(324 days)
Not Found
No
The device description and performance studies focus on a competitive immunoassay and fluorescence measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an In Vitro Diagnostic (IVD) assay used to screen for amphetamine in oral fluid, providing only preliminary results for diagnostic purposes rather than directly treating or preventing a disease or condition.
Yes
Explanation: The device is described as an "In Vitro Diagnostic competitive immunoassay" which provides a "qualitative screen for amphetamine" and an "analytical result" indicating positive or negative for amphetamine, all of which fall under the definition of a diagnostic device.
No
The device description clearly states it is an In Vitro Diagnostic competitive immunoassay involving reagents (fluorophores, antibodies) and a system that measures fluorescence resonance energy transfer (FRET). This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use Only." This is a clear declaration of its intended purpose.
- Device Description: The "Device Description" section also states: "The RapidFRET Oral Fluid Assay for Amphetamine is an In Vitro Diagnostic competitive immunoassay..."
- Function: The device is designed to perform a qualitative screen for amphetamine in human oral fluid samples. This is a diagnostic test performed outside of the body (in vitro) on a biological sample.
- Components: The description mentions calibrators and controls, which are standard components of IVD assay kits used for quality control and result interpretation.
- Intended User/Setting: It is intended for prescription use in central laboratories, which is a typical setting for performing IVD tests.
N/A
Intended Use / Indications for Use
The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine 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 Amphetamine Calibrator Set and RapidFRET Oral Fluid Amphetamine Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine 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 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)
DKZ, DLJ, LAS
Device Description
The RapidFRET Oral Fluid Assay for Amphetamine is an In Vitro Diagnostic competitive immunoassay used to detect amphetamine 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 or negative 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, Clinical setting
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
Not Found
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: Not explicitly stated as a single number, but involved analyzing three lots, four times daily, for a minimum of 20 days.
Key Results:
| 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
|---|---|---|---|---|---|---|---|---|---|
| POS | 0% | 0% | 0% | 0% | 67% | 100% | 100% | 100% | 100% |
| NEG | 100% | 100% | 100% | 100% | 36% | 0% | 0% | 0% | 0% |
| N | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |
Correlation with MS Quantitation:
Study Type: Correlation with MS Quantitation
Sample Size: n=415
Key Results: The data indicate that the RapidFRET Oral Fluid Assay for Amphetamine 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
Sample Size: A compound library of approximately 167 different structurally related and unrelated compounds was used.
Key Results: No interference was seen with the tested structurally unrelated compounds. Cross-reactivity data for structurally related compounds are summarized in a table.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 99% (from Correlation with MS Quantitation study)
Precision data available in the Summary of Performance Studies.
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.
Roche Diagnostics DAT Oral Fluid Amphetamine (K110446)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Public Health
Image /page/0/Picture/1 description: The image contains a logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a way that suggests unity and collaboration. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profiles.
DEPARTMENT OF HEALTH & HUMAN SERVICES Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
BIOPHOR DIAGNOSTICS, INC. NATHANIEL BUTLIN, PH.D. VICE PRESIDENT 1201 DOUGLAS AVE REDWOOD CITY CA 94063
Re: K141748
Trade/Device Name: RapidFRET Oral Fluid Assay for Amphetamine, RapidFRET Oral Fluid Amphetamine Calibrator Set, RapidFRET Oral Fluid Amphetamine Control Set Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DLJ, LAS Dated: April 27, 2015 Received: April 30, 2015
Dear Dr. Nathaniel Butlin:
This letter corrects our substantially equivalent letter of May 20, 2015.
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.
1
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 Part 801).
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801) please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141748
Device Name
RapidFRET Oral Fluid Assay for Amphetamine RapidFRET Oral Fluid Amphetamine Calibrator Set RapidFRET Oral Fluid Amphetamine Control Set
Indications for Use (Describe)
The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine 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 Amphetamine Calibrator Set and RapidFRET Oral Fluid Amphetamine Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine 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 controls are used to monitor laboratory systems, operators, 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) |
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510(k) Summary for the RapidFRET Oral Fluid Assay for Amphetamine
Preparation Date: May 13, 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: K141748
807.92(a)(1): Contact Information
| Name: | Biophor Diagnostics, Inc. | ||||
|---|---|---|---|---|---|
| Address: | |||||
| Redwood City, CA 94063 | |||||
| A |
- 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 Amphetamine (Enzyme Immunoassay for Amphetamine) RapidFRET Oral Fluid Amphetamine Calibrator Set (Clinical Toxicology Calibrator) RapidFRET Oral Fluid Amphetamine Control Set (Drug Mixture Control Materials)
| Product | Code | Class | Regulation Section | Panel |
|---|---|---|---|---|
| RapidFRET Oral Fluid Assay | ||||
| for Amphetamine | DKZ | II | 862.3100 | 91 - Toxicology |
| RapidFRET Oral Fluid | ||||
| Amphetamine Calibrator Set | DLJ | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral Fluid | ||||
| Amphetamine Control Set | LAS | I, | ||
| Reserved | 862.3280 | 91 - Toxicology |
807.92(a)(3): Identification of Legally Marketed Predicate Devices
Roche Diagnostics DAT Oral Fluid Amphetamine (K110446).
807.92(a)(4): Device Description
The RapidFRET Oral Fluid Assay for Amphetamine is an In Vitro Diagnostic competitive immunoassay used to detect amphetamine 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
4
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 or negative result. Controls are used to establish and monitor precision and accuracy.
807.92(a)(5): Intended Use
The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine 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 Calibrator Set and RapidFRET Oral Fluid Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine 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 result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.
| | Candidate Device
(RapidFRET AMP) | Predicate Device
(Roche AMP, K110446) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Qualitative determination of
amphetamine in human oral fluid in
clinical setting. | Qualitative and semi-quantitative
determination of amphetamine in human
oral fluid in clinical setting. |
| Methodology | Competitive homogeneous
immunoassay. | Competitive homogeneous
immunoassay. |
| Kit
Components | 1 Drug specific antibody reagent in liquid,
ready to use format.
1 Drug conjugate reagent in liquid, ready
to use format. | 1 Drug specific antibody reagent in liquid,
ready to use format.
1 Drug conjugate reagent in liquid, ready
to use format. |
| Performance
Characteristics | Precision, accuracy, cross
reacting/interfering studies demonstrate
equivalence to the predicate device. | Precision, accuracy, cross
reacting/interfering studies are similar to
the RapidFRET Oral Fluid Assay for
Amphetamine. |
| Safety and | Demonstrated in bench testing and | Demonstrated in bench testing and |
807.92(a)(6): Technological Similarities and Differences to the Predicate
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| | Candidate Device
(RapidFRET AMP) | Predicate Device
(Roche AMP, K110446) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effectiveness | described in PI, equivalent to predicate. | described in PI. |
| Neat Oral Fluid
Cutoff Level | 50 ng/mL neat oral fluid. | 120 ng/mL neat oral fluid using a 40
ng/mL cutoff calibrator to account for
sample dilution by collection device. |
| Platform | RapidFRET Integrated Workstation
available exclusively from Biophor
Diagnostics, Inc. | Roche Modular P Analyzer |
| Sample
Collection | Neat oral fluid is collected with the
RapidEASE Oral Fluid Collector via direct
expectoration. No diluent is used and
sample is stored in glass sample tube
with inert screw cap. | Oral fluid is collected with the Intercept
Oral Specimen Collection Device. This
device uses an absorbent swab and
diluent. Sample is stored in plastic tube
with snap cap. |
| Principle and
Procedure | Drugs in the oral fluid sample compete
with the drug conjugate donor
fluorophore for a fixed number of binding
sites on the individual drug antibody
acceptor reagents. When acceptor and
donor fluorophores are brought into
close proximity, through the binding
event, fluorescent energy transfer is
measured.
The amount of drug in the specimen
sample is inversely proportional to the
assay signal as measured by time
resolved fluorescence. | The assay is based on the sample
analytes competing with analyte
conjugates to antibody coated
microparticles for antibody binding sites.
The amount of drug in the specimen is
directly proportional to the assay signal
as measured by absorbance. |
| Controls and
Calibrator
Levels | Calibrators are available at 0 ng/mL and
50 ng/mL. Controls are available at 25
ng/mL and 75 ng/mL. | Calibrators are available at 0 ng/mL and
40 ng/mL for qualitative mode. Controls
are available at 20 ng/mL (0.5X) and 60
ng/mL (1.5X) levels. |
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 analytical specificity that are summarized below.
Precision and Analytical Sensitivity
Three lots of the RapidFRET Oral Fluid Assay for Amphetamine were analyzed, four times daily, for a minimum of 20 days. Negative oral fluid pools were spiked with amphetamine 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. Spiked oral fluid was then processed with a RapidEASE Oral Fluid Collector prior to analysis. The aggregate data is
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| All Lots Precision Results Summary by Percent Agreement | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
| POS | 0% | 0% | 0% | 0% | 67% | 100% | 100% | 100% | 100% |
| NEG | 100% | 100% | 100% | 100% | 36% | 0% | 0% | 0% | 0% |
| N | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |
summarized in the table below:
Correlation with MS Quantitation
Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for amphetamine. The samples (n=415) were randomized and blinded to the instrument operator and assayed using RapidFRET AMP reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.
| Combined Accuracy Data - Detailed Grouping. | ||||
|---|---|---|---|---|
| N = 415 | Negative by the predicate device or less than half the cutoff concentration by MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| Positive | 14* | 0 | 6 | 35 |
| Negative | 321 | 37 | 2** | 0 |
*Of the fourteen samples contained MDA above the cutoff equivalent cross reactivity level (in ng/mL: 151, 113, 109, 93, 90, 82, 73, 70, 56, 51, 51, and 51). The remaining two samples contained high levels of Dimethylcathinone (DMC), a metabolite of the designer drug dimethylmethcathinone and member of the cathinone class of drugs that share significant structural similarities to amphetamine. **Samples contained 71.6 ng/mL and 70.3 ng/mL amphetamine.
The data indicate that the RapidFRET Oral Fluid Assay for Amphetamine 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 approximately 167 different structurally related and unrelated compounds including metabolites, over-the-counter and prescription medications and other drugs of abuse was used to evaluate cross reactivity and interference. Structurally related compounds were spiked at 30,000 ng/mL into neat oral fluid pool aliquots with 0 ng/mL amphetamine for cross-reactivity determinations, and structurally unrelated compounds were spiked at 30,000 ng/mL into neat oral fluid pool aliquots with 25 ng/mL and 75 ng/mL of amphetamine for interference determinations. All samples were processed with the RapidEASE Collector and tested with the RapidFRET AMP assay.
No interference was seen with the tested structurally unrelated compounds. The list of compounds that do not interfere with the assay are listed in the product insert.
For cross-reactivity, the compounds that gave an unexpected result were further titrated to
- Usui, K., Aramamaki, T., et. Al., Legal Medicine, 16, (2014), 222 -226.
7
determine the concentration at which the cross-reacting compound yielded a result approximately equivalent to the cutoff. The cross-reactivity of structurally related compounds are summarized below.
| Cross-Reactivity Data | |||||
|---|---|---|---|---|---|
| Compound | Level | ||||
| (ng/mL) | Cutoff Equivalent Concentration | Percent Cross-Reactivity | |||
| Benzodioxolylbutanamine | 30,000 | 388 ng/mL | 13% | ||
| Phenethylamine | 30,000 | 5,500 ng/mL | 0.9% | ||
| Methylenedioxyamphetamine (MDA) | 30,000 | 95 ng/mL | 53% | ||
| Methylenedioxyethylamphetamine (MDEA) | 30,000 | 24,167 ng/mL | 0.2% | ||
| Methylenedioxymethamphetamine (MDMA) | 30,000 | NEG | 0.0% | ||
| Phentermine | 30,000 | 1,789 ng/mL | 2.8% | ||
| para-Methoxyamphetamine (PMA) | 30,000 | 533 ng/mL | 9.4% | ||
| I-Amphetamine | 30,000 | 4,987 ng/mL | 1.0% | ||
| d-Amphetamine | 3,750 | 50 ng/mL | 100% | ||
| d/l-Amphetamine | 60,000 | 118 ng/mL | 42.4% | ||
| d-Methamphetamine | 30,000 | NEG | 0.0% | ||
| l-Methamphetamine | 30,000 | NEG | 0.0% | ||
| Ephedrine | 30,000 | NEG | 0.0% |
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, IgM and salivary α-amylase were spiked into neat oral fluid pool aliquots that contained either 25 ng/mL or 75 ng/mL of d-amphetamine. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with d-amphetamine to 25 ng/mL or 75 ng/mL and assayed with the RapidFRET AMP 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 damphetamine to 25 ng/mL or 75 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET AMP device. All compounds at the listed concentrations gave a NEG result when spiked with 25 ng/mL d-amphetamine and a POS result when spike with 75 ng/mL d-amphetamine.
807.92(b)(3): Conclusions
The RapidFRET Oral Fluid Assay for Amphetamine including the RapidFRET Oral Fluid Negative and Cutoff Calibrators, the RapidFRET Oral Fluid Negative and Positive Controls and the RapidEASE Oral Fluid Collector were determined to be safe and effective for their intended use.