ROCHE FLUDI METHAMPHETAMINE

K093884 · Roche Diagnostics · LAF · Feb 25, 2011 · Clinical Toxicology

Device Facts

• Record ID: K093884
• Device Name: ROCHE FLUDI METHAMPHETAMINE
• Applicant: Roche Diagnostics
• Product Code: LAF · Clinical Toxicology
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiguantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS. DAT Oral Fluid Methamphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

Device Story

In vitro diagnostic assay for methamphetamine detection in human oral fluid; utilizes Kinetic Interaction of Microparticles in Solution (KIMS) technology. Input: oral fluid sample collected via Intercept® device. Principle: drug in sample competes with drug-derivative conjugate for microparticle-bound antibody; inhibition of particle lattice formation reduces absorbance proportional to drug concentration. Output: qualitative or semiquantitative result on automated clinical chemistry analyzers. Used in clinical laboratories by technicians; results provide preliminary analytical data requiring confirmation by chromatography/mass spectrometry (e.g., LC/MS/MS). Assists healthcare providers in drug abuse screening; clinical judgment required for interpretation.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance characteristics and comparison to predicate device.

Technological Characteristics

KIMS (Kinetic interaction of microparticles in solution) technology. Automated clinical chemistry analyzer platform. Calibrators and controls prepared in synthetic oral fluid matrix, gravimetrically prepared and verified by LC/MS/MS. Cutoff: 120 ng/mL.

Indications for Use

Indicated for qualitative and semiquantitative detection of methamphetamine in human oral fluid at 120 ng/mL cutoff. For use with Intercept® Oral Specimen Collection Device. Intended for prescription use in laboratory settings.

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

• Methamphetamine Intercept® MICRO-PLATE EIA (K993208)

Submission Summary (Full Text)

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FEB 2 5 2011

## K093884 510(k) Summary: Oral Fluid Methamphetamine Assay

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name, Address, Contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>317-521-3742<br>Contact Person: Michelle Neff<br>Date Prepared: February 9, 2011 |
| Device Name | Proprietary name: Oral Fluid Methamphetamine Assay<br>Common name: Methamphetamine test system<br>Classification name: Gas Chromatography, Methamphetamine<br>Product Code: LAF |
| Device Description | The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.<br><br>Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS. |

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DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the Intended Use qualitative and semiquantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.

> DAT Oral Fluid Methamphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

## Comparison to Predicate Device

The Oral Fluid Methamphetamine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed Methamphetamine Intercept® Micro-Plate EIA assay (K993208).

| Comparison Table | | |
|------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Feature | Roche Oral Fluid Methamphetamines Assay | Predicate Device:<br>Methamphetamine Intercept®<br>MICRO-PLATE EIA (K993208) |
| Methodology | KIMS, Kinetic interaction of microparticles in<br>solution | Competitive micro-plate immunoassay |
| Sample Type | Oral Fluid | Oral Fluid |
| Intended Use | Qualitative and semi-quantitative detection of<br>methamphetamine | Qualitative detection of<br>methamphetamine |
| Cutoff | 120 ng/mL in Neat Oral Fluid | 40 ng/mL when oral fluid collected<br>with the Oral Specimen Collection<br>Device |
| Controls | Synthetic oral fluid matrix:<br>Zero, Negative (.5X), and Positive (1.5X) | Synthetic oral fluid matrix:<br>Negative (.5X) and Positive (2X) |
| Calibrator | Synthetic oral fluid matrix:<br>Zero, .5X, Cutoff, 2X, 4X, and 8X | Synthetic oral fluid matrix:<br>Zero, Cutoff |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and human services.

#### Public Health Service

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

### FEB 2 5 2011

Roche Diagnostics c/o Ms. Michelle Lee Neff Regulatory Affairs Principal 9115 Hague Road, PO Box 50416 Indianapolis, IN, 46250-0416

k093884 Re:

> Trade Name: Oral Fluid Methamphetamine Assay Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF, DKB, DIF Dated: January 07, 2011 Received: January 24, 2011

Dear Ms. Neff:

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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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 mber [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 Form

510(k) Number (if known): k093884

Device Name: DAT Oral Fluid Methamphetamine

Indications for Use:

DAT Oral Fluid Methamphetamine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methamphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiguantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.

DAT Oral Fluid Methamphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

| Prescription Use _XX_ | AND/OR | Over-The-Counter Use _ |
|-----------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

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

510(k) k093884

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## Indications for Use

510(k) Number (if known): k093884

Device Name: DAT Oral Fluid Methamphetamine

Indications for Use:

The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature of Officer

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

510(k) K093884

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