ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

K973535 · Schiapparelli Biosystems, Inc. · KLT · Oct 20, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973535
• Device Name: ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer. Carbamazepine is an anticonvulsant drug, used in particular for the treatment of trigeminal neuralgia, all forms of partial epilepsy, generalized tonic-clonic seizures, and simple and complex partial seizures. The specific mechanism of carbamazepine is proposed as a depressant action on transmission through the nucleus ventralis anterior of the thalamus.

Device Story

ACE® Carbamazepine Reagent is an enzyme immunoassay for quantitative measurement of carbamazepine in human serum. Device uses competitive binding between carbamazepine in patient sample and G6PDH-labeled drug for specific antibody binding sites. In absence of sample drug, antibody binds labeled G6PDH, inhibiting enzyme activity; presence of sample drug releases labeled G6PDH, allowing enzyme activity. Enzyme activity is measured bichromatically at 340/505 nm on ACE® clinical chemistry analyzer. Used in clinical laboratory settings by trained personnel. Output is carbamazepine concentration, used by physicians to monitor therapeutic drug levels and adjust anticonvulsant treatment.

Clinical Evidence

Bench testing only. Performance assessment included within-run (<4.7% CV) and between-run (<8.2% CV) precision. Method correlation study (N=48) against Hitachi 717 analyzer showed slope 0.947, intercept 0.21, and r=0.986. Assay range 0.3 µg/mL to 20 µg/mL.

Technological Characteristics

Liquid reagent kit containing antibody/substrate and enzyme conjugate. Principle: Competitive enzyme immunoassay using G6PDH label. Detection: Bichromatic spectrophotometry at 340/505 nm. Analyte: Carbamazepine. Sample: Serum. Assay temperature: 37 °C.

Indications for Use

Indicated for quantitative determination of carbamazepine in human serum for patients requiring monitoring of anticonvulsant therapy for trigeminal neuralgia, partial epilepsy, generalized tonic-clonic seizures, and simple/complex partial seizures.

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) - Carbamazepine Reagent (K955100)

Submission Summary (Full Text)

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# OCT 20 1997

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### 510(k) PREMARKET NOTIFICATION ACE® Carbamazepine 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® Carbamazepine Reagent |
|----------------------|------------------------------------------------------------------------------------|
| Common Name: | Enzyme immunoassay for carbamazepine (Tegretol®) |
| Classification Name: | Carbamazepine test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Carbamazepine Reagent [510(k)<br>Number K955100] |

### Device Description

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

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# 510(k) PREMARKET NOTIFICATION ACE® Carbamazepine Reagent

# SUMMARY OF SAFETY AND EFFECTIVENESS

## COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|
| Trade Name | DRI Carbamazepine Enzyme<br>Immunoassay | ACE® Carbamazepine Reagent |
| Reference No. | K955100 | TBD |
| Analyte | Carbamazepine | Carbamazepine |
| Intended Use | Quantitative determination of<br>carbamazepine | Quantitative determination of<br>carbamazepine |
| 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>5 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® Carbamazepine 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 | 0.5 µg/mL to 20 µg/mL<br><3.1 %CV<br><8.2 %CV | 0.3 µg/mL to 20 µg/mL<br><4.7 %CV<br><8.2 %CV |
| Correlation vs<br>Slope<br>Intercept<br>r<br>N | Commercial Carbamazepine assay<br>0.91<br>-0.1<br>0.970<br>99 | Hitachi 717<br>0.947<br>0.21<br>0.986<br>48 |

Based on these data, the Schiapparelli Biosystems ACE® Carbamazepine Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. Carbamazepine 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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OCT 20 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K973535 ACE® Carbamazepine Reagent Regulatory Class: II Product Code: KLT, DKB September 17, 1997 Dated: Received: September 18, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (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 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 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 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

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 **_ of _**

510(k) Number (if known): K673535

ACE® Carbamazepine Reagent Device Name:_

Indications For Use:

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

Carbamazepine is an anticonvulsant drug, used in particular for the treatment of trigeminal neuralgia, all forms of partial epilepsy, generalized tonic-clonic seizures, and simple and complex partial seizures. The specific mechanism of carbamazepine is proposed as a depressant action on transmission through the nucleus ventralis anterior of the thalamus.

(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 | K973535 |

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use ______ |
|----------------------|--------------------------------------------|----|-----------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |