample size for the current 510(k) submission's test set. It refers to "verification studies" for the multi-drug cup modification, including interference studies and a lay-user study. The analytical performance was established in previous 510(k) submissions (e.g., K141532 for Amphetamine). To get the detailed sample sizes for the analytical performance, one would need to refer to those predicate submissions.
- Data Provenance: The document does not specify the country of origin for the data used in the "verification studies" or the previous analytical performance studies. It mentions the submitter is Guangzhou Wondfo Biotech Co., Ltd., from P.R. China, but this doesn't directly indicate where the clinical or analytical samples were sourced. The studies appear to be retrospective in the sense that the individual drug test performance was already established and used, but the verification of the multi-drug cup format would likely involve prospective testing with new samples in the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not provide this information. Given that this is an in vitro diagnostic device for drug detection in urine, the "ground truth" for analytical performance is typically established by reference laboratory methods (e.g., GC/MS or LC/MS), not human expert consensus on subjective interpretations. For the lay-user study, if included, experts might be involved in evaluating user comprehension and performance, but this is not detailed.
4. Adjudication Method for the Test Set:
Not applicable. For a qualitative drug test where ground truth is established by chemical analysis (GC/MS or LC/MS), there is no need for expert adjudication in the traditional sense, as the reference method provides a definitive result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with image-based diagnostics where multiple readers interpret cases and their performance is compared with and without AI assistance. The Wondfo CR3 Keyless Split Sample Cup is a rapid, qualitative immunoassay for drug detection, where the result is typically read visually as "positive" or "negative" based on line appearance, not complex interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the analytical performance studies (both for the predicate devices and the verification studies for the new cup format) represent standalone performance. The device itself produces a visual result, and its accuracy is tested against a chemical comparator without a human actively "interpreting" or making a diagnostic decision beyond reading the visual output. The device's performance is independent of human interpretation variability once the result lines are formed.
7. The Type of Ground Truth Used:
The primary type of ground truth used would be chemical analysis, specifically GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry). The document explicitly states: "A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that these methods serve as the gold standard for confirming drug presence and concentration.
8. The Sample Size for the Training Set:
The document does not explicitly state a sample size for the training set. For in vitro diagnostic devices like this, antibody and assay development would involve extensive experimentation and optimization (which can be considered analogous to "training") using a variety of standards and spiked samples, but a formal "training set" in the machine learning sense is not typically described in these submissions. The analytical performance data from the predicate devices could be considered the "learned" performance that the new device aims to replicate in its modified format.
9. How the Ground Truth for the Training Set Was Established:
As above, the concept of a "training set" in the machine learning context isn't directly applicable here. For the development and optimization of the assays (the "training" equivalent), ground truth would have been established using known concentrations of drug analytes and metabolites in synthetic or drug-free human urine samples, confirmed through highly accurate analytical methods like GC/MS or LC/MS. This allows for precise calibration and characterization of the assay's sensitivity and specificity.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877
Re: K151478
Trade/Device Name: Wondfo CR3 Keyless Split Sample Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, LFG, LCM, DKZ, DIS, JXM, LDJ, DIO, LAF, DJR Dated: May 26, 2015 Received: June 2, 2015
Dear Mr. Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151478
Device Name
Wondfo CR3 Keyless Split Sample Cup
Indications for Use (Describe)
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Secobarbital | 300 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Phencyclidine | 25 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methadone | 300 ng/mL |
| Notriptyline | 1000ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the above listed drug analytes.
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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Type of Use (Select one or both, as applicable)
X 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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SUMMARY
| 1. Date the summary was prepared: | June 29, 2015 |
|---|---|
| 2. Submitter's name:Address: | Guangzhou Wondfo Biotech Co., Ltd.South China University of TechnologyGuangzhou, P.R. China 510641Phone: 012-86-20-32296069 |
| 3. Name of contact person: | Joe ShiaLSI International Inc. 504 East Diamond Ave.Suite F Gaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213 |
| 4. Name of the device: |
-
- Name of the device
| Common or usual name: | Multi-Drug Urine Test Cup |
|---|---|
| Trade or proprietary name: | Wondfo CR3 Keyless Split Sample Cup |
-
- Classification: All are Class II medical devices with the following various product codes with Code of Federal
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| DKZ | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| LDJ | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| DIO | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| LAF | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| DJG | II | 21 CFR § 862.3650, Opiate test system | Toxicology (91) |
| JXM | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| LCM | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| DIS | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| DJR | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
| LFG | II | 21 CFR § 862.3910, Tricyclic antidepressant drug Test System | Toxicology (91) |
-
- Description of the device:
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The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
-
- Test Principle
The Wondfo CR3 Keyless Split Sample Cup is a rapid test for the qualitative detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in urine samples and contains lateral flow chromatographic immunoassays for these analytes. Each assay uses a mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies coated on the test membranes. When the absorbent end of the test is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentrations below the target cut-off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cut-off, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result. A band should form in the control region (C) of the device regardless of the presence of drug or metabolite in the sample.
- Test Principle
-
- Intended use of the device:
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
- Intended use of the device:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 or 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the
{6}------------------------------------------------
above listed drug analytes.
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.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
-
- Comparison to the predicate device
The Wondfo CR3 Keyless Split Sample Cup is a modified product format derived from the previously FDA-cleared Wondfo CR3 Keyless dual drug of abuse tests. A summary comparison of features of the Wondfo CR3 Keyless Split Sample Cup and the predicate devices is provided in the following Table.
- Comparison to the predicate device
| Item | New Devices | Predicate devices(K141532, K140089,K142044, K142609,K143535, K150179,K150602) |
|---|---|---|
| Indication(s)for use | For the qualitative determination of Amphetamine (AMP),Secobarbital (BAR), Oxazepam (BZO), Cocaine (COC),Cannabinoids (THC), Methamphetamine (MET),Methylenedioxymethamphetamine (MDMA),Morphine (MOP), Phencyclidine (PCP), Oxycodone(OXY),Buprenorphine (BUP), Methadone (MTD) and Notriptyline(TCA) in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographicassays based on the principle of antigen antibodyimmunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on antigen- antibodyinteractions to indicate positive or negative result | Same |
| Results | Qualitative | Same |
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| Specimen Type | Human urine | Same |
|---|---|---|
| Cut Off Values | Amphetamine (AMP): 1,000 ng/ml, Secobarbital(BAR): 300 ng/ml, Oxazepam (BZO):300 ng/ml, Cocaine(COC): 300 ng/ml, Cannabinoids (THC):50 ng/ml, Methamphetamine (MET): 1,000 ng/ml, Methylenedioxymethamphetamine (MDMA): 500 ng/ml, Morphine (MOP): 300 ng/ml or 2000ng/ml, Phencyclidine (PCP): 25 ng/ml, Oxycodone(OXY) : 100 ng/ml, Buprenorphine (BUP): 10 ng/ml, Methadone (MTD): 300 ng/ml, Notriptyline (TCA): 1000 ng/mL | Same |
| Configurations | Cup, can detect from 2 to 13 drugs | Cup, each test can only detect up to 2 drugs |
| Intended Use | OTC Use & Prescription Use | Same |
10. Performance Characteristics
The test strips of the candidate device are the same as those cleared with the predicate devices. Drug cutoffs of the candidate device are also identical to the predicate devices. Analytical performance was established for each device in the submissions as stated below. In addition, verification studies were conducted in support of the modification to have a multi-drug test cup (that detects 2 to 13 drugs at the same time), including interference studies and a lay-user study.
| Drug(Identifier) | 510(K) # |
|---|---|
| Amphetamine(AMP) | K141532 |
| Secobarbital (BAR) | K143535 |
| Oxazepam (BZO) | K140089 |
| Cocaine (COC) | K141532 |
| Cannabinoids (THC) | K150179 |
| Methamphetamine (MET) | K150602 |
| Methylenedioxymethamphetamine(MDMA) | K142044 |
| Morphine (MOP) | K150602 |
| Morphine 2000 (OPI) | K140089 |
| Phencyclidine (PCP) | K142044 |
| Oxycodone (OXY) | K150179 |
| Buprenorphine (BUP) | K142609 |
| Methadone (MTD) | K143535 |
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| Notriptyline (TCA) | K142609 |
|---|
11. Conclusion
Based on the test principle and acceptable performance characteristics, it's concluded that the Wondfo CR3 Keyless Split Sample Cup is substantially equivalent to the predicates.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).