The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma on the Abbott Aeroset® System.

Device Description

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 theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay is a homogenous enzyme assay intended for use in quantitative analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Theophylline Assay (K913123) with regard to intended use, assay sample, and overall performance characteristics.

AI/ML Overview

The Abbott Aeroset Theophylline Assay is a homogeneous enzyme immunoassay intended for the quantitative analysis of theophylline in human serum or plasma. The assay is intended to be substantially equivalent to the Emit 2000 Theophylline Assay (K913123).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document describes performance for two key areas: comparative analysis and precision. It establishes that "excellent correlation" and "acceptable" precision are the acceptance criteria, comparing the Abbott Aeroset Theophylline Assay to the predicate device, the Emit® 2000 Theophylline Assay (K913123).

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Comparative Analysis	Excellent correlation to the predicate method (Emit® 2000 Theophylline Assay)	Correlation of 1.0 with a slope value of 1.07
Precision	Acceptable within-run precision (coefficient of variation, %CV)	Ranged from 1.52% to 2.07%
	Acceptable total precision (coefficient of variation, %CV)	Ranged from 2.19% to 2.87%

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "comparative analysis" and "Precision study" but does not provide the number of samples or subjects used in these studies.
Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Not applicable for this type of in vitro diagnostic device (immunoassay). The "truth" is established by the reference method (predicate device) and analytical measurements, not by expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

Not applicable. The quantitative nature of the assay and comparison to a predicate device does not involve adjudication by experts.

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

Not applicable. This is an in vitro diagnostic device, not an imaging or diagnostic interpretation aid that would involve human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the Abbott Aeroset Theophylline Assay's performance (precision) was evaluated independently. However, its primary "standalone" claim is substantial equivalence to a predicate device, meaning its performance is considered acceptable if it correlates well with the established predicate. The precision study evaluates the device's inherent variability.

7. Type of Ground Truth Used

Predicate Device/Reference Method: For the comparative analysis, the "ground truth" or reference was the Emit® 2000 Theophylline Assay (K913123). This is a legally marketed predicate device with established performance.
Analytical Measurement: For the precision study, inherent analytical measurements of samples at different concentrations were used to determine the variability (%CV).

8. Sample Size for the Training Set

Not applicable. This device is an immunoassay reagent kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the assay is inherent in its chemical and biological design, and its calibration is part of its routine use rather than an external training phase for an algorithm.

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

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The assay's performance characteristics, including its analytical range and accuracy, are established through internal validation studies by the manufacturer and comparison to a predicate device, as described.

Summary

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K993029

JAN 2 7 2000

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

Contact Information: Paul Rogers 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 "Theophylline Test System" as Class II. Reference: 21 CFR 862.3880. revised April 1. 1993.

3. Intended Use:

Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the quantitative analysis of theophylline 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.

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

Comparative Analysis: The Abbott Aeroset Theophylline Assay and Calibrators showed 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 1.07.

Precision: A Precision study was performed and the Abbott Aeroset Theophylline Assay demonstrated acceptable within-run precision with coefficients of variation (%CV) ranging from 1.52 to 2.07% and acceptable total precision with coefficients of variation (%CV) ranging from 2.19 to 2.87%.

5. Substantial Equivalence:

In conclusion, Abbott Laboratories considers the Abbott Aeroset® Theophylline Assay and Abbott Aeroset® Theophylline Calibrators to be substantially equivalent to the Emit® 2000 Theophylline Assay(K913123) and Emit® 2000 Theophylline Calibrators(K913123) with regard to intended use, assay sample, and overall performance characteristics.

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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: K993029

Trade/Device Name: Abbot Aeroset Theophylline Assay Abbot Aeroset Theophylline Calibrators Regulation Number: Theophylline test system. Regulation Name: 21 CFR 862.3880 Regulatory Class: II Product Code: KLS, 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 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):

KC993029

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

Indications for Use:

The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended f ne Abbott Across of theophylline in human serum or plasma on the Abbott for acc in the quartificallY of the physiological effects of the antiasthmatic drug theophylline Acreeate better with the drug's concentration in serum than with dosage. Since serious toxic effects of theophylline are related to the serum concentration and are not always preceded by minor adverse symptoms, serum theophylline monitoring helps to avoid serious toxicity(1-5).

When theophylline is used to treat acute symptoms, monitoring serum concentrations allows the physician to adjust the dosage regimen to compensate for interpatient variations in the theophylline elimination rate (1). The chronic treatment of asthma and other bronchospastic diseases also requires individualization of the theophylline dosage to maintain serum concentrations within the therapeutic range (2,3). A theophylline dosage generally can be maintained without further monitoring for six months in rapidly growing children and for twelve months in other patients. Changes in concurrent drug therapy, variations in drug elimination, or the appearance of side effects, uncontrolled symptoms, or altered drug clearance signal the need for measuring the serum theophylline concentration (1,3).

Methods historically used to monitor serum theophylline concentrations include gas-liquid chromatography, high-performance liquid chromatography, and immunoassay (1,5,6).

Continued on next page

Sean Cooper

(Division Sign-Off)

Division of Curical La!

510(k) Numbe: K993029

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

510kabbttheo1.doc

Regulation Number and Section

§ 862.3880 Theophylline test system.

(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.