The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

Device Description

The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.

AI/ML Overview

This submission describes Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set, which are assayed quality control materials used to monitor the performance of specific Triage® tests (Troponin I, BNP, Cardio2 Panel, Cardio3 Panel) and the Triage® Meter. The device is being compared to a predicate device, the Triage® Total 5 Controls and Calibration Verification Set.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the new device. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "performance testing." The key performance characteristic mentioned is "value assignment and stability."

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Value Assignment	Perform comparably to the predicate device.	"evaluated for value assignment" - deemed substantially equivalent
Stability	Perform comparably to the predicate device (8 months).	"4 weeks (real time stability on-going)"
Safety	As safe as the predicate device.	"as safe...as the predicate device"
Effectiveness	As effective as the predicate device.	"as effective...as the predicate device"
Overall Performance	Performs as well as the predicate device.	"performs as well as the predicate device"

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample size used for the performance testing. It generally refers to "bench performance testing."

It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given that it's a Triage® product, the test is likely performed in clinical laboratories, which could be in the US or other regions where Triage® products are used. The testing described appears to be laboratory-based ("bench performance testing") rather than patient-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given that this device is a quality control material, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologists interpreting images) is not applicable. The "ground truth" in this context would be the accurately determined concentrations of the analytes (CKMB, cardiac troponin I, and BNP) within the control materials. These values are established through rigorous analytical methods and reference standards, not human expert consensus. The document does not specify the number or qualifications of experts involved in this process, as it falls under standard quality control manufacturing practices.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for quality control materials is established through analytical validation and reference methods, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a quality control material for in vitro diagnostic tests, not an AI or imaging device that would involve human readers. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)

Yes. The performance testing described (value assignment and stability) represents standalone performance of the control materials in conjunction with the Triage® meter/assays, without direct human intervention in the "performance" aspect itself beyond standard laboratory procedures for running controls. The device's function is to objectively monitor the performance of other diagnostic tests.

7. Type of Ground Truth Used

The "ground truth" for this type of device would be the analytically determined concentrations of the target analytes (CKMB, cardiac troponin I, and BNP) within the control materials, established through validated reference methods and traceable standards. The document doesn't explicitly detail the methodology for establishing these values but implies they are part of the "value assignment" process.

8. Sample Size for the Training Set

Not applicable. This device is a quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device involves the manufacturing process and analytical validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the target values) for such quality control materials are established during their development and manufacturing through precise analytical methods.

Summary

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510(k) Summary

Image /page/0/Picture/1 description: The image shows the word "BIOSITE" in all caps. The "O" in the word is replaced with a circular image of the earth. The word is written in a bold, sans-serif font and is black in color.

NEW DIMENSIONS !N DIAGNOSIS™

510(k) Summary

510(k) number:

NOV 1 3 2000

Date Prepared: 03 November 2009

Submitter:	Biosite, Inc.	Contact:	Mara Caler
Address:	9975 Summers Ridge Road		Regulatory Affairs
	San Diego, CA 92121	Telephone:	858 805 2083
Telephone:	858 805 2083	Fax:	858 695 7100
Fax:	858 695 7100	Email:	mcaler@biosite.com

Trade (proprietary) name:	Common Name (Device Type):
Triage® Total 3 Controls and Triage®Total 3 Calibration Verification Set	Assayed Quality Control materials

Class:	1
Regulation number:	21 CFR 862.1660
Product Code:	JJY
Panel:	Clinical Chemistry

Predicate devices:

K072892: Triage® Total 5 Controls and Calibration Verification Set

The Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set is substantially equivalent to other products in commercial distribution intended for similar use, with substantial equivalency to the currently marketed Triage® Total 5 Controls and Triage® Total 5 Calibration Verification Set

Biosite, Inc.

Section 5

Triage® Total 3 Controls and Triage® Total 3 Calibration Verification

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510(k) Summary

Device Description:

Intended Use / Indications for Use:

Summary of Changes from Predicate Device:

The predicate device is the Triage® Total 5 controls and Triage® Total 5 Calibration Verification Set. The changes from the predicate device are:

Lower levels of analyte .
Removing the d-dimer analyte and the myoglobin analyte from the controls .

Substantial Equivalence to Predicate Device:

The predicate device is the Triage® Total 5 Controls and Triage® Total 5 Calibration Verification Set.

The proposed Triage® Total 3 Controls and Triage® Total 3 Calibration . Verification Set are substantially equivalent to Triage® Total 5 Controls and Total 5 Calibration Verification Set in intended use, technology and performance.
Bench performance testing was performed comparing the new device and the . predicate device, and was found to be substantially equivalent.

List of Similarities:

Intended use is unchanged (except for the removal of the d-dimer analyte and the . myoglobin analyte from the control set)
Indications for use is unchanged .
The operating principle is unchanged .
The technology is unchanged .
The analytical performance is unchanged or improved .

Biosite, Inc.

Section 5

Triage® Total 3 Controls and Triage® Total 3 Calibration Verification

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List of Differences:

Control level 1 contains a lower level of troponin I than the predicate device .
The individual assays contained within the control material has been reconfigured . (myoglobin and d-dimer have been removed from the control set).

Comparison Table:

Characteristic	Predicate: K072892: Triage® Total 5 Controls and Calibration Verification Set	Triage® Total 3 Controls and Calibration Verification Set
Intended use	The Triage® Total 5 Controls are assayed controls to be used with the Triage® BNP Test, Triage® CardioProfilER Panel, Triage® Cardiac Panel and Triage® S.O.B Panel devices and the Triage® Meter to assist the end user in monitoring product performance.The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® BNP Test, Triage® CardioProfilER Panel, Triage® Cardiac Panel and Triage® S.O.B Panel devices and the Triage® Meter to assist the end user in monitoring product performance.	The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.
Levels	2	2 (same)
Format	Liquid/frozen	Liquid/frozen (same)
Handling	Thaw, no other user manipulation required	Thaw, no other user manipulation required (same)
Stability	8 months	4 weeks (real time stability on-going)
Matrix	Human EDTA plasma	Human EDTA plasma (same)

Performance Characteristics:

The Triage® Total 3 Controls and Cal Verification set were evaluated for value assignment and stability.

Biosite, Inc.

Section 5

Triage® Total 3 Controls and Triage® Total 3 Calibration Verification

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Conclusion :

Performance testing demonstrates that the Triage® Total 3 Control and Triage® Total 3 Calibration Verification Set are as safe, as effective and performs as well as the predicate device.

Biosite, Inc.

Section 5

Triage® Total 3 Controls and Triage® Total 3 Calibration Verification

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Biosite Incorporated c/o Mara Caler 9975 Summers Ridge Road San Diego, California 92121

NOV 1 3 2009

K093032 Re:

Trade Name: Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set Regulation Number: 21 CFR §862.1660 Regulation Name: Assayed Quality Control Materials Regulatory Class: Class I Product Codes: JJY Dated: September 25, 2009 Received: September 29, 2009

Dear Ms. Caler:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. 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 Form

510(k) Number (if known): 5093032

Device Name: Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set

Indications for Use:

The Triage® Total 3 Controls are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification Set are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF 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) K093032

Page 1 of 1

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.