ACE VALPROIC ACID REAGENT, AED CALIBRATORS

K973581 · Schiapparelli Biosystems, Inc. · LEG · Nov 12, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973581
• Device Name: ACE VALPROIC ACID REAGENT, AED CALIBRATORS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.

Device Story

ACE® Valproic Acid Reagent is an enzyme immunoassay for quantitative measurement of valproic acid in human serum. The assay utilizes competitive binding between valproic acid in the patient sample and drug-labeled glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of specific antibody. In the absence of sample drug, antibody binds the drug-labeled G6PDH, inhibiting enzyme activity; presence of sample drug displaces the labeled drug, resulting in proportional enzyme activity. The ACE® clinical chemistry analyzer measures G6PDH activity bichromatically at 340/505 nm by monitoring the conversion of NAD+ to NADH. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in monitoring therapeutic drug levels to optimize anticonvulsant treatment and manage patient dosing.

Clinical Evidence

Bench testing only. Performance assessment included within-run precision (<5.9% CV) and between-run precision (<7.5% CV) over an assay range of 3.1 µg/mL to 150 µg/mL. Method correlation against a Hitachi 717 analyzer (N=49) yielded a slope of 1.079, intercept of 7.33, and correlation coefficient (r) of 0.979.

Technological Characteristics

Liquid-based enzyme immunoassay reagents (Antibody/Substrate and Enzyme Conjugate). Detection via bichromatic spectrophotometry (340/505 nm). Designed for use on the ACE® clinical chemistry analyzer. Operates at 37 °C.

Indications for Use

Indicated for the quantitative determination of valproic acid in human serum to monitor anticonvulsant therapy in patients with primary/secondary generalized seizures, absence seizures, myoclonus, photosensitive epilepsy, or lithium-insensitive bipolar disorders.

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

• Diagnostic Reagents, Inc. (DRI) - Valproic Acid Reagent (K961988)

Submission Summary (Full Text)

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1115581

## 510(k) PREMARKET NOTIFICATION ACE® Valproic Acid Reagent

NOV 1 2 1997

### SUMMARY OF SAFETY AND EFFECTIVENESS

In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.

#### Submitter

Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: [phone]

#### Contact Person

Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: [phone]

Device Names

| Proprietary Name: | ACE® Valproic Acid Reagent |
|----------------------|------------------------------------------------------------------------------------|
| Common Name: | Enzyme immunoassay for valproic acid |
| Classification Name: | Valproic Acid test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Valproic Acid Reagent [510(k) Number<br>K961988] |

#### Device Description

The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

#### Intended Use of the Device

ACE® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.

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# 510(k) PREMARKET NOTIFICATION ACE® Valproic Acid Reagent

## SUMMARY OF SAFETY AND EFFECTIVENESS

# COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Trade Name | DRI Valproic Acid Enzyme<br>Immunoassay | ACE® Valproic Acid Reagent |
| Reference No. | K961988 | TBD |
| Analyte | Valproic Acid | Valproic Acid |
| Intended Use | Quantitative determination of<br>valproic acid | Quantitative determination of<br>valproic acid |
| Methodology | Enzyme immunoassay | Enzyme immunoassay |
| Reagents<br>Reagent 1<br>Volume | Liquid; Antibody/Substrate<br>210 µL | Liquid; Antibody/Substrate<br>210 µL |
| Reagent 2<br>Volume | Liquid; Enzyme conjugate<br>70 µL | Liquid; Enzyme conjugate<br>70 µL |
| Specimen<br>Type<br>Volume | Serum and plasma<br>15 µL | Serum<br>10 µL |
| Assay System<br>Reagent 1 + Sample<br>Reagent 2<br>Temperature | Incubate 300 sec<br>Read 60 and 120 sec<br>37 °C | Incubate 240 sec<br>Read 63 and 203 sec<br>37 °C |
| Detection Method<br>Type<br>Wavelength, nm | Spectrophotometric<br>Bichromatic: 340/505 | Spectrophotometric<br>Bichromatic: 340/505 |

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## 510(k) PREMARKET NOTIFICATION ACE® Valproic Acid Reagent

### SUMMARY OF SAFETY AND EFFECTIVENESS

### PERFORMANCE ASSESSMENT

Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------|
| Performance Summary<br>Assay Range<br>Precision<br>Within Run<br>Between Run | 3 µg/mL to 150 µg/mL<br><3.4 %CV<br><2.7 %CV | 3.1 µg/mL to 150 µg/mL<br><5.9 %CV<br><7.5 %CV |
| Correlation vs<br>Slope<br>Intercept<br>r<br>N | Commercial valproic acid assay<br>1.1<br>-5.8<br>0.981<br>88 | Hitachi 717<br>1.079<br>7.33<br>0.979<br>49 |

Based on these data, the Schiapparelli Biosystems ACE® Valproic Acid Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. Valproic Acid Enzyme Immunoassay). On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a central graphic. The graphic consists of a stylized human figure with three faces in profile, one behind the other, creating a sense of depth and continuity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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NOV 1 2 1997

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Mr. Steven Dalessio Manager, Quality Assurance/ Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, New Jersey 07004

Re : K973581/S1 Trade Name: ACE® Valproic Acid Reagent Regulatory Class: II Product Code: LEG Dated: October 24, 1997 Received: October 27, 1997

Dear Mr. Dalessio:

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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 note the 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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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Page_ 1 __of__1

510(k) Number (if known):

ACE® Valproic Acid Reagent Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

15:39

ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.

Valproic acid (VPA, 2-propylpentanoic acid, Depakene®) is an anticonvulsant used chiefly for the treatment of primary and secondary generalized seizures, but is also effective against absence seizures. Valproic acid is particularly effective in myoclonus, and is the drug of choice in photosensitive epilepsy. Valproic acid can be used concurrently with other anticonvulsants or alone. Valproic acid may also be useful in the treatment of affective disorders, in particular, lithium-insensitive bipolar disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1973581

Prescription Use \$\surd\$
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__

(Optional Format 1-2-96)