The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range. The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains heparin.

AI/ML Overview

The provided text is a 510(k) summary for the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and does not contain information about acceptance criteria or a study demonstrating device performance against such criteria in the way a typical efficacy or performance study would.

This document describes a quality control material, which is used to verify the calibration of an already approved diagnostic device (the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter). The purpose of this 510(k) submission is to demonstrate substantial equivalence to previously approved predicate devices, not to establish the diagnostic performance of a new primary diagnostic tool.

Therefore, many of the requested sections about acceptance criteria, clinical study design, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth for a diagnostic device are not applicable or cannot be extracted from this document, as this is not the type of study presented for quality control materials for calibration verification.

Here's what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated for this quality control material in terms of diagnostic performance. For quality control materials, acceptance criteria would typically relate to their stability, homogeneity, and their ability to produce expected results within a predefined range when run on the associated diagnostic system. These specific criteria are not detailed in the provided summary.
Reported Device Performance: The primary "performance" reported is its substantial equivalence to predicate devices, noting the only difference is the matrix (EDTA vs. heparin). No specific numerical performance metrics are provided for the control material itself in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. A "test set" in the context of clinical performance is not relevant here as this is a calibration verification control.

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

Not applicable; "ground truth" in a diagnostic sense is not relevant for a calibration control material.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 a quality control material, not a diagnostic device involving human readers or AI.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm or a diagnostic test with a "training set" in that sense.

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

Not applicable.

Summary of what is available from the document:

The study presented is a substantial equivalence comparison between the new device and predicate devices.

Key finding: The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are substantially equivalent to previously approved predicate devices (Triage® Cardiac Calibration Verification Controls (K974827) and Triage® BNP Calibration Verification Controls (K000231)).
Difference from Predicates: The only difference noted is that the new controls are prepared in a matrix containing EDTA, while the predicate Triage® Cardiac Calibration Verification Controls were prepared in a matrix containing heparin. This indicates that the study likely focused on demonstrating that this change in matrix did not negatively affect the control's ability to perform its intended function (verify calibration) compared to the heparin-based controls.
Intended Use: To verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range when used with the Triage® Meter.

In conclusion, this document describes a regulatory submission for a quality control product, not a clinical study to establish diagnostic performance against specific acceptance criteria in the manner requested.

Summary

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No30053

JAN 1 7 2003

510(k) Summary of Safety and Effectiveness

Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls

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:	1/7/03

B. Device Names

1. Trade Name
  Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls
1. Common / Usual Name
  Not Applicable
1. Classification Name
  Quality Control Material (Assayed and Unassayed) 21 CFR 862:1660 Class I Product Code: JJY

C. Predicate Devices

Triage® Cardiac Calibration Verification Controls (K974827) Triage® BNP Calibration Verification Controls (K000231)

D. Device Description and Intended Use

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac

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Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.

E. Summary of Comparison Data

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains heparin.

F. Conclusion

The information provided in the premarket notification demonstrates that the Triage® Cardio ProfilER / Triaqe® Cardiac Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are safe and effective for their intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 7 2003

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

Re: K030088

Trade/Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class II Product Code: JJY Dated: January 7, 2003 Received: January 10, 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, 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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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). Other general information on your responsibilities under the Act may be obtained 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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Page 1 of 1

K030088

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

Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Looper

Clinical Laboratory Devices
K030088

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The Counter Use__

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.