ABBOTT AXSYM MYOGLOBIN by ABBOTT LABORATORIES

AxSYM® Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System. Measurements obtained by this device aid in the rapid diagnosis of heart or renal disease.

Device Description

AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma. AxSYM Myoglobin is calibrated with Abbott AxSYM Myoglobin Calibrators. Abbott AxSYM Myoglobin Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

AI/ML Overview

This submission describes the Abbott AxSYM® Myoglobin assay, a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma. The study aims to demonstrate substantial equivalence to the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a comparison to a predicate device, the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The reported performance demonstrates a strong correlation between the two assays.

Performance Metric	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (AxSYM Myoglobin vs. Dade Stratus Myoglobin)
Correlation Coefficient (r)	High correlation (implied by "substantially equivalent")	0.981
Slope (Least Squares Linear Regression)	Close to 1.0 (implied by "substantially equivalent")	1.09 (95% CI: 1.07 to 1.11)
Y-axis Intercept (Least Squares Linear Regression)	Close to 0 (implied by "substantially equivalent")	1.0 ng/mL (95% CI: -3.7 to 5.7)

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

Sample Size for Test Set: 383 specimens.
Data Provenance: Not explicitly stated, but clinical specimens are implied for a device intended for human serum or plasma testing. The submission does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This study is a comparative effectiveness study between two diagnostic assays, not an AI-based image analysis or expert review process. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical adjudication is not applicable here. The ground truth for the comparison is the measurement obtained by the predicate device (Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay).

4. Adjudication Method for the Test Set

Not applicable. This is a measurement comparison study, not a study involving expert adjudication of clinical findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an MRMC study and does not involve AI assistance or human readers. It is a direct comparison between two in vitro diagnostic assays.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this can be considered a standalone performance study. The Abbott AxSYM Myoglobin assay's performance is assessed independently against a predicate device, without human intervention in the assay's execution or result interpretation beyond standard laboratory procedures. The "algorithm" here refers to the MEIA methodology of the AxSYM system itself.

7. The type of ground truth used

The "ground truth" for this substantial equivalence study is the measurements provided by the legally marketed predicate device, the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The comparison aims to show that the new device's measurements are equivalent to those of the established predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning study where a "training set" in the computational sense is typically used. The development of the AxSYM Myoglobin assay would have involved its own internal validation and optimization, but the submission describes a performance comparison, not a training process for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no explicitly defined "training set" in the context of this 510(k) submission. The ground truth for the comparative study (test set) is the predicate device's results.

Summary

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K983848

NOV 16 1998

510(k) Summary Abbott AxSYM® Myoglobin

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k)] for Abbott AxSYM® Myoglobin constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the AxSYM Myoglobin assav and the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The intended use of the AxSYM Myoglobin assay is for the quantitative determination of myoglobin in human serum or plasma. The intended use of the Dade Stratus Myoglobin assay is for the determination of myoglobin concentrations in serum and plasma to aid in the rapid diagnosis of acute myocardial infarction.

Both assays are automated, in vitro immunoassays that use antibodies specific for myoglobin. The fluorescent signal measured by both assays is directly related to the concentration of myoglobin in the sample. A least squares linear regression analysis between these two assays, using 383 specimens within the dynamic range of both assays, yielded a correlation coefficient of 0.981, a slope of 1.09 (95% confidence interval of 1.07 to 1.11), and a y-axis intercept of 1.0 ng/mL (95% confidence interval of -3.7 to 5.7).

AxSYM Myoglobin 510(k) October 1998 lmyo 510k.lwp

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In conclusion, these data demonstrate that the AxSYM Myoglobin assay is as safe and effective as, and is substantially equivalent to, the Dade Stratus Myoglobin Fluorometric Enzyme Immunoassay.

Prepared and Submitted October 29, 1998 by: Laura Granitz Senior Regulatory Specialist ADD Regulatory Affairs 1-847-938-0092 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

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NOV 16 1998

Ms. Laura L. Granitz Senior Regulatory Specialist ADD Requlatory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537

Re : K983848 Abbott AxSYM® Myoglobin Trade Name: Regulatory Class: II Product Code: DDR Dated: October 29, 1998 Received: October 30, 1998

Dear Ms. Granitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K983848 Device Name: Abbott AxSYM® Myoglobin

Indications For Use:

(Division Sign-Off)

Division of Clinical Laboratory De 510(k) Number J

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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)

Regulation Number and Section

§ 866.5680 Myoglobin immunological test system.

(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).