The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.

Device Description

AI/ML Overview

The provided document focuses on the Triage® Profiler S.O.B. Panel, a fluorescence immunoassay device. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, the document does not contain acceptance criteria, detailed study results, or information typically found in a clinical performance study report (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance metrics like sensitivity/specificity).

Instead, the document is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission relies heavily on comparisons to existing, approved devices rather than comprehensive de novo clinical trials establishing performance against predefined statistical criteria.

Therefore, the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth details, etc.) cannot be extracted from this document because it is not included.

The document primarily states:

"A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods."
"A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92."
"The analytical performance characteristics for each of the assays were equivalent with the predicate methods."

This indicates that the "study" was primarily a method comparison study against existing, approved devices/methods, not a clinical study to establish performance against defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a summary of what can be inferred or directly stated from the document regarding the "study" conducted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Method Comparison)	Reported Device Performance
Equivalence to predicate device methods	CK-MB, Troponin I, Myoglobin, and BNP assays demonstrated equivalence to predicate methods.
Linear relationship to predicate D-dimer results	D-dimer: Slope = 0.999, Intercept = -85.89, Correlation Coefficient = 0.92 (vs. predicate method).
Analytical performance equivalent to predicate methods	Each assay's analytical performance was equivalent with the predicate methods.

2. Sample size(s) used for the test set and the data provenance

Sample Size for D-dimer comparison: 180 specimens.
Sample Size for other assays (CK-MB, Troponin I, Myoglobin, BNP): Not explicitly stated, described generally as "a method comparison."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is likely laboratory-based analytical data rather than patient-level clinical data from a specific geographical region.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The "ground truth" for a method comparison study relies on the results of the predicate (established, approved) devices/methods. The document does not mention human expert interpretation for establishing ground truth for the device's measurements.

4. Adjudication method for the test set

Not applicable/Not provided. This type of method comparison does not typically involve human adjudication of results in the way a diagnostic imaging study might. The comparison is between the new device's quantitative outputs and the predicate device's quantitative outputs.

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 AI-based device, nor is it a multi-reader, multi-case study as typically understood in diagnostic imaging or complex interpretation tasks. It is an in vitro diagnostic (IVD) assay quantifying biomarkers.

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

The study described is inherently "standalone" in principle, as it evaluates the device's analytical performance in generating quantitative results. There is no "human-in-the-loop" aspect described for the measurement itself, beyond potentially a lab technician operating the device. The reported performance refers to the device's output compared to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" was established by the predicate devices' quantitative results. The comparison aimed to show that the Triage® Profiler S.O.B. Panel's measurements align with those of already approved and marketed devices (Triage® Cardiac Panel, Triage® BNP Test, Dade Behring Stratus CS DDMR TestPak).

8. The sample size for the training set

Not applicable/Not provided. This is a 510(k) submission for a new immunoassay, not a machine learning or AI algorithm that requires a separate "training set" in the computational sense. The "training" of such a device is typically done during its development and calibration phases, not as a distinct "training set" sample size reported in the context of a 510(k) comparison study.

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

Not applicable/Not provided, for the same reasons as point 8.

Summary

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JUN 2 5 2004

510(k) Summary of Safety and Effectiveness

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

K040437 510(k) Number:

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:	6/24/04

B. Device Names

1. Trade Name
  Triage® Profiler S.O.B. Panel
1. Common / Usual Name
  Triage® Profiler S.O.B. Panel

3. 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) Product Code NBC

Fibrinogen/Fibrin Degradation Products Assay (864.7320) Product Code GHH

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C. Predicate Devices

Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976)

D. Device Description and Intended Use

The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (iniury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes.

E. Summary of Comparison Data

A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods. A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics for each of the assays were equivalent with the predicate methods.

F. Conclusion

The assays on the Triage Profiler S.O.B. Panel are substantially equivalent to the predicate methods. The evaluation has led to assurance that the Triage Profiler S.O.B. Panel is safe and effective for the intended use and no new issues of safety and effectiveness have been raised.

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three wing-like shapes and a tail.

JUN 2 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jeffrey R. Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121

K040437 Re:

Trade/Device Name: Triage® Profiler S.O.B. Panel Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin degradation products assay Regulatory Class: Class II Product Code: DAP, NBC,MMI, JHX, DDR Dated: June 1, 2004 Received: June 2, 2004

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreas, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Coometer fore, market the device, subject to the general controls provisions of the Act. The I va may, therefore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 it may be subject to bach additions beend 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I vith 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) I ms loter will and in your of substantial equivalence of your device of your device to a legally prematication: "The Blassification 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, II you desire spoolitie niemand advertising of your device, please contact the Office of of questions on the promotion 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 Tou may obtain other getterers, 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,

Jean M. Cooper, U.S., Div.

Jean M. Cooper, MS, 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

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Indications for Use

510(k) Number (if known): K040437

Device Name: Triage® Profiler S.O.B. Panel

Indications For Use:

Prescription Use
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AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) K040437

Page 1 of

Regulation Number and Section

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).