(65 days)
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
Assay: The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant ofucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Calibrator / Control: The Emit® II Plus Ecstasy Calibrators / Controls are liquid, four-level calibrators prepared from MDMA, urine and preservatives.
Acceptance Criteria and Device Performance for Emit® II Plus Ecstasy Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are not explicitly stated as numerical targets in the provided document. Instead, the demonstration of substantial equivalence relies on a comparison to a legally marketed predicate device (Microgenics DRI® Ecstasy Enzyme Immunoassay, K012110) in terms of intended use, methodology, and performance characteristics.
The study presented focuses on demonstrating qualitative agreement with a reference method (GC/MS) at two different cutoff concentrations. While no specific "acceptance criteria" tables are given for overall performance, the study implicitly aims to show high agreement.
For the purpose of this response, "Acceptance Criteria" will be extrapolated from the observed performance and the overall goal of demonstrating a high level of agreement with the reference method.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (300 ng/mL Cutoff) | Reported Device Performance (500 ng/mL Cutoff) |
|---|---|---|---|
| Qualitative Agreement with GC/MS | High percentage agreement | 98% (98/100) | 96% (96/100) |
| False Negative Rate (samples positive by GC/MS but negative by Assay) | Low | 2/57 (3.5%) | 4/57 (7.0%) |
| False Positive Rate (samples negative by GC/MS but positive by Assay) | 0 (desired) | 0/43 (0%) | 0/43 (0%) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size:
- For the 300 ng/mL cutoff study: 100 urine specimens.
- For the 500 ng/mL cutoff study: 100 urine specimens.
- Data Provenance: The document does not explicitly state the country of origin of the data. The study is retrospective, as it involves testing collected urine specimens and comparing results to a previously established reference method (GC/MS).
3. Number of Experts and Qualifications for Ground Truth
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document does not specify the number of experts or their qualifications for performing and interpreting the GC/MS results. GC/MS is a laboratory analytical method, and its interpretation would typically be performed by trained laboratory personnel or chemists specializing in toxicology, rather than clinical experts like radiologists.
4. Adjudication Method for the Test Set
No explicit adjudication method is described for the test set. The comparison is directly between the Emit® II Plus Ecstasy Assay results and the GC/MS reference results. Discrepancies are noted and analyzed (e.g., that discrepant samples were within ±50% of the cutoff concentration), but there isn't a stated adjudication process involving multiple human reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study described is a comparison of a single device's performance against a reference method (GC/MS) for detecting MDMA in urine. It does not involve human readers or assess the effectiveness of human readers with or without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.
6. Standalone (Algorithm Only) Performance Study
Yes, the study primarily evaluates the standalone performance of the Emit® II Plus Ecstasy Assay. It directly compares the assay's output to the GC/MS reference method without any human intervention or interpretation of the assay results themselves (beyond reading the instrument output).
7. Type of Ground Truth Used
The type of ground truth used is objective analytical data from a reference chemical method: Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is considered the "gold standard" for confirming drug presence and concentration in toxicology.
8. Sample Size for the Training Set
The document does not specify a separate "training set" size. The information provided relates to the performance evaluation of the Emit® II Plus Ecstasy Assay, implying it is a finished product being evaluated, not a model undergoing active training. Therefore, sample size for a training set is not applicable to the presented data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, the method for establishing its ground truth is not applicable to this document.
{0}------------------------------------------------
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
510(k) Summary Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
| Contact Information: | Dade Behring Inc. |
|---|---|
| P.O. Box 6101 | |
| Newark, DE 19714 | |
| Attn: Yuk-Ting Lewis | |
| Tel: 302-631-7626 |
Date of Preparation:
Nov. 1, 2004
Device Name / Classification 2.
Emit® II Plus Ecstasy Assay: Amphetamine Test System Classification: Class II (862.3100)
Emit® II Plus Ecstasy Calibrators / Controls: Clinical Toxicology Calibrator Classification: Class II (862.3200)
Emit® II Plus Ecstasy Calibrators / Controls: Clinical Toxicology Control Classification: Class I (862.3280)
3. Identification of the Legally Marketed Device
DRI® Ecstasy Enzyme Immunoassay, K012110 DRI® Ecstasy Urine Calibrators, K012109 Emit® Calibrator/Control, K993755.
{1}------------------------------------------------
4. Device Description
Assav
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant ofucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Calibrator / Control
The Emit® II Plus Ecstasy Calibrators / Controls are liquid, four-level calibrators prepared from MDMA, urine and preservatives.
5. Device Intended Use
Assay
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Calibrator / Control
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
{2}------------------------------------------------
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
6. Medical device to which equivalence is claimed and comparison information
Assay
The Emit® II Plus Ecstasy Assav is substantially equivalent in intended use and methodology to the Microgenics DR1® Ecstasy Enzvme Immunoassay (K012110). Both devices are enzyme immunoassays intended for use in the qualitative and semiquantitative determination of ecstasy drugs in human urine. The Emit® II Plus Ecstasy Assay has two cutoffs: 300 ng/mL and 500 ng/mL, while the DRI® Assay has a single cutoff at 500 ng/mL.
Comparison Information
A. 300 ng/mL cutoff
One hundred (100) urine specimens were tested with the Emit® II Plus Ecstasy Assay on the SYVA®-30R Biochemical System. Results were compared to the reference method (GC/MS). The Assay used a cutoff level of 300 nq/mL for MDMA.
Fifty-seven (57) samples were found to be positive by GC/MS (≥200 ng/mL MDMA, MDEA or MDA using UK quidelines) and fifty-five (55) were found to be positive by the Emit® II Plus Ecstasy Assay.
Forty-three (43) samples were found to be negative by GC/MS (<200 ng/mL MDMA, MDEA or MDA using UK Guidelines) and forty-five (45) were found to be negative by the Emit® II Plus Ecstasy Assay.
There were two (2) discrepant samples. Both discrepant samples were identified as negative by the Emit® II Plus Ecstasy and positive by GC/MS. The discrepant samples were within ±50% of the cutoff,
| Reference Method GC/MS | |||
|---|---|---|---|
| Positive | Negative | ||
| Emit® II PlusEcstasy Assay | Positive | 55 | 0 |
| Negative | 2 | 43 |
Qualitative Results at the 300 ng/mL Cutoff
Percent Agreement: 98% (98 / 100)
{3}------------------------------------------------
B. 500 ng/mL cutoff
One hundred (100) urine specimens were tested with the Emit® II Plus Ecstasy Assay on the SYVA®-30R Biochemical System. Results were compared to the reference method (GC/MS). The Assay used a cutoff level of 500 ng/mL for MDMA.
Fifty-seven (57) samples were found to be positive by GC/MS (≥250 ng/mL MDMA, MDEA or MDA using proposed SAMHSA Mandatory Guidelines) and fifty-three (53) were found to be positive by the Emit® II Plus Ecstasy Assay.
Forty-three (43) samples were found to be negative by GC/MS (<250 ng/mL MDMA, MDEA or MDA using proposed SAMHSA Mandatory Guidelines) and forty-seven (47) were found to be negative by the Emit® II Plus Ecstasy Assay.
There were four (4) discrepant samples. All discrepant samples were identified as negative by the Emit® II Plus Ecstasy and positive by GC/MS. The discrepant samples were within ±50% of the cutoff.
| Reference Method GC/MS | |||
|---|---|---|---|
| Positive | Negative | ||
| Emit® II PlusEcstasy Assay | Positive | 53 | 0 |
| Negative | 4 | 43 |
Qualitative Results at the 500 ng/mL Cutoff
Percent Agreement: 96% (96 / 100)
Calibrators / Controls
The Emit® II Plus Ecstasy Calibrators / Controls are substantially equivalent in intended use and methodology to the Microgenics DRI® Ecstasy Urine Calibrators (K012109). Both devices are multi-levels controls used for calibrating their respective assays.
The Emit® II Plus Ecstasy Calibrators / Controls are liguid and contain MDMA in the following concentrations: Level 1 - 150 ng/mL, Level 2 - 300 ng/mL, Level 3 - 500 ng/mL, and Level 4 - 1000 ng/mL. The MDMA concentration is traceable to a Master Lot and to confirmation by GC/MS.
Shelf life was evaluated by testing each calibrator / control level in their final containers. Testing was performed on the SYVA®-30R analyzer.
{4}------------------------------------------------
Excerpted from Emit® II Plus Ecstasy Assay 510k, K043028
| Feature | DRI® Ecstasy EnzymeImmunoassay, K012110 | Emit® II Plus Ecstasy Assay |
|---|---|---|
| Intended Use | The DRI® Ecstasy EnzymeImmunoassay is a homogeneousenzyme immunoassay intendedfor the qualitative orsemiquantitative determination ofecstasy drugs in human urine.The assay provides a simple andrapid analytical screeningprocedure for detecting ecstasydrugs at a cutoff level of 500ng/mL.This assay provides only apreliminary analytical test result.A more specific alternate chemicalmethod must be used in order toobtain a confirmed analyticalresult. Gas chromatography /mass spectrometry (GC/MS) isthe preferred confirmatorymethod. Clinical considerationand professional judgment shouldbe applied to any drug of abusetest result, particularly whenpreliminary positive results areused. | The Emit® II Plus Ecstasy Assayis a homogeneous enzymeimmunoassay with a 300 ng/mL or500 ng/mL cutoff. The assay isintended for use in laboratories forthe qualitative and/or semi-quantitative analysis ofmethylenedioxymethamphetamine(MDMA) and closely related drugsin human urine. Emit® II PlusAssays are designed for use witha number of chemistry analyzers.The Emit® II Plus Ecstasy Assayprovides only a preliminaryanalytical test result. A morespecific alternate chemicalmethod must be used to obtain aconfirmed analytical result. Gaschromatography / massspectrometry (GC/MS) is thepreferred confirmatory method.Other clinical confirmationmethods are available. Clinicalconsideration and professionaljudgment should be applied toany drug-of-abuse test result,particularly when preliminarypositive results are used. |
| Principle | Homogeneous enzymeimmunoassay | Homogeneous enzymeimmunoassay |
| Antibody | Monoclonal anti-MDMA antibody. | Sheep polyclonal antibodies tomethylenedioxymethamphetamine(MDMA). |
| ReagentComposition | Antibody/Substrate Reagent:Monoclonal anti-MDMA antibody,G6P, NAD in tris buffer withsodium azide as a preservative.Enzyme Conjugate Reagent:Methylenedioxymethamphetamine(MDMA) labeled with G6PDH, trisbuffer, and sodium azide as apreservative. | Antibody/Substrate Reagent A:Sheep polyclonal antibodies tomethylenedioxymethamphetamine(MDMA), bovine serum albumin,G6P, NAD, preservatives andstabilizers.Enzyme Reagent B:Methylenedioxyamphetamine(MDA) labeled with bacterialG6PDH, tris buffer, bovine serum |
| albumin, preservatives andstabilizers. | ||
| Cutoff | 500 ng/mL | 300 ng/mL and 500 ng/mL |
| SemiquantitativeRange | 22* – 1000 ng/mL(* estimation based on thereported sensitivity) | 100*– 1000 ng/mL(* based on recovery study) |
| Sensitivity | 22 ng/mL | 75 ng/mL |
| Specimen Type | Human urine | Human urine |
| Instrument | Chemistry analyzers | Chemistry analyzers |
Comparison of features of the Assays Tahle 1·
{5}------------------------------------------------
Table 2: Comparison of features of the Calibrators
| Feature | DRI® Ecstasy Urine Calibrators,K012109 | Emit® II Plus EcstasyCalibrators / Controls |
|---|---|---|
| Intended Use | The DRI® Ecstasy urinecalibrators are intended for thecalibration of the DRI® EcstasyImmunoassay. | The Emit® II Plus EcstasyCalibrators / Controls are used inthe calibration of the Emit® II PlusEcstasy Assay. These standardsmay also be used as qualitycontrol materials based upon theEcstasy assay cutoff. |
| Matrix | Methylenedioxymethamphetamine,human urine. | Methylenedioxymethamphetamine(MDMA), human urine,preservatives. |
| CalibratorLevels | 250 ng/mL Calibrator500 ng/mL Calibrator750 ng/mL Calibrator1000 ng/mL Calibrator | Level 1: 150 ng/mL MDMALevel 2: 300 ng/mL MDMALevel 3: 500 ng/mL MDMALevel 4: 1000 ng/mL MDMA |
| Form | Liquid | Liquid |
| Instrument | Chemistry analyzers | Chemistry analyzers |
:
{6}------------------------------------------------
| Comparison of features of the Controls | ||
|---|---|---|
| Table 3: | ||
| Feature | Emit® Calibrator/ControlK993755 | Emit® II Plus EcstasyCalibrators / Controls |
| Intended Use | The Emit® Calibrators/Controlsare used in the calibration of theEmit® II Plus drugs-of-abuseassays. These standards mayalso be used as quality controlmaterials based upon specifiedassay cutoff levels. The Emit®Calibrators/Controls are used forthe Emit II Plus Barbiturate,Benzodiazepine, Cannabinoid,Cocaine Metabolite, Methadone,Methaqualone, MonoclonalAmphetamine/Methamphetamine,Opiates, Phencyclidine andPropoxyphene Assays. | The Emit® II Plus EcstasyCalibrators / Controls are used inthe calibration of the Emit® II PlusEcstasy Assay. These standardsmay also be used as qualitycontrol materials based upon theEcstasy assay cutoff. |
| Matrix | Benzoylecgonine, lormetazepam,methadone, d-methamphetamine,Methaqualone, morphine, 11-Δ9-THC-9-COOH, phencyclidine,propoxyphene, secobarbital,human urine, preservatives. | Methylenedioxymethamphetamine(MDMA), human urine,preservatives. |
| CalibratorLevels | Level 0 – drug freeLevel 1Level 2Level 3Level 4Level 5 | Level 1: 150 ng/mL MDMALevel 2: 300 ng/mL MDMALevel 3: 500 ng/mL MDMALevel 4: 1000 ng/mL MDMA |
| Form | Liquid | Liquid |
| Instrument | Chemistry analyzers | Chemistry analyzers |
{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2005
Yuk-Ting Lewis Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Re: K043028
Trade/Device Name: Emit® II Plus Ecstasy Assay Emit® II Plus Ecstasy Calibrator / Control Level 1 Emit® II Plus Ecstasy Calibrator / Control Level 2 Emit® II Plus Ecstasy Calibrator / Control Level 3 Emit® II Plus Ecstasy Calibrator / Control Level 4 Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DLJ, DIF Dated: November 2, 2004 Received: November 3, 2004
Dear Yuk-Ting Lewis:
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. Iisting 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).
{8}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin finaling of substantial equivalence of your device to a legally prematication of the 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, If you desire specific infortion and advertising of your device, please contact the Office of In or questions on the promotion and Safety at (240)276-0484. 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 r ou may obtain of Senall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sincerely yours,
Camila B. Pools
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{9}------------------------------------------------
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
Indications for Use
510(k) Number (if known):
KO43028 Emit® Il Plus Ecstasy Assay
Device Name:
2017年07月11日 08:00:00 PM 10:00 PM 11:00 PM 11:00 PM 11:00 PM 20:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 1
Emit® II Plus Ecstasy Calibrator / Control Level 1 Emit® Il Plus Ecstasy Calibrator / Control Level 2 Emit® II Plus Ecstasy Calibrator / Control Level 3 Emit® Il Plus Ecstasy Calibrator / Control Level 4
Indications For Use:
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® Il Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043028
00008
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).