(354 days)
Not Found
No
The device description and performance studies focus on a competitive immunoassay and fluorescence resonance energy transfer (FRET) signal measurement, which are traditional biochemical methods. There is no mention of AI, ML, or related concepts in the text.
No
The device is an in vitro diagnostic assay used to detect cocaine in oral fluid, which is not a therapeutic intervention.
Yes
The device is explicitly stated to be an "In Vitro Diagnostic competitive immunoassay" in the "Device Description" section and its "Intended Use" is to perform a "qualitative screen for cocaine", which are functions characteristic of a diagnostic device.
No
The device description clearly outlines a competitive immunoassay involving chemical reagents (fluorophores, antibodies, drug labels) and a physical process (energy transfer). This is an in vitro diagnostic assay that relies on physical and chemical components, 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 and direct indication.
- Device Description: The "Device Description" section also states, "The RapidFRET Oral Fluid Assay for Cocaine is an In Vitro Diagnostic competitive immunoassay..."
- Nature of the Test: The device is designed to test human oral fluid samples in vitro (outside the body) to detect the presence of cocaine. This aligns with the definition of an in vitro diagnostic device.
- Intended Use: The intended use is for prescription use in central laboratories to perform a qualitative screen for cocaine in oral fluid. This is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The RapidFRET Oral Fluid Assay for Cocaine 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 cocaine at 20 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated with Cocaine and 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 Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine 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.
Product codes
DIO, DLJ, DIF
Device Description
The RapidFRET Oral Fluid Assay for Cocaine is an In Vitro Diagnostic competitive immunoassay used to detect cocaine 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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision and Analytical Sensitivity:
- Study type: Precision and analytical sensitivity study.
- Sample size: 180 samples per concentration level (total 9 concentration levels, so 1620 individual tests).
- Key results: The analytical sensitivity is between 75% and 125% of cutoff (15 ng/mL to 25 ng/mL), and expected results were achieved at a 97% frequency within this range.
Correlation with MS Quantitation:
- Study type: Correlation study with GC/MS and LC/MS/MS.
- Sample size: n=294
- Data source: Neat oral fluid collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for opiates.
- Key results: The RapidFRET Oral Fluid Assay for Cocaine 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 study.
- Sample size: Approximately 171 different compounds, plus various common substances (foods, dental products) and pH variations.
- Key results: 13 structurally related compounds were determined to cross-react below 30,000 ng/mL in the absence of cocaine. Various common substances and pH variations were evaluated, and all compounds at specified concentrations gave a NEG result when spiked with 10 ng/mL cocaine and a POS result when spiked with 30 ng/mL cocaine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical sensitivity: between 75% and 125% of cutoff.
- Accuracy: >99% (correlation with MS Quantitation study).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
BIOPHOR DIAGNOSTICS, INC. NATHANIEL BUTLIN VICE PRESIDENT 1201 DOUGLAS AVE REDWOOD CITY CA 94063
Re: K142129
Trade/Device Name: RapidFRET Oral Fluid Assay for Cocaine. RapidFRET Oral Fluid Cocaine Calibrator Set. RapidFRET Oral Fluid Cocaine Control Set Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DLJ, DIF Dated: July 1, 2015 Received: July 6, 2015
Dear 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
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 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) K142129
Device Name
RapidFRET Oral Fluid Assay for Cocaine RapidFRET Oral Fluid Cocaine Calibrator Set RapidFRET Oral Fluid Cocaine Control Set
Indications for Use (Describe)
The RapidFRET Oral Fluid Assay for Cocaine 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 cocaine at 20 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated with Cocaine and 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 Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(k) Summary for the RapidFRET Oral Fluid Assay for Cocaine
Preparation Date: July 23, 2015
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: K142129
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 Cocaine (Cocaine Test System) RapidFRET Oral Fluid Cocaine Calibrator Set (Clinical Toxicology Calibrator) RapidFRET Oral Fluid Cocaine Control Set (Drug Mixture Control Materials)
| Product | Code | Class | Regulation
Section | Panel |
|---------------------------------------------|------|-------------|-----------------------|-----------------|
| RapidFRET Oral Fluid Assay for Cocaine | DIO | II | 862.3250 | 91 - Toxicology |
| RapidFRET Oral Fluid Cocaine Calibrator Set | DLJ | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral Fluid Cocaine Control Set | DIF | I, Reserved | 862.3280 | 91 - Toxicology |
807.92(a)(3): Identification of Legally Marketed Predicate Devices
CEDIA® Cocaine OFT Assay (K101742) marketed by Microgenics Corporation, Thermo Fisher Scientific Clinical Diagnostic Division.
807.92(a)(4): Device Description
The RapidFRET Oral Fluid Assay for Cocaine is an In Vitro Diagnostic competitive immunoassay used to detect cocaine 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
4
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 Cocaine 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 cocaine at 20 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated with Cocaine and 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 Cocaine Calibrator Set and RapidFRET Oral Fluid Cocaine Control Set are intended for use with the RapidFRET Oral Fluid Assay for Cocaine 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.
| | Candidate Device
(RapidFRET COC) | Predicate Device
(Microgenics COC, K101742) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Qualitative determination of cocaine in
human oral fluid in clinical setting. | Qualitative determination of cocaine 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
(marketed in combination as a lyophilized
reagent and reconstitution buffer).
1 Drug conjugate reagent (marketed in
combination as a lyophilized reagent and
reconstitution buffer). |
| 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
Cocaine. |
| 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 COC) | Predicate Device
(Microgenics COC, K101742) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effectiveness | described in PI, equivalent to predicate. | described in PI. |
| Neat Oral Fluid
Cutoff Level | 20 ng/mL neat oral fluid. | 15 ng/mL neat oral fluid using a 5 ng/mL
cutoff calibrator to account for sample
dilution by collection device. |
| Platform | RapidFRET Integrated Workstation
available exclusively from Biophor
Diagnostics, Inc. | MGC240 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 Oral-Eze
Saliva Collection System. 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 one inactive fragment of ß-
galactosidase for antibody binding sites.
The amount of drug in the specimen is
proportional to the assay signal as
measured by absorbance. |
| Controls and
Calibrator
Levels | Calibrators are available at effective
concentrations of 0 ng/mL and 20 ng/mL.
Controls are available at effective
concentrations of 10 ng/mL and 30
ng/mL. | Calibrators are available at 0 ng/mL, 5
ng/mL, and 50 ng/mL. Controls are
available at additional 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
One lot of RapidFRET Oral Fluid Assay for Cocaine was used to verify precision, four times daily, triplicate samples per run for 5 days using 3 independent lots of reagent. Negative oral fluid pools were spiked with cocaine at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 5, 10, 15, 20, 25, 30, 35 and 40
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Summary Precision Data for All Lots | |||||||||
---|---|---|---|---|---|---|---|---|---|
0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
POS | 0 | 0 | 0 | 1 | 86 | 171 | 180 | 180 | 180 |
NEG | 180 | 180 | 180 | 179 | 94 | 9 | 0 | 0 | 0 |
N | 180 | 180 | 180 | 180 | 180 | 180 | 180 | 180 | 180 |
ng/mL. The aggregate data is summarized in the table below:
Summary Precision Data for All Lots: Percent Agreement | |||||||||
---|---|---|---|---|---|---|---|---|---|
0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
POS | 0% | 0% | 0% | 1% | 48% | 95% | 100% | 100% | 100% |
NEG | 100% | 100% | 100% | 99% | 52% | 5% | 0% | 0% | 0% |
N | 180 | 180 | 180 | 180 | 180 | 180 | 180 | 180 | 180 |
The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 97% frequency within this range.
Correlation with MS Quantitation
Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for opiates. The samples (n=294) were randomized and blinded to the instrument operator and assayed using RapidFRET COC reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.
| n = 294 | Low Negative
(30 ng/mL) |
|------------------|-----------------------------|-----------------------------------------|-----------------------------------------|------------------------------|
| RapidFRET
POS | 1§ | 2§ | 5 | 55 |
| RapidFRET
NEG | 226 | 5 | 0 | 0 |
ී One sample contained cinnamoyl cocaine at 388 ng/mL; a second sample contained cocaine, and cinnamoyl cocaine at 10 ng/mL equivalent concentration; a third sample contained high levels of hydroxymethcathinone (HMMC), a major metabolite of methylone, which shares structural similarities to isoxsuprine, a known cross-reactant."
The data indicate that the RapidFRET Oral Fluid Assay for Cocaine 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 171 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 and 30 ng/mL of cocaine, processed with the RapidEASE Collector, and tested with the RapidFRET COC 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
4 Kamata et al., Japanese Journal of Forensic Science and Technology, (2007), 12(1):97-106. Ellefsen, Kayla N., et al., Forensic Toxicology (2015): 1-11.
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equivalent to the cutoff. Thirteen (13) structurally related compounds were determined to |
---|
cross-react below 30,000 ng/mL in the absence of cocaine. These are noted in the labeling. |
Compound | Concentration (ng/mL) | Cross-Reactivity (%) |
---|---|---|
Benzoylecgonine | 18 | 111% |
Chlorpromazine | 17,705 | 0.1% |
Cinnamoylcocaine | 224 | 8.2% |
Clomipramine | 13,824 | 0.1% |
Cocaethylene | 15 | 133% |
Cocaine | 20.5 | 98% |
Cyclobenzaprine | 18,218 | 0.1% |
Ecgonine | 3,384 | 0.6% |
Ecgonine methyl ester | 3,365 | 0.6% |
Imipramine | 19,847 | 0.1% |
Isoxsuprine* | 846 | 2.4% |
Norcocaine | 1,730 | 1.2% |
Perphenazine | 5,959 | 0.3% |
Thioridazine | 23,723 | 0.1% |
Trifluoperazine | 21,831 | 0.1% |
*Hydroxymethoxymethcathinone (HMMC), a major methylone, shares structural similarities to isoxsuprine and has been shown to cause interference.
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, lgA, lgG and IgM were spiked into neat oral fluid pool aliquots that contained either 10 ng/mL of cocaine. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with cocaine to 10 ng/mL or 30 ng/mL and assayed with the RapidFRET COC 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 cocaine to 10 ng/mL or 30 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET COC device. All compounds at the listed concentrations gave a NEG result when spiked with 10 ng/mL cocaine and a POS result when spike with 30 ng/mL cocaine.
807.92(b)(3): Conclusions
The RapidFRET Oral Fluid Assay for Cocaine 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.