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 pentide, 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.

Device Description

AI/ML Overview

This 510(k) summary explicitly states that no new study was performed for this submission (K042723).

The key statement is in section E: "There have been no changes to the test performance, design, reagents and manufacture. These are identical to 510(k) document number K040437. The indications for use have been revised for clarity."

Therefore, the acceptance criteria and study details would be found in the original submission K040437, not in this document. Since this document refers to K040437 for identical test performance, design, reagents, and manufacture, it implies that the device met the acceptance criteria defined in K040437.

Without access to the K040437 document, I cannot provide the specific details of the acceptance criteria and the study that proved the device met them.

Based solely on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance: Not provided in this document. The document states that the performance is "identical to 510(k) document number K040437."
Sample size used for the test set and the data provenance: Not provided in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document.
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 device is a fluorescence immunoassay for quantitative determination of biomarkers, not an AI-assisted diagnostic imaging device for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" as understood for AI devices. It is a standalone diagnostic test in the sense that it provides quantitative results of biomarkers. This document confirms the test performance is identical to the prior submission, implying standalone performance was evaluated earlier.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document. For an immunoassay, the "ground truth" would typically refer to a reference method or clinical diagnosis based on established guidelines/outcomes at the time of the original submission (K040437).
The sample size for the training set: Not provided in this document. Immunoassays typically don't have "training sets" in the same way machine learning models do. Performance is validated through analytical and clinical studies.
How the ground truth for the training set was established: Not applicable for "training set" in this context.

Summary

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DEC - 7 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.

K040427 K042723 510(k) Number:

A. Name and Address of Submitter

Company Name:	Biosite Incorporated
Address:	11030 Roselle StreetSan Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8350
Contact Person:	Jeffrey R. Dahlen, Ph.D.
Date Summary Prepared:	9/30/04

B. Device Names

1. Trade Name
  Triage® Profiler S.O.B. Panel
1. Common / Usual Name
  Triage® Profiler S.O.B. 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) Product Code NBC

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

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C. Predicate Devices

Triage® Profiler S.O.B. Panel (K040437) K 04-2 7 2 3

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 1, B-type natriuretic peptide, and cross-linked fibrin dearadation 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 having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.

E. Summary of Comparison Data

There have been no changes to the test performance, design, reagents and manufacture. These are identical to 510(k) document number K040437. The indications for use have been revised for clarity.

F. Conclusion

The revision to the indications for use raises no new issues of safety and effectiveness for the Triage Profiler S.O.B. Panel. Because there were no modifications to the test performance, design, reagents and manufacture, the test system is substantially equivalent to the predicate method.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing snakes intertwined around a staff.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 7 2004

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

Re: K042723

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, MMI, JHX, DDR, NBC Dated: September 30, 2004 Received: October 1, 2004

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, 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).

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotest 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, rr you stions 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,

Cornelia B. Lorkes

Cornelia B. Rooks, MA Acting 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): IBO K042723

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

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 C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042723

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).