(102 days)
Not Found
No
The description details a standard immunoassay technology based on fluorescence resonance energy transfer (FRET) and competitive binding. 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 detect THC in oral fluid samples, providing a preliminary screening result rather than a therapeutic intervention.
Yes.
The "Intended Use / Indications for Use" section states: "The RapidFRET Oral Fluid Assay for THC 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 Tetrahydrocannabinol at 4 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector." This describes a device used to screen for the presence of a substance in a body fluid, which is a diagnostic purpose. The section also explicitly states "For In Vitro Diagnostic Use Only." and the "Device Description" section begins with "The RapidFRET Oral Fluid Assay for THC is an In Vitro Diagnostic competitive immunoassay used to detect THC in human oral fluid."
No
The device description clearly states it is an "In Vitro Diagnostic competitive immunoassay" and a "ready-to-use homogenous system" involving "energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug." This describes a chemical assay with physical components (reagents, fluorophores, antibodies), not a software-only device. It also mentions being used on a "RapidFRET Integrated Workstation," which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only." This is repeated for both the assay and the calibrator/control sets.
- Device Description: The "Device Description" section also explicitly states: "The RapidFRET Oral Fluid Assay for THC is an In Vitro Diagnostic competitive immunoassay..."
- Nature of the Test: The device performs a test on a biological sample (oral fluid) in vitro (outside the body) to detect the presence of a substance (THC) for diagnostic purposes (screening for drug use).
These points definitively identify the device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The RapidFRET Oral Fluid Assay for THC 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 Tetrahydrocannabinol at 4 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 THC Calibrator Set and RapidFRET Oral Fluid THC Control Set are intended for use only with theRapidFRET Oral Fluid Assay for THC 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
LDJ, DKB, DIF
Device Description
The RapidFRET Oral Fluid Assay for THC is an In Vitro Diagnostic competitive immunoassay used to detect THC 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 samples
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
Not Found
Summary of Performance Studies
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.
Precision and Analytical Sensitivity:
- Study Type: Evaluation of precision and analytical sensitivity over a minimum of 20 days.
- Sample Size: Three lots of RapidFRET Oral Fluid Assay for THC were analyzed. Negative oral fluid pools were spiked with THC at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 and 8.0 ng/mL.
- Results: The analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a >97% frequency.
Correlation with MS:
- Study Type: Correlation study with mass spectrometry (GC/MS and LC/MS/MS).
- Sample Size: n=236 neat oral fluid samples collected from volunteers.
- Data Source: Samples were collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for THC.
- Protocol: Samples were randomized and blinded to the instrument operator and assayed using RapidFRET THC reagents. Following screening, positive and negative samples were sent for confirmatory testing.
- Results:
- RapidFRET POS / MS POS: 91
- RapidFRET POS / MS NEG: 2 (Samples contained 3.4 and 3.7 ng/mL THC)
- RapidFRET NEG / MS POS: 2 (Samples contained 4.5 and 4.6 ng/ml THC)
- RapidFRET NEG / MS NEG: 141
- Agreement for MS POS: 98%
- Agreement for MS NEG: 99%
- Key Results: The RapidFRET Oral Fluid Assay for THC was accurate >98% of the time in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector.
Cross Reactivity and Analytical Specificity:
- Study Type: Evaluation of cross reactivity and specificity with a compound library.
- Sample Size: 167 different structurally related and unrelated compounds.
- Protocol: Compounds were spiked at 30,000 ng/mL into neat oral fluid pool aliquots with 0 ng/mL, 2 ng/mL and 6 ng/mL THC, processed with the RapidEASE Collector, and tested with the RapidFRET THC 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.
- Results: Six structurally related compounds were determined to cross-react below 10,000 ng/mL in the absence of THC.
- 11-Hydroxy-d9-THC: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 10 [40%]
- Cannabidiol: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 6,400 [0.6%]
- Cannabinol: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 8 [50%]
- d8-THC: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 46 [8.7%]
- d8-THC Acid: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 4 [100%]
- d9-THC Acid: Level 30,000 ng/mL, 0% THC (0 ng/mL) result: 6 [67%]
- A second study evaluated common substances such as foods and dental products as well as pH variations.
- Protocol: 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 2 ng/mL or 6 ng/mL of THC. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with THC to 2 ng/mL or 6 ng/mL and assayed with the RapidFRET THC Assay. Volunteers consumed specific items (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) and provided oral fluid samples, which were then spiked with THC to 2 ng/mL or 6 ng/mL, processed with a RapidEASE Collector and assayed.
- Results: All compounds at the listed concentrations gave a NEG result when spiked with 2 ng/mL THC and a POS result when spiked with 6 ng/mL THC.
Key Metrics
Precision and Analytical Sensitivity:
- Analytical sensitivity is between 75% and 125% of cutoff.
- Expected results were achieved at a >97% frequency.
Correlation with MS:
- % Agreement (MS POS): 98%
- % Agreement (MS NEG): 99%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
510(k) Summary for the RapidFRET Oral Fluid Assay for THC
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: K132096
Contact Information
- Name: Biophor Diagnostics, Inc. Address: 1201 Douglas Avenue Redwood City, CA 94063
OCT 1 8 2013
Contact: Nathaniel G. Butlin, Ph.D. Phone: 650-367-4954 Fax: 650-364-4985 Email: nbutlin@biophor.com
Device Name, Common Name and Classification
RapidFRET Oral Fluid Assay for THC (Enzyme Immunoassay for Tetrahydrocannbinol) RapidFRET Oral Fluid Calibrator Set (Clinical Toxicology Calibrator) RapidFRET Oral Fluid Control Set (Drug Mixture Control Materials)
| Product | Code | Class | Regulation
Section | Panel |
|-------------------------------------|------|-------|-----------------------|-----------------|
| RapidFRET Oral Fluid Assay for THC | LDJ | II | 862.3870 | 91 - Toxicology |
| RapidFRET Oral Fluid Calibrator Set | DKB | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral Fluid Control Set | DIF | I | 862.3280 | 91 - Toxicology |
ldentification of Legally Marketed Predicate Devices
Thermo Scientific CEDIA® Cannabinoids (THC) OFT Assay (K101744).
Device Description
The RapidFRET Oral Fluid Assay for THC is an In Vitro Diagnostic competitive immunoassay used to detect THC 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
1
used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy.
Intended Use
The RapidFRET Oral Fluid Assay for THC 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 Tetrahydrocannabinol at 4 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 THC Calibrator Set and RapidFRET Oral Fluid THC Control Set are intended for use only with theRapidFRET Oral Fluid Assay for THC 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
RapidFRET THC | Predicate
Thermo THC (K101744 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Same | Qualitative determination of
tetrahydrocannabinol
(cannabinoid family) in human
oral fluid. |
| Methodology | Same | Homogeneous competitive
immunoassay. |
| Kit Components | 1 THC specific antibody reagent
in liquid, ready to use format.
1 THC drug conjugate reagent in
liquid, ready to use format. | 1 THC specific antibody reagent
(marketed in combination as a
lyophilized reagent and
reconstitution buffer).
1 THC drug conjugate reagent
(marketed in combination as a
lyophilized reagent and
reconstitution buffer). |
| | Neat Oral Fluid
Cutoff Level | 4 ng/mL neat oral fluid. |
| Platform | RapidFRET Integrated
Workstation | MGC240 analyzer |
| Sample Collection | Neat oral fluid is collected with
the RapidEASE Oral Fluid | Oral fluid is collected with the
Oral-Eze Saliva Collection |
Technological Similarities and Differences to the Predicate
2
| | Candidate
RapidFRET THC | Predicate
Thermo THC (K101744 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Collector via direct
expectoration. No diluent is
used and sample is stored in
glass sample tube with inert
screw cap. | 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 THC
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 β-
galactosidase for antibody
binding sites.
The amount of drug in the
specimen is inversely
proportional to the assay signal
as measured by absorbance. |
| Controls and
Calibrator Levels | Calibrators are available at 0
ng/mL and 4 ng/mL. Controls
are available at 2 ng/mL and 6
ng/mL | Calibrators are available at 0
ng/mL, 1 ng/mL, and 10 ng/mL. |
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 THC were analyzed, four times daily, for a minimum of 20 days. Negative oral fluid pools were spiked with THC at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0 and 8.0 ng/mL. The aggregate data is summarized in the table below:
| THC | 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% |
|---|---|---|---|---|---|---|---|---|---|
| POS | 0 | 0 | 0 | 7 | 196 | 268 | 259 | 274 | 274 |
| NEG | 275 | 275 | 274 | 268 | 79 | 6 | 0 | 0 | 0 |
| N | 275 | 275 | 274 | 275 | 275 | 274 | 259 | 274 | 274 |
3
| THC | 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% |
|---|---|---|---|---|---|---|---|---|---|
| POS | 0% | 0% | 0% | 3% | 71% | 98% | 100% | 100% | 100% |
| NEG | 100% | 100% | 100% | 97% | 29% | 2% | 0% | 0% | 0% |
| N | 275 | 275 | 274 | 275 | 275 | 274 | 259 | 274 | 274 |
The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a >97% frequency.
Correlation with MS
Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for THC. The samples (n=236) were randomized and blinded to the instrument operator and assayed using RapidFRET THC reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.
| n = 236 | MS POS | MS NEG |
|---|---|---|
| RapidFRET POS | 91 | 2† |
| RapidFRET NEG | 2§ | 141 |
| % Agreement | 98% | 99% |
Samples contained 3.4 and 3.7 ng/mL THC. Samples contained 4.5 and 4.6 ng/ml THC.
The data indicate that the RapidFRET Oral Fluid Assay for THC was accurate >98% of the time in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector.
Cross Reactivity and Analytical Specificity
A compound library of 167 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, 2 ng/mL and 6 ng/mL THC, processed with the RapidEASE Collector, and tested with the RapidFRET THC 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. Six structurally related compounds were determined to cross-react below 10,000 ng/mL in the absence of THC.
| Compound | Level
(ng/mL) | 0% THC+
(0 ng/mL) | 50% THC+
(2 ng/mL) | 150% THC+
(6 ng/mL) |
|------------------------------------------------------------------------------------------|------------------|----------------------|-----------------------|------------------------|
| Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with 0 ng/mL THC | | | | |
| 11-Hydroxy-d9-THC | 30,000 | 10 [40%] | POS | POS |
| Cannabidiol | 30,000 | 6,400 [0.6%] | POS | POS |
| Cannabinol | 30,000 | 8 [50%] | POS | POS |
| d8-THC | 30,000 | 46 [8.7%] | POS | POS |
| d8-THC Acid | 30,000 | 4 [100%] | POS | POS |
4
| Compound | Level
(ng/mL) | 0% THC+
(0 ng/mL) | 50% THC+
(2 ng/mL) | 150% THC+
(6 ng/mL) |
|------------------------------------------------------------------------------------------|------------------|----------------------|-----------------------|------------------------|
| Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with 0 ng/mL THC | | | | |
| d9-THC Acid | 30,000 | 6 [67%] | POS | POS |
+Results are presented as either the RapidFRET THC screening result (POS / NEG) or the concentration in ng/mL of the cross-reactant that gives a Cutoff equivalent response. Values in square brackets represent percent cross reactivity.
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 2 ng/mL or 6 ng/mL of THC. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with THC to 2 ng/mL or 6 ng/mL and assayed with the RapidFRET THC 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 THC to 2 ng/mL or 6 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET THC assay. All compounds at the listed concentrations gave a NEG result when spiked with 2 ng/mL THC and a POS result when spike with 6 ng/mL THC.
Conclusions
The RapidFRET Oral Fluid Assay for THC 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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOPHOR DIAGNOSTICS, INC. c/o Nathaniel Butlin, Ph.D. 1201 Douglas Ave REDWOOD CITY CA 94063
Re: K132096
Trade/Device Name: RapidFRET Oral Fluid Assay for THC RapidFRET Oral Fluid Calibrator Set RapidFRET Oral Fluid Control Set Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DKB, DIF Dated: September 10, 2013 Received: September 27, 2013
Dear Dr. 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 (Act (Act (Act (Act the provisions of the Federal Food, Drug,
You may, therefore, market the douice and in proval of a premarket approval application (P 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 misting and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device Intornation realed to contract hability
warranties. We remind you, however, that device labeling must be truthful and not misl
October 18, 2013
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if 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 (reporting (reporting (reporting (reporting (reporting (reporting of as set forth in the quality events) (21 CFR 803); good manufacturing of
as set forth in the quality 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 electronic product radiation control provisions (21 CFR Part 820); and it applicable, the
1050 1050.
6
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Carol[E.Benson -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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K132096
Device Name
RapidFRET Oral Fluid Assay for THC, RapidFRET Oral Fluid Calibrator Set, RapidFRET Oral Fluid Control Set, RapidEASE Oral Fluid Collector
Indications for Use (Describe)
The RapidFRET Oral Fluid Assay for THC 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 Tetrahydrocannabinol at 4 ng/mLin 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 dricularly when using preliminary positive results. For h Vitro Diagnostic Use Only.
The RapidFRET Oral Fluid THC Calibrator Set and RapidFRET Oral Fluid THC Control Set are intended for use only with theRapidFRET Oral Fluid Assay for THC and samples collected with the RapidEASE or all Finches on one only will nelevanine the cutoff level and translate the assay measurement into a positive and negative and negative control over in the esse to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Univ.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page 1 of 2
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