DRI PRIMIDONE CALIBRATORS

K023780 · Microgenics Corp. · DLJ · Feb 10, 2003 · Clinical Toxicology

Device Facts

• Record ID: K023780
• Device Name: DRI PRIMIDONE CALIBRATORS
• Applicant: Microgenics Corp.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Primidone Calibrators are in-vitro diagnostic medical devices intended to be used for calibration of DRI Primidone EIA Assay for quantitative determination of Primidone in human serum or plasma.

Device Story

Primidone Calibrators are in-vitro diagnostic products used to calibrate the DRI Primidone EIA Assay. The calibrators are used by laboratory professionals in clinical settings to establish a standard curve for the quantitative determination of Primidone levels in human serum or plasma samples. By providing known concentrations of Primidone, the calibrators allow the assay to accurately measure patient drug levels, assisting clinicians in therapeutic drug monitoring.

Clinical Evidence

No clinical data provided; device is a calibrator for an in-vitro diagnostic assay.

Technological Characteristics

In-vitro diagnostic calibrator; liquid-based matrix for use with DRI Primidone EIA Assay; Class II device under 21 CFR 862.1150.

Indications for Use

Indicated for the calibration of the DRI Primidone EIA Assay for the quantitative measurement of Primidone in human serum or plasma samples.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

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

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lakshmi Anne, Ph. D. Director, Product Development Microgenics Corporation 46360 Fremont Boulevard Fremont, CA 94538

Re: k023780 Trade/Device Name: Primidone Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DLJ Dated: November 10, 2002 Received: November 12, 2002

Dear Dr. Anne:

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.

FEB I 0 2003

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97), 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K 023780 510(K) Number (if known): _

Primidone Calibrators. Device Name:

Indications For Use:

The Primidone Calibrators are in-vitro diagnostic medical devices intended to be used for calibration of DRI Primidone EIA Assay for quantitative determination of Primidone in human serum or plasma.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023780 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)