DIMENSION(R) VALPROIC (VALP) ACID METHOD

K982880 · Dade Behring, Inc. · LEG · Aug 25, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982880
• Device Name: DIMENSION(R) VALPROIC (VALP) ACID METHOD
• Applicant: Dade Behring, Inc.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The VALP method for the Dimension® clinical chemistry system is a device used to quantitatively measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

Device Story

The VALP method is an in vitro diagnostic assay for the Dimension clinical chemistry system. It utilizes a particle-enhanced turbidimetric inhibition immunoassay (PETINIA) principle. Input: patient serum or plasma sample. Mechanism: valproic acid in the sample competes with latex particle-valproic acid conjugates for binding to valproic acid-specific monoclonal antibodies; this competition inhibits particle aggregation. The rate of aggregation is inversely proportional to the valproic acid concentration. The system measures the rate of aggregation via bichromatic turbidimetric readings at 340nm and 700nm. Output: quantitative valproic acid concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in managing anti-convulsant therapy and diagnosing overdose.

Clinical Evidence

Clinical performance established via split-sample comparison against the Abbott AxSYM® Valproic Acid Assay. Study included 158 clinical patient samples with concentrations ranging from 11 to 147.7 µg/mL. Results showed a correlation coefficient of 0.995, a slope of 1.10, and an intercept of -2.82 µg/mL.

Technological Characteristics

Particle-enhanced turbidimetric inhibition immunoassay (PETINIA). Reagents include latex particle-valproic acid conjugate and valproic acid-specific monoclonal antibody. Detection via bichromatic turbidimetric absorption at 340nm and 700nm. Designed for use on the Dimension® clinical chemistry system. Sample volume: 3µL.

Indications for Use

Indicated for the quantitative measurement of valproic acid in human serum or plasma for the diagnosis and treatment of valproic acid overdose and therapeutic drug monitoring.

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Predicate Devices

• Abbott AxSYM® Valproic Acid Assay

Submission Summary (Full Text)

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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

# DADE BEHRING K98280

### Summary of Safety and Effectiveness Information

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.

| Submitter's Name: | Rebecca S. Ayash<br>Dade Behring Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 8/13/98 |
| Device Name: | Valproic Acid Method |
| Classification Name: | Enzyme Immunoassay, Valproic Acid |
| Predicate Device: | Abbott AxSYM® Valproic Acid Assay |

Device Description: The VALP method for the Dimension® clinical chemistry system is a particle enhanced turbidimetric inhibition immunoassay which uses a latex particle-valproic acid conjugate and valproic-acid specific monoclonal antibody (Ab). Valproic acid present in the sample competes with the particles for the antibody, thereby decreasing the rate of aggregation. The rate of aggregation is inversely proportional to the concentration of valproic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340nm and 700nm

Valproic acid + PR + Ab ------------------------------------------------------------------------------------------------------------------------------------------------------(scatters light at 340nm)

Intended Use: The VALP method for the Dimension® clinical chemistry system is a device used to quantitatively measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

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#### Comparison to Predicate Device:

| Item | Dimension® VALP<br>Method | Abbott AxSYM® Valproic<br>Acid |
|--------------|--------------------------------------------------------------|---------------------------------------------------------|
| Technology | Particle Enhanced<br>Turbidimetric Inhibition<br>Immunoassay | Fluorescence<br>Polarization<br>Immunoassay |
| Detection | Rate turbidimetric<br>absorption | Fluorometric endpoint<br>measurement |
| Sample Size | 3μL | 150μL |
| Sample Type | Serum or plasma | serum or plasma |
| Intended Use | For the quantitative<br>measurement of valproic<br>acid | For the quantitative<br>measurement of valproic<br>acid |

#### Comments on Substantial

Equivalence: Split sample comparison between the VALP method for the Dimension® system and the Abbott AxSYM® Valproic Acid assay gave a correlation coefficient of 0.995, slope of 1.10, and an intercept of -2.82 µg/mL when tested with 158 clinical patient samples ranging from 11 - 147.7 ug/mL.

Conclusion: The VALP Method for the Dimension® clinical chemistry system is substantially equivalent in principle and performance to the Abbott AxSYM® Valproic Acid Assay based on the split sample comparison summarized above.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/13/98

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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 a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 25 1998

Rebecca S. Ayash Regulatory Affairs and Compliance Manger Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re : K982880 Valproic Acid Method Regulatory Class: II Product Code: LEG Dated: Auqust 13, 1998 Received: August 14, 1998

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications Statement

Device Name: Valproic Acid (VALP) Method

Indications for Use: The VALP method for the Dimension® RxL clinical chemistry system is a device used to measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

Rebecca S. Ayresk

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 8/13/98

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K982880
510(k) Number

Division Sign-Off Office of Device Evaluation

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use