THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

K101742 · Microgenics Corp. · DIO · Apr 8, 2011 · Clinical Toxicology

Device Facts

• Record ID: K101742
• Device Name: THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
• Applicant: Microgenics Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

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.

Device Story

In vitro diagnostic assay for qualitative cocaine detection in human oral fluid; utilizes recombinant DNA technology and bacterial enzyme β-galactosidase; enzyme engineered into inactive fragments (enzyme acceptor and enzyme donor) that reassociate to form active enzyme; competitive immunoassay format; performed on MGC240 clinical chemistry analyzer; requires Oral-Eze™ Saliva Collection System; provides preliminary results for clinical laboratory use; requires confirmation via GC/MS or LC-MS/MS; assists clinicians in drug abuse screening; professional judgment required for interpretation.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical performance data: precision/reproducibility (N=50/level), cross-reactivity/interference testing, and method comparison studies. Method comparison (n=41 and n=82 samples) against LC-MS/MS showed 100% agreement in one study and 97.6% positive/negative agreement in another. Bench testing only.

Technological Characteristics

Homogeneous enzyme immunoassay using recombinant DNA technology (US Patent 4708929). Based on bacterial β-galactosidase engineered into inactive enzyme acceptor (EA) and enzyme donor (ED) fragments. Performed on MGC240 analyzer. Requires Oral-Eze™ Saliva Collection System for specimen collection.

Indications for Use

Indicated for qualitative determination of cocaine and cocaine metabolites in neat oral fluid at 15 ng/mL cutoff. For prescription professional use in clinical chemistry laboratories; not for Point of Care settings. Requires Oral-Eze Saliva Collection System and MGC 240 analyzer.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA (K001197)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] Email: [e-mail]

#### 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 Device<br>CEDIA® Cocaine OFT Assay | Predicate Device<br>OTI Cocaine Metabolite Intercept®<br>MICRO-PLATE EIA<br>K001197 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Cocaine OFT Assay is<br>intended for use in the qualitative<br>determination of cocaine in human<br>oral fluid at a cutoff concentration of<br>15 ng/mL in neat oral fluid. The<br>specimen must be collected<br>exclusively with the Oral-Eze™<br>Saliva Collection System. The<br>assay is calibrated against<br>benzoylecgonine and performed on<br>the MGC240. This <i>in vitro</i> diagnostic<br>device is intended for clinical<br>laboratory use only.<br><br>The CEDIA Cocaine OFT Assay<br>provides only a preliminary<br>analytical test result. A more<br>specific alternative method must be<br>used to obtain a confirmed<br>analytical result. Gas<br>Chromatography/Mass<br>Spectrometry (GC/MS) and Liquid<br>Chromatography-Tandem Mass<br>Spectrometry (LC-MS/MS) are the<br>preferred confirmatory methods.<br>Clinical consideration and<br>professional judgment should be<br>applied to any drug of abuse test<br>result particularly when preliminary<br>positive results are used. | The OTI Cocaine Metabolite<br>Intercept® MICRO-PLATE EIA is<br>intended for use by clinical<br>laboratories in the qualitative<br>determination of cocaine and<br>cocaine metabolites in oral fluid<br>collected with the Intercept® Drugs<br>of Abuse (DOA) Oral Specimen<br>Collection Device. For In Vitro<br>Diagnostic Use.<br><br>The OTI Cocaine Metabolite<br>Intercept® MICRO-PLATE EIA<br>provides only a preliminary<br>analytical test result. A more<br>specific alternative chemical method<br>should be used in order to obtain a<br>confirmed analytical result. Gas<br>chromatography/mass<br>spectrometry/mass spectrometry<br>(GC/MS/MS) is the preferred<br>confirmatory method. This is a<br>confirmation method that is currently<br>pending SAMHSA acceptance.<br>Clinical consideration and<br>professional judgment should be<br>applied to any drugs of abuse test<br>result, particularly when a<br>preliminary, positive result is<br>observed. |
| Principle Of<br>the Assay | The CEDIA® Cocaine OFT Assay<br>uses recombinant DNA technology<br>(US Patent No. 4708929) to<br>produce a unique homogeneous<br>enzyme immunoassay system. The<br>assay is based on the bacterial<br>enzyme β-galactosidase, which has<br>been genetically engineered into<br>two inactive fragments i.e., enzyme<br>acceptor (EA) and enzyme donor<br>(ED). These fragments<br>spontaneously reassociate to form<br>fully active enzyme that, in the | The OTI Cocaine Metabolite<br>Intercept® MICRO-PLATE EIA is a<br>competitive immunoassay for the<br>detection of cocaine and cocaine<br>metabolites in oral fluid collected<br>with the Intercept® Oral Specimen<br>Collection Device. Specimen or<br>standard is added to an EIA well in<br>combination with an enzyme –<br>labeled hapten derivative. In an EIA<br>well containing an oral fluid<br>specimen positive for cocaine or<br>cocaine 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 [phone]. 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 [phone] or [phone] 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