RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU

K133047 · Biophor Diagnostics, Inc. · LAF · Dec 18, 2014 · Clinical Toxicology

Device Facts

• Record ID: K133047
• Device Name: RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
• Applicant: Biophor Diagnostics, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Dec 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only. The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

Device Story

Homogeneous competitive immunoassay for MDMA detection in neat oral fluid; utilizes RapidEASE Oral Fluid Collector for sample collection. Principle: energy transfer between acceptor fluorophore-labeled antibody and donor fluorophore-labeled drug; FRET signal inversely proportional to drug concentration. Used in central laboratories on RapidFRET Integrated Workstation; operated by laboratory personnel. Output: qualitative screen result (positive/negative) based on 50 ng/mL cutoff. Preliminary results require confirmation via GC/MS or LC/MS/MS. Assists clinicians in drug testing workflows; professional judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated over 20+ days using 9 levels (0-200% of cutoff). Method comparison study of 308 samples against GC/MS showed 107/107 high positives and 180/180 negatives correctly identified; 6 false positives were noted and attributed to cross-reactivity with other substances. Stability studies confirmed performance for 7 days ambient shipping, 21 days refrigerated, and 6 months frozen. Analytical specificity tested against numerous structurally related and unrelated compounds.

Technological Characteristics

Homogeneous time-resolved fluorescence immunoassay. Reagents: liquid, ready-to-use. Platform: RapidFRET Integrated Workstation. Sample collection: RapidEASE Oral Fluid Collector (direct expectoration, no diluent). Cutoff: 50 ng/mL. Calibrators: 0 and 50 ng/mL. Controls: 25 and 75 ng/mL. Storage: refrigerated.

Indications for Use

Indicated for qualitative screening of Methylenedioxymethamphetamine (MDMA) at 50 ng/mL in neat oral fluid samples. Intended for prescription use in central laboratories by professional operators. Requires confirmatory testing via GC/MS or LC/MS/MS for preliminary positive results.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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

• CEDIA Methamphetamine OFT Assay and CEDIA Methamphetamine OFT Calibrators (k101753)
• Salivabuse Liquid Oral Fluid Control (k132688)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

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

BIOPHOR DIAGNOSTICS, INC. NATHANIEL BUTLIN VICE PRESIDENT 1201 DOUGLAS AVE REDWOOD CITY CA 94063

December 18, 2014

Re: K133047

Trade/Device Name: RapidFRET Oral Fluid Assay for MDMA RapidFRET Oral Fluid MDMA Calibrator Set RapidFRET Oral Fluid MDMA Control Set Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DLJ, DIF Dated: November 18, 2014 Received: November 19, 2014

Dear Dr. Nathaniel Butlin:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Katherine Serrano -S

For : 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) k133047

#### Device Name

RapidFRET Oral Fluid Assay for MDMA RapdFRET Oral Fluid MDMA Calibrator Set RapidFRET Oral Fluid MDMA Control Set

#### Indications for Use (Describe)

The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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### 510(k) Summary for the RapidFRET Oral Fluid Assay for MDMA

December 15, 2014

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: k133047

#### 807.92(a)(1): Contact Information

| Name: | Biophor Diagnostics, Inc. |
|----------|-----------------------------------------------|
| Address: | 1201 Douglas Avenue<br>Redwood City, CA 94063 |
| Contact: | Nathaniel G. Butlin, Ph.D. |
| Phone: | 650-367-4954 |
| Fax: | 650-364-4985 |

#### 807.92(a)(2): Device Name, Common Name and Classification

RapidFRET Oral Fluid Assay for MDMA (Enzyme Immunoassay for Methylenedioxymethamphetamine) RapidFRET Oral Fluid MDMA Calibrator Set (Clinical Toxicology Calibrator) RapidFRET Oral Fluid MDMA Control Set (Drug Mixture Control Materials)

| Product | Code | Class | Regulation<br>Section | Panel |
|------------------------------------------|------|-------|-----------------------|-----------------|
| RapidFRET Oral Fluid Assay for MDMA | LAF | II | 862.3610 | 91 - Toxicology |
| RapidFRET Oral Fluid MDMA Calibrator Set | DLJ | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral Fluid MDMA Control Set | DIF | I | 862.3280 | 91 - Toxicology |

#### 807.92(a)(3): Identification of Legally Marketed Predicate Devices

CEDIA Methamphetamine OFT Assay and CEDIA Methamphetamine OFT Calibrators (k101753) Salivabuse Liquid Oral Fluid Control (k132688)

#### 807.92(a)(4): Device Description

The RapidFRET Oral Fluid Assay for MDMA is an In Vitro Diagnostic competitive immunoassay used to detect MDMA in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff

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Calibrator is used to translate the sample measurement into a positive result. Controls are used to establish and monitor precision and accuracy.

### 807.92(a)(5): Intended Use

The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

| Similarities | | |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Item | Predicate | Device |
| | CEDIA Methamphetamine OFT assay<br>and CEDIA Methamphetamine OFT<br>Calibrators<br>k101753 | RapidFRET Oral Fluid Assay for<br>MDMA and RapidFRET Oral<br>Fluid MDMA Calibrator Set<br>k133047 |
| Intended Use | Assay: Qualitative detection of<br>methamphetamine based analyte in<br>neat oral fluid.<br>Calibrators: Calibration of d-<br>methamphetamine for assay system | Same except analyte is MDMA |
| Methodology | Homogenous competitive<br>immunoassay | Same |
| Kit Components | 1 specific antibody reagent and 1<br>drug conjugate reagent | Same |

#### 807.92(a)(6): Technological Similarities and Differences to the Predicate

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| Differences | | | | |
|---------------------------|------------------------------------|------------------------------------|--|--|
| | Predicate | Device | | |
| | CEDIA Methamphetamine OFT | RapidFRET Oral Fluid Assay for | | |
| ltem | assay and CEDIA | MDMA and RapidFRET Oral Fluid | | |
| | Methamphetamine OFT | MDMA Calibrator Set | | |
| | Calibrators | k133047 | | |
| | k101753 | | | |
| Analyte | Methamphetamine | MDMA | | |
| | Oral fluid is collected with the | Neat oral fluid is collected with | | |
| | Oral-Eze Saliva Collection System. | the RapidEASE Oral Fluid Collector | | |
| Sample Collection | This device uses an absorbent | via direct expectoration. No | | |
| | swab and diluent. Sample is | diluent is used and sample is | | |
| | stored in plastic tube with snap | stored in glass sample tube with | | |
| | сар. | inert screw cap. | | |
| Sample dilution | Yes | No | | |
| | 120 ng/mL neat oral fluid using a | | | |
| Neat Oral Fluid<br>Cutoff | 40 ng/mL cutoff calibrator to | 50 ng/mL neat oral fluid. | | |
| | account for sample dilution by | | | |
| | collection device. | | | |
| Platform | MGC 240 Analyzer | RapidFRET Integrated Workstation | | |
| | | from Biophor Diagnostics | | |
| Reagent Format | Lyophilized reagent with | Liquid, ready to use | | |
| | reconstitution buffer | | | |
| Calibrator Levels | Calibrators at 0, 40, and 200 | Calibrators at 0 and 50 ng/mL. | | |
| | ng/mL | | | |

| Similarities and Differences | | |
|------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Item | Predicate<br>Salivabuse Liquid Oral Fluid Control<br>k132688 | Device<br>RapidFRET Oral Fluid MDMA<br>Control Set<br>k133047 |
| Intended Use | Quality control material for oral fluid<br>drugs of abuse assays to monitor<br>system performance | Same |
| Control Levels | Negative, -60% cutoff, ±50% cutoff, -<br>30% cutoff, ±25% cutoff, 2X cutoff,<br>and 3x cutoff | 25 ng/mL and 75 ng/mL |
| Analyte | Multiple drugs of abuse | MDMA |
| Stability | Shelf: 12 months frozen or<br>refrigerated<br>Open: 31 days refrigerated | Shelf: 12 months refrigerated<br>Open: 30 days refrigerated |

## 807.92(b)(1): Brief Description of Study Data:

A series of studies were performed that evaluated the device performance characteristics including precision and analytical sensitivity, correlation with GC/MS and LC/MS/MS, cross reactivity, and

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analytical specificity that are summarized below.

### Precision and Analytical Sensitivity

Three lots of the RapidFRET Oral Fluid Assay for MDMA were analyzed, four times daily, for a minimum of 20 days. Negative oral fluid pools were spiked with MDMA at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5 and 100 ng/mL. The aggregate data is summarized in the table below:

| | 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% |
|-----|-----|-----|-----|-----|------|------|------|------|------|
| POS | | O | | | 266 | 278 | 263 | 294 | 278 |
| NEG | 279 | 279 | 278 | 279 | 13 | | 0 | | |
| z | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |

| | 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% |
|-----|------|------|------|------|------|------|------|------|------|
| POS | 0% | 0% | 0% | 0% | 95% | 100% | 100% | 100% | 100% |
| NEG | 100% | 100% | 100% | 100% | 5% | 0% | 0% | 0% | 0% |
| N | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |

The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 100% frequency.

### Correlation with MS Quantitation

Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for MDMA. The samples (n=325) were randomized and blinded to the instrument operator and assayed using RapidFRET MDMA reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.

| n = 325 | MS POS | MS NEG |
|---------------|--------|--------|
| RapidFRET POS | 119 | 6+ |
| RapidFRET NEG | 0 | 200 |
| % Agreement | 100% | 97% |

Samples contained compounds at concentrations that are known to cross react including d-methamphetamine, damphetamine, I-amphetamine, 4-Methylethcathionone (4-MEC) and Methylone.

The data indicate that the RapidFRET Oral Fluid Assay for MDMA was accurate 99% of the time in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector.

## Cross Reactivity and Analytical Specificity

A compound library of more than 170 different structurally related and unrelated compounds including metabolites, OTC and prescription medications and drugs of abuse was used to evaluate the device cross reactivity and specificity. Compounds were spiked at

30,000 ng/mL into neat oral fluid pool aliquots with 0 ng/mL, 25 ng/mL and 75 ng/mL MDMA, processed with the RapidEASE Collector, and tested with the RapidFRET MDMA assay. Those compounds that gave an unexpected result were further titrated to determine the concentration at which the cross-reacting compound yielded a result approximately equivalent to the cutoff. Twenty

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nine structurally related compounds were determined to cross-react below 30,000 ng/mL in the absence of MDMA with twelve cross-reacting at 1000 ng/mL or less. An additional four compounds were determined to cross react below 30,000 ng/mL in the presence of 25 ng/mL MDMA.

| Compound | Level (ng/mL) | 0% MDMA†<br>(0 ng/mL) | 50% MDMA†<br>(25 ng/mL) | 150% MDMA†<br>(75 ng/mL) |
|--------------------------------------------------------------------------------------------|---------------|-----------------------|-------------------------|--------------------------|
| Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with 0 ng/mL MDMA | | | | |
| (-) Ephedrine | 30,000 | 9000 [0.6%] | POS | POS |
| (R, 2R) Pseudoephedrine | 30,000 | 2800 [1.8%] | POS | POS |
| Amitriptyline | 30,000 | 1900 [2.6%] | POS | POS |
| Benzodioxolylbutanamine | 30,000 | 390 [13%] | POS | POS |
| Phenethylamine | 30,000 | 15,500 [0.3%] | POS | POS |
| d-Amphetamine | 30,000 | 16,900 [0.2%] | POS | POS |
| d-Ephedrine | 30,000 | 4800 [1.0%] | POS | POS |
| d,l-Amphetamine | 9,000 | 6,500 [0.7%] | ND1 | ND1 |
| d,l-Ephedrine | 66,000 | 11,000 [0.5%] | ND1 | ND1 |
| d-Methamphetamine | 30,000 | 1200 [4.2%] | POS | POS |
| Doxepin | 30,000 | 11,000 [0.5%] | POS | POS |
| Fenfluramine | 30,000 | 37 [135%] | POS | POS |
| Imipramine | 30,000 | 26,000 [0.2%] | POS | POS |
| Isoxsuprine | 30,000 | 100 [50%] | POS | POS |
| I-Amphetamine | 30,000 | 2100 [2.4%] | POS | POS |
| I-Methamphetamine | 30,000 | 90 [56%] | POS | POS |
| I-Phenylephrine | 30,000 | 16,600 [0.3%] | POS | POS |
| MBDB | 30,000 | 42 [119%] | POS | POS |
| MDA | 30,000 | 130 [38%] | POS | POS |
| MDEA | 30,000 | 40 [125%] | POS | POS |
| 4-Methylethcathinone (4-MEC) | 30,000 | 7,839 [0.6%] | ND1 | ND1 |
| Mephentermine | 30,000 | 120 [42%] | POS | POS |
| Methylone | 30,000 | 3,783 [1.3%] | ND1 | ND1 |
| Nortriptyline | 30,000 | 23,100 [0.2%] | POS | POS |
| Phentermine | 30,000 | 1000 [5%] | POS | POS |
| PMA | 30,000 | 350 [14%] | POS | POS |
| PMMA | 30,000 | 39 [128%] | POS | POS |
| Dihydrobupropion | 30,000 | 460 [10.9%] | POS | POS |
| Verapamil | 60,000 | 1,800 [2.7%] | ND1 | ND1 |
| Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with 25 ng/mL MDMA | | | | |
| (+/-) Pseudoephedrine | 30,000 | NEG | >20,000 [< 0.3%] | POS |
| Cyclobenzaprine | 30,000 | NEG | >10,000 [< 0.5%] | POS |
| Fentanyl | 30,000 | NEG | 4,000 [1.3%] | POS |
| Buproprion | 30,000 | NEG | >20,000 [< 0.3%] | POS |

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(1) ND – Not Determined. †Results are presented as either the RapidFRET MDMA screening result (POS / NEG) or the concentration in ng/mL of the cross-reactant that gives a Cutoff equivalent response.

A second study evaluated common substances such as foods and dental products as well as pH variations. HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, IgA, IgG and IgM were spiked into neat oral fluid pool aliquots that contained either 25 ng/mL of MDMA. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with MDMA to 25 ng/mL or 75 ng/mL and assayed with the RapidFRET MDMA Assay. The effects of antiseptic mouthwash, cough syrup, cranberry juice, orange juice, tooth paste, chewing tobacco, cigarettes, chewing gum, hard candy, teeth whitening strips, cola, water, antacid, coffee and tea were evaluated by asking volunteers to use a specific item and provide an oral fluid sample. These samples were then spiked with MDMA to 25 ng/mL or 75 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET MDMA device. All compounds at the listed concentrations gave a NEG result when spiked with 25 ng/mL MDMA and a POS result when spike with 75 ng/mL MDMA.

#### 807.92(b)(3): Conclusions

The RapidFRET Oral Fluid Assay for MDMA including the RapidFRET Oral Fluid Negative and Cutoff MDMA Calibrators, the RapidFRET Oral Fluid Negative and Positive MDMA Controls and the RapidEASE Oral Fluid Collector were determined to be safe and effective for their intended use.