ACE PRIMIDONE REAGENT, AED CALIBRATORS

K973582 · Schiapparelli Biosystems, Inc. · DJD · Nov 12, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973582
• Device Name: ACE PRIMIDONE REAGENT, AED CALIBRATORS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: DJD · Clinical Toxicology
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3680
• Device Class: Class 2

Intended Use

ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer. Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

Device Story

ACE® Primidone Reagent is an enzyme immunoassay for quantitative determination of primidone in human serum. Input: 3 µL serum sample. Principle: Competitive immunoassay using specific antibodies to primidone and G6PDH-labeled drug; in absence of free drug, labeled drug binds antibody, inhibiting enzyme activity; enzyme activity inversely proportional to drug concentration. Output: Spectrophotometric measurement of G6PDH activity at 340/505 nm, converted to drug concentration. Used in clinical laboratories on the ACE® clinical chemistry analyzer. Results assist physicians in adjusting patient dosage to optimize therapeutic effect and avoid toxicity.

Clinical Evidence

Bench testing only. Performance assessment compared ACE® Primidone Reagent to a commercial primidone assay (Hitachi 717). Study (n=50) showed correlation coefficient (r) of 0.988, slope of 0.998, and intercept of -0.33. Precision: within-run <3.5% CV, between-run <7.0% CV. Assay range: 0.3 µg/mL to 24 µg/mL.

Technological Characteristics

Liquid-based enzyme immunoassay reagents (Antibody/Substrate and Enzyme Conjugate). Detection via bichromatic spectrophotometry at 340/505 nm. Operates on the ACE® clinical chemistry analyzer. Energy source: electrical (analyzer-dependent). Connectivity: standalone analyzer system.

Indications for Use

Indicated for patients with grand mal, psychomotor, or focal epileptic seizures treated with primidone (alone or in combination with other anticonvulsants) to monitor serum drug levels for dosage adjustment.

Regulatory Classification

Identification

A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.

Predicate Devices

• Diagnostic Reagents, Inc. (DRI) - Primidone Reagent (K960526)

Submission Summary (Full Text)

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NOT : 1997

- Jec

### 510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent

# 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® Primidone Reagent |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Enzyme immunoassay for primidone |
| Classification Name: | Primidone test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Primidone Reagent [510(k) Number<br>K960526] |

Device Description

The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone 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® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.

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## 510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent

0

1

### SUMMARY OF SAFETY AND EFFECTIVENESS

# COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Trade Name | DRI Primidone Enzyme<br>Immunoassay | ACE® Primidone Reagent |
| Reference No. | K960526 | TBD |
| Analyte | Primidone | Primidone |
| Intended Use | Quantitative determination of<br>primidone | Quantitative determination of<br>primidone |
| 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>5 µL | Serum<br>3 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 273 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® Primidone Reagent

# SUMMARY OF SAFETY AND EFFECTIVENESS

# PERFORMANCE ASSESSMENT

Non-clinical test results submitted in the premarket notification include within-run and between-run
er in the submitted in the first in a dote summary Non-cinlical test resures submitted in the proving is a data summary.

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|------------------------------------|----------------------------|-----------------------|
| Performance Summary<br>Assay Range | 0.5 µg/mL to 24 µg/mL | 0.3 µg/mL to 24 µg/mL |
| Precision<br>Within Run | <7.9 %CV | <3.5 %CV |
| Between Run | <5.6 %CV | <7.0 %CV |
| Correlation vs | Commercial primidone assay | Hitachi 717 |
| Slope | 0.92 | 0.998 |
| Intercept | 1.61 | -0.33 |
| r | 0.978 | 0.988 |
| N | 104 | 50 |

Based on these data, the Schiapparelli Biosystems ACE® Primidone Reagent is substantially Based on these data, the Schiappatic Reagents, Inc. Princidone Enzyme Immunossay). On
equivalent to the predicate device (Diagnostic Reagents, Inc. Princeded use Performance equivalent to the predicate device (Libertine Reagents) me. I mindent of the programs of the programmendetails
this basis, the reagent is determined to be safe and effective are included in the reagent product labeling.

ﺍﻟﺘﻲ ﺗﻌﻠﻴﻘﺎ

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV I 2 1997

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

K973582 Re: ACE® Primidone Reagent Regulatory Class: II Product Code: DJD Dated: September 19, 1997 Received: September 22, 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, 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. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 obliqation 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 requlations.

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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 onthe 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 [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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510(k) Number (if known):_

ACE® Primidone Reagent Device Name:__

Indications For Use:

ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.

Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

(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 | 6973582 |
| Prescription Use | OR | Over-The-Counter Use_ |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |