(137 days)
VITROS Chemistry Products BENZ Reagent is used on VITROS 5.1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
The VITROS BENZ assay is a homogeneous enzyme immunoassay that is performed using the VITROS Chemistry Products BENZ Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS BENZ Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzodiazepines in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to diazepam, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzodiazepines in the treated urine sample and diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzodiazepines in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD*) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. VITROS FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzodiazepine (BENZ).
VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS BENZ assay on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.
The VITROS 5.1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products.
The provided text describes a 510(k) premarket notification for the VITROS Chemistry Products BENZ assay and associated calibrators and verifiers. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI device might.
Therefore, much of the requested information (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, and specific acceptance criteria with reported performance values) is not detailed in this type of regulatory submission. The document emphasizes comparison to a predicate device for equivalence rather than setting and meeting novel performance benchmarks.
However, I can extract information related to the device, its intended use, and the comparison to the predicate.
Here's an attempt to answer based only on the provided text, with many fields necessarily left blank or noted as "Not applicable" due to the nature of the document:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics. Instead, it claims "good agreement" with the predicate device.
| Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | "demonstrated good agreement between the two immunoassay methods." |
| Similar performance characteristics to predicate device | (Implied by the "good agreement" statement) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document generically mentions "patient samples" were used for comparison.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for drug screening assays typically refers to confirmatory methods rather than expert interpretation of images or clinical data.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. The "ground truth" for drug screening is established through highly specific alternative chemical methods like GC/MS, not expert adjudication in the traditional sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is not an AI device or an imaging device requiring human reader interpretation in the context of an MRMC study. This is an in vitro diagnostic assay.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device is a standalone automated chemical assay (an in vitro diagnostic). Its performance is evaluated by comparing its results to a predicate device and, implicitly, to confirmatory methods. There is no "human-in-the-loop" component in the sense of a diagnostic interpretation aid, though lab personnel operate the system. The reported performance refers to the assay's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The document states: "A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." Therefore, GC/MS serves as the reference standard (ground truth) for confirming benzodiazepine presence.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that undergoes "training" in the computational sense. It is an enzymatic immunoassay.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an immunoassay. The calibrators are prepared from human urine with known added drugs/metabolites, and controls are prepared similarly, but these are for calibration and monitoring, not for training a learning algorithm.
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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics, which is a Johnson & Johnson company. The logo features a stylized caduceus symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a clean, sans-serif font. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, cursive font.
100 Indigo Creek Drive
Rochester, New York 14626-5101
.
5.0 510(k) Summary
DEC 2 2 2006
| This summary of 510(k) safety and effectiveness information is beingsubmitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92. | ||
|---|---|---|
| The assigned 510(k) number is: K062285 | ||
| 1. Submittername,address,contact | Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4253Contact Person: Darlene Phillips | |
| 2. PreparationDate | August 4, 2006 | |
| 3. Device name | Trade or Proprietary Names:VITROS Chemistry Products BENZ ReagentVITROS Chemistry Products Calibrator Kit 26VITROS Chemistry Products FS Calibrator 1VITROS Chemistry Products DAT Performance VerifiersI, II, III, IV & VCommon Names:Benzodiazepine (BENZ) assay and controlsClassification Names:Benzodiazepine test system (862.3170) Class IIClinical toxicology calibrators (862.3200) Class IIClinical toxicology control material (862.3280) Class I, VITROS DATPerformance Verifiers are assayed controls, so they meet thereserved criteria under Section 510(l) of the Food, Drug andCosmetic Act. | |
| 4. PredicateDevices | The VITROS Chemistry Products BENZ assay is substantiallyequivalent to the DADE BEHRING Syva® EMIT® II PlusBenzodiazepine Assay.The VITROS Chemistry Products DAT Performance Verifiers aresubstantially equivalent to the BIO-RAD Liquichek™ Urine ToxicologyControls. |
Continued on next page
·
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The VITROS BENZ assay is a homogeneous enzyme immunoassay 5. Device that is performed using the VITROS Chemistry Products BENZ description Reagent with the VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1, and VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.
The VITROS BENZ Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect benzodiazepines in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibody reactive to diazepam, glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD), followed by Reagent 2 containing diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH). The assay is based on competition between benzodiazepines in the treated urine sample and diazepam labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of benzodiazepines in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD*) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.
VITROS Chemistry Products Calibrator Kit 26 is prepared from human urine to which drugs of abuse, metabolites of drugs of abuse, organic salt, surfactants, and preservative have been added. VITROS FS Calibrator 1 is prepared from sodium chloride and processed water. VITROS Calibrator Kit 26 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of benzodiazepine (BENZ).
VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS BENZ assay on VITROS 5,1 FS Chemistry Systems.
The VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.
Continued on next page
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510(k) Summary (continued)
- The VITROS 5.1 FS Chemistry System is a clinical chemistry 5. Device instrument that provides automated use of the VITROS Chemistry description Products MicroTip® and MicroSlides® range of products. The VITROS (continued) 5.1 FS System was cleared for market by 510(k) premarket notification (K031924).
-
- Device intended uses
VITROS Chemistry Products BENZ Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BENZ Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
VITROS Chemistry Products Calibrator Kit 26: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
VITROS Chemistry Products DAT Performance Verifiers I, III, IV and V: For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assaved controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Continued on next page
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- The VITROS Chemistry Products BENZ assay and VITROS Chemistry Comparison 7. Products DAT Performance Verifiers are substantially equivalent to the to predicate DADE BEHRING Syva® EMIT® II Plus Benzodiazepine Assay devices (K993985) and BIO-RAD Liquichek™ Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use.
The performance of the VITROS BENZ assay on the VITROS 5,1 FS Chemistry System was compared to the Syva® EMIT® II Plus Benzodiazepine assay on the Syva® 30R Biochemical System. The results demonstrated good agreement between the two immunoassay methods.
The VITROS BENZ assay and the VITROS DAT Performance Verifiers have the following similarities to the predicate devices: the same intended use, the same cutoff values of 200 and 300 ng/mL, consist of liquid, ready to use reagents, have similar performance characteristics, are used on an automated clinical chemistry analyzer and calibrated against the same drug, lormetazepam.
- Similarities and differences of the assays performed using the VITROS Table 1 BENZ assay and the VITROS DAT Performance Verifiers and the EMIT® Benzodiazepine assay and BIO-RAD® Liquichek™ Urine Toxicology Controls.
| Device Similarities | |
|---|---|
| Device Characteristic | Description |
| Indications for Use | The assays are intended for use in the qualitative and semi-quantitative analysis of benzodiazepines in human urine. |
| Test Principle | Homogeneous enzyme immunoassay |
| Cut-Off values | 200 and 300 ng/mL |
| Sample Type | Human Urine |
| Reagent Format | Liquid ready to use |
| Antibody source | Sheep polyclonal antibodies reactive to diazepam |
| Calibration traceability | Lormetazepam with confirmation by GC/MS |
| Calibrator matrix | Human urine |
| Control matrix | Human urine |
Table 1 continued on next page
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| Differences | ||
|---|---|---|
| DeviceCharacteristic | VITROS BENZ assay(New device) | EMIT® Benzodiazepines assayand LiquichekTM UrineToxicology Controls(Predicate devices) |
| Reportable Range | 85 - 800 ng/mL | 40 - 900 ng/mL |
| Calibrator: Number oflevels | Six | Qualitative: Three at each cutoffvalueSemi-quantitative: Five |
| Calibrator format | Frozen Liquid ready to use | Refrigerated liquid ready to use |
| Instrumentation | To be used on VITROS 5,1 FSChemistry Systems | Multiple automated clinicalchemistry systems |
| Control claimedanalytes | Cocaine metabolites(benzoylecgonine),benzodiazepines(lormetazepam), methadone,amphetamines (d-methamphetamine), opiates(morphine), cannabinoids (11-nor-delta-THC-9-COOH),phencyclidine and barbiturates(secobarbital). | Methamphetamine, secobarbital,lormetazepam,tetrahydrocannabinol (THC),benzoylecgonine, ethanol,lysergic acid diethylamide (LSD),methadone, methaqualone,morphine, (Free), phencyclidine,propoxyphene, nortriptyline andaddition of creatinine, pH,specific gravity. |
| Control: Number oflevels | Five | Two |
-
- Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products BENZ Reagent, VITROS Chemistry Products Calibrator Kit 26, VITROS Chemistry Products FS Calibrator 1 and VITROS Chemistry Products DAT Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Darlene J. Phillips, RAC Regulatory Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
DEC 2 2 2006
Re: K062285
Trade Name: Vitros Chemistry Products BENZ Reagent, Calibrator Kit 26, DAT Performance Verifiers I. II. III. IV & V Regulation Number: 21 CFR 862.3170 Benzodiazepine Test System Regulation Name: JXM, DKB, DIF Product Code: Dated: December 14, 2006 Received: December 15, 2006
Dear Ms. Phillips:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K
$$\alpha$$
6228$
Page 1 of 2
Device Name: VITROS Chemistry Products BENZ Reagent
Indications for Use:
VITROS Chemistry Products BENZ Reagent is used on VITROS 5.1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzodiazepines (BENZ) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.
The VITROS Chemistry Products BENZ assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vasion-Off
of In Vitro Diagnostic Device tion and Safet
062285
{8}------------------------------------------------
Indications for Use
510(k) Number (if known):
K06228$\$
Page 2 of 2
Device Name: VITROS Chemistry Products Calibrator Kit 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V
Indications For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit for Use: 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).