(115 days)
The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/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 used.
Immunalysis Multi-Drug Calibrators:
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.
The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative.
Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay.
The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.
Here's a breakdown of the acceptance criteria and study information for the Immunalysis Barbiturates Urine Enzyme Immunoassay:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets within the provided text. However, the studies demonstrate the performance of the device in various metrics, and the conclusion states that the device is "substantially equivalent to the legally marketed predicate device for its intended use." This implies that the performance shown met the, albeit unstated, acceptance criteria for substantial equivalence to the predicate device.
For this analysis, I will infer the acceptance criteria from the context of how the results are presented, specifically the aim of demonstrating that the cutoff serves as a boundary between negative and positive interpretations, demonstrating appropriate cross-reactivity and non-interference, and showing high agreement with LC/MS-MS.
| Test / Performance Characteristic | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Qualitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff (e.g., concentrations significantly below cutoff are consistently negative, significantly above consistently positive, at cutoff shows mixed results). | - 0-150 ng/mL: 80/80 Negative (100%) - 200 ng/mL (Cutoff): 33/80 Negative, 47/80 Positive - 250-400 ng/mL: 80/80 Positive (100%) |
| Semi-Quantitative Analysis (Precision/Cutoff Characterization) | Clear discrimination around the 200 ng/mL cutoff and mixed results at cutoff. | - 0-150 ng/mL: 80/80 Negative (100%) - 200 ng/mL (Cutoff): 23/80 Negative, 57/80 Positive - 250-400 ng/mL: 80/80 Positive (100%) |
| Specificity and Cross-Reactivity (Structurally Related Compounds) | Detect target compound (Secobarbital) at cutoff with 100% cross-reactivity; minimal or varying cross-reactivity for other barbiturates, with higher concentrations needed for positive results; Negative results for Phenytoin. | - Secobarbital: 100% Cross-Reactivity - Other Barbiturates: Cross-reactivity % varied from 0.3% (Hexobarbital, Mephobarbital) to 105.3% (Alphenal, Butobarbital) - Phenytoin (100,000 ng/mL): Negative, <0.2% Cross-Reactivity |
| Interference (Structurally Unrelated Compounds) | No interference (Negative at -25% cutoff, Positive at +25% cutoff). | All tested compounds (over 60) showed: - -25% Cutoff (150 ng/mL): Consistently Negative - +25% Cutoff (250 ng/mL): Consistently Positive |
| Interference (Endogenous Compounds) | No interference (Negative at -25% cutoff, Positive at +25% cutoff). | All tested compounds (16) showed: - -25% Cutoff (150 ng/mL): Consistently Negative - +25% Cutoff (250 ng/mL): Consistently Positive |
| Boric Acid Interference | No interference at concentrations around the cutoff. | - 1% w/v Boric Acid at -25% Cutoff (150 ng/mL): Negative - 1% w/v Boric Acid at +25% Cutoff (250 ng/mL): Negative - (Further tested): 1% w/v Boric Acid at -50% Cutoff (100 ng/mL) and +50% Cutoff (300 ng/mL): Negative |
| pH Interference | No interference across a physiological pH range. | - pH 3.0 to 11.0: - At -25% Cutoff (150 ng/mL): All Negative - At +25% Cutoff (250 ng/mL): All Positive |
| Specific Gravity Interference | No interference across a physiological specific gravity range. | - SG 1.000 to 1.030: - At -25% Cutoff (150 ng/mL): All Negative - At +25% Cutoff (250 ng/mL): All Positive |
| Linearity/Recovery | Good linearity and recovery across a relevant concentration range. | - Recovery within 89.3% to 104.9% for expected concentrations from 100 ng/mL to 1100 ng/mL. |
| Method Comparison (LC/MS-MS) | High agreement (e.g., 100%) with a confirmatory method (LC/MS-MS) for positive and negative samples outside of the equivocal zone. | - Qualitative Positive: 100% Agreement (for >200 ng/mL and 200-300 ng/mL) - Qualitative Negative: 100% Agreement (for <200 ng/mL) - Semi-Quantitative Positive: 100% Agreement (for >200 ng/mL and 200-300 ng/mL) - Semi-Quantitative Negative: 100% Agreement (for <200 ng/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Cutoff Characterization Study: 80 drug-free urine samples spiked with secobarbital. Test samples were within the USA (implied as no other country is mentioned and this is an FDA submission). The study appears to be prospective (controlled spiking to evaluate performance).
- Specificity and Cross-Reactivity: Not explicitly stated as a "sample size" in terms of patient samples. Structurally similar compounds were spiked into drug-free urine. Data provenance is implied to be within the USA. This is a prospective study design.
- Interference (Structurally Unrelated & Endogenous Compounds): Not explicitly stated as a "sample size." Potential interferents were spiked into drug-free urine containing secobarbital. Data provenance is implied to be within the USA. This is a prospective study design.
- Boric Acid Interference: Not explicitly stated as a "sample size." Boric acid was spiked into drug-free urine containing secobarbital. Data provenance is implied to be within the USA. This is a prospective study design.
- pH Interference: Not explicitly stated as a "sample size." Test samples were prepared in drug-free urine containing secobarbital at various pH levels. Data provenance is implied to be within the USA. This is a prospective study design.
- Specific Gravity Interference: Not explicitly stated as a "sample size." Test samples were prepared in drug-free urine containing secobarbital at various specific gravity levels. Data provenance is implied to be within the USA. This is a prospective study design.
- Linearity/Recovery: Not explicitly stated as a "sample size" in terms of patient samples. Drug-free urine was spiked with secobarbital and serially diluted. Each pool was tested in triplicate. Data provenance is implied to be within the USA. This is a prospective study design.
- Method Comparison: 96 de-identified, unaltered leftover clinical urine samples. Data provenance is implied to be from clinical testing laboratories within the USA (as no other country is mentioned and this is an FDA submission). The study is retrospective, as it used "leftover clinical urine samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No human experts were used to establish the ground truth for this device. The ground truth was established by:
- Mass Spectrometry (MS/LC-MS/MS): This is considered the "gold standard" for confirmatory drug testing.
- Controlled spiking: For precision, specificity, interference, pH, specific gravity, and linearity studies, known concentrations of the drug or interfering substances were added to drug-free urine samples. This provides a precisely known "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the ground truth was established by mass spectrometry or controlled spiking, there was no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic immunoassay, not an imaging device requiring human reader interpretation. Therefore, assessing how human readers improve with AI vs without AI assistance is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone performance evaluations of the assay system itself. The device is an automated immunoassay intended for laboratories and provides preliminary analytical test results, which may then be confirmed by other methods (like GC-MS or LC-MS/MS). The performance reported is of the immunoassay system operating without human interpretation involved in the result generation process, other than standard laboratory procedures.
7. The Type of Ground Truth Used
The ground truth used was primarily:
- Mass Spectrometry (LC-MS/MS): Used to confirm concentrations in spiked samples for precision/cutoff determination and as the comparator method for the method comparison study.
- Known concentrations via controlled spiking: For studies on precision/cutoff, specificity, interference (structurally unrelated, endogenous, boric acid), pH, specific gravity, and linearity, the "ground truth" was the precisely known concentration of the drug or interferent added to a drug-free matrix.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of an algorithm or AI. This device is an immunoassay, which does not typically involve machine learning training sets in the same way an AI-based diagnostic might. The device formulation and parameters would have been developed and optimized, but this isn't described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of AI/machine learning is not relevant for this immunoassay device. The scientific principles of antigen-antibody reactions and enzyme kinetics underpin the assay's function, rather than data-driven learning.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767
Re: K161714
Trade/Device Name: Immunalysis Barbiturates Urine Enzyme Immunoassay. Immunalysis Multi-Drug Calibrators Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: II Product Code: DIS, DKB Dated: September 1, 2016 Received: September 6, 2016
Dear Joseph Ginete:
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.
{1}------------------------------------------------
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) K161714
Device Name
Immunalysis Barbiturates Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators
Indications for Use (Describe) Immunalysis Barbiturates Urine Enzyme Immunoassay
The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/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 used.
Immunalysis Multi-Drug Calibrators:
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.
| 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) |
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510(k) SUMMARY
| A. General Information | |
|---|---|
| 1. Applicant Name: | Immunalysis Corporation829 Towne Center DrivePomona, CA 91767 |
| 2. Company Contact: | Joseph GineteRegulatory Affairs Specialist IIPhone: (909) 482-0840Email: jginete@immunalysis.com |
| 3. Date prepared: | October 13, 2016 |
| B. Device Identification | |
| 1. Trade Name: | Immunalysis Barbiturates Urine Enzyme ImmunoassayImmunalysis Multi-Drug Calibrators |
| 2. Common Name: | Barbiturates Urine Enzyme ImmunoassayMulti-Drug Calibrators |
| C. Regulatory Information | |
| 1. Device Classification: | II |
| 2. Regulation Number: | 21 CFR 862.3150 Barbiturate Test System21 CFR 862.3200 Calibrators, Drug Specific |
| 3. Panel: | Toxicology (91) |
| 4. Product Code: | DISDKB |
| 5. Predicate Device: | DRI ® Barbiturates EIA Assay |
| 6. Predicate Company: | Diagnostic Reagents, Inc. |
| 7. Predicate K Number: | K955928 |
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D. Device Description
The Immunalysis Barbiturates Urine Enzyme Immunoassay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes a recombinant antibody to Secobarbital, a mouse monoclonal antibody to Secobarbital, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes Barbiturates labeled with glucose-6phosphate dehydrogenase (G6PDH) in HEPES buffer with sodium azide as a preservative.
Immunalysis Multi-Drug Calibrators are included as part of the test system and provided separately. The calibrator kit includes four levels of drugs and a negative calibrator in a ready-touse format. Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates spectrophotometrically at 340nm can be used to perform the assay.
The Immunalysis Barbiturates Urine Enzyme Immunoassay uses barbiturates recombinant and monoclonal antibody. The assay is based on the competition of Barbiturates labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.
E. Intended Use
- The Immunalysis Barbiturates Urine Enzyme Immunoassay is a homogeneous enzyme 1. immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Barbiturates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Secobarbital. This in vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Barbiturates Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/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 used.
2. Immunalysis Multi-Drug Calibrators
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the following analytes: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam. The calibrators are designed for prescription use with immunoassays.
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F. Comparison With Predicate
| Attribute | Predicate DeviceDRI Barbiturates Assay | Candidate DeviceImmunalysis Barbiturates UrineEIA |
|---|---|---|
| Similarities | ||
| Intended Use | For the qualitative and semi-quantitative determination of the presence of Barbiturates in human urine at a cutoff of 200 ng/mL | Same |
| UserEnvironment | For use in laboratories | Same |
| MeasuredAnalytes | Barbiturate | Same |
| Test System | Enzyme immunoassay | Same |
| Materials | Antibody/substrate reagents and enzyme labeled conjugate | Same |
| Sample Matrix | Urine | Same |
| Cutoff Levels | 200 ng/mL of Barbiturates | Same |
| MassSpectrometryConfirmation | Required for preliminary positive analytical results | Same |
| Storage | 2 – 8° C until expiration date | Same |
| Calibrator Form | Liquid | Same |
| Control Levels | Two levels (150 ng/mL and 250 ng/mL) | Same |
| Calibrator Levels | One negative and four levels (100, 200, 500 and 1000 ng/mL) | Same |
| Differences | ||
| Antibody | Monoclonal antibody to Barbiturates | Recombinant and monoclonal antibodies to Barbiturates |
-
G. Performance Characteristics:
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Barbiturates Urine Enzyme Immunoassay to the predicate. All studies utilized the Beckman Coulter AU 400e instrument. -
- Precision/ Cutoff Characterization Study was performed for 20 days, 2 runs per day in replicates of 2 on drug free urine (N=80) spiked with secobarbital to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff (200 ng/mL). The spiked concentrations were confirmed by mass spectrometry (MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result.
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| Table 1 - Qualitative Analysis | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Total Result |
| 0 | -100% | 80 | 80 Negative |
| 50 | -75% | 80 | 80 Negative |
| 100 | -50% | 80 | 80 Negative |
| 150 | -25% | 80 | 80 Negative |
| 200 | Cutoff | 80 | 33 Neg/47 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
The following is a summary table of the qualitative analysis for the 200 ng/mL cutoff test data results.
The following is a summary table of the semi-quantitative analysis for the 200 ng/mL cutoff test data results.
| Concentration (ng/mL) | % of cutoff | # of determinations | Total Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 50 | -75% | 80 | 80 Negative |
| 100 | -50% | 80 | 80 Negative |
| 150 | -25% | 80 | 80 Negative |
| 200 | Cutoff | 80 | 23 Neg/ 57 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
-
- Specificity and Cross-Reactivity Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs, in both the qualitative and semi-quantitative modes.
| Table 3 - Structurally Related Compounds - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Secobarbital | 200 | Positive | 100 |
| Allobarbital | 690 | Positive | 29.0 |
| Alphenal | 190 | Positive | 105.3 |
| Amobarbital | 200 | Positive | 100.0 |
| Aprobarbital | 700 | Positive | 28.6 |
| Barbital | 9,000 | Positive | 2.2 |
| Butabarbital | 510 | Positive | 39.2 |
| Butalbital | 290 | Positive | 69.0 |
| Butobarbital | 190 | Positive | 105.3 |
| Cyclopentobarbital | 200 | Positive | 100.0 |
| Hexobarbital | 70,000 | Positive | 0.3 |
| Mephobarbital | 65,000 | Positive | 0.3 |
The following is a summary table of qualitative results:
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| Table 3 - Structurally Related Compounds – Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Pentobarbital | 420 | Positive | 47.6 |
| Phenobarbital | 460 | Positive | 43.5 |
| Phenytoin | 100,000 | Negative | <0.2 |
| Talbutal | 220 | Positive | 90.9 |
| Thiopental | 3,700 | Positive | 5.4 |
The following is a summary table of semi-quantitative results:
| Table 4 - Structurally Related Compounds – Semi-Quantitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Secobarbital | 200 | Positive | 100 |
| Allobarbital | 690 | Positive | 29.0 |
| Alphenal | 190 | Positive | 105.3 |
| Amobarbital | 200 | Positive | 100.0 |
| Aprobarbital | 700 | Positive | 28.6 |
| Barbital | 9,000 | Positive | 2.2 |
| Butabarbital | 510 | Positive | 39.2 |
| Butalbital | 290 | Positive | 69.0 |
| Butobarbital | 190 | Positive | 105.3 |
| Cyclopentobarbital | 200 | Positive | 100.0 |
| Hexobarbital | 70,000 | Positive | 0.3 |
| Mephobarbital | 65,000 | Positive | 0.3 |
| Pentobarbital | 420 | Positive | 47.6 |
| Phenobarbital | 460 | Positive | 43.5 |
| Phenytoin | 100,000 | Negative | <0.2 |
| Talbutal | 220 | Positive | 90.9 |
| Thiopental | 3,700 | Positive | 5.4 |
- Interference - Structurally unrelated compounds were evaluated in qualitative and semiquantitative modes by spiking the potential interferent into drug free urine containing secobarbital at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds. The results of this study are indicated in the table below.
| Table 5 - Structurally Unrelated Compounds | ||||||
|---|---|---|---|---|---|---|
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | |||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |||
| 4-Bromo-2,5,Dimethoxyphenethylamine | 100,000 | Negative | Negative | Positive | Positive | |
| Acetaminophen | 500,000 | Negative | Negative | Positive | Positive | |
| AcetylsalicyclicAcid | 100,000 | Negative | Negative | Positive | Positive | |
| Table 5 - Structurally Unrelated Compounds | ||||||
| -25% Cutoff | +25% Cutoff | |||||
| Concentration | (150 ng/mL) | (250 ng/mL) | ||||
| Compound | Tested(ng/mL) | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| 6-Acetylcodeine | 100.000 | Negative | Negative | Positive | Positive | |
| 6-Acetylmorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Alprazolam | 100,000 | Negative | Negative | Positive | Positive | |
| 7-Aminoclonazepam | 100,000 | Negative | Negative | Positive | Positive | |
| 7-Aminoflunitrazepam | 100,000 | Negative | Negative | Positive | Positive | |
| 7-Aminonitrazepam | 100.000 | Negative | Negative | Positive | Positive | |
| Amitriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| S-(+) Amphetamine | 100,000 | Negative | Negative | Positive | Positive | |
| Benzylpiperazine | 100,000 | Negative | Negative | Positive | Positive | |
| Bromazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Buprenorphrine | 100,000 | Negative | Negative | Positive | Positive | |
| Bupropion | 100,000 | Negative | Negative | Positive | Positive | |
| Caffeine | 500,000 | Negative | Negative | Positive | Positive | |
| Cannabidiol | 100,000 | Negative | Negative | Positive | Positive | |
| Cannabinol | 100,000 | Negative | Negative | Positive | Positive | |
| Carbamazepine | 100,000 | Negative | Negative | Positive | Positive | |
| Carisoprodol | 100,000 | Negative | Negative | Positive | Positive | |
| Chlordiazepoxide | 100,000 | Negative | Negative | Positive | Positive | |
| Chlorpromazine | 100,000 | Negative | Negative | Positive | Positive | |
| cis-Tramadol | 100,000 | Negative | Negative | Positive | Positive | |
| Clobazam | 100,000 | Negative | Negative | Positive | Positive | |
| Clomipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Clonazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Clozapine | 100,000 | Negative | Negative | Positive | Positive | |
| Codeine | 100,000 | Negative | Negative | Positive | Positive | |
| Cotinine | 100,000 | Negative | Negative | Positive | Positive | |
| Cyclobenzaprine | 100,000 | Negative | Negative | Positive | Positive | |
| Demoxepam | 100,000 | Negative | Negative | Positive | Positive | |
| Desalkyflurazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Desipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Dextromethorphan | 100,000 | Negative | Negative | Positive | Positive | |
| Diazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Digoxin | 100,000 | Negative | Negative | Positive | Positive | |
| Dihydrocodeine | 100,000 | Negative | Negative | Positive | Positive | |
| Diphenhydramine | 500,000 | Negative | Negative | Positive | Positive | |
| Dehydronorketamine | 25,000 | Negative | Negative | Positive | Positive | |
| Delta-9-THC | 100,000 | Negative | Negative | Positive | Positive | |
| Doxepin | 100,000 | Negative | Negative | Positive | Positive | |
| EDDP | 100,000 | Negative | Negative | Positive | Positive | |
| EMDP | 100,000 | Negative | Negative | Positive | Positive | |
| 1R,2S(-)-Ephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| 1S,2R(+)-Ephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| Ethyl glucuronide | 100,000 | Negative | Negative | Positive | Positive | |
| Table 5 - Structurally Unrelated Compounds | ||||||
| -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | |||||
| Compound | ConcentrationTested(ng/mL) | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| Ethylmorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Fenfluramine | 100,000 | Negative | Negative | Positive | Positive | |
| Fentanyl | 100,000 | Negative | Negative | Positive | Positive | |
| Flunitrazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Fluoxetine | 100,000 | Negative | Negative | Positive | Positive | |
| Flurazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Haloperidol | 100,000 | Negative | Negative | Positive | Positive | |
| Heroin | 100,000 | Negative | Negative | Positive | Positive | |
| Hydrocodone | 100,000 | Negative | Negative | Positive | Positive | |
| Hydromorphone | 100,000 | Negative | Negative | Positive | Positive | |
| 11-hydroxy-delta-9-THC | 100,000 | Negative | Negative | Positive | Positive | |
| Ibuprofen | 500,000 | Negative | Negative | Positive | Positive | |
| Imipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Ketamine | 100,000 | Negative | Negative | Positive | Positive | |
| Lamotrignine | 100,000 | Negative | Negative | Positive | Positive | |
| Levorphanol tartrate | 100,000 | Negative | Negative | Positive | Positive | |
| Lidocaine | 100,000 | Negative | Negative | Positive | Positive | |
| Lorazepam | 100,000 | Negative | Negative | Positive | Positive | |
| LorazepamGlucuronide | 50,000 | Negative | Negative | Positive | Positive | |
| Lormetazepam | 100,000 | Negative | Negative | Positive | Positive | |
| LSD | 100,000 | Negative | Negative | Positive | Positive | |
| Maprotiline | 100,000 | Negative | Negative | Positive | Positive | |
| (+)-MDA | 100,000 | Negative | Negative | Positive | Positive | |
| MDEA | 100,000 | Negative | Negative | Positive | Positive | |
| MDMA | 100,000 | Negative | Negative | Positive | Positive | |
| Meperidine | 100,000 | Negative | Negative | Positive | Positive | |
| Meprobamate | 100,000 | Negative | Negative | Positive | Positive | |
| S(+)-Methamphetamine | 100,000 | Negative | Negative | Positive | Positive | |
| Methadone | 500,000 | Negative | Negative | Positive | Positive | |
| Methaquolone | 100,000 | Negative | Negative | Positive | Positive | |
| Methoxetamine | 100,000 | Negative | Negative | Positive | Positive | |
| Methylone | 100,000 | Negative | Negative | Positive | Positive | |
| Methylphenidate | 100,000 | Negative | Negative | Positive | Positive | |
| Midazolam | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine-3-glucuronide | 100,000 | Negative | Negative | Positive | Positive | |
| Morphine-6-glucuronide | 50,000 | Negative | Negative | Positive | Positive | |
| N-desmethyltapentadol | 100,000 | Negative | Negative | Positive | Positive | |
| Nalorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Table 5 - Structurally Unrelated Compounds | ||||||
| -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | |||||
| Compound | ConcentrationTested(ng/mL) | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| Naloxone | 100,000 | Negative | Negative | Positive | Positive | |
| Naltrexone | 100,000 | Negative | Negative | Positive | Positive | |
| Naproxen | 100,000 | Negative | Negative | Positive | Positive | |
| Nitrazepam | 100,000 | Negative | Negative | Positive | Positive | |
| 11-nor-9 carboxyTHC | 100,000 | Negative | Negative | Positive | Positive | |
| Norbuprenorphine | 50,000 | Negative | Negative | Positive | Positive | |
| Norcodeine | 100,000 | Negative | Negative | Positive | Positive | |
| Nordiazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Norketamine | 100,000 | Negative | Negative | Positive | Positive | |
| Normorphine | 100,000 | Negative | Negative | Positive | Positive | |
| Norpropoxyphene | 100,000 | Negative | Negative | Positive | Positive | |
| Norpseudoephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| Nortriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| Olanzapine | 100,000 | Negative | Negative | Positive | Positive | |
| Oxazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Oxycodone | 100,000 | Negative | Negative | Positive | Positive | |
| Oxymorphone | 100,000 | Negative | Negative | Positive | Positive | |
| PCP | 100,000 | Negative | Negative | Positive | Positive | |
| Pentazocine | 100,000 | Negative | Negative | Positive | Positive | |
| Phentermine | 100,000 | Negative | Negative | Positive | Positive | |
| Phenylephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| Phenylpropanolamine | 100,000 | Negative | Negative | Positive | Positive | |
| PMA | 100,000 | Negative | Negative | Positive | Positive | |
| Prazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Proproxyphene | 100,000 | Negative | Negative | Positive | Positive | |
| Propranolol | 100,000 | Negative | Negative | Positive | Positive | |
| Protriptyline | 100,000 | Negative | Negative | Positive | Positive | |
| R,R(-)-Pseudoephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| S,S(+)-Pseudoephedrine | 100,000 | Negative | Negative | Positive | Positive | |
| Ranitidine | 100,000 | Negative | Negative | Positive | Positive | |
| Ritalinic Acid | 100,000 | Negative | Negative | Positive | Positive | |
| Salicylic Acid | 500,000 | Negative | Negative | Positive | Positive | |
| Sertraline | 100,000 | Negative | Negative | Positive | Positive | |
| Sufentanil Citrate | 50,000 | Negative | Negative | Positive | Positive | |
| Tapentadol | 100,000 | Negative | Negative | Positive | Positive | |
| Temazepam | 100,000 | Negative | Negative | Positive | Positive | |
| Theophylline | 100,000 | Negative | Negative | Positive | Positive | |
| Thioridazine | 100,000 | Negative | Negative | Positive | Positive | |
| Triazolam | 100,000 | Negative | Negative | Positive | Positive | |
| Trifluoromethylphenyl-piperazine | 100,000 | Negative | Negative | Positive | Positive | |
| Table 5 - Structurally Unrelated Compounds | ||||||
| Compound | ConcentrationTested(ng/mL) | -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | |||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |||
| Trimipramine | 100,000 | Negative | Negative | Positive | Positive | |
| Trazodone | 100,000 | Negative | Negative | Positive | Positive | |
| Venlafaxine | 100,000 | Negative | Negative | Positive | Positive | |
| Verapamil | 100,000 | Negative | Negative | Positive | Positive | |
| Zolpidem Tartrate | 100,000 | Negative | Negative | Positive | Positive |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
-
- Interference Endogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free urine containing secobarbital at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by internally existing physiological conditions. The results of this study are indicated in the table below:
| Table 6 - Endogenous Compounds | |||||
|---|---|---|---|---|---|
| -25% Cutoff | +25% Cutoff | ||||
| ConcentrationTested | (150 ng/mL) | (250 ng/mL) | |||
| Compound | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| Acetone | 1.0 g/dL | Negative | Negative | Positive | Positive |
| Ascorbic Acid | 1.5 g/dL | Negative | Negative | Positive | Positive |
| Bilirubin | 0.002 g/dL | Negative | Negative | Positive | Positive |
| Creatinine | 0.5 g/dL | Negative | Negative | Positive | Positive |
| Ethanol | 1.0 g/dL | Negative | Negative | Positive | Positive |
| Galactose | 0.01 g/dL | Negative | Negative | Positive | Positive |
| γ-Globulin | 0.5 g/dL | Negative | Negative | Positive | Positive |
| Glucose | 2.0 g/dL | Negative | Negative | Positive | Positive |
| Hemoglobin | 0.300 g/dL | Negative | Negative | Positive | Positive |
| Human SerumAlbumin | 0.5 g/dL | Negative | Negative | Positive | Positive |
| Oxalic Acid | 0.1 g/dL | Negative | Negative | Positive | Positive |
| Riboflavin | 0.0075 g/dL | Negative | Negative | Positive | Positive |
| Sodium Azide | 1% w/v | Negative | Negative | Positive | Positive |
| SodiumChloride | 6.0 g/dL | Negative | Negative | Positive | Positive |
| SodiumFluoride | 1% w/v | Negative | Negative | Positive | Positive |
| Urea | 6.0 g/dL | Negative | Negative | Positive | Positive |
{12}------------------------------------------------
- રું. Boric Acid Interference - Boric acid at a concentration of 1% w/v was evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free urine containing secobarbital at ±25% of the cutoff. The results of this study are indicated in the table below. Due to the interference observed at ±25% of the cutoff, potential interference was also evaluated at ±50% of the cutoff. The results of this study are indicated in the table below.
| Table 7 – Boric Acid | |||||
|---|---|---|---|---|---|
| Compound | ConcentrationTested | -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | ||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | ||
| Boric Acid | 1% w/v | Negative | Negative | Negative | Negative |
| Table 8 – Boric Acid | |||||
|---|---|---|---|---|---|
| Compound | Concentration Tested | -50% Cutoff (100 ng/mL) | +50% Cutoff (300 ng/mL) | ||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | ||
| Boric Acid | 1% w/v | Negative | Negative | Negative | Negative |
-
- pH Interference To evaluate potential interference from the effect of urine pH, device performance in the qualitative and semi-quantitative modes was tested using a range of urine pH values (3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free urine containing secobarbital at ±25% of the cutoff. No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 for each test mode. The results of this study are indicated in the table below.
| Table 9 - Effect of pH | ||||
|---|---|---|---|---|
| pH Value | -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | ||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | |
| 3.0 | Negative | Negative | Positive | Positive |
| 4.0 | Negative | Negative | Positive | Positive |
| 5.0 | Negative | Negative | Positive | Positive |
| 6.0 | Negative | Negative | Positive | Positive |
| 7.0 | Negative | Negative | Positive | Positive |
| 8.0 | Negative | Negative | Positive | Positive |
| 9.0 | Negative | Negative | Positive | Positive |
| 10.0 | Negative | Negative | Positive | Positive |
| 11.0 | Negative | Negative | Positive | Positive |
-
- Specific Gravity Interference - To evaluate potential interference from the specific gravity of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of physiologically relevant urine specific gravity values (1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing secobarbital at ±25% of the cutoff. No positive or negative interference was observed at urine specific gravity values ranging from 1.000 to 1.030 for each test mode. The results of this study are indicated in the table below.
{13}------------------------------------------------
| Table 10 - Effect of Specific Gravity | |||||
|---|---|---|---|---|---|
| Specific GravityValue | -25% Cutoff(150 ng/mL) | +25% Cutoff(250 ng/mL) | |||
| Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | ||
| 1.000 | Negative | Negative | Positive | Positive | |
| 1.002 | Negative | Negative | Positive | Positive | |
| 1.005 | Negative | Negative | Positive | Positive | |
| 1.010 | Negative | Negative | Positive | Positive | |
| 1.015 | Negative | Negative | Positive | Positive | |
| 1.020 | Negative | Negative | Positive | Positive | |
| 1.025 | Negative | Negative | Positive | Positive | |
| 1.030 | Negative | Negative | Positive | Positive |
-
- Linearity/ Recovery A linearity study in the semi-quantitative mode was conducted by spiking a drug free urine pool with a high concentration of secobarbital above the highest calibrator. Additional pools were made by serially diluting the high concentration specimen with drug free urine to achieve concentrations ranging from 100 ng/mL. The 0 ng/mL. The 0 ng/mL specimen was made from drug free urine. Each pool was tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. The results of this study are indicated in the table below.
| Table 11 - Linearity/ Recovery | ||
|---|---|---|
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
| 0 | -0.6 | N/A |
| 100 | 93.2 | 93.2 |
| 200 | 196.0 | 98.0 |
| 300 | 314.7 | 104.9 |
| 400 | 418.1 | 104.5 |
| 500 | 487.9 | 97.6 |
| 600 | 604.1 | 100.7 |
| 700 | 724.2 | 103.5 |
| 800 | 819.3 | 102.4 |
| 900 | 891.2 | 99.0 |
| 1000 | 968.7 | 96.9 |
| 1100 | 981.8 | 89.3 |
-
- Method Comparison Ninety-six deidentified, unaltered leftover clinical urine samples obtained from clinical testing laboratories were analyzed for barbiturates at an assay cutoff of 200 ng/mL with the Immunalysis Barbiturates Urine Enzyme Immunoassay in both qualitative and semiquantitative modes and compared to results by mass spectrometry (LC/MS-MS). The instruments used were a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometer.
{14}------------------------------------------------
| Table 12 – Qualitative Assay Performance verified by LC/MS-MS | |||||
|---|---|---|---|---|---|
| Type | Barbiturates Concentration | Agreement (%) | |||
| < 100 ng/mL | 100 ~ 199 ng/mL | 200 ~ 300 ng/mL | > 300 ng/mL | ||
| Qualitative/ Positive | 0 | 0 | 8 | 44 | 100 |
| Qualitative/ Negative | 36 | 8 | 0 | 0 | 100 |
The following is a summary table of qualitative assay results:
The following is a summary table of semi-quantitative assay results:
| Table 13 – Semi-Quantitative Assay Performance verified by LC/MS-MS | |||||
|---|---|---|---|---|---|
| Type | Barbiturates Concentration | Agreement (%) | |||
| < 100 ng/mL | 100 ~ 199 ng/mL | 200 ~ 300 ng/mL | > 300 ng/mL | ||
| Semi-Quantitative/Positive | 0 | 0 | 8 | 44 | 100 |
| Semi-Quantitative /Negative | 36 | 8 | 0 | 0 | 100 |
10. Immunalysis Multi-Drug Calibrators
- Traceability all components of the calibrators have been traced to a commercially available a. secobarbital solution.
- Value Assignment Calibrators are manufactured and tested by mass spectrometry. The b. negative calibrator is a processed, drug free urine matrix. The negative calibrator is compared to a reference negative standard to ensure that it is free of analyte. The non-zero calibrators are prepared by spiking a known concentration of secobarbital in the negative calibrator matrix. If any of the analytes are not within the acceptable range, then the calibrator is adjusted and re-tested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Barbiturates Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.
§ 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).