(102 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the RapidFRET Oral Fluid Assay for THC, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | Achieve expected results (>97% frequency) between 75% and 125% of the 4 ng/mL cutoff level (i.e., between 3 ng/mL and 5 ng/mL). | >97% frequency of expected results between 75% and 125% of cutoff. |
| Correlation with MS | High agreement with confirmatory methods (GC/MS or LC/MS/MS). | 98% agreement for MS POS; 99% agreement for MS NEG. |
| Cross-Reactivity | Limited or no cross-reactivity with common compounds and structurally related substances, or cross-reactivity clearly defined. | Identified 6 structurally related compounds with cross-reactivity below 10,000 ng/mL in the absence of THC. |
| Analytical Specificity | No interference from common substances (foods, dental products) and pH variations at specified THC levels (2 ng/mL and 6 ng/mL). | All tested compounds and pH variations gave expected results (NEG at 2 ng/mL THC, POS at 6 ng/mL THC). |
Study Information
2. Sample size used for the test set and the data provenance:
- Analytical Sensitivity: 275 samples (spiked oral fluid pools) were tested per THC concentration level (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200% of cutoff). Total samples for this study were 275 x 9 = 2475 measurements, though the table shows slight variations in 'N' for some percentages due to rounding or reporting.
- Data Provenance: The oral fluid pools were "Negative oral fluid pools" spiked with THC, suggesting laboratory-prepared samples. No specific country of origin is mentioned, but typically such studies are conducted domestically. The study is prospective in nature as samples were specifically prepared and tested for this evaluation.
- Correlation with MS: 236 neat oral fluid samples from volunteers.
- Data Provenance: "Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for THC." This indicates prospective collection from human volunteers. No specific country of origin is mentioned.
- Cross-Reactivity: 167 different compounds were tested. The number of aliquots tested for each compound is not explicitly stated but implies multiple tests (0%, 50%, 150% THC levels).
- Data Provenance: Laboratory-prepared spiked oral fluid pool aliquots.
- Analytical Specificity: A range of common substances and pH variations were tested. Volunteers provided oral fluid samples after using certain items.
- Data Provenance: Laboratory-prepared spiked oral fluid pool aliquots for most common substances and pH levels. For certain items (e.g., mouthwash, chewing gum), oral fluid samples were collected prospectively from volunteers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Analytical Sensitivity, Cross-Reactivity, Analytical Specificity: The ground truth for these studies was established by the known concentration of THC (and other compounds) in spiked samples. This does not involve human experts establishing ground truth in the same way as, for example, image interpretation.
- Correlation with MS: The ground truth was established by confirmatory testing using GC/MS or LC/MS/MS. These are highly precise and sensitive analytical chemistry techniques, considered the "gold standard" for drug confirmation. The document does not specify the number or qualifications of experts running these confirmatory tests, as the methods themselves are the standard.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of these analytical chemistry studies. The "adjudication" is inherent in the analytical methods used for ground truth (GC/MS or LC/MS/MS) and the pre-defined spiking concentrations. Discrepancies would be resolved by re-testing or reviewing analytical data, not by expert consensus in the typical sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-based system designed to assist human readers in, for instance, image interpretation. Its performance is measured directly against analytical standards.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies described are all standalone (algorithm only). The RapidFRET Oral Fluid Assay for THC operates as an automated (or semi-automated) analytical system on the RapidFRET Integrated Workstation. Its performance is evaluated based on its ability to correctly identify THC concentrations in samples, independent of human interpretation or "human-in-the-loop" interaction for result generation. Professional judgment is applied to the test result (as stated in the Intended Use), but the device itself generates a preliminary positive or negative result without human interpretation of the primary signal.
7. The type of ground truth used:
- Known concentrations: For analytical sensitivity, cross-reactivity, and analytical specificity studies, the ground truth was the known concentration of THC or other compounds in the spiked oral fluid samples.
- Confirmatory analytical methods: For the correlation study, the ground truth was established by GC/MS or LC/MS/MS analysis of the neat oral fluid samples.
8. The sample size for the training set:
- The document describes performance validation studies, not development/training of a machine learning algorithm. Therefore, there is no explicit "training set" mentioned in the context of machine learning. The device is a "homogeneous time-resolved fluorescence assay" based on competitive immunoassay principles, a well-established biochemical method, not an AI algorithm that undergoes a training phase with a dataset. Any internal development or calibration within Biophor Diagnostics would not typically be referred to as a "training set" in the context of FDA submissions for such assays.
9. How the ground truth for the training set was established:
- As there is no explicit "training set" for an AI algorithm, this question is not applicable. The underlying biochemical principles and internal calibration methods for the assay would rely on precisely prepared standards and controls to establish its performance characteristics.
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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 | RegulationSection | 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
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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.
| CandidateRapidFRET THC | PredicateThermo THC (K101744 | |
|---|---|---|
| Indications for Use | Same | Qualitative determination oftetrahydrocannabinol(cannabinoid family) in humanoral fluid. |
| Methodology | Same | Homogeneous competitiveimmunoassay. |
| Kit Components | 1 THC specific antibody reagentin liquid, ready to use format.1 THC drug conjugate reagent inliquid, ready to use format. | 1 THC specific antibody reagent(marketed in combination as alyophilized reagent andreconstitution buffer).1 THC drug conjugate reagent(marketed in combination as alyophilized reagent andreconstitution buffer). |
| Neat Oral FluidCutoff Level | 4 ng/mL neat oral fluid. | |
| Platform | RapidFRET IntegratedWorkstation | MGC240 analyzer |
| Sample Collection | Neat oral fluid is collected withthe RapidEASE Oral Fluid | Oral fluid is collected with theOral-Eze Saliva Collection |
Technological Similarities and Differences to the Predicate
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| CandidateRapidFRET THC | PredicateThermo THC (K101744 | |
|---|---|---|
| Collector via directexpectoration. No diluent isused and sample is stored inglass sample tube with inertscrew cap. | System. This device uses anabsorbent swab and diluent.Sample is stored in plastic tubewith snap cap. | |
| Principle andProcedure | Drugs in the oral fluid samplecompete with the THCconjugate donor fluorophore fora fixed number of binding siteson the individual drug antibodyacceptor reagents. Whenacceptor and donorfluorophores are brought intoclose proximity, through thebinding event, fluorescentenergy transfer is measured.The amount of drug in thespecimen sample is inverselyproportional to the assay signalas measured by time resolvedfluorescence. | The assay is based on thesample analytes competing withanalyte conjugates to oneinactive fragment of β-galactosidase for antibodybinding sites.The amount of drug in thespecimen is inverselyproportional to the assay signalas measured by absorbance. |
| Controls andCalibrator Levels | Calibrators are available at 0ng/mL and 4 ng/mL. Controlsare available at 2 ng/mL and 6ng/mL | Calibrators are available at 0ng/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 |
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| 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 |
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| 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.
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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.
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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
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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
PSC Publishing Services (301) 443-6740 દિવ
§ 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).