ORAL FLUID PHENCYCLIDINE

K093989 · Roche Diagnostics · LCM · Jan 25, 2011 · CH

Device Facts

• Record ID: K093989
• Device Name: ORAL FLUID PHENCYCLIDINE
• Applicant: Roche Diagnostics
• Product Code: LCM · CH
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 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 Phencyclidine 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.

Device Story

In vitro diagnostic assay for Phencyclidine 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-conjugate for antibody-bound microparticles; inhibition of particle lattice formation reduces absorbance proportional to drug concentration. Output: qualitative or semiquantitative result relative to 6 ng/mL cutoff. Used in clinical laboratories on automated chemistry analyzers; operated by laboratory technicians. Results are preliminary; require confirmation via chromatography/mass spectrometry. Assists clinicians in drug abuse screening; professional judgment required for interpretation.

Clinical Evidence

No clinical data provided; bench testing only. Performance verified using synthetic oral fluid matrix spiked with phencyclidine at concentrations of 0, 1, 2, 4, 8, and 16 ng/mL. Calibrator and control concentrations verified by LC/MS/MS.

Technological Characteristics

KIMS (Kinetic interaction of microparticles in solution) technology. Reagents include antibody-bound microparticles and drug-conjugates. Calibrators and controls prepared in synthetic oral fluid matrix. Designed for use on automated clinical chemistry analyzers. No specific materials or connectivity standards listed.

Indications for Use

Indicated for qualitative and semiquantitative detection of Phencyclidine in human oral fluid collected via Intercept® Oral Specimen Collection Device. Intended for laboratory use to provide preliminary analytical results requiring confirmation by alternate chemical methods (e.g., LC/MS/MS).

Predicate Devices

• PCP Intercept® MICRO-PLATE EIA (K000399)

Submission Summary (Full Text)

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## K093989

## 510(k) Summary: Oral Fluid Phencyclidine 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<br>Name, Address,<br>Contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>317-521-3742 | JAN 25 2011 |
| | Contact Person: Michelle Neff<br>Date Prepared: January 27, 2011 | |
| Device Name | Proprietary name: Oral Fluid Phencyclidine Assay | |
| | Common name: Phencyclidine test system | |
| | Classification name: Enzyme Immunoassay, Phencyclidine | |
| | Product Code: LCM | |
| Device<br>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. | |
| | 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 by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 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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| Intended Use | DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 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 Phencyclidine 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 Phencyclidine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed PCP Intercept® Micro-Plate EIA assay (K000399).

| Feature | Roche Oral Fluid Phencyclidines Assay | Predicate Device: PCP Intercept®<br>MICRO-PLATE EIA (K000399) |
|--------------|---------------------------------------------------------------------------|--------------------------------------------------------------------|
| 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>Phencyclidine | Qualitative detection of Phencyclidine |
| Neat Cutoff | 6 ng/mL | 3 ng/mL |
| Controls | Synthetic oral fluid matrix:<br>Zero, Negative (.5X), and Positive (1.5X) | Synthetic oral fluid matrix:<br>Negative (.5X) and Positive (1.5X) |
| Calibrator | Synthetic oral fluid matrix:<br>Zero, .5X, Cutoff, 2X, 4X, and 8X | Synthetic oral fluid matrix:<br>Zero, Cutoff |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is black, while the text and the circle are a lighter color, possibly white or light gray.

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

Roche Diagnostics c/o Ms. Michelle Lee Neff 9115 Hague Road Indianapolis, IN, 46250

Re: k093989

> Trade Name: DAT Oral Fluid Phencyclidine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: LCM, DKB. DIF Dated: January 7, 2011 Received: January 24, 2011

JAN 2 5 2011

Dear Ms. Neff:

100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

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 Viro 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 number [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 Form

510(k) Number (if known): k093989

Device Name: DAT Oral Fluid Phencyclidine

Indications for Use:

DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 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 Phencyclidine 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 (Part 21 CFR 801 Subpart D)

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

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

510(k) K093989

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## Indications for Use Form

510(k) Number (if known): k093989

Device Name: DAT Oral Fluid Phencyclidine

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)

Carl

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

510(k) K093989

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