Who is the manufacturer of EMIT II PLUS ECSTASY ASSAY?

Dade Behring, Inc. filed the 510(k) submission for EMIT II PLUS ECSTASY ASSAY (K043028).

What is the FDA product code for EMIT II PLUS ECSTASY ASSAY?

DKZ. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for EMIT II PLUS ECSTASY ASSAY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EMIT II PLUS ECSTASY ASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EMIT II PLUS ECSTASY ASSAY

Q: What are the predicate devices for EMIT II PLUS ECSTASY ASSAY?

DRI® Ecstasy Enzyme Immunoassay (K012110); DRI® Ecstasy Urine Calibrators (K012109); Emit® Calibrator/Control (K993755).

K043028 · Dade Behring, Inc. · DKZ · Jan 7, 2005 · Clinical Toxicology

Device Facts

Record ID	K043028
Device Name	EMIT II PLUS ECSTASY ASSAY
Applicant	Dade Behring, Inc.
Product Code	DKZ · Clinical Toxicology
Decision Date	Jan 7, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended 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® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.

Device Story

Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay for detecting MDMA and related compounds in human urine. Input: urine specimen; Principle: competition between drug in specimen and drug-labeled recombinant G6PDH for antibody binding sites; enzyme activity inversely proportional to drug concentration; active enzyme converts NAD to NADH, measured via spectrophotometry. Output: qualitative or semiquantitative drug concentration. Used in clinical laboratories on chemistry analyzers; operated by laboratory technicians. Results are preliminary; require confirmation by GC/MS. Clinical decision-making relies on professional judgment; benefits include rapid screening for drugs of abuse.

Clinical Evidence

Bench testing only. Performance evaluated using 100 urine specimens compared to GC/MS reference method. At 300 ng/mL cutoff: 98% agreement (55/57 positive, 43/43 negative). At 500 ng/mL cutoff: 96% agreement (53/57 positive, 43/43 negative). Discrepant samples were within ±50% of the cutoff.

Technological Characteristics

Homogeneous enzyme immunoassay; sheep polyclonal antibodies to MDMA; bacterial G6PDH enzyme label; spectrophotometric detection of NADH production; liquid form; compatible with chemistry analyzers; includes preservatives and stabilizers (bovine serum albumin).

Indications for Use

Indicated for laboratory use for qualitative and/or semiquantitative analysis of MDMA and related drugs in human urine. Intended for preliminary screening; requires confirmatory testing via GC/MS or similar methods. No specific age or gender restrictions stated.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

DRI® Ecstasy Enzyme Immunoassay (K012110)
DRI® Ecstasy Urine Calibrators (K012109)
Emit® Calibrator/Control (K993755)

Related Devices

K033094 — ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) · Lin-Zhi International, Inc. · Dec 19, 2003
K240670 — DRI Ecstasy Plus Assay · Microgenics Corporation · Oct 30, 2024
K012110 — DRI ECSTASY ENZYME IMMUNOASSAY · Microgenics Corp. · Aug 27, 2001
K020395 — AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) · Lin-Zhi International, Inc. · Jun 4, 2002

Submission Summary (Full Text)

{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 Plus Ecstasy 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 Plus Ecstasy 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 Enzyme Immunoassay, K012110 | Emit® II Plus Ecstasy Assay | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The DRI® Ecstasy Enzyme Immunoassay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. | 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 semi- quantitative 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 alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred confirmatory method. Other clinical 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. | | Principle | Homogeneous enzyme immunoassay | Homogeneous enzyme immunoassay | | Antibody | Monoclonal anti-MDMA antibody. | Sheep polyclonal antibodies to methylenedioxymethamphetamine (MDMA). | | Reagent Composition | Antibody/Substrate Reagent: Monoclonal anti-MDMA antibody, G6P, NAD in tris buffer with sodium azide as a preservative. Enzyme Conjugate Reagent: Methylenedioxymethamphetamine (MDMA) labeled with G6PDH, tris buffer, and sodium azide as a preservative. | Antibody/Substrate Reagent A: Sheep polyclonal antibodies to methylenedioxymethamphetamine (MDMA), bovine serum albumin, G6P, NAD, preservatives and stabilizers. Enzyme Reagent B: Methylenedioxyamphetamine (MDA) labeled with bacterial G6PDH, tris buffer, bovine serum | | | | albumin, preservatives and stabilizers. | | Cutoff | 500 ng/mL | 300 ng/mL and 500 ng/mL | | Semiquantitative Range | 22* – 1000 ng/mL (* estimation based on the reported 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 Ecstasy Calibrators / Controls | |----------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The DRI® Ecstasy urine calibrators are intended for the calibration of the DRI® Ecstasy Immunoassay. | 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. | | Matrix | Methylenedioxymethamphetamine, human urine. | Methylenedioxymethamphetamine (MDMA), human urine, preservatives. | | Calibrator Levels | 250 ng/mL Calibrator 500 ng/mL Calibrator 750 ng/mL Calibrator 1000 ng/mL Calibrator | Level 1: 150 ng/mL MDMA Level 2: 300 ng/mL MDMA Level 3: 500 ng/mL MDMA Level 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/Control K993755 | Emit® II Plus Ecstasy Calibrators / Controls | | Intended Use | The Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit® Calibrators/Controls are used for the Emit II Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine and Propoxyphene Assays. | 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. | | Matrix | Benzoylecgonine, lormetazepam, methadone, d-methamphetamine, Methaqualone, morphine, 11-Δ9- THC-9-COOH, phencyclidine, propoxyphene, secobarbital, human urine, preservatives. | Methylenedioxymethamphetamine (MDMA), human urine, preservatives. | | Calibrator Levels | Level 0 – drug free Level 1 Level 2 Level 3 Level 4 Level 5 | Level 1: 150 ng/mL MDMA Level 2: 300 ng/mL MDMA Level 3: 500 ng/mL MDMA Level 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