The Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range.

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

Device Description

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

Matrix: EDTA plasma
Form: Liquid
Analytes: CK-MB, Troponin I, Myoglobin, BNP, D-dimer
Storage: -20 °C or colder

AI/ML Overview

The provided document is a 510(k) summary for Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance as typically seen for diagnostic algorithms.

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

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

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics rather than defining specific performance acceptance criteria for the new device and then showing it met them through a study.

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 present in the provided 510(k) summary. The document does not describe a clinical study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary. Given that this is a quality control material and not a diagnostic device directly interpreting patient data, a "ground truth" derived from expert consensus on patient cases is not applicable in this context.

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

This information is not present in the provided 510(k) summary. This type of adjudication method is relevant for studies involving human interpretation of diagnostic results, not for quality control materials.

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

This information is not applicable and not present in the provided 510(k) summary. The device is a quality control material, not an AI or a diagnostic tool intended to assist human readers.

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

This information is not applicable and not present in the provided 510(k) summary. The device is a quality control material, not a standalone diagnostic algorithm.

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

This information is not present in the provided 510(k) summary. For quality control materials, the "ground truth" would typically refer to the known, assigned values of the analytes within the control material itself, established through robust analytical methods, rather than clinical ground truth from patient data. The document does not detail how these "true" values were established for the controls.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. The document does not describe the development or training of an algorithm using a training set.

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

This information is not present in the provided 510(k) summary. As mentioned, the document does not describe the development or training of an algorithm.

Summary of what the document does provide regarding the study:

The document describes a submission for a quality control material, not a diagnostic device that performs analysis on patient samples. Therefore, the "study" described is a comparison to predicate devices to demonstrate substantial equivalence, rather than a performance study against clinical acceptance criteria.

The comparison focuses on:

Intended Use: Assayed control for monitoring test performance.
Matrix: EDTA plasma.
Form: Liquid.
Analytes: CK-MB, Troponin I, Myoglobin, BNP, D-dimer (for the new device) vs. CK-MB, Troponin I, Myoglobin, BNP (for the predicate). The only difference is the addition of D-dimer in the new device's analyte list.
Storage: -20 °C or colder.

The conclusion is that the new controls are substantially equivalent to the predicate devices based on these characteristics. No specific performance data (e.g., recovery rates, precision) or acceptance criteria for these performance characteristics are provided in this summary.

Summary

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JUL - 6 2004

K040459

510(k) Summary of Safety and Effectiveness

Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. 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 StreetSan Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8350
Contact Person:	Jeffrey R. Dahlen, Ph.D.
Date Summary Prepared:	2/20/05

B. Device Names

1. Trade Name
  Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls
1. Common / Usual Name
  Not Applicable
1. Classification Name
  Quality Control Material (Assayed and Unassaved) 21 CFR 862:1660 Class I Product Code: JJY

C. Predicate Devices

Triage Cardio ProfilER Calibration Verification Controls (K030088) Triage Cardio ProfilER Controls (K030089)

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D. Device Description and Intended Use

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

E. Summary of Comparison Data

The table below provides a comparison of the technical principles between the Triage® Profiler S.O.B. Calibration Verification Controls / Triage® Profiler S.O.B. Controls and the predicate devices.

Characteristic	Triage®ProfilerS.O.B.Controls /CalibrationVerificationControls	Triage®CardioProfilerControls /CalibrationVerificationControls(K030088,K030089)
Intended Use	Assayedcontrol formonitoringtestperformance	Assayedcontrol formonitoringtestperformance
Matrix	EDTAplasma	EDTAplasma
Form	Liquid	Liquid
Analytes	CK-MB,Troponin I,Myoglobin,BNP, D-dimer	CK-MB,Troponin I,Myoglobin,BNP
Storage	-20 °C orcolder	-20 °C orcolder

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F. Conclusion

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare.

Public Health Service

JUL - 6 2004

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

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

K040459 Re:

Trade/Device Name: Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls Triage® Profiler S.O.B. (Shortness of Breath) Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assay and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 28, 2004 Received: June 29, 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

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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,

Jean M. Cooper, MS, DVM.

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): K040459

Device Name: Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls

Triage® Profiler S.O.B. (Shortness of Breath) Controls

Indications For Use:

The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

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 Benson
Division Sign-Off

Office of In Vitro Diagn Device Evaluation and So

510(k) K040459

Page 1 of

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.