The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

Device Description

The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System.

AI/ML Overview

The provided text describes a 510(k) summary for the Abbott AxSYM® Troponin-I ADV assay. This is an in vitro diagnostic (IVD) device, and the evaluation for such devices often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on clinical outcomes or improved human reader performance in the same way a software-as-a-medical-device (SaMD) might be evaluated.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence between the Abbott AxSYM® Troponin-I ADV assay and the Beckman Coulter Access® AccuTnI assay. The acceptance criteria for analytical performance typically involve correlation and agreement statistics between the new device and the predicate.

Acceptance Criterion	Reported Device Performance (AxSYM Troponin-I ADV vs. Beckman Coulter Access AccuTnI)
Passing-Bablok Regression (All Specimens)
Correlation Coefficient (r)	0.97
Slope	1.47
Intercept	-0.05
Passing-Bablok Regression (ADV Dynamic Range)
Correlation Coefficient (r)	0.95
Slope	1.47
Intercept	-0.05

Note on Acceptance Criteria: The specific numerical acceptance criteria (e.g., minimum 'r' value, acceptable range for slope and intercept) are not explicitly stated in this summary. However, given the FDA's clearance, it can be inferred that the reported performance values met the internal and FDA's requirements for demonstrating substantial equivalence to the predicate device.

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

Sample Size:
- All Specimens: n = 546
- ADV Dynamic Range: n = 531
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is clinical sample data used for method comparison.

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

For IVD devices like this, particularly when demonstrating substantial equivalence via method comparison, the "ground truth" is typically the result obtained from the predicate device (the Beckman Coulter Access® AccuTnI assay). There isn't an "expert" panel establishing a consensus ground truth in the way one might for image-based diagnostic AI. The predicate device itself serves as the reference standard.

4. Adjudication Method

Not applicable for this type of IVD device evaluation. Adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers are interpreting imaging or clinical data, and a consensus ground truth needs to be established. Here, the comparison is directly between two analytical assays.

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

No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is not relevant for an IVD assay like the Abbott AxSYM® Troponin-I ADV.

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

Yes, in a sense, a standalone performance study was done. The performance metrics (correlation, slope, intercept) compare the Abbott AxSYM® Troponin-I ADV assay (the "algorithm" in this context) directly against the predicate device without human intervention influencing the assay's output. The device is intended for quantitative determination, and its output is a numerical value, not an interpretation requiring a human in the loop for diagnosis.

7. The Type of Ground Truth Used

The ground truth or reference standard was the performance of the legally marketed predicate device: the Beckman™ Coulter Access® AccuTnI assay. The study aimed to show that the new device's quantitative measurements of cardiac troponin-I were highly correlated and in agreement with those obtained from the predicate device.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. For traditional IVD assays, there isn't typically a distinct 'training set' in the same way there is for AI/ML models. The development and optimization of the assay reagents and parameters would have occurred prior to this substantial equivalence study, but the specific sample sizes for those developmental phases are not provided. The numbers cited (546 and 531) refer to the test set used for the method comparison study to demonstrate substantial equivalence.

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

As noted above, the concept of a "training set" with established ground truth, as understood in AI/ML, doesn't directly apply here. The Abbott AxSYM® Troponin-I ADV is a microparticle enzyme immunoassay, not an AI/ML algorithm that learns from data. Its "ground truth" for development would involve analytical accuracy, precision, linearity, and other performance characteristics established against known standards or reference materials during product development.

Summary

{0}------------------------------------------------

K060875

510(k) Summary

JUN 1 4 2006

Abbott AxSYM® Troponin-I ADV

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 Troponin-I ADV constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the AxSYM Troponin-I ADV assay and the Beckman™ Coulter Access® AccuTnI assay The intended use of the AxSYM Troponin-I ADV assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to assist in the diagnosis of myocardial infarction, and in the risk stratification of patients with acute coronary syndromes, (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. The intended use of the Beckman Coulter Access AccuTnI assay is for the quantitative determination of cardiac troponin-I in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac troponin-I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

Regression Method	n	r	Slope	Intercept
Passing-Bablok(All Specimens)	546	0.97	1.47	-0.05
Passing-Bablok(ADV Dynamic Range)	531	0.95	1.47	-0.05

n = number of specimens

r = correlation coefficient

{1}------------------------------------------------

In conclusion, these data demonstrate that the AxSYM Troponin-I ADV assay is as safe and effective as, and is substantially equivalent to, the Beckman Coulter Access AccuTnI assay.

Prepared and submitted 29 March 2006 by:

Margaret Derchinik 3/29/06

Abbott Laboratories Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Dept. 9VA, Bldg AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500 Phone: (847) 937-4106 Fax: E-Mail: Margaret.Prochniak@abbott.com

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Margaret Prochniak, M.S. Sr. Regulatory Affairs Specialist ADD Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9VA AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-3500

JUN 1 4 2006

Re: K060875

Trade/Device Name: Abbott AxSYM® Troponin-I ADV Reagent Regulation Number: 21 CFR§862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 29, 2006 Received: March 30, 2006

Dear Ms. Prochniak:

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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin 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.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):_KOLeO875

Device Name: Abbott AxSYM® Troponin-I ADV Reagent

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060875

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.