DRI OXYCODONE ASSAY

K040411 · Microgenics Corp. · LAS · May 27, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040411
• Device Name: DRI OXYCODONE ASSAY
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The DRL® Oxycodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative detection of oxycodone in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

Device Story

DRI® Oxycodone Assay is a liquid, ready-to-use homogeneous enzyme immunoassay for urine drug screening. Principle: competitive binding between sample oxycodone and G6PDH-labeled oxycodone for specific antibody sites. Absence of drug allows antibody binding to labeled enzyme, decreasing enzyme activity; presence of drug inhibits this binding, maintaining enzyme activity. Activity measured spectrophotometrically at 340 nm via NAD to NADH conversion. Used in clinical settings by professionals; provides preliminary results requiring GC/MS confirmation. Benefits: rapid screening for oxycodone presence to guide clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated through analytical performance comparison and validation against GC/MS confirmatory methods.

Technological Characteristics

Liquid, ready-to-use homogeneous enzyme immunoassay. Sensing principle: spectrophotometric measurement of G6PDH enzyme activity at 340 nm. Includes calibrators and controls. Storage: 2°C to 8°C.

Indications for Use

Indicated for use as a simple and rapid analytical screening procedure to detect oxycodone in human urine. Provides preliminary analytical test results; requires confirmation by alternative chemical method (GCMS preferred).

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Rapidone-Oxy Test (K014101)

Submission Summary (Full Text)

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## MAY 2 7 2004

# SECTION II

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**510(k) Number:** K040411

#### Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: [phone] Facsimile: [phone]

#### Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: [phone] Facsimile: [phone]

#### Preparation Date:

February 17, 2004

#### Device Information:

| | Device Classification Name: Radioimmunoassay, Oxycodone |
|--------------------|---------------------------------------------------------|
| Common/Usual Name: | Oxycodone Immunoassay Test System |
| Proprietary Name: | DRI® Oxycodone Assay |
| Regulation Number: | 21 CFR§862.3650 |
| Regulatory Name: | Oxycodone test system |
| Product Code: | DJG |
| Regulatory Class: | Class II |

#### Predicate Devices:

The DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use.

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### Device Description:

The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

#### Intended Use:

The DRL® Oxycodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative detection of oxycodone in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

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## Comparison to Predicate Device(s):

The information provided in this pre-market notification demonstrates that the DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use.

| Device<br>Characteristics | Subject Device | Predicate Device (K014101) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DRI®Oxycodone Enzyme<br>Immunoassay is intended for the<br>qualitative and semi-quantitative<br>detection of oxycodone in human<br>urine. | RapidOne-OXY Test is a one-step,<br>lateral flow immunoassay for<br>detection of oxycodone in urine. |
| | | RapidOne-OXY Test is intended for<br>the qualitative detection of oxycodone<br>in human urine at 100 ng/mL. |
| | | RapidOne-OXY Test is intended for<br>professional use. It is not intended for<br>over the counter sales to non-<br>professionals. The assay is easy to<br>perform, but should not be used<br>without proper supervision. This<br>immunoassay is a simplified<br>qualitative screening method that<br>provides only a preliminary result for<br>use in determining the need for<br>additional confirmatory testing, i.e.,<br>gas chromatography/mass<br>spectrometry (GC/MS). |
| | The assay provides only a preliminary<br>analytical test result. A more specific<br>alternative chemical method must be<br>used to obtain a confirmed analytical<br>result. Gas chromatography /mass<br>spectrometry (GC/MS) is the<br>preferred confirmatory method.<br>Clinical and professional judgment<br>should be applied to any drug of abuse<br>test result, particularly when<br>preliminary results are used. | The RapidOne-OXY Test provides<br>only a preliminary analytical test<br>result. A more specific alternative<br>chemical method must be used to<br>obtain a more confirmed analytical<br>result. Gas chromatography /mass<br>spectrometry (GC/MS) is the<br>preferred confirmatory method.<br>Clinical and professional judgment<br>should be applied to any drug of abuse<br>test result, particularly when<br>preliminary results are used. |
| Analyte | Oxycodone | Oxycodone |
| Matrix | Urine | Urine |
| Calibrator Form | Liquid | None |
| Calibrator Levels | Five (5) Levels (0, 100, 300, 500 and<br>1000 ng/mL) | None |
| Storage | 2°C to 8°C until expiration date | Room temperature or refrigerated (2<br>to 8°C). |
| Stability | Until expiration date noted on vial<br>label and Package Insert for Kit and<br>reconstituted reagents. | Until expiration date noted on vial<br>label. |

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#### Summary:

The information provided in this pre-market notification demonstrates that the DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry, an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the DRT® Oxycodone Assay is safe and effective for its stated intendcd use.

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# MAR 1 1 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostic Division c/o Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538-6406

Re: k040411

> Trade/Device Name: DRI Oxycodone Assay DRI Oxycodone Calibrators DRI Oxycodone Controls Regulation Number: 21CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: February 17, 2004 Received: March 2, 2004

Dear Ms. Charter:

This letter corrects our substantially equivalent letter of May 27, 2004.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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.html for the 2DRH'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 tollome number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

CA

Courtney C. 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

K040411

510(k) Number (if known): He

Device name: DRI® Oxycodone Assay

Indications for Use:

The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.

The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.

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

Over-the Counter Use (21 CFR §807 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)

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510(k) k040411