THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

K101744 · Microgenics Corp. · LDJ · Apr 8, 2011 · Clinical Toxicology

Device Facts

• Record ID: K101744
• Device Name: THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
• Applicant: Microgenics Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

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 3.0 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-Δ⁹ THC and performed on the MGC240. 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 1-Δ⁹ 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.

Device Story

Homogeneous enzyme immunoassay for qualitative detection of cannabinoids in human oral fluid; utilizes recombinant DNA technology with bacterial β-galactosidase enzyme engineered into two inactive fragments. Input: oral fluid collected via Oral-Eze™ Saliva Collection System. Principle: competitive binding; analyte in sample competes with enzyme-conjugated analyte for antibody binding sites; free inactive fragments re-associate to form active enzyme; active enzyme cleaves substrate to produce spectrophotometrically measurable color change. Output: absorbance change proportional to analyte concentration. Used in clinical chemistry laboratories; operated by laboratory technicians. Results provide preliminary screening; clinical judgment required; positive results necessitate confirmatory testing via GC/MS or LC-MS/MS. Benefits: rapid, automated screening for drug abuse in clinical settings.

Clinical Evidence

Bench testing only. Precision studies (n=50 per concentration) showed 100% agreement for negative and near-cutoff samples. Method comparison studies (n=42 and n=81) against GC/MS/LC-MS-MS confirmed 98-100% agreement for positive and negative results. Analytical specificity evaluated against numerous structurally related and unrelated compounds; no significant interference observed.

Technological Characteristics

Homogenous enzyme immunoassay; recombinant β-galactosidase technology. Reagents: lyophilized enzyme donor/acceptor fragments, monoclonal anti-THC antibody, chlorophenol red-β-D-galactopyranoside. Form factor: liquid/lyophilized reagents for MGC240 analyzer. Connectivity: standalone analyzer. Sterilization: N/A. Software: rule-based spectrophotometric analysis.

Indications for Use

Indicated for qualitative determination of cannabinoids in human oral fluid for clinical laboratory use. Requires collection via Oral-Eze™ Saliva Collection System. Not for point-of-care settings. Provides preliminary results requiring confirmation by GC/MS or LC-MS/MS.

Regulatory Classification

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 include delta-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.

Special Controls

*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).

Predicate Devices

• STC Cannabinoids Intercept Micro-plate EIA, OTI, Orasure Technologies Inc (k002375)

Submission Summary (Full Text)

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

#### Date Prepared

May 15, 2010

#### Requlatory Declarations

| Common / Usual Name | CEDIA® Cannabinoids OFT Assay<br>CEDIA® THC OFT Calibrators |
|---------------------------|---------------------------------------------------------------------------|
| Trade/ Proprietary Name | Thermo CEDIA® Cannabinoids OFT Assay<br>Thermo CEDIA® THC OFT Calibrators |
| Classification Regulation | 21 CFR 862.3870<br>21 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 Device<br>CEDIA® Cannabinoids OFT Assay | Predicate Device<br>OTI Cannabinoids Intercept® MICRO-PLATE EIA<br>K002375 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Cannabinoids OFT Assay is intended for use in the<br>qualitative determination of<br>Cannabinoids in human oral fluid at<br>a cutoff concentration of 3 ng/mL in<br>neat oral fluid. The specimen must<br>be collected exclusively with the<br>Oral-Eze™ Saliva Collection<br>System. The assay is calibrated<br>against l-Δ9 THC and performed on<br>the MGC 240. This <i>in vitro</i><br>diagnostic device is intended for<br>clinical laboratory use only. | The OTI Cannabinoids Intercept®<br>MICRO-PLATE EIA is intended for<br>use by clinical laboratories in the<br>qualitative determination of<br>cannabinoids in oral fluid collected<br>with the Intercept® Drugs of Abuse<br>(DOA) Oral Specimen Collection<br>Device. For <i>In Vitro</i> Diagnostic Use. |
| | The CEDIA THC OFT Calibrators<br>are intended for use in the<br>calibration of I-Δ9 THC when used<br>with the CEDIA Cannabinoids OFT<br>Assay. This <i>in vitro</i> diagnostic<br>device is intended for clinical<br>laboratory use only. | The OTI Cannabinoids Intercept®<br>MICRO-PLATE EIA provides only a<br>preliminary analytical test result. A<br>more specific alternative chemical<br>method should be used in order to<br>obtain a confirmed analytical result.<br>Gas chromatography/mass<br>spectrometry (GC/MS/MS) is the<br>preferred confirmatory method. This<br>is a confirmation method that is<br>currently pending SAMHSA<br>acceptance. Clinical consideration<br>and professional judgment should<br>be applied to any drugs of abuse<br>test result, particularly when a<br>preliminary, positive result is<br>observed. |
| | The CEDIA Cannabinoids OFT<br>Assay provides only a preliminary<br>analytical test result. A more specific<br>alternative method must be used to<br>obtain a confirmed analytical result.<br>Gas 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. | |
| Test<br>Principle | Microgenics CEDIA® Cannabinoids<br>OFT Assay uses recombinant DNA<br>technology to produce a unique<br>homogeneous enzyme<br>immunoassay system. The assay is<br>based on the bacterial enzyme β-<br>galactosidase, which has been<br>genetically engineered into two | The OTI Cannabinoids Intercept®<br>MICRO-PLATE EIA is a competitive<br>immunoassay for the detection of<br>cannabinoids in oral fluid collected<br>with the Intercept® DOA Oral<br>Specimen Collection Device.<br>Specimen or standard is added to<br>an EIA well in combination with an |
| | spontaneously re-associate to form<br>fully active enzyme that, in the<br>assay format, cleave a substrate,<br>generating a color change that can<br>be measured<br>spectrophotometrically.<br><br>In the assay, analyte in the sample<br>competes with analyte conjugated to<br>one inactive fragment (enzyme<br>donor) of β-galactosidase for<br>antibody binding site. If analyte is<br>present in the sample, it binds to<br>antibody, leaving the inactive<br>enzyme fragment free to form active<br>enzyme. If the analyte is not present<br>in the sample, antibody binds to<br>analyte conjugated on the inactive<br>fragment, inhibiting the re-<br>association of inactive β-<br>galactosidase fragments, and no<br>active enzyme is formed. The<br>amount of active enzyme formed<br>and resultant absorbance change<br>are directly proportional to the<br>amount of analyte present in the<br>sample. | In an EIA well containing an oral<br>fluid specimen positive for<br>cannabinoids, there is a competition<br>between the drug and the enzyme<br>labeled hapten to bind the antibody<br>fixed on the EIA well. EIA wells are<br>then washed, substrate is added,<br>and color is produced. The<br>absorbance measured for each well<br>at 450 nm is inversely proportional<br>to the amount of cannabinoids<br>present in the specimen or<br>calibrator/control. |
| Sample<br>Matrix | Oral Fluid | Oral Fluid |
| Calibrator<br>levels | 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 |
| Unassayed<br>Control<br>levels | 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 [phone]. 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 [phone] or [phone] 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