ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90

K993028 · Syva Co. · KLT · Jan 27, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993028
• Device Name: ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
• Applicant: Syva Co.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

Abbott Aeroset® Carbamazepine Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of carbamazpine in human serum or plasma.

Device Story

Homogeneous enzyme immunoassay for quantitative analysis of carbamazepine in human serum or plasma; performed on Abbott Aeroset clinical chemistry analyzer. Input: patient serum or plasma sample. Principle: enzyme immunoassay technology. Output: quantitative carbamazepine concentration. Used in clinical laboratory settings by trained laboratory personnel. Results used by physicians to monitor therapeutic drug levels, adjust anticonvulsant dosage, and improve seizure control. Benefits: enables individualized dosing regimens, accounts for interindividual variability and changes in drug half-life, and helps maintain concentrations within narrow therapeutic ranges.

Clinical Evidence

Bench testing only. Comparative analysis against predicate method (Emit® 2000) demonstrated a correlation of 0.99 (slope 1.06). Precision studies performed: within-run %CV 1.42% to 2.88%; total precision %CV 2.74% to 3.28%. No clinical patient outcome data provided.

Technological Characteristics

Homogeneous enzyme immunoassay; quantitative analysis of carbamazepine; utilizes Abbott Aeroset analyzer platform. Reagent-based chemistry system. No specific materials or software architecture details provided beyond standard clinical chemistry assay components.

Indications for Use

Indicated for the quantitative analysis of carbamazepine in human serum or plasma to monitor serum concentrations for improved seizure control and dosage individualization in patients receiving anticonvulsant therapy.

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

• Emit® 2000 Carbamazepine Assay (K913066)

Submission Summary (Full Text)

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K993028

# JAN 2 7 2000

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Abbott Aeroset Carbamazepine Assay

## 1. Manufacturer and Contact Information:

| Manufacturer: | Syva Company<br>3403 Yerba Buena Rd.<br>P.O. Box 49013<br>San Jose, CA 95161-9013 |
|---------------|-----------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------|

Abbott Laboratories 820 Mission Street South Pasadena, CA 91030

Distributor:

Abbott Laboratories K-Complex Route 41 & Martin Luther King Drive North Chicago, IL 60064

Paul Rogers Contact Information: Syva Company 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: [phone]

### 2. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "CarbamazepineTest System" as Class II.

### 3. Intended Use:

Abbott Aeroset® Carbamazepine Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of carbamazpine in human serum or plasma.

## 4. Device Description and Characteristics:

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Syva Company is submitting the Premarket Notification, 510(k) on behalf of Abbott Laboratories to convey Abbott's intention to commercially market an in vitro diagnostic reagent test kit for the analysis of carbamazepine in human serum or plasma. The Abbott Aeroset® Carbamazepine Assay is a homogenous enzyme assay intended for use in quantitative analysis of carbamazepine in human serum or plasma. The Abbott Aeroset® Carbamazepine Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Carbamazepine Assay (K913066) with regard to intended use, assay sample, and overall performance characteristics.

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Abbott Aeroset Carbamazepine Assay (cont.)

Comparative Analysis: The Abbott Aeroset® Carbamazepine Assay and calibrators showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 0.99 with a slope value of 1.06.

Precision: A Precision study was performed and the Abbott Aeroset® Carbamazepine Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.42% to 2.88% and acceptable total precision with coefficients of variation (%CV) ranging from 2.74% to 3.28%.

## 5. Substantial Equivalence:

In conclusion, Abbott Laboratories considers the Abbott Aeroset® Carbamazepine Assay and Abbott Aeroset®Carbamazepine Calibrators to be substantially equivalent to the Emit® 2000 Carbamazepine Assay(K913066) and Emit® 2000 Carbamazepine Calibrators(K913066) with regard to intended use, assay sample, and overall performance characteristics.

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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 features a stylized eagle with its wings forming three curved lines. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 5 2007

Abbott Laboratories C/O Mary Beth Fennel Syva Company Regulatory Affairs 3403 Yerba Buena Road P.O. Box 49013 San Jose, CA 95161-9013

Re: k993028

Trade/Device Name: Abbot Aeroset Carbamazepine Assay Abbot Aeroset Carbamazepine Calibrators Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system. Regulatory Class: II Product Code: KLT, DLJ Dated: January 10, 2000 Received: January 11, 2000

Dear Ms. Femmel:

This letter corrects our substantially equivalent letter of January 27, 2000.

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 (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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.

You may obtain 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,

Carol Bensonfor

Jean M. Cooper, M.S. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure: Indications for Use Statement

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11993026

510(k) Number (If known):

Device Name: Abbott Aeroset® Carbamazepine Assay Abbott Aeroset® Carbamazepine Calibrators

#### Indications for Use:

The Abbott Aeroset® Carbamazepine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of carbamazepine in human serum or plasma on intended for as in the quarkhatr. 900367). Monitoring serum carbamazepine concentrations, the Abbot Acresul clinical assessment, is the most effective means of improving seizure control, along with barchar oliniour associeting the need for additional anticonvulsant medication for the following reasons (1, 2):

- the following reasons (1) 2).
Serum carbamazepine concentrations correlate better with pharmacologic activity than does . dosage.
- Changes in carbamazepine's half-life with prolonged treatment and interindividual . Official of Carbamazepine of name it difficult to predict serum levels from the differed dosage, particularly during concomitant therapy with other anticonvulsants. Serum level monitoring helps physicans individualize dosage regimens.

Carbamazepine is safe and effective only in a narrow range of serum concentrations. . Carbamazepine-10,11-epoxide, a major metabolite of carbamazepine, is pharmacologically active and found in plasma and tissues (3).

Methods historically used to monitor serum carbamazepine concentrations include gas-liquid chromatography, high-performance liquid chromatography, and immunoassay (1,2,4,5).

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Division of Clinical Laboraci

510(k) Numbe: K993028

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

510kabbtcarb.doc