THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

K101745 · Microgenics Corp. · DKZ · Apr 8, 2011 · Clinical Toxicology

Device Facts

• Record ID: K101745
• Device Name: THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
• Applicant: Microgenics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 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-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Amphetamine 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 anv drug of abuse test result particularly when preliminary positive results are used.

Device Story

Homogeneous enzyme immunoassay for qualitative amphetamine detection in oral fluid. Uses recombinant DNA technology with bacterial enzyme beta-galactosidase split into inactive enzyme acceptor (EA) and enzyme donor (ED) fragments. Analyte in sample competes with analyte-conjugated inactive fragment for antibody binding sites. If analyte present, antibody binds to sample analyte, allowing EA and ED to reassociate into active enzyme; active enzyme cleaves substrate, producing spectrophotometrically measurable color change. Absorbance change proportional to drug concentration. Used in clinical laboratories on MGC 240 analyzer. Requires Oral-Eze Saliva Collection System. Provides preliminary results; requires confirmatory testing via GC/MS or LC-MS/MS. Clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision study (n=50 per level) followed CLSI EP5-A2 protocol. Method comparison studies against LC-MS/MS (n=42 and n=81 samples) showed 100% concordance in the first study and 98.8% concordance in the second, with 97.6% sensitivity and 100% specificity. Interference studies evaluated endogenous/exogenous substances and common oral products (tobacco, gum, etc.) with no impact on assay performance.

Technological Characteristics

Homogeneous enzyme immunoassay using recombinant beta-galactosidase fragments (EA/ED). Spectrophotometric detection. Calibrated against d-amphetamine. Performed on MGC 240 analyzer. Requires Oral-Eze Saliva Collection System for specimen collection.

Indications for Use

Indicated for qualitative determination of amphetamine in human oral fluid at 150 ng/mL cutoff. For prescription professional use in clinical chemistry laboratories. Not for Point of Care settings. Requires confirmation by GC/MS or LC-MS/MS.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

• Immunalysis Amphetamine ELISA for Oral Fluids (k051579)

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: K101745

### 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

February 14, 2011

#### Requlatory Declarations

| Common / Usual Name | CEDIA® Amphetamine OFT Assay |
|---------------------------|-------------------------------------|
| Trade/ Proprietary Name | Thermo CEDIA® Amphetamine OFT Assay |
| Classification Regulation | 21 CFR 862.3100 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | DKZ |

#### Intended use

The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 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-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Amphetamine 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 anv drug of abuse test result particularly when preliminary positive results are used.

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## Conditions for use

The CEDIA® Amphetamine OFT Assay is for prescription professional use only in clinical chemistry laboratories. It is not for use in Point of Care settings.

### Legally marketed device to which equivalency is claimed

CEDIA® Amphetamine OFT Assay is substantially equivalent to the previously cleared Immunalysis Amphetamine ELISA for Oral Fluids (K051579).

## DESCRIPTION OF DEVICE

## Principle of the CEDIA® Amphetamine OFT Assay

The CEDIA® Amphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, 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-qalactosidase 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 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® Amphetamine OFT Assay is substantially equivalent to the previously cleared Immunalysis Amphetamine ELISA for Oral Fluids (K051579).

| Comparison | Proposed Device<br>CEDIA® Amphetamine OFT Assay | Predicate Device<br>Immunalysis Amphetamine ELISA<br>for Oral Fluids, K051579 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The CEDIA® Amphetamine OFT<br>Assay is intended for use in the<br>qualitative determination of<br>amphetamine in human oral fluid at<br>a cutoff concentration of 150 ng/mL<br>in neat oral fluid. The specimen<br>must be collected exclusively with<br>the Oral-Eze™ Saliva Collection<br>System. The assay is calibrated<br>against d-amphetamine and<br>performed on the MGC 240. This <i>in<br/>vitro</i> diagnostic device is intended<br>for clinical laboratory use only.<br><br>The CEDIA Amphetamine 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. | The Immunalysis Amphetamine<br>ELISA test system utilizes an<br>Enzyme Linked Immunoassay<br>(ELISA) for the qualitative detection<br>of Amphetamine in oral fluid<br>samples collected with the<br>Quantisal™ oral fluid collection<br>device using a cutoff of 50 ng/mL of<br>d-Amphetamine. This <i>in-vitro</i><br>diagnostic device is intended for<br>clinical laboratory use only.<br><br>The Immunalysis Amphetamine<br>ELISA Kit for Oral Fluids provides<br>only a preliminary analytical rest<br>result. A more specific alternate<br>chemical method must be used in<br>order to obtain a confirmed<br>analytical result. Gas<br>chromatography/mass spectrometry<br>(GC/MS) is the preferred<br>confirmatory method. Clinical 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 | The CEDIA® Amphetamine OFT<br>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 ß-<br>galactosidase, which has been<br>genetically engineered into two<br>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<br>assay format cleaves a substrate | Enzyme-labeled drug and drug<br>present in the sample compete for<br>limited antibody binding sites.<br>Binding of the enzyme-labeled drug<br>inhibits its reaction with the<br>substrate, thereby influencing the<br>rate of absorbance change<br>measured by the instrument. The<br>rate of absorbance change is<br>proportional to the concentration of<br>drug in the sample. Concentrations<br>of controls and unknowns are<br>calculated from the standard curve.<br>Results are read at 450 and 620 |
| | 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 of β-<br>galactosidase for antibody binding<br>site. If analyte is present in the<br>sample, it binds to antibody, leaving<br>the inactive enzyme fragments free<br>to form active enzyme. If analyte is<br>not present in the sample, antibody<br>binds to analyte conjugated on the<br>inactive fragment, inhibiting the<br>reassociation 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 drug present in the<br>sample. | nm. |
| Sample<br>Matrix | Oral Fluid | Oral Fluid |
| Cutoff value | 150 ng/mL in neat oral fluid | 200 ng/ml in neat oral fluid<br>50 ng/ml diluted sample |
| Calibrator<br>levels | 0, 50, 200 ng/mL | 50 ng/mL |
| Cutoff level | 50 ng/mL | 50 ng/mL |
| Unassayed<br>Control<br>levels | 25, 75 ng/mL | 25, 100 ng/mL |

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# SUMMARY OF PERFORMANCE 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.

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#### 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.

#### Amphetamine Method Comparison

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

#### Conclusion

As summarized, the CEDIA® Amphetamine OFT Assay is substantially equivalent to the Immunalysis Amphetamine ELISA for oral fluid. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Microgenics Corporation c/o Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538

APR 0 8 2011

Re: k101745

> Trade Name: Thermo Scientific CEDIA Amphetamine OFT Assay Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ 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 tollfire mo [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

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): K101745

Device Name: Thermo Scientific CEDIA® Amphetamine OFT Assay

# Indication for Use:

The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 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-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Amphetamine 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 X (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) K101745