(58 days)
Not Found
No
The description focuses on a homogeneous time-resolved fluorescence assay and its components (reagents, calibrators, controls). There is no mention of AI, ML, or any computational analysis beyond translating a measurement into a positive or negative result based on a cutoff calibrator.
No
This device is an in vitro diagnostic (IVD) assay used to screen for opiates in oral fluid samples, not to treat or diagnose a disease in a patient directly.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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... This assay provides only a preliminary result." This indicates its use in identifying the presence of opiates, which is a diagnostic purpose.
No
The device description explicitly states it is provided in an all liquid, ready to use format with reagents and microtiter plates, indicating it is a physical assay kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only." This is a definitive indicator.
- Nature of the Test: The device performs a qualitative screen for Opiates in oral fluid samples. This is a laboratory test performed on a biological sample outside of the body, which is the definition of an in vitro diagnostic test.
- Intended Use: The assay is intended for prescription use in central laboratories, further reinforcing its use in a clinical or laboratory setting for diagnostic purposes.
- Components: The description mentions reagents, calibrators, and controls, which are standard components of IVD kits used for performing diagnostic tests.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKB, DIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
central laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Description: Neat oral fluid was collected with the RapidEASE Oral Fluid Collection Device from volunteers potentially positive and negative for opiates.
Sample Size: n=245
Data Source: Volunteers
Annotation Protocol: The samples 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 (GC/MS and LC/MS/MS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Precision and Analytical Sensitivity
Sample Size: Not specified (refers to number of runs and days, not patients)
Key Results: The data indicate that the analytical sensitivity is between 75% and 125% of cutoff, and expected results were achieved at a 100% frequency.
Study Type: Correlation with MS Quantitation
Sample Size: 245
Key Results: 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.
Study Type: Cross Reactivity and Analytical Specificity
Sample Size: A compound library of 167 different compounds; not specified for the second study of common substances.
Key Results: 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. For the second study (common substances), 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision and Analytical Sensitivity:
At 100% (40 ng/mL), 66% POS, 34% NEG.
At 125% (50 ng/mL) and above, 100% POS.
At 75% (30 ng/mL) and below, 0% POS.
Correlation with MS Quantitation (Table of Summary Results):
Agreement for positive samples: >98%
Agreement for negative samples: 100%
One discordant result: RapidFRET positive at 40 ng/mL cutoff, but LC/MS value was 36.5 ng/mL total opiates.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Thermo Scientific CEDIA® Opiates OFT Assay (K101754).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 | Regulation
Section | 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.
1
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 for
Use | Qualitative determination of opiates in
human oral fluid in central labs.
Prescription use only. | - Qualitative determination of opiates in
human oral fluid in clinical setting. |
| Methodology | Competitive homogeneous
immunoassay. | Competitive homogeneous
immunoassay. |
| Kit
Components | 1 Drug specific antibody reagent in liquid,
ready to use format.
1 Drug conjugate reagent in liquid, ready
to use format. | 1 Drug specific antibody reagent
(marketed in combination as a lyophilized
reagent and reconstitution buffer).
1 Drug conjugate reagent (marketed in
combination as a lyophilized reagent and
reconstitution buffer). |
| | Candidate Device
(RapidFRET OPIATES) | Predicate Device
(Thermo Opiates, K101754) |
| Performance
Characteristics | Precision, accuracy, cross
reacting/interfering studies demonstrate
equivalence to the predicate device. | Precision, accuracy, cross
reacting/interfering studies are similar to
the RapidFRET Oral Fluid Assay for
OPIATES. |
| Safety and
Effectiveness | Demonstrated in bench testing and
described in PI, equivalent to predicate. | Demonstrated in bench testing and
described in PI. |
| Neat Oral Fluid
Cutoff Level | 40 ng/mL neat oral fluid. | 30 ng/mL neat oral fluid using a 10 ng/mL
cutoff calibrator to account for sample
dilution by collection device. |
| Platform | RapidFRET Integrated Workstation
available exclusively from Biophor
Diagnostics, Inc. | MGC240 analyzer |
| Sample
Collection | Neat oral fluid is collected with the
RapidEASE Oral Fluid Collector via direct
expectoration. No diluent is used and
sample is stored in glass sample tube
with inert screw cap. | Oral fluid is collected with the Oral-Eze
Saliva Collection System. This device uses
an absorbent swab and diluent. Sample is
stored in plastic tube with snap cap. |
| Principle and
Procedure | Drugs in the oral fluid sample compete
with the drug conjugate donor
fluorophore for a fixed number of binding
sites on the individual drug antibody
acceptor reagents. When acceptor and
donor fluorophores are brought into
close proximity, through the binding
event, fluorescent energy transfer is
measured.
The amount of drug in the specimen
sample is inversely proportional to the
assay signal as measured by time
resolved fluorescence. | The assay is based on the sample
analytes competing with analyte
conjugates to one inactive fragment of ß-
galactosidase for antibody binding sites.
The amount of drug in the specimen is
directly proportional to the assay signal
as measured by absorbance. |
| Controls and
Calibrator
Levels | Calibrators are available at 0 ng/mL and
40 ng/mL. Controls are available at 20
ng/mL and 60 ng/mL. | Calibrators are available at 0 ng/mL, 10
ng/mL, and 80 ng/mL. Controls are
available at additional levels. |
807.92(a){6): Technological Similarities and Differences to the Predicate
2
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
.
3
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 Cutoff
Negative | Near Cutoff
Positive | High Positive |
|----------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------|
| | As determined by the
predicate device or less
than half the cutoff
concentration by
GC/MS | Between 50%
below the cutoff
and the cutoff
concentration | Between the
cutoff and 50%
above the cutoff
concentration | Greater than
50% above the
cutoff
concentration |
| Positive | 0 | 1 | 10 | 53 |
| Negative | 177 | 4 | 0 | 0 |
4
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/mL
Morphine 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 |
5
| 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.
6
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
7
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
8
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