The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB. myoglobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.

The Triage® Cardiac Panel is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnesis of myocardial infarction (injury).

Device Description

The Triage® Cardio ProfilER is a fluorescence immunoassay to be used with the Triage® Meter for the quantitative determination of Creatine Kinase MB, myoqlobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the traditional sense of a clinical trial with performance metrics.

Instead, the document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance criteria through a new clinical effectiveness study.

The primary "study" mentioned is the comparison data used to show substantial equivalence.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria or detailed performance metrics are provided in this 510(k) summary. The document asserts substantial equivalence to predicate devices.

Acceptance Criteria (Not Explicitly Stated, Implied Equivalence to Predicates)	Reported Device Performance (Summary of Comparison Data)
Analytical sensitivity of troponin assay equivalent to or better than predicate.	Troponin assay has a lower analytical sensitivity than the troponin assay on the Triage® Cardiac Panel (predicate).
Compatibility with EDTA anticoagulant.	Triage® Cardio ProfilER uses EDTA as an anticoagulant (predicate used heparin).
Overall performance (diagnosis of MI, CHF, risk stratification) equivalent to predicate devices.	The design control process led to a determination that the Triage® Cardio ProfilER and Triage® Cardiac Panel are substantially equivalent to the previously cleared predicate devices.

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

Sample Size: Not specified.
Data Provenance: Not specified. The document only refers to "comparison data" without detailing its origin or nature (e.g., patient samples, spiked samples, retrospective vs. prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or implied. The focus is on demonstrating analytical (and likely clinical, through equivalence) performance of the device itself, not on how human readers would perform with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Was a standalone study done? The document describes the device as a "fluorescence immunoassay to be used with the Triage® Meter." This implies a standalone performance of the analytical system (immunoassay + meter) is being evaluated for its quantitative determination of biomarkers. However, the details of such a study (e.g., accuracy, precision, limits of detection) are not included in this summary. The 510(k) summary focuses on the comparison to predicates.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For an immunoassay, the "ground truth" would typically be established by reference methods or laboratory standards for the concentrations of the biomarkers (Creatine Kinase MB, myoglobin, troponin I, BNP). Given the context of a 510(k) summary for substantial equivalence, clinical ground truth (e.g., pathology, outcomes data) for diagnosis of MI or CHF is not described as being established directly for this specific device's performance study; instead, its intended use is tied to its ability to accurately measure biomarkers, which then aids in diagnosis.

8. Sample Size for the Training Set

Sample Size: Not applicable/Not specified. This device is an immunoassay, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The "training" of such a device involves assay development, calibration, and optimization using manufacturing and quality control standards.

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

How Ground Truth Was Established: Not applicable/Not specified, as it's not a machine learning model. For a diagnostic immunoassay, "ground truth" during development involves using highly characterized reference materials, calibrators, and known-concentration samples to ensure the assay's accuracy and precision across its measuring range.

Summary

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510(k) Summary of Safety and Effectiveness

Ko 70286

Triage® Cardio ProfilER / Triage® Cardiac Panel

FEB 2 1 2003

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: (To be determined)

A. Name and Address of Submitter

Company Name:	Biosite Incorporated
Address:	11030 Roselle Street
	San Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8350
Contact Person:	Jeffrey R. Dahlen, Ph.D.
Date Summary Prepared:	1/27/03

B. Device Names

1. Trade Name
  Triage® Cardio ProfilER / Triage® Cardiac Panel
1. Common / Usual Name
  Triage® Cardio ProfilER / Triage® Cardiac Panel
1. Classification Name
  Fluorometric Method, CPK or Isoenzymes (862.1215) Product Code JHX

Immunoassay Method, Troponin Subunit (862.1215) Product Code MMI

Myoglobin, Antigen, Antiserum, Control (866.5680) Product Code DDR

Test, Natriuretic Peptide (862.1117) (Triage® Cardio ProfilER) Product Code NBC

C. Predicate Devices

Triage® Cardiac Panel (K973126)

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Triage® BNP Test (K021317)

D. Device Description and Intended Use

E. Summary of Comparison Data

The Triage® Cardio ProfilER is a combination of the two predicate devices. The only differences between the Triage® Cardio ProfilER and the predicate devices is that the Triage® Cardio uses EDTA as an anticoagulant, while the Triage® Cardiac Panel uses heparin as an anticoagulant, and the troponin assay has a lower analytical sensitivity than the troponin assay on the Triage® Cardiac Panel. The only difference between the modified Triage® Cardiac Panel and the Triage® Cardio ProfilER is the absense of a BNP assay on the Triage® Cardiac Panel.

F. Conclusion

The design control process led to a determination that the Triage® Cardio ProfilER and Triage® Cardiac Panel are substantially equivalent to the previously cleared predicate devices. The evaluation has led to assurance that the Triage® Cardio ProfilER and Triage® Cardiac Panel are safe and effective for their intended uses and no new issues of safety and effectiveness have been raised.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head, with three lines representing the feathers. The eagle's head is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 1 2003

Jeffery R. Dahlen, Ph.D. Principal Scientist Clinical & Regulatory Affairs Biosite® Inc. 11030 Roselle Street San Diego, CA 92121

Re: K030286

Trade/Device Name: Triage® Cardio ProfilER/Triage® Cardiac Panel Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: NBC; JHX; MMI; DDR Dated: January 27, 2003 Received: January 28, 2003

Dear Dr. Dahlen:

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. Iisting 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).

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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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Ko30286 510(k) Number (if known): (to be determined)

Device Name: Triage® Cardio ProfilER / Triage® Cardiac Panel

Indications For Use:

Acan (Arabili (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_KO3078

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1117 B-type natriuretic peptide test system.

(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”