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):

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).

Device Description

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.

AI/ML Overview

This Abbott Aeroset Carbamazepine Assay 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria for standalone performance against clinical outcomes. Therefore, the information provided reflects this equivalence-based approach.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation to Predicate Method	Coefficient of variation (%CV) for within-run precision: 1.42% to 2.88%
> 0.95 (implied good correlation from predicate equivalence)	Coefficient of variation (%CV) for total precision: 2.74% to 3.28%
Precision:	Correlation of 0.99 with a slope value of 1.06 to the predicate method (Emit® 2000 Carbamazepine Assay K913066).
Acceptable within-run precision (implied by "demonstrated acceptable within-run precision")
Acceptable total precision (implied by "demonstrated acceptable total precision")

2. Sample Size Used for the Test Set and Data Provenance

Specific sample sizes for the comparative analysis and precision studies are not explicitly stated in the provided document. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. For this in vitro diagnostic device (IVD), the "ground truth" for evaluating the new assay's performance is typically established by comparing its results to a legally marketed predicate device (Emit® 2000 Carbamazepine Assay). This is a quantitative comparison, not one requiring expert interpretation of primary data like images or clinical cases.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, the comparison is quantitative against a predicate device, not involving human expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for devices where human readers interpret data (e.g., imaging devices) and the AI aims to assist or replace them. This is an in vitro diagnostic assay for chemical analysis, so an MRMC study is not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The reported performance characteristics (correlation and precision) are for the Abbott Aeroset® Carbamazepine Assay as a standalone analytical device. There's no mention of human-in-the-loop performance; it's a quantitative measurement system.

7. The Type of Ground Truth Used

The ground truth used for comparison was the results obtained from the legally marketed predicate device, the Emit® 2000 Carbamazepine Assay (K913066).

8. The Sample Size for the Training Set

Not applicable/Not explicitly stated. For traditional in vitro diagnostic assays like this homogeneous enzyme immunoassay, there isn't a "training set" in the sense of machine learning algorithms. The assay development involves optimizing reagents and protocols, but not training an algorithm on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" in the machine learning sense for this type of device. The assay itself is a chemical reaction-based system.

Summary

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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 Company3403 Yerba Buena Rd.P.O. Box 49013San 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: 408-239-2000

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 (800) 638-2041 or (240) 276-3150 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 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).

Continued on next page

Han

(Division Sign-Off)

Division of Clinical Laboraci

510(k) Numbe: K993028

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

510kabbtcarb.doc

Regulation Number and Section

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)
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.(b)
Classification. Class II.