(58 days)
The RapidFRET Oral Fluid Assay for OPIATES 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 Opiates at 40 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated against Morphine. 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 OPIATES and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to translate the sample 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 Opiates is provided in an all liquid, ready to use format. Two reagents are provided included a drug specific reagent and a second competitive donor reagent. The kit is provided with reagents and microtiter plates. 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. Calibrators and controls are sold separately.
Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided 510(k) summary for the RapidFRET Oral Fluid Assay for OPIATES:
Acceptance Criteria and Device Performance Study
The RapidFRET Oral Fluid Assay for OPIATES is a qualitative screening device intended to detect opiates in oral fluid. The acceptance criteria and supporting studies focus on the analytical performance of the device, particularly its precision, correlation with confirmatory methods, and analytical specificity (cross-reactivity).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this diagnostic device are implied through the performance observed in the studies designed to demonstrate substantial equivalence to the predicate device. The key performance characteristics evaluated were precision (analytical sensitivity), correlation with mass spectrometry (GC/MS or LC/MS/MS), and cross-reactivity/analytical specificity.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Precision (Analytical Sensitivity) | The device should demonstrate consistent and accurate results around the cutoff concentration (40 ng/mL). Specifically, it should reliably identify samples below 75% of cutoff as negative and samples above 125% of cutoff as positive. Performance at the cutoff (100%) should show a mix of positive and negative results, indicating appropriate sensitivity. |
| Correlation with Confirmatory Methods (Accuracy) | High agreement between the device's screening results and a more specific alternate chemical method (GC/MS or LC/MS/MS) for both positive and negative samples, particularly within the clinically relevant concentration ranges. |
| Analytical Specificity (Cross-Reactivity) | The device should not show significant cross-reactivity with structurally unrelated compounds or common substances/interferents at clinically relevant concentrations that would lead to false positive or false negative results, while appropriately reacting with structurally related opiate compounds. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Analytical Sensitivity Test Set: For precision, samples were created by spiking negative oral fluid pools with Morphine at various concentrations (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, and 200% of the 40 ng/mL cutoff). Three lots of the assay were run four times daily for a minimum of 20 days.
- The total number of individual runs/data points (N) per concentration level varied from 263 to 294 (e.g., N=279 for 0% and 25%, N=278 for 50%, N=279 for 75%, N=279 for 100%, N=278 for 125%, N=263 for 150%, N=294 for 175%, N=278 for 200%).
- Data Provenance: Retrospective, as negative oral fluid pools were "spiked" to create controlled samples. The origin of the negative oral fluid pools is not explicitly stated (e.g., country of origin, volunteer demographics).
- Correlation with MS Quantitation Test Set:
- Sample Size: 245 neat oral fluid samples from volunteers potentially positive and negative for opiates.
- Data Provenance: Prospective, as samples were collected from volunteers and then tested. The origin of the volunteers (e.g., country) is not specified. The samples were handled in a blinded and randomized manner for instrument operators.
- Cross-Reactivity and Analytical Specificity Test Set:
- Sample Size: 167 different compounds (for cross-reactivity). For interference, common substances were tested (specific number of substances not explicitly stated, but includes HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, lgA, lgG, IgM; various pH values; and items like mouthwash, cough syrup, etc., tested after volunteers used them).
- Data Provenance: Retrospective for the spiked compound library. For common substances, it involved volunteer participation (prospective for the collection part for some items) and then spiking or testing original samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Precision/Analytical Sensitivity: The ground truth was established by precise spiking concentrations of Morphine into negative oral fluid pools. No human experts were involved in establishing this analytical ground truth.
- Correlation with MS Quantitation: The ground truth was established by confirmatory testing using GC/MS or LC/MS/MS. These are highly accurate analytical methods considered the gold standard for drug confirmation. The document does not specify the number or qualifications of the analysts performing the GC/MS or LC/MS/MS.
- Cross-Reactivity/Analytical Specificity: The ground truth was established by the known concentration of the spiked compounds and the known presence/absence of morphine. No human experts were involved in establishing this analytical ground truth.
4. Adjudication Method for the Test Set
- Precision/Analytical Sensitivity, Cross-Reactivity/Analytical Specificity: No adjudication method was mentioned as these were analytical studies with predefined concentrations and expected outcomes.
- Correlation with MS Quantitation: The comparison was directly between the RapidFRET assay results and the established gold-standard GC/MS or LC/MS/MS results. The text implies a direct comparison rather than an adjudication process involving multiple human reviewers for interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, where the output is typically a quantitative or qualitative (positive/negative) result generated by an instrument. The studies focus on the analytical performance of the assay itself, not on how human readers interpret images or data with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the RapidFRET Oral Fluid Assay for OPIATES. The device is intended for use in central laboratories, and the performance characteristics (precision, correlation with MS, cross-reactivity) are evaluated for the assay system itself, without an explicit "human-in-the-loop" component altering the assay's direct output. The assay provides a preliminary result, and a human professional interprets the results and applies judgment, but this is post-analysis, not part of the primary device performance evaluation described here.
7. The Type of Ground Truth Used
- Precision/Analytical Sensitivity: Spiked concentrations (known amounts of opiate in negative matrix).
- Correlation with MS Quantitation: Confirmatory analytical methods (GC/MS or LC/MS/MS) results.
- Cross-Reactivity/Analytical Specificity: Known concentrations of spiked compounds and known presence/absence of morphine.
8. The Sample Size for the Training Set
The document does not specify a separate training set for the device. As an immunoassay (competitive homogeneous immunoassay), the "training" (development and optimization) would involve biochemical and chemical engineering processes, often using various concentrations of analytes and interferents during the assay's development prior to validation. The studies described are validation and verification studies using manufactured products.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is described in the context of machine learning or AI, the concept of ground truth for a training set in this biological assay context refers to the controlled conditions and known spiking concentrations used during the assay's development and optimization phase. This would typically involve:
- Precisely prepared calibrators and controls: Manufactured with known concentrations of the target analyte (Morphine) to set the assay's detection limits and cutoff.
- Reference materials: Use of pure chemical standards for opiates and potential interferents.
- Known negative and positive samples: Prepared by either ensuring the absence of the analyte or by spiking known concentrations into a verified negative matrix.
These known values guide the formulation and calibration of the assay reagents and the setting of the cutoff level for discriminating positive from negative results.
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JAN 2 4 2014
510(k) Summary for the RapidFRET Oral Fluid Assay for OPIATES
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: K133642
807.92(a){1}: Contact Information
Biophor Diagnostics, Inc. Name: Address: 1201 Douglas Avenue Redwood City, CA 94063
Nathaniel G. Butlin, Ph.D. Contact: 650-367-4954 Phone: Fax: 650-364-4985
807.92(a){2): Device Name, Common Name and Classification
RapidFRET Oral Fluid Assay for OPIATES (Enzyme Immunoassay for Opiates) 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 OPIATES | DJG | II | 862.3650 | 91 - Toxicology |
| RapidFRET Oral Fluid Calibrator Set | DKB | II | 862.3200 | 91 - Toxicology |
| RapidFRET Oral Fluid Control Set | DIF | I | 862.3280 | 91 - Toxicology |
807.92(a){3}: Identification of Legally Marketed Predicate Devices
Thermo Scientific CEDIA® Opiates OFT Assay (K101754).
807.92(a)(4): Assay Principle
The RapidFRET Oral Fluid Assay for OPIATES is an In Vitro Diagnostic competitive immunoassay used to detect opiates 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.
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Device Description
The RapidFRET Oral Fluid Assay for Opiates is provided in an all liquid, ready to use format. Two reagents are provided included a drug specific reagent and a second competitive donor reagent. The kit is provided with reagents and microtiter plates. 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. Calibrators and controls are sold separately.
807.92(a){5}: Intended Use
The RapidFRET Oral Fluid Assay for OPIATES 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 Opiates at 40 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated against Morphine. 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 OPIATES 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 OPIATES) | Predicate Device(Thermo Opiates, K101754) | |
|---|---|---|
| Indications forUse | Qualitative determination of opiates inhuman oral fluid in central labs.Prescription use only. | - Qualitative determination of opiates inhuman oral 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(marketed in combination as a lyophilizedreagent and reconstitution buffer).1 Drug conjugate reagent (marketed incombination as a lyophilized reagent andreconstitution buffer). |
| Candidate Device(RapidFRET OPIATES) | Predicate Device(Thermo Opiates, K101754) | |
| PerformanceCharacteristics | Precision, accuracy, crossreacting/interfering studies demonstrateequivalence to the predicate device. | Precision, accuracy, crossreacting/interfering studies are similar tothe RapidFRET Oral Fluid Assay forOPIATES. |
| Safety andEffectiveness | Demonstrated in bench testing anddescribed in PI, equivalent to predicate. | Demonstrated in bench testing anddescribed in PI. |
| Neat Oral FluidCutoff Level | 40 ng/mL neat oral fluid. | 30 ng/mL neat oral fluid using a 10 ng/mLcutoff calibrator to account for sampledilution by collection device. |
| Platform | RapidFRET Integrated Workstationavailable exclusively from BiophorDiagnostics, Inc. | MGC240 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 Oral-EzeSaliva Collection System. This device usesan absorbent swab and diluent. Sample isstored in plastic tube with 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 one inactive fragment of ß-galactosidase 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 and40 ng/mL. Controls are available at 20ng/mL and 60 ng/mL. | Calibrators are available at 0 ng/mL, 10ng/mL, and 80 ng/mL. Controls areavailable at additional levels. |
807.92(a){6): Technological Similarities and Differences to the Predicate
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Biophor Diagnostics, Inc.
Traditional Premarket Notification 510(k) Submission RapidFRET Oral Fluid Assay for Opiates
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
.
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Three lots of the RapidFRET Oral Fluid Assay for OPIATES were analyzed, four times daily, for a minimum of 20 days. Negative oral fluid pools were spiked with Morphine at 0%, 25%, 50%, 75%, 100%, 125%, 150%, 175% and 200% of the cutoff level corresponding to approximately 0, 10, 20, 30, 40, 50, 60, 70 and 80 ng/mL. The aggregate data is summarized in the table below:
| Table 18.2.7. All Lots Precision Results Summary by Data Points | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
| POS | 0 | 0 | 0 | 0 | 185 | 278 | 263 | 294 | 278 |
| NEG | 279 | 279 | 278 | 279 | 94 | 0 | 0 | 0 | 0 |
| N | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |
| Table 18.2.8. All Lots Precision Results Summary by Percent Agreement | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0% | 25% | 50% | 75% | 100% | 125% | 150% | 175% | 200% | |
| POS | 0% | 0% | 0% | 0% | 66% | 100% | 100% | 100% | 100% |
| NEG | 100% | 100% | 100% | 100% | 34% | 0% | 0% | 0% | 0% |
| N | 279 | 279 | 278 | 279 | 279 | 278 | 263 | 294 | 278 |
The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 100% frequency.
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=245) were randomized and blinded to the instrument operator and assayed using RapidFRET Opiates reagents. Following screening, positive and negative samples were sent for confirmatory testing. The summarized data are shown below.
Table of Summary Results
| Negative | Near CutoffNegative | Near CutoffPositive | High Positive | |
|---|---|---|---|---|
| As determined by thepredicate device or lessthan half the cutoffconcentration byGC/MS | Between 50%below the cutoffand the cutoffconcentration | Between thecutoff and 50%above the cutoffconcentration | Greater than50% above thecutoffconcentration | |
| Positive | 0 | 1 | 10 | 53 |
| Negative | 177 | 4 | 0 | 0 |
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Table of Discordant Results
| Cutoff Value | Assay(POS / NEG) | Drug / Metabolite LC/MS Value (ng/mL) |
|---|---|---|
| 40 ng/mL | Positive | Total Opiates = 36.5 ng/mL (26.8 ng/mLMorphine and 9.7 ng/mL Codeine) |
The data indicate that the RapidFRET Oral Fluid Assay for OPIATES had an agreement of >98% for RapidFRET positive samples and an agreement of 100% for RapidFRET negative samples 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, 20 ng/mL and 60 ng/mL of morphine, processed with the RapidEASE Collector, and tested with the RapidFRET OPIATES 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. Twenty nine (29) structurally related compounds were determined to cross-react below 30,000 ng/mL in the absence of morphine with twelve cross-reacting at 1000 ng/mL equivalence or less.
| Compound | Level(ng/mL) | 0% Morphinet(0 ng/mL) | 50% Morphinet(20 ng/mL) | 150% Morphinet(60 ng/mL) |
|---|---|---|---|---|
| Structurally Related Compounds That Cross React in Neat Oral Fluid Pool with 0 ng/ml Morphine | ||||
| 6-Monoacetylmorphine | 30,000 | 36 [111%] | POS | POS |
| Amitriptyline | 30,000 | 12,854 [0.3%] | POS | POS |
| Chlorpromazine | 30,000 | 12,215 [0.3%] | POS | POS |
| Clomipramine | 30,000 | 2,017 [2.0%] | POS | POS |
| Codeine | 30,000 | 31 [129%] | POS | POS |
| Cyclizine | 30,000 | 10,179 [0.4%] | POS | POS |
| Cyclobenzaprine | 30,000 | 17,887 [0.2%] | POS | POS |
| Desipramine | 30,000 | 6,754 [0.6%] | POS | POS |
| Diacetylmorphine (Heroin) | 30,000 | 40 [100%] | POS | POS |
| Dihydrocodeine | 30,000 | 32 [125%] | POS | POS |
| Doxepin | 30,000 | 19,538 [0.2%] | POS | POS |
| d-Propoxyphene | 30,000 | 23,593 [0.2%] | POS | POS |
| Ethylmorphine | 30,000 | 31 [129%] | POS | POS |
| Flurazepam | 30,000 | 5,905 [0.7%] | POS | POS |
| Hydrocodone | 30,000 | 41 [98%] | POS | POS |
| Hydromorphone | 30,000 | 35 [114%] | POS | POS |
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| Table 18.8.2. Structurally Related Cross Reactants | ||||
|---|---|---|---|---|
| Compound | Level(ng/mL) | 0% Morphinet(0 ng/mL) | 50% Morphinet(20 ng/mL) | 150% Morphinet(60 ng/mL) |
| Imipramine | 30,000 | 1,368 [2.9%] | POS | POS |
| Levorphanol | 30,000 | 348 [11%] | POS | POS |
| Meperidine | 30,000 | 12,634 [0.3%] | POS | POS |
| Morphine-3βDG | 30,000 | 31 [129%] | POS | POS |
| Nalorphine | 30,000 | 37 [108%] | POS | POS |
| Naloxone | 30,000 | 429 [9.3%] | POS | POS |
| Naltrexone | 30,000 | 2,720 [1.5%] | POS | POS |
| Normorphine | 30,000 | 3,318 [1.2%] | POS | POS |
| Oxycodone | 30,000 | 533 [7.5%] | POS | POS |
| Oxymorphone | 30,000 | 831 [4.8%] | POS | POS |
| Rifampin | 30,000 | 8,371[0.5%] | POS | POS |
| Thioridazine | 30,000 | 18,104 (0.2%) | POS | * |
| Trimipramine | 30,000 | 1,947 (2.1%) | POS | POS |
t Results are presented as either the RapidFRET OPIATES screening result (POS / NEG) or the concentration in ng/mL of the cross-reactant that gives a Cutoff equivalent response. *Due to high cross reactivity at 0 ng/mL morphine, a 60 ng/mL morphine spike was not analyzed.
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 20 ng/mL or 60 ng/ml of morphine. Neat oral fluid pool was titrated to pH values of 5, 6, 7, 8 and 9, spiked with morphine to 20 ng/mL or 60 ng/mL and assayed with the RapidFRET OPIATES 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 morphine to 20 ng/mL or 60 ng/mL, processed with a RapidEASE Collector and assayed with the RapidFRET OPIATES device. All compounds at the listed concentrations gave a NEG result when spiked with 20 ng/mL morphine and a POS result when spike with 60 ng/mL morphine.
807.92(b)(3): Conclusions
The RapidFRET Oral Fluid Assay for OPIATES 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 substantially equivalent in safety and effectiveness for their intended use.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of 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 fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2014
BIOPHOR DIAGNOSTICS, INC. NATHANIEL BUTLIN VICE PRESIDENT 1201 DOUGLAS AVE REDWOOD CITY CA 94063
Re: K133642
Trade/Device Name: RapidFRET Oral Fluid Assay For Opiates RapidFRET Oral Fluid Calibrator Set RapidFRET Oral Fluid Control Set Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKB, DIF
Dated: November 26, 2013 Received: November 27, 2013
Dear Mr. 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 (OS) regulation (21 CFR Part 820); and if applicable, the
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Page 2-Mr. Butlin
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 CER 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/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133642
Device Name
RapidFRET Oral Fluid Assay for OPIATES; RapidFRET Oral Fluid Calibrator Set; RapidFRET Oral Fluid Control Set
Indications for Use (Describe)
The RapidFRET Oral Fluid Assay for OPIATES is a homogeneous ime-resolved fluorescence assay that is intended for pressiption use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Opiates at 40 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated against Morphine. This assay provides only a prelimined analytical result, a more specific alternate chemical method such as GCMS or LCMSMS 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 OPIATES and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to delemine 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.
Type of Use (Select one or both, as applicable)
P 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)
T. Danishefskv -
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 441-6740 EF
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).