(447 days)
No
The description details a competitive immunoassay based on fluorescence resonance energy transfer (FRET) and standard laboratory procedures for calibration and control. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making. The results are determined by comparing the FRET signal to a cutoff calibrator.
No.
The device is an in vitro diagnostic assay used to screen for MDMA in oral fluid, providing only a preliminary result. It is not intended for treating, preventing, or curing a disease or condition in a patient.
Yes
This device is intended for "qualitative screen for Methylenedioxymethamphetamine" and "for In Vitro Diagnostic Use Only," which identifies it as a diagnostic device.
No
The device description explicitly states it is an "In Vitro Diagnostic competitive immunoassay" and describes 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." This indicates a chemical and biological assay, not a software-only device. It also mentions the need for a "RapidFRET Integrated Workstation" for use, implying hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section and the "Device Description" both explicitly state "For In Vitro Diagnostic Use Only."
- Nature of the Test: The device performs a qualitative screen for Methylenedioxymethamphetamine (MDMA) in human oral fluid. This is a laboratory test performed on a biological sample outside of the body, which is the definition of an in vitro diagnostic.
- Intended Use: The assay is intended for prescription use in central laboratories to analyze oral fluid samples for the presence of MDMA. This aligns with the typical use case for IVDs.
- Components: The description mentions calibrators and controls, which are common components of IVD test kits used for quality control and result interpretation.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LAF, DLJ, DIF
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 Calibrator is used to translate the sample measurement into a positive result. Controls are used to establish and monitor precision and accuracy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
central laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision and Analytical Sensitivity:
Sample Size: Not explicitly stated, but 279, 278, 263, and 294 for N across different concentrations.
Data Source: Negative oral fluid pools spiked with MDMA.
Annotation Protocol: The samples 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. Three lots of the RapidFRET Oral Fluid Assay for MDMA were analyzed, four times daily, for a minimum of 20 days.
Correlation with MS Quantitation:
Sample Size: n=325
Data Source: Neat oral fluid collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for MDMA.
Annotation Protocol: The samples 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.
Cross Reactivity and Analytical Specificity:
Data Source: A compound library of more than 170 different structurally related and unrelated compounds including metabolites, OTC and prescription medications and drugs of abuse.
Annotation Protocol: 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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision and Analytical Sensitivity:
Study Type: Precision and Analytical Sensitivity
Sample Size: Varied per concentration (e.g., 279 for 0% and 25%, 278 for 50%, 279 for 75% etc.)
Key Results: The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 100% frequency.
POS results for 100% cutoff were 95%. NEG results for 100% cutoff were 5%.
POS results for 125%, 150%, 175%, 200% cutoff were 100%. NEG results for these cutoffs were 0%.
POS results for 0%, 25%, 50%, 75% cutoff were 0%. NEG results for these cutoffs were 100%.
Correlation with MS Quantitation:
Study Type: Correlation with MS Quantitation
Sample Size: n=325
Key Results:
RapidFRET POS / MS POS: 119
RapidFRET POS / MS NEG: 6+ (Samples contained compounds at concentrations that are known to cross react including d-methamphetamine, d-amphetamine, l-amphetamine, 4-Methylethcathionone (4-MEC) and Methylone.)
RapidFRET NEG / MS POS: 0
RapidFRET NEG / MS NEG: 200
% Agreement MS POS: 100%
% Agreement MS NEG: 97%
Conclusion: 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:
Study Type: Cross Reactivity and Analytical Specificity
Key Results:
29 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.
All common substances (foods, dental products) and pH variations tested resulted in a NEG result when spiked with 25 ng/mL MDMA and a POS result when spiked with 75 ng/mL MDMA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision and Analytical Sensitivity:
Analytical Sensitivity: Between 75% and 125% of cutoff.
Frequency of Expected Results: 100%
Correlation with MS Quantitation:
Positive Percent Agreement (Sensitivity using MS as reference): 100% (119/119)
Negative Percent Agreement (Specificity using MS as reference): 97% (200/206)
Accuracy: 99% (based on summary statement)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
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.(b)
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).
0
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
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| 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
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
4
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 | ||
| and CEDIA Methamphetamine OFT | ||
| Calibrators | ||
| K101753 | RapidFRET Oral Fluid Assay for | |
| MDMA and RapidFRET Oral | ||
| Fluid MDMA Calibrator Set | ||
| K133047 | ||
| Intended Use | Assay: Qualitative detection of | |
| methamphetamine based analyte in | ||
| neat oral fluid. | ||
| Calibrators: Calibration of d- | ||
| methamphetamine for assay system | Same except analyte is MDMA | |
| Methodology | Homogenous competitive | |
| immunoassay | Same | |
| Kit Components | 1 specific antibody reagent and 1 | |
| drug conjugate reagent | Same |
807.92(a)(6): Technological Similarities and Differences to the Predicate
5
| 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 | ||||
| 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 | |
| Salivabuse Liquid Oral Fluid Control | ||
| K132688 | Device | |
| RapidFRET Oral Fluid MDMA | ||
| Control Set | ||
| K133047 | ||
| Intended Use | Quality control material for oral fluid | |
| drugs of abuse assays to monitor | ||
| system performance | Same | |
| Control Levels | Negative, -60% cutoff, ±50% cutoff, - | |
| 30% cutoff, ±25% cutoff, 2X cutoff, | ||
| and 3x cutoff | 25 ng/mL and 75 ng/mL | |
| Analyte | Multiple drugs of abuse | MDMA |
| Stability | Shelf: 12 months frozen or | |
| refrigerated | ||
| Open: 31 days refrigerated | Shelf: 12 months refrigerated | |
| 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
6
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
7
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†
(0 ng/mL) | 50% MDMA†
(25 ng/mL) | 150% MDMA†
(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 [10,000 [20,000 [