The Triage® Cardio ProfilER / Triage® Cardiac Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to assist the laboratory in monitoring test performance.

Device Description

AI/ML Overview

This 510(k) summary describes a device that is a quality control material, not a diagnostic or prognostic device that relies on studies with human subjects. Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

The document focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances for such products.

Here's a breakdown of the available information in relation to your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance criterion for this 510(k) submission is "substantial equivalence" to predicate devices. The reported "performance" is that the device is substantially equivalent.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices	The Triage® Cardio ProfilER / Triage® Cardiac Controls are substantially equivalent to previously approved predicate devices (Triage® Cardiac Controls K974461 and Triage® BNP Controls K000230).
Safe and Effective for Intended Use	The Triage® Cardio ProfilER / Triage® Cardiac Controls are safe and effective for their intended use (monitoring test performance of the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter).

Study Information (as applicable for a Quality Control Device)

Sample size used for the test set and the data provenance: Not applicable. This is a quality control material, not a diagnostic test evaluated on patient samples. The "test set" would typically refer to stability studies, linearity, or value assignment studies for the control material itself, but these details are not provided in this 510(k) summary. The comparison focuses on the matrix difference.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for a quality control material's 510(k) submission.
Adjudication method for the test set: Not applicable.
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 device or a diagnostic device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
The type of ground truth used: Not applicable in the sense of clinical "ground truth." The ground truth for a control material would be its assigned target values based on a robust value assignment process, but this is not detailed in the summary.
The sample size for the training set: Not applicable. There is no "training set" in the context of an algorithm or AI.
How the ground truth for the training set was established: Not applicable.

Explanation Based on Device Type

This 510(k) submission is for Quality Control Material. For such devices, "studies" usually involve:

Manufacturing and Lot Release Testing: Ensuring consistency between lots, correct analyte concentrations, and stability over the shelf life.
Method Comparison: If there are changes to components or manufacturing, studies may show that the new control material behaves similarly in the assay to the previous version or predicate.
Value Assignment: Determining the target values and ranges for the control material using accepted statistical methods and reference instruments/methods.

The core of this 510(k) summary revolves around the statement: "The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Controls are prepared in a matrix that contains heparin." This implies that the manufacturer would have performed internal testing to demonstrate that this matrix difference does not adversely affect the control's performance with the intended assay, thus maintaining substantial equivalence. These details, however, are not explicitly provided in the summary but would have been part of the full 510(k) submission.

Summary

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510(k) Summary of Safety and Effectiveness

Triage® Cardio ProfilER / Triage® Cardiac Controls

K030089

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

(To be determined) 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:	1/7/03

B. Device Names

1. Trade Name
  Triage® Cardio ProfilER / Triage® Cardiac Controls
1. Common / Usual Name
  Not Applicable

Classification Name

Quality Control Material (Assayed and Unassaved) 21 CFR 862:1660 Class I Product Code: JJY

C. Predicate Devices

Triage® Cardiac Controls (K974461) Triage® BNP Controls (K000230)

D. Device Description and Intended Use

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E. Summary of Comparison Data

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

F. Conclusion

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

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JAN 2 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K030089

Trade/Device Name: Triage® Cardio ProfilER / Triage® Cardiac Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I 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 vour 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) 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

K030089

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

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

Laporatory Devices
5 biky Number 2630089

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

(Optional Format 1-2-96)

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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.