ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54

K993031 · Syva Co. · DLZ · Jan 27, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993031
• Device Name: ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
• Applicant: Syva Co.
• Product Code: DLZ · Clinical Toxicology
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3660
• Device Class: Class 2

Intended Use

Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital 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 anticonvulsant medication for the following reasons (1-3): - Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached. - Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens.

Device Story

Abbott Aeroset Phenobarbital Assay is a homogeneous enzyme immunoassay for quantitative measurement of phenobarbital in human serum or plasma. Used on Abbott Aeroset analyzer; operated by laboratory personnel in clinical settings. Assay principle involves competitive binding; phenobarbital in sample competes with enzyme-labeled drug for antibody binding sites. Enzyme activity is inversely proportional to drug concentration in sample. Output is quantitative serum phenobarbital concentration. Results assist physicians in individualizing dosage regimens, improving seizure control, and reducing toxicity risk. Benefits include optimized therapeutic drug monitoring compared to dosage-only management.

Clinical Evidence

Bench testing only. Comparative analysis against predicate method (Emit® 2000) demonstrated a correlation of 1.00 with a slope of 1.02. Precision study demonstrated acceptable within-run precision (%CV 1.18% to 2.03%) and total precision (%CV 2.41% to 3.09%).

Technological Characteristics

Homogeneous enzyme immunoassay reagent kit. Designed for use on the Abbott Aeroset® analyzer. Quantitative measurement based on competitive enzyme-labeled drug binding principle. No specific materials of construction or software algorithm architecture details provided beyond standard clinical chemistry analyzer integration.

Indications for Use

Indicated for quantitative analysis of phenobarbital in human serum or plasma to monitor serum concentrations in patients undergoing phenobarbital therapy for seizure control.

Regulatory Classification

Identification

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

Predicate Devices

• Emit® 2000 Phenobarbital Assay (K913190)

Reference Devices

• Abbott Aeroset® analyzer (K980367)

Submission Summary (Full Text)

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K993031

# JAN 2 7 2000

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Abbott Aeroset Phenobarbital 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 "Phenobarbital Test System" as Class II.

#### 3. Intended Use:

Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of phenobarbital 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 phenobarbital in human serum or plasma. The Abbott Aeroset™ Phenobarbital Assay is a homogenous enzyme assay intended for use in quantitative analysis of phenobarbital in human serum or plasma. The Abbott Aeroset™ Phenobarbital Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Phenobarbital Assay (K913190) 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 Phenobarbital Assay (cont.)

Comparative Analysis: The Abbott Aeroset® Phenobarbital Assay and calibrators showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in a correlation of 1.00 with a slope value of 1.02.

Precision: A Precision study was performed and the Abbott Aeroset® Phenobarbital Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.18% to 2.03% and acceptable total precision with coefficients of variation (%CV) ranging from 2.41% to 3.09%.

### 5. Substantial Equivalence:

In conclusion, Abbott Laboratories considers the Abbott Aeroset® Phenobarbital Assay and Abbott Aeroset® Phenobarbital Calibrators to be substantially equivalent to the Emit® 2000 Phenobarbital Assay(K913190) and Emit® 2000 Phenobarbital Calibrators(K913190) with reqard 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 three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug 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: k993031

Trade/Device Name: Abbot Aeroset Phenobarbital Assay Abbot Aeroset Phenobarbital Calibrators Regulation Number: Phenobarbital test system. Regulation Name: 21 CFR 862.3660 Regulatory Class: II Product Code: DLZ, 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 Benson 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): 1/99303/

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

#### Indications for Use:

The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital 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 anticonvulsant medication for the following reasons (1-3):

- Serum phenobarbital concentrations correlate better with concentration in the brain than ● does dosage once steady state is reached.
- Patients taking the same dosage of phenobarbital show considerable variation in serum . phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens.

Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radioimmunoassay, and immunoassay (1,2).

Continued on next page

Sean Coogan

(Division Sign-off)
Division
510(k) K993631

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Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)