(290 days)
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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.
The CEDIA® Cocaine OFT Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the presence of cocaine or cocaine metabolites, will have reduced activity due to competition for binding sites.
The CEDIA® Cocaine OFT Assay is an in vitro diagnostic device intended for qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL using the Oral-Eze™ Saliva Collection System on the MGC240. The assay provides a preliminary analytical test result, requiring a more specific alternative method like GC/MS or LC-MS/MS for confirmation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with numerical targets for sensitivity, specificity, or concordance. Instead, it presents the "Method Comparison" results as the primary performance metrics. The implicit acceptance criterion appears to be "high concordance" with the confirmatory method (GC/MS).
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Concordance with GC/MS | High Concordance | 97.6% |
| Sensitivity (vs. GC/MS) | High Sensitivity | 97.6% |
| Specificity (vs. GC/MS) | High Specificity | 97.6% |
| Qualitative Precision | Samples < cutoff read negative; Samples > cutoff read positive | All samples tested recovered accurately |
| Qualitative Cutoff Characterization | Low control negative; High control positive | All samples tested recovered accurately |
| Interferences | No significant interference | No significant interference from endogenous and exogenous substances or pH range (5-9) |
| Specificity and Cross-Reactivity | No significant cross-reactivity with unrelated compounds | No significant cross-reactivity observed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the method comparison study. It only mentions "All samples tested" for qualitative precision and cutoff characterization, which is not a specific number.
The data provenance is not explicitly stated regarding country of origin. The study appears to be a retrospective comparison, as it's comparing the device's results to a confirmatory method (GC/MS) implying the samples were processed and analyzed. There is no indication of a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a laboratory analytical method, not human expert consensus.
4. Adjudication Method for the Test Set
Since the ground truth was established by a laboratory analytical method (GC/MS) rather than human interpretation, an adjudication method for human readers is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The study focuses on the standalone performance of the assay compared to a gold standard analytical method.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Method Comparison" directly assesses the performance of the CEDIA® Cocaine OFT Assay itself (the "device") against the GC/MS reference method. The assay produces a preliminary analytical test result without direct human interpretation being part of its core performance measurement in this context. While clinical consideration and professional judgment are mentioned for the use of the preliminary positive results, the performance metrics (sensitivity, specificity, concordance) are purely for the device's analytical capability.
7. Type of Ground Truth Used
The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate and preferred confirmatory analytical method for drug testing, essentially serving as an objective "gold standard" for the presence or absence of cocaine.
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. As this is an immunoassay, the "training" analogous to machine learning would typically involve assay development and optimization using characterized samples, but this is not detailed.
9. How the Ground Truth for the Training Set Was Established
The document provides no information on how the ground truth for any training set was established. The focus of the provided text is on the performance evaluation of the final commercialized assay.
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APR - 8 2011 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: K101742
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 Email: Lisa.Charter@ThermoFisher.com
Date Prepared
January 6, 2011
יות האמר
Regulatory Declarations
| Common / Usual Name | CEDIA® Cocaine OFT Assay |
|---|---|
| Trade/ Proprietary Name | Thermo Scientific CEDIA® Cocaine OFT Assay |
| Classification Regulation | 21 CFR 862.3250 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | DIO |
Intended use
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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® Cocaine 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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Comparison of Technological Characteristics
The CEDIA® Cocaine OFT Assay is substantially equivalent to the OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA. (K001197)
| Comparison | Subject DeviceCEDIA® Cocaine OFT Assay | Predicate DeviceOTI Cocaine Metabolite Intercept®MICRO-PLATE EIAK001197 |
|---|---|---|
| Intended Use | The CEDIA® Cocaine OFT Assay isintended for use in the qualitativedetermination of cocaine in humanoral fluid at a cutoff concentration of15 ng/mL in neat oral fluid. Thespecimen must be collectedexclusively with the Oral-Eze™Saliva Collection System. Theassay is calibrated againstbenzoylecgonine and performed onthe MGC240. This in vitro diagnosticdevice is intended for clinicallaboratory use only.The CEDIA Cocaine OFT Assayprovides only a preliminaryanalytical test result. A morespecific alternative method must beused to obtain a confirmedanalytical result. GasChromatography/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. | The OTI Cocaine MetaboliteIntercept® MICRO-PLATE EIA isintended for use by clinicallaboratories in the qualitativedetermination of cocaine andcocaine metabolites in oral fluidcollected with the Intercept® Drugsof Abuse (DOA) Oral SpecimenCollection Device. For In VitroDiagnostic Use.The OTI Cocaine MetaboliteIntercept® MICRO-PLATE EIAprovides only a preliminaryanalytical test result. A morespecific alternative chemical methodshould be used in order to obtain aconfirmed analytical result. Gaschromatography/massspectrometry/mass spectrometry(GC/MS/MS) is the preferredconfirmatory method. This is aconfirmation method that is currentlypending SAMHSA acceptance.Clinical consideration andprofessional judgment should beapplied to any drugs of abuse testresult, particularly when apreliminary, positive result isobserved. |
| Principle Ofthe Assay | The CEDIA® Cocaine OFT Assayuses recombinant DNA technology(US Patent No. 4708929) toproduce a unique homogeneousenzyme immunoassay system. Theassay is based on the bacterialenzyme β-galactosidase, which hasbeen genetically engineered intotwo inactive fragments i.e., enzymeacceptor (EA) and enzyme donor(ED). These fragmentsspontaneously reassociate to formfully active enzyme that, in the | The OTI Cocaine MetaboliteIntercept® MICRO-PLATE EIA is acompetitive immunoassay for thedetection of cocaine and cocainemetabolites in oral fluid collectedwith the Intercept® Oral SpecimenCollection Device. Specimen orstandard is added to an EIA well incombination with an enzyme –labeled hapten derivative. In an EIAwell containing an oral fluidspecimen positive for cocaine orcocaine metabolites, there is a |
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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.
Interferences
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.
Method Comparison
The overall concordance between the CEDIA® Cocaine OFT Assay and GC/MS is 97.6%. The comparison of sample results by the CEDIA® Cocaine OFT Assay to GC/MS showed 97.6% sensitivity and 97.6% specificity. - 森林
Conclusion
As summarized, the CEDIA® Cocaine OFT Assay is substantially equivalent to the OTI Cocaine Metabolite 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Microgenics Corp. c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd Fremont, CA 94538
APR 0 8 2011,
Re: K101742
Trade Name: Thermo Scientific CEDIA Cocaine OFT Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system. Regulatory Class: Class II Product Codes: DIO Dated: April 6, 2011 Received: April 7, 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 paremarket 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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courthey 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): K101742
Device Name: CEDIA® Cocaine OFT Assay
Indications for Use:
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzovlecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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 C. Benson
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101742
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).