(324 days)
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.
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.
The provided document describes the RapidFRET Oral Fluid Assay for Amphetamine and its performance characteristics. Here's a breakdown of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
The document implicitly defines acceptance criteria through the performance study results. While specific percentage targets aren't always explicitly stated as "acceptance criteria," the reported performance demonstrates what the device achieved and, by extension, what was considered acceptable for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | High agreement for negative samples (below cutoff) | At 0%, 25%, 50%, and 75% of cutoff: 100% agreement for NEGATIVE results. |
| High agreement for positive samples (above cutoff) | At 125%, 150%, 175%, and 200% of cutoff: 100% agreement for POSITIVE results. | |
| Reasonable agreement around cutoff (e.g., 100% of cutoff) | At 100% of cutoff: 67% POS, 36% NEG (indicating expected variability around the cutoff). | |
| Accuracy / Correlation with MS | High overall accuracy compared to a confirmatory method (GC/MS or LC/MS/MS) | Overall accuracy: 99% in neat oral fluid samples when compared to GC/MS or LC/MS/MS. - False Positives: 14 samples (out of 335 true negatives by MS) (12 due to MDA/DMC cross-reactivity). - False Negatives: 2 samples (out of 43 true positives by MS) (amphetamines at 71.6 ng/mL and 70.3 ng/mL). |
| Cross-Reactivity | Minimal or acceptable cross-reactivity with other substances | Some structurally related compounds showed cross-reactivity at varying levels (e.g., MDA at 53%, Benzodioxolylbutanamine at 13%). Many other substances and common products showed no interference. |
| Analytical Specificity | No interference from common substances, oral products, or pH variations | No interference seen from 167 structurally unrelated compounds. No interference from HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, IgA, IgG, IgM, salivary α-amylase, or pH variations (5-9). No interference from antiseptic mouthwash, cough syrup, cranberry juice, orange juice, toothpaste, chewing tobacco, cigarettes, chewing gum, hard candy, teeth whitening strips, cola, water, antacid, coffee, and tea. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Test Set Sample Size:
- 3 lots were analyzed, 4 times daily, for a minimum of 20 days.
- For each concentration level tested (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200% of cutoff), the "N" value represents the total number of tests performed. These ranged from 263 to 294 for each concentration, across all lots.
- Correlation with MS Test Set Sample Size:
- N = 415 neat oral fluid samples.
- Cross-Reactivity and Analytical Specificity Test Set Sample Size:
- Approximately 167 different structurally related and unrelated compounds were tested.
- Additional common substances (HSA, ethanol, baking soda, etc.), pH variations, and oral products (antiseptic mouthwash, coffee, etc.) were also tested individually or through volunteer samples.
- Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective bench testing and clinical sample testing performed specifically for this submission. The "Correlation with MS Quantitation" study mentions samples collected "from volunteers potentially positive and negative for amphetamine."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for interpretation of results. For the Correlation with MS Quantitation study, the "ground truth" was established by confirmatory testing using more specific alternate chemical methods such as GC/MS or LC/MS/MS.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, where the output is a qualitative (positive/negative) result based on a measurement against a specific cutoff, not a diagnostic image or interpretation requiring multiple human readers.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
Yes, the studies presented describe the standalone performance of the RapidFRET Oral Fluid Assay for Amphetamine. The performance metrics (precision, accuracy, cross-reactivity, analytical specificity) are derived directly from the assay's output based on given samples, without human interpretation influencing the result. The device provides a "preliminary result," which then requires a human to potentially send the sample for confirmatory testing, but the performance data outlined specifically relates to the device's ability to generate that preliminary result.
7. The Type of Ground Truth Used
- Precision and Analytical Sensitivity: Controlled spiking of known concentrations of amphetamine into negative oral fluid pools.
- Correlation with MS Quantitation: Confirmatory analytical methods: GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This represents a highly specific and accurate chemical analysis, often considered the "gold standard" for drug confirmation.
- Cross-Reactivity and Analytical Specificity: Controlled spiking of known concentrations of interfering substances into oral fluid samples with and without amphetamine, and analysis of oral fluid from volunteers after exposure to common oral products.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" as it would be understood for machine learning algorithms. This device is an immunoassay, which typically does not involve a separate training phase like AI/ML models. Its operational parameters are determined during assay development and validation, not through iterative training on a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no explicit "training set" mentioned in the context of an AI/ML model, this question is not directly applicable. The performance characteristics are established through the validation studies described, which include controlled spiking experiments and correlation with a gold standard method.
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Public Health
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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.
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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 Assayfor Amphetamine | DKZ | II | 862.3100 | 91 - Toxicology |
| RapidFRET Oral FluidAmphetamine Calibrator Set | DLJ | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral FluidAmphetamine 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
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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 forUse | Qualitative determination ofamphetamine in human oral fluid inclinical setting. | Qualitative and semi-quantitativedetermination of amphetamine in humanoral fluid in clinical setting. |
| Methodology | Competitive homogeneousimmunoassay. | Competitive homogeneousimmunoassay. |
| KitComponents | 1 Drug specific antibody reagent in liquid,ready to use format.1 Drug conjugate reagent in liquid, readyto use format. | 1 Drug specific antibody reagent in liquid,ready to use format.1 Drug conjugate reagent in liquid, readyto use format. |
| PerformanceCharacteristics | Precision, accuracy, crossreacting/interfering studies demonstrateequivalence to the predicate device. | Precision, accuracy, crossreacting/interfering studies are similar tothe RapidFRET Oral Fluid Assay forAmphetamine. |
| 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 FluidCutoff Level | 50 ng/mL neat oral fluid. | 120 ng/mL neat oral fluid using a 40ng/mL cutoff calibrator to account forsample dilution by collection device. |
| Platform | RapidFRET Integrated Workstationavailable exclusively from BiophorDiagnostics, Inc. | Roche Modular P Analyzer |
| SampleCollection | Neat oral fluid is collected with theRapidEASE Oral Fluid Collector via directexpectoration. No diluent is used andsample is stored in glass sample tubewith inert screw cap. | Oral fluid is collected with the InterceptOral Specimen Collection Device. Thisdevice uses an absorbent swab anddiluent. Sample is stored in plastic tubewith snap cap. |
| Principle andProcedure | Drugs in the oral fluid sample competewith the drug conjugate donorfluorophore for a fixed number of bindingsites on the individual drug antibodyacceptor reagents. When acceptor anddonor fluorophores are brought intoclose proximity, through the bindingevent, fluorescent energy transfer ismeasured.The amount of drug in the specimensample is inversely proportional to theassay signal as measured by timeresolved fluorescence. | The assay is based on the sampleanalytes competing with analyteconjugates to antibody coatedmicroparticles for antibody binding sites.The amount of drug in the specimen isdirectly proportional to the assay signalas measured by absorbance. |
| Controls andCalibratorLevels | Calibrators are available at 0 ng/mL and50 ng/mL. Controls are available at 25ng/mL and 75 ng/mL. | Calibrators are available at 0 ng/mL and40 ng/mL for qualitative mode. Controlsare available at 20 ng/mL (0.5X) and 60ng/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.
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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.
§ 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).