THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY

K101753 · Microgenics Corp. · LAF · Apr 8, 2011 · Clinical Toxicology

Device Facts

• Record ID: K101753
• Device Name: THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
• Applicant: Microgenics Corp.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-methamphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Eze™ Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Methamphetamine 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

The CEDIA® Methamphetamine OFT Assay is a homogeneous enzyme immunoassay for clinical laboratory use. It utilizes recombinant DNA technology to produce a bacterial ß-galactosidase enzyme engineered into two inactive fragments (enzyme acceptor and enzyme donor). In the assay, methamphetamine in the oral fluid sample competes with methamphetamine conjugated to the enzyme donor for antibody binding sites. If methamphetamine is present, it binds to the antibody, allowing the inactive enzyme fragments to reassociate and form active enzyme; the active enzyme then cleaves a substrate, producing a color change measured spectrophotometrically. The absorbance change is directly proportional to the drug concentration. The device is used by laboratory technicians on the MGC 240 analyzer. Results provide a preliminary screen for methamphetamine; positive results require confirmation via GC/MS or LC-MS/MS. Clinical decision-making must incorporate professional judgment. The system benefits patients by providing a rapid, standardized method for drug screening in oral fluid.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=50/level). Method comparison studies performed on 41 and 81 clinical samples against GC/MS/LC-MS/MS reference methods. Analytical specificity tested against structurally related/unrelated compounds, endogenous substances, and common food/dental products. No clinical trials performed.

Technological Characteristics

Homogeneous enzyme immunoassay using recombinant ß-galactosidase fragments. Analyte detection via spectrophotometric measurement of color change. Requires Oral-Eze™ Saliva Collection System (absorbent pad with volume adequacy indicator). Calibrated against d-methamphetamine. Performed on MGC 240 clinical chemistry analyzer.

Indications for Use

Indicated for qualitative detection of methamphetamine in neat oral fluid at 120.0 ng/mL cutoff. For use in clinical chemistry laboratories by professional staff. Not for point-of-care settings. Requires Oral-Eze™ Saliva Collection System and MGC 240 Analyzer.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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 Methamphetamine Intercept® MICRO-PLATE EIA (K993208)

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: K101753

## Company/Contact person

APR - 8 2011

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: April 4, 2011

#### Regulatory Declarations

| Common / Usual Name | CEDIA® Methamphetamine OFT Assay |
|----------------------------|----------------------------------------------------|
| | CEDIA® Methamphetamine OFT Calibrators |
| Trade/ Proprietary Name | Thermo Scientific CEDIA® Methamphetamine OFT Assay |
| | Thermo Scientific CEDIA® Methamphetamine OFT |
| | Calibrators |
| Classification Regulations | 21 CFR 862.3610 |
| | 21 CFR 862.3200 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Codes | LAF, DLJ |

## Intended use

The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-methamphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Eze™ Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine 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® Methamphetamine 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® Methamphetamine OFT Assay is substantially equivalent to the previously cleared STC Methamphetamine Intercept® MICRO-PLATE EIA, K993208 (At present OT), OraSure Technologies Inc.)

### DESCRIPTION OF DEVICE

#### CEDIA® Methamphetamine OFT Assay

The CEDIA® Methamphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-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 assay format, cleaves 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 of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug 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

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The CEDIA® Methamphetamine OFT Assay is substantially equivalent to the OTI Methamphetamine Intercept® MICRO-PLATE EIA. (K993208)

| Comparison | Subject Device<br>CEDIA® Methamphetamine OFT Assay | Predicate Device<br>OTI Methamphetamine Intercept® MICRO-PLATE EIA<br>K993208 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-methamphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.<br><br>The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Eze™ Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only.<br><br>The CEDIA Methamphetamine 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 OTI Methamphetamine Intercept® MICRO-PLATE EIA is intended for use in the qualitative determination of methamphetamine in oral fluid collected with the Intercept Drugs of Abuse (DOA) Oral Specimen Collection Device. For In Vitro Diagnostic Use. |
| Test<br>Principle | Microgenics CEDIA® Methamphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system (5) | The OTI Methamphetamine Intercept® MICRO-PLATE EIA is a competitive immunoassay for the detection of methamphetamine in oral fluid collected with the Intercept® Oral Specimen Collection |
| | enzyme β-galactosidase, which has<br>been genetically engineered into<br>two inactive fragments. These<br>fragments spontaneously re-<br>associate to form fully active<br>enzyme that, in the assay format,<br>cleave a substrate, generating a<br>color change that can 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. | Device. Specimen or standard is<br>added to an EIA well in combination<br>with an enzyme -labeled hapten<br>derivative. In an EIA well containing<br>an oral fluid specimen positive for<br>cocaine or cocaine metabolites,<br>there is a competition between<br>cocaine and/or cocaine metabolite<br>and the enzyme labeled hapten to<br>bind to the antibody fixed onto the<br>EIQ well. EIA wells are then<br>washed, substrate is added, and<br>color is produced. The absorbance<br>measured at 450 nm is inversely<br>proportional to the amount of<br>cocaine or cocaine metabolite<br>present in the specimen or calibrator<br>/ control. |
| Sample<br>Matrix | Oral Fluid | Oral Fluid |
| Calibrator<br>levels | 0, 40, 200 ng/mL | 0 and 40 ng/mL |
| Cutoff level | 120 ng/mL in neat oral fluid | 40 ng/mL |
| Unassayed<br>Control<br>levels | 20 and 60 ng/mL | 20 and 80 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.

#### Method Comparison

The overall concordance between the CEDIA® Methamphetamine OFT Assay and GC/MS is 98.8%. The comparison of sample results by the CEDIA® Methamphetamine OFT Assay to GC/MS showed 97.6% sensitivity and 100.0% specificity.

## Conclusion

As summarized, the CEDIA® Methamphetamine OFT Assay is substantially equivalent to the OTI Methamphetamine Metabolite Intercept® MICRO-PLATE ElA. 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 logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an image of a stylized eagle or bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Microgenics Corp. c/o Lisa Charter 46360 Fremont Blvd. Fremont, CA 94538

APR 0 8 2011

Re: k101753

> Trade Name: Thermo Scientific CEDIA Methamphetamine OFT Assay and Thermo Scientific CEDIA Methamphetamine OFT Calibrators Regulation Number: 21 CFR 862.3610 Regulatory Class: II Product Codes: LAF, 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 from mber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

CJC.

Courtney 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): K101753

## Device Name: CEDIA® Methamphetamine OFT Assay CEDIA® Methamphetamine OFT Calibrators

## Indications for Use:

The CEDIA® Methamphetamine OFT Assay is intended for use in the qualitative detection of methamphetamine at a cutoff concentration of 120.0 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-methambhetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine OFT Calibrators are intended for use in the calibration of d-Methamphetamine when used with the CEDIA Methamphetamine OFT Assay for human oral fluid samples collected with the Oral-Eze™ Saliva Collection System. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Methamphetamine 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 Liguid 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)

Cawlf Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101753