One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Description

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Barbiturates, Benzodiazepines, Methylenedioxymethamine, Methadone, Oxycodone, Phencyclidine and their metabolites at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument.

AI/ML Overview

The provided document describes the Co-Innovation Biotech Co.,Ltd. One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard for qualitative detection of drugs of abuse in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay tests like these are typically assessed by comparing the device's results (positive/negative) against a gold standard (GC/MS) especially around the cutoff concentration. While explicit numerical acceptance criteria (e.g., % agreement, sensitivity, specificity targets) are not explicitly stated as 'acceptance criteria' in the document, the performance data implicitly serves as the demonstration that the device performs acceptably. The study evaluates the device's ability to correctly identify drug-free, less than half cutoff, near cutoff negative, near cutoff positive, and high positive samples.

The tables below synthesize the reported device performance for both the Test Cup and Test Dipcard formats for single and multi-drug tests, against the GC/MS analysis. The "Total" column in the original tables sums up the sample distribution across concentration categories, not the total number of samples processed for each drug test condition. The key performance indicator here is the consistency of results, particularly for samples around the cutoff concentration.

Device Performance for One Step Single/Multi-drug Test Cup & Dipcard (Single Drug Test Example - All Drugs follow similar pattern)

Drug Test	Co-Innovation Result	GC/MS Analysis (Drug-free)	GC/MS Analysis (<0.5x Cutoff)	GC/MS Analysis (Near Cutoff Negative)	GC/MS Analysis (Near Cutoff Positive)	GC/MS Analysis (>1.5x Cutoff)	Total Samples
BAR	+	0	0	0	6	34	80
	-	33	0	7	0	0	80
BZO	+	0	0	1	7	33	80
	-	31	0	8	0	0	80
MDMA	+	0	0	0	5	34	80
	-	32	3	5	1	0	80
MTD	+	0	0	1	5	35	80
	-	32	2	5	0	0	80
OXY	+	0	0	0	6	34	80
	-	35	0	5	0	0	80
PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0	80

Analysis of Discordant Results (Example for Test Cup and Dipcard, Single and Multi-drug)

Drug Test	Cutoff (ng/mL)	Device Result	GC/MS Drug Concentration (ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine
(Note: These discordant results are consistent across all four tables presented for Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, and Multi-drug Test Dipcard)

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

Sample Size: 80 clinical urine specimens were used for each drug tested, for each device format (Single Drug Test Cup, Single Drug Test Dipcard, Multi-drug Test Cup, Multi-drug Test Dipcard). Therefore, for each drug, a total of 320 samples were analyzed (80 * 4). The samples were categorized into five groups based on concentration relative to the cutoff (drug-free, less than half the cutoff negative, near cutoff negative, near cutoff positive, and high positive).
Data Provenance: The data is from "clinical urine specimens," implying human origin. However, the country of origin is not specified, and it is a retrospective analysis as the specimens were analyzed by GC/MS for comparison with the device.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is considered the "preferred confirmatory method" for drug of abuse testing.
No human "experts" are mentioned as having established the ground truth through consensus or individual reading of the device results for the purpose of the primary accuracy study. The device results were compared directly against the GC/MS findings.

4. Adjudication Method for the Test Set

None in the traditional sense of multiple human readers adjudicating results. The device's qualitative results (positive/negative) were directly compared to the quantitative GC/MS results for each sample. Discordant results were individually listed with the GC/MS concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not performed. The study's focus was on the standalone performance of the devices against a gold standard (GC/MS). Human readers' improvement with or without AI assistance is not relevant here as it's a diagnostic test that provides a clear positive/negative result, not an AI-assisted diagnostic imaging interpretation.

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

Yes, this was a standalone performance study. The "One Step Single/Multi-drug Test Cup" and "One Step Single/Multi-drug Test Dipcard" are qualitative, lateral flow immunochromatographic assays designed to be read directly without an instrument or human interpretation loop beyond reading the presence or absence of test lines. The performance data presented directly reflects the device's output (positive/negative) compared to GC/MS.

7. The Type of Ground Truth Used

The ground truth used was quantitative analytical data from Gas Chromatography/Mass Spectrometry (GC/MS), which is the preferred confirmatory method for drug of abuse testing. This is a highly objective and precise method for determining drug concentration.

8. The Sample Size for the Training Set

This document describes a performance evaluation of a medical device, not an AI algorithm that requires a training set. Therefore, no training set for an algorithm is mentioned or applicable in this context. The devices are immunoassay tests, not machine learning algorithms.

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

As mentioned above, there is no training set for an algorithm as the device is an immunoassay test.

Summary

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KI40215

JUN 1 6 2014

Co-Innovation Biotech Co.,Ltd.

Section 5 - 510(k) Summary

Date of Summary Preparation: 5/19/2014

1. Submitter's Identifications

Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

Correspondent's Identifications

Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No. 13, Yanyuan Road, Tianhe District, Guangzhou, P.R. China Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-62867285 Fax: + 86 -20-62867285

3. Name of the Device

Recommended classification regulation:

21 CFR 862.3150 Barbiturate test system 21 CFR 862.3170 Benzodiazepine test system 21 CFR 862.3610 Methamphetamine test system 21 CFR 862.3620 Methadone test system 21 CFR 862.3650 Opiate test system Unclassified,Enzyme immunoassay,phencyclidine

Device class: Class II Panel: Toxicology (91) Product code: DIS,JXM,DJC,DJR,DJG,LCM Common Name:

Barbiturates (BAR) Test System

Benzodiazepines (BZO) Test System Methylenedioxymethamphetamine (MDMA) Test System Methadone (MTD) Test System Oxycodone (OXY) Test System Phencyclidine (PCP) Test System

Proprietary names:

One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard

05-1

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4. The Predicate Devices

UCP Home™ Drug Screening Test Cards K091588 UCP Home™ Drug Screening Test Cup

5. Device Description

6. Intended Use of Device

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

7. Comparison to Predicate Devices:

A summary comparison of features of the One Step Single/Multi-drug Test Cup and One Step

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Single/Multi-drug Test Dipcard and the predicate devices is provided in the following Table:

Item	Device	Predicate (K091588)
Indication for use	Qualitative detection ofdrugs-of-abuse in urine (Barbiturates, Benzodiazepines,Methylenedioxymethamphetamine,Methadone,Oxycodone,Phencyclidine)	Same (but the number ofdrugs detected different)
Intended Users	Prescription Use	Over the Counter (OTC) Useand Prescription Use
Specimen	Urine	Same
Cutoff	Barbiturates:300 ng/mLBenzodiazepines:300 ng/mLMethylenedioxymethamphetamine:500ng/mLMethadone:300 ng/mLOxycodone:100 ng/mLPhencyclidine:25 ng/mL	Same
Read time	5 minutes	Same
Storage	4~30 °C	2 ~ 30 °C
Results	Qualitative	Same
Methodology	Competitive binding, Lateral flowimmunochromatographic assay basedon the principle of antigen antibodyimmunochemistry	Same
Configuration	Dipcard and Cup	Card and Cup

Remark:

1. The subject devices have all features of the predicate device except the number of drugs detected and storage temperature condition . These differences do not affect the performance characteristics of the subject devices.

8. Performance Data:

Accuracy

Single drug Test:

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

DrugTest	Co-InnovationResult	Drug free byGC/MS analysis	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration)	Near CutoffPositive (Betweenthe cutoff and50% above thecutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)	Total
BAR	+	0	0	0	6	34	80

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		33	0	7	0	0
BZO	+	0	0	1	7	33	80
	-	31	0	8	0	0
MDMA	+	0	0	0	5	34	80
	-	32	3	5	1	0
MTD	+	0	0	1	5	35	80
	-	32	2	5	0	0
OXY	+	0	0	0	6	34	80
	-	35	0	5	0	0
PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0

Analysis of Discordant Results with One Step Single drug Test Cup

One Step Single drug Test Cup			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	Drug Concentration (ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Single drug Test Dipcard. Samples were divided by concentration into five categories: drug free,less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows:

DrugTest	Co-InnovationResult	Drug free byGC/MS analysis	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration)	Near CutoffPositive (Betweenthe cutoff and50% above thecutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)	Total
BAR	÷	0	0	0	6	34	80
	-	33	0	7	0	0
BZO	+	0	0	1	7	33	80
	-	31	0	8	0	0
MDMA	+	0	0	0	5	34	80
	-	32	3	5	1	0
MTD	+	0	0	1	5	35	80
	-	32	2	5	0	0
OXY	+	0	0	0	6	34	80
	-	35	0	5	0	0
PCP	+	0	0	1	5	35	80
	-	35	0	4	0	0

Analysis of Discordant Results with One Step Single drug Test Dipcard

	One Step Single drug Test Dipcard	GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	DrugConcentration(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone

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PCP	25	Positive	23	Phencyclidine
-----	----	----------	----	---------------

Multi-drug Test:

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Cup. Samples were divided by concentration into five categories:drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

DrugTest	Co-InnovationResult	Drug free byGC/MS analysis	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration)	Near CutoffPositive (Betweenthe cutoff and50% above thecutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)	Total
BAR	+	0	0	0	6	34	80
BAR	-	33	0	7	0	0	80
BZO	+	0	0	1	7	33	80
BZO	-	31	0	8	0	0	80
MDMA	+	0	0	0	5	34	80
MDMA	-	32	3	5	1	0	80
MTD	+	0	0	1	5	35	80
MTD	-	32	2	5	0	0	80
OXY	+	0	0	0	6	34	80
OXY	-	35	0	5	0	0	80
PCP	+	0	0	1	5	35	80
PCP	-	35	0	4	0	0	80

Analysis of Discordant Results with One Step Multi-drug Test Cup

Drug Test	Cutoff(ng/mL)	Test Result	DrugConcentration(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:

DrugTest	Co-InnovationResult	Drug free byGC/MS analysis	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration)	Near CutoffPositive (Betweenthe cutoff and50% above thecutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)	Total
BAR	+	0	0	0	6	34	80
BAR	-	33	0	7	0	0
BZO	+	0	0	1	7	33	80
BZO	-	31	0	8	0	0
MDMA	+	0	0	0	5	34	80
MDMA	-	32	3	5	1	0
MTD	+	0	0	1	5	35	80

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Analysis of Discordant Results with One Step Multi-drug Test Dipcard

One Step Multi-drug Test Dipcard			GC/MS Analysis
Drug Test	Cutoff(ng/mL)	Test Result	DrugConcentration(ng/mL)	Drug in Urine
BZO	300	Positive	188	Oxazepam
MDMA	500	Negative	715	3,4-Methylenedioxymethamphetamine
MTD	300	Positive	209	Methadone
PCP	25	Positive	23	Phencyclidine

Other Information About Performance Characteristics:

The performance characteristics of One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard perform satisfactorily when used according to the package inserts.

10. Conclusion:

One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are substantially equivalent to UCP Home™ Drug Screening Test Cards and UCP Home™ Drug Screening Test Cup.

--- End of this section ---

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.

Public Health Service

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

June 16, 2014

CO-INNOVATION BIOTECH CO., LTD. HONG FENG, PRODUCT MANAGER NO. 13 YANYUAN ROAD. TIANHE DISTRICT GUANGZHOU, GUANGDONG 510507 CH

Re: K140215

Trade/Device Name: One Step Single/Multi-drug Test Cup; One Step Single/Multi-drug Test Dipcard Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: II Product Code: DIS, JXM, DJC, DJR, DJG, LCM Dated: January 28, 2014 Received: January 28, 2014

Dear Hong Feng:

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.

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

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also. please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

: ··· ・・・・

http://www.lda.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 Small Manufacturers. International and Consumer Assistance 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140215

Device Name

One Step Single/Multi-drug Test Cup One Step Single/Multi-drug Test Dipcard

Indications for Use (Describe)

One Step SingleMulti-drug Test Cup and One Step SingleMulti-drug Test Dipcard are lateral Now chromatographic immunoassy designed to qualitatively detect the presence of drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL

The tests contain two formats:1) Test Cup, 2) Test Dipcard, The test configuration comes with single drug screening test or any combinations of multiple drug sereening test is intended for in viro diagnostics use. They are intended for prescription use in clinical laboratories only and not for point-of-care use.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectromerry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

. · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Denise Johnson-

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).