The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following reasons:

Serum phenytoin concentrations correlate better with pharmacologic activity than does . dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens.
The hepatic enzyme system for metabolizing phenytoin can become saturated within the . drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity.
Phenytoin is safe and effective only in a narrow range of serum concentrations. .
Methods historically used to monitor serum phenytoin concentrations include . chromatographic assays and immunoassays.

Device Description

The Abbott Aeroset® Phenytoin Assay is a homogenous enzyme assay intended for use in quantitative analysis of Phenytoin in human serum or plasma.

AI/ML Overview

The Abbott Aeroset Phenytoin Assay device is a homogeneous enzyme immunoassay intended for the quantitative analysis of phenytoin in human serum or plasma.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Comparative Analysis: Equivalent to predicate device (Emit® 2000 Phenytoin Assay) with strong correlation.	Comparative Analysis: Correlation of 1.0 with a slope value of 1.04 to the predicate method.
Precision (Within-run %CV): Acceptable	Precision (Within-run %CV): Ranging from 1.67% to 1.83%
Precision (Total %CV): Acceptable	Precision (Total %CV): Ranging from 2.82% to 3.54%

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A Precision study was performed" and "The comparative analysis to the predicate method".

3. Number of Experts and Qualifications

This information is not provided in the document. The nature of this in vitro diagnostic device (quantitative analysis of a chemical compound) typically relies on laboratory measurements and comparison to a predicate device rather than expert interpretation of images or clinical cases.

4. Adjudication Method

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) to establish ground truth from multiple experts. For this device, the performance is based on analytical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone analytical assay like the Abbott Aeroset Phenytoin Assay.

6. Standalone Performance

Yes, a standalone performance was done. The document describes the "Comparative Analysis" and "Precision" studies of the Abbott Aeroset Phenytoin Assay, which represent its performance without human-in-the-loop assistance for the core measurement. The device's output is a quantitative value.

7. Type of Ground Truth Used

The ground truth for the "Comparative Analysis" was the results obtained from the predicate device, Emit® 2000 Phenytoin Assay (K913429). For the "Precision" study, typical ground truth would be based on expected values for control samples or replicate measurements.

8. Sample Size for the Training Set

This information is not provided. For an enzyme immunoassay, the "training set" would typically refer to the data used for assay development, optimization, and calibration curve generation. The document does not detail this.

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

This information is not provided. For an immunoassay, the training set's ground truth would likely be established through:

Reference materials: Known concentrations of phenytoin used to create calibration curves.
Analytical methods: Independent, highly accurate analytical methods (e.g., GC-MS or HPLC) to confirm the concentrations of standards and controls.
Predicate device results: If the assay was benchmarked against an existing method during development, results from the predicate device would also serve as a form of ground truth for method development.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '993026'. The characters are written in a bold, slightly irregular style, giving them a distinct, hand-drawn appearance.

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

1. Manufacturer and Contact Information:

Manufacturer:	Syva Company3403 Yerba Buena Rd.P.O. Box 49013San Jose, CA 95161-9013
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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 "Diphenylhydantoin Test System" as Class II. Reference: 21 CFR 862.3650, revised April 1, 1993.

3. Intended Use:

Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of phenytoin 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 Phenytoin in human serum or plasma. The Abbott Aeroset® Phenytoin Assay is a homogenous enzyme assay intended for use in quantitative analysis of Phenytoin in human serum or plasma. The Abbott Aeroset® Phenytoin Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Phenvtoin Assay (K913429) 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 Phenytoin Assay (cont.)

The Abbott Aeroset Phenytoin Assay and calibrators showed Comparative Analysis: excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 1.0 with a slope value of 1.04.

Precision: A Precision study was performed and the Abbott Aeroset Phenytoin Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.67 to 1.83% and acceptable total precision with coefficients of variation (%CV) ranging from 2.82 to 3.54%.

5. Substantial Equivalence:

In conclusion, Abbott Laboratories considers the Abbott Aeroset Phenytoin Assay and Abbott Aeroset Phenytoin Calibrators to be substantially equivalent to the Emit 2000 Phenytoin Assay(K913429) and Emit 2000 Phenytoin Calibrators(K913429) 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 and Human Services. The logo features a stylized eagle with three heads facing to the right. The words "U.S. Department of Health & Human Services - USA" are arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

NOV 1 5 2007

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

Re: K993026

Trade/Device Name: Abbot Aeroset Phenytoin Assay Abbot Aeroset Phenytoin Calibrators Regulation Number: Diphenylhydantoin test system. Regulation Name: 21 CFR 862.3350 Regulatory Class: II Product Code: DIP, 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 C. Benam for

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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510(k) Number (If known): K 993026

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

Indications for Use:

Serum phenytoin concentrations correlate better with pharmacologic activity than does . dosage because of individual differences in absorption, metabolism, disease states, concomitant medication, and compliance. Serum concentration monitoring helps physicans individualize dosage regimens.
The hepatic enzyme system for metabolizing phenytoin can become saturated within the . drug's therapeutic range. When this occurs, small dosage alterations can lead to unexpected drug accumulation and clinical toxicity.
Phenytoin is safe and effective only in a narrow range of serum concentrations. .
Methods historically used to monitor serum phenytoin concentrations include . chromatographic assays and immunoassays.

(Division Sign-Off) Division of Clinical Laboratory onlinued on next page 510(k) Number __ 993

(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)

510kabbtpheny.doc

Regulation Number and Section

§ 862.3350 Diphenylhydantoin test system.

(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.