(290 days)
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.
Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.
Acceptance Criteria and Device Performance for CEDIA® Cannabinoids OFT Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Precision | Samples below cutoff read as negative, samples above cutoff read as positive. | All samples tested recovered accurately. Samples at levels below the cutoff read as negative and samples at levels above the cutoff read as positive. |
| Qualitative Cutoff | Low control reads as negative, high control reads as positive. | All samples tested recovered accurately, low control as negative and high control level as positive. |
| Interference | No significant interference from endogenous and exogenous substances at tested concentrations and pH range of 5 to 9. | Results demonstrated that there was no significant interference from endogenous and exogenous substances in oral fluid at the tested concentrations and in samples adjusted to pH range of 5 to 9. |
| Specificity & Cross-Reactivity | No significant cross-reactivity with structurally unrelated compounds. Cross-reactivity to metabolites and structurally related compounds tested. | Cross-reactivity to metabolites and structurally related compounds was tested in the assay. No significant cross-reactivity was observed with other structurally unrelated compounds. |
| Overall Concordance with GC/MS | High concordance with GC/MS. Explicit threshold not specified. | The overall concordance between the CEDIA® Cannabinoids OFT Assay and GC/MS is 98.8%. |
| Sensitivity (vs. GC/MS) | Not explicitly stated, but high sensitivity is expected for drug screening assays. | The comparison of sample results by the CEDIA® Cannabinoids OFT Assay to GC/MS showed 97.6% sensitivity. |
| Specificity (vs. GC/MS) | Not explicitly stated, but high specificity is expected for drug screening assays. | The comparison of sample results by the CEDIA® Cannabinoids OFT Assay to GC/MS showed 100.0% specificity. |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state the sample size used for the qualitative method comparison test set (comparison with GC/MS). It only reports percentages for concordance, sensitivity, and specificity.
The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is highly likely that the studies were conducted in a retrospective manner using collected human oral fluid samples. The country of origin of the data is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The ground truth appears to be established by Gas Chromatography/Mass Spectrometry (GC/MS), which is typically considered a definitive method, minimizing the need for expert adjudication in interpreting the GC/MS results themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-powered image analysis tool or decision support system that would involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire summary of clinical testing (Qualitative Precision, Qualitative Cutoff Characterization, Interference, Specificity and Cross-Reactivity, and Qualitative Method Comparison) evaluates the performance of the CEDIA® Cannabinoids OFT Assay as a standalone algorithm (without human-in-the-loop performance). The comparison with GC/MS directly assesses its analytical accuracy.
7. Type of Ground Truth Used (Test Set)
The type of ground truth used for the significant performance metrics (concordance, sensitivity, and specificity) was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method, implying GC/MS is the primary reference.
8. Sample Size for Training Set
The document does not provide any information about a training set or its sample size. This is typical for traditional in vitro diagnostic assays which are often developed and validated using analytical studies rather than machine learning models that require distinct training and test sets.
9. How Ground Truth for Training Set Was Established
Since no training set is mentioned, information on how its ground truth was established is not provided.
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510K SUMMARY
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: K101744
Company/Contact person
Lisa Charter Manager, Regulatory Affairs Thermo Fisher Scientific, Clinical Diagnostic Division 46360 Fremont Blvd Fremont, CA 94538 Phone: (510) 979-5142 Facsimile: (510) 979-5422 e-Mail: Lisa.Charter@ThermoFisher.com
Date Prepared
May 15, 2010
Requlatory Declarations
| Common / Usual Name | CEDIA® Cannabinoids OFT AssayCEDIA® THC OFT Calibrators |
|---|---|
| Trade/ Proprietary Name | Thermo CEDIA® Cannabinoids OFT AssayThermo CEDIA® THC OFT Calibrators |
| Classification Regulation | 21 CFR 862.387021 CFR 862.3200 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | LDJ, DLJ |
Intended use
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.
Conditions for use
The CEDIA® Cannabinoids OFT Assay is for prescription professional use only in clinical chemistry laboratories. It is not for use in Point of Care settings.
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Legally marketed device to which equivalency is claimed
CEDIA® Cannabinoids OFT Assay is substantially equivalent to the previously cleared STC Cannabinoids Intercept® MICRO-PLATE EIA, K002375 (At present OTI, OraSure Technologies Inc.)
DESCRIPTION OF DEVICE
CEDIA® Cannabinoids OFT Assay
Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
Principle of Oral-Eze™ Saliva Collection System
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.
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Comparison of Technological Characteristics
CEDIA® Cannabinoids OFT Assay is compared below to the previously cleared STC
Cannabinoids Intercept® MICRO-PLATE EIA, K002375 (At present OTI, OraSure Technologies Inc.)
| Comparison | Subject DeviceCEDIA® Cannabinoids OFT Assay | Predicate DeviceOTI Cannabinoids Intercept® MICRO-PLATE EIAK002375 |
|---|---|---|
| Intended Use | The CEDIA® Cannabinoids OFT Assay is intended for use in thequalitative determination ofCannabinoids in human oral fluid ata cutoff concentration of 3 ng/mL inneat oral fluid. The specimen mustbe collected exclusively with theOral-Eze™ Saliva CollectionSystem. The assay is calibratedagainst l-Δ9 THC and performed onthe MGC 240. This in vitrodiagnostic device is intended forclinical laboratory use only. | The OTI Cannabinoids Intercept®MICRO-PLATE EIA is intended foruse by clinical laboratories in thequalitative determination ofcannabinoids in oral fluid collectedwith the Intercept® Drugs of Abuse(DOA) Oral Specimen CollectionDevice. For In Vitro Diagnostic Use. |
| The CEDIA THC OFT Calibratorsare intended for use in thecalibration of I-Δ9 THC when usedwith the CEDIA Cannabinoids OFTAssay. This in vitro diagnosticdevice is intended for clinicallaboratory use only. | The OTI Cannabinoids Intercept®MICRO-PLATE EIA provides only apreliminary analytical test result. Amore specific alternative chemicalmethod should be used in order toobtain a confirmed analytical result.Gas chromatography/massspectrometry (GC/MS/MS) is thepreferred confirmatory method. Thisis a confirmation method that iscurrently pending SAMHSAacceptance. Clinical considerationand professional judgment shouldbe applied to any drugs of abusetest result, particularly when apreliminary, positive result isobserved. | |
| The CEDIA Cannabinoids OFTAssay provides only a preliminaryanalytical test result. A more specificalternative method must be used toobtain a confirmed analytical result.Gas Chromatography/MassSpectrometry (GC/MS) and LiquidChromatography-Tandem MassSpectrometry (LC-MS/MS) are thepreferred confirmatory methods.Clinical consideration andprofessional judgment should beapplied to any drug of abuse testresult particularly when preliminarypositive results are used. | ||
| TestPrinciple | Microgenics CEDIA® CannabinoidsOFT Assay uses recombinant DNAtechnology to produce a uniquehomogeneous enzymeimmunoassay system. The assay isbased on the bacterial enzyme β-galactosidase, which has beengenetically engineered into two | The OTI Cannabinoids Intercept®MICRO-PLATE EIA is a competitiveimmunoassay for the detection ofcannabinoids in oral fluid collectedwith the Intercept® DOA OralSpecimen Collection Device.Specimen or standard is added toan EIA well in combination with an |
| spontaneously re-associate to formfully active enzyme that, in theassay format, cleave a substrate,generating a color change that canbe measuredspectrophotometrically.In the assay, analyte in the samplecompetes with analyte conjugated toone inactive fragment (enzymedonor) of β-galactosidase forantibody binding site. If analyte ispresent in the sample, it binds toantibody, leaving the inactiveenzyme fragment free to form activeenzyme. If the analyte is not presentin the sample, antibody binds toanalyte conjugated on the inactivefragment, inhibiting the re-association of inactive β-galactosidase fragments, and noactive enzyme is formed. Theamount of active enzyme formedand resultant absorbance changeare directly proportional to theamount of analyte present in thesample. | In an EIA well containing an oralfluid specimen positive forcannabinoids, there is a competitionbetween the drug and the enzymelabeled hapten to bind the antibodyfixed on the EIA well. EIA wells arethen washed, substrate is added,and color is produced. Theabsorbance measured for each wellat 450 nm is inversely proportionalto the amount of cannabinoidspresent in the specimen orcalibrator/control. | |
| SampleMatrix | Oral Fluid | Oral Fluid |
| Calibratorlevels | 0, 1.0, 10.0 ng/mL | 0, 1.0 ng/mL |
| Cutoff level | 3.0 ng/mL in neat oral fluid | 1.0 ng/mL |
| UnassayedControllevels | 0.5, 1.5 ng/mL | 0.5, 2.0 ng/mL |
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SUMMARY OF CLINICAL TESTING
Qualitative Precision
All samples tested recovered accurately. Samples at levels below the cutoff read as negative and samples at levels above the cutoff read as positive.
Qualitative Cutoff Characterization
All samples tested recovered accurately, low control as negative and high control level as positive.
Interference
Results demonstrated that there was no significant interference from endogenous and exogenous substances in oral fluid at the tested concentrations and in samples adjusted to pH range of 5 to 9.
Specificity and Cross-Reactivity
Cross-reactivity to metabolites and structurally related compounds was tested in the assay. No significant cross-reactivity was observed with other structurally unrelated compounds.
Qualitative Method Comparison
The overall concordance between the CEDIA® Cannabinoids OFT Assay and GC/MS is 98.8%. The comparison of sample results by the CEDIA® Cannabinoids OFT Assay to GC/MS showed 97.6% sensitivity and 100.0% specificity.
Conclusion
As summarized, the CEDIA® Cannabinoids OFT Assay is substantially equivalent to the OTI Cannabinoids Intercept® MICRO-PLATE EIA. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of several curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 0 8 2011
Microgenics Corp. c/o Lisa Charter 46360 Fremont Blvd. Fremont, CA 94538
Re: K101744
Trade Name: Thermo Scientific CEDIA Cannabinoids OFT Assay and Thermo Scientific CEDIA THC OFT Calibrators Regulation Number: 21 CFR 862.3870 Regulatory Class: Class II Product Codes: LDJ, DLJ Dated: March 10, 2011 Received: March 14, 2011
Dear Ms. Charter:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101744
Device Name: CEDIA® Cannabinoids OFT Assay CEDIA® THC OFT Calibrators
Indications for Use:
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 no/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against I-A THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-A THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.
Prescription Use × (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101744
§ 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).