The Triage D-Dimer Calibration Verification Controls are to be used with the The Thage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimor Test throughout the measurable range.

The Triage D-Dimer Controls are assayed materials to be used with the The Thage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

Device Description

The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.

The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

AI/ML Overview

The provided text is a 510(k) summary for Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study evaluating the performance of a medical device in terms of diagnostic accuracy against clinical outcomes.

Therefore, many of the requested criteria regarding device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of document.

The document primarily focuses on the intended use and classification of the control materials.

Here's an analysis based on the provided text, highlighting what is not applicable:

A table of acceptance criteria and the reported device performance:
- N/A. This document describes "Calibration Verification Controls" and "D-Dimer Controls," which are materials used to verify the calibration and monitor the performance of a diagnostic test (the Triage D-Dimer Test), not a diagnostic device itself that has performance metrics like sensitivity, specificity, etc. As such, there are no acceptance criteria and reported device performance in the typical sense for a diagnostic algorithm. The document states the controls are "safe and effective for their intended use," which is their primary claim.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. There is no "test set" in the context of device performance evaluation described here, as this is a submission for control materials.
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):
- N/A. As no test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set for diagnostic performance is described.
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:
- N/A. This device is control material, not an AI-assisted diagnostic tool or a device requiring human reader interpretation, so MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is control material, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. Ground truth for diagnostic performance is not relevant to this submission for control materials. The "truth" for these controls would be their assigned D-Dimer concentration values, which are established as part of their manufacturing and assay process.
The sample size for the training set:
- N/A. This is control material, not a machine learning model, so there is no training set mentioned.
How the ground truth for the training set was established:
- N/A. This is control material, not a machine learning model, so there is no training set or associated ground truth establishment described.

Summary

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JUN 2 9 2005

510(k) Summary of Safety and Effectiveness

Triage D-Dimer Calibration Verification Controls / Triage D-Dimer 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.

K050799 510(k) Number:

A. Name and Address of Submitter

Company Name:	Biosite Incorporated
Address:	11030 Roselle Street
	San Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8344
Contact Person:	Rachael S. Williamson
Date Summary Prepared:	6/22/05

B. Device Names

1. Trade Name
  Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls
1. Common / Usual Name
  Not Applicable

3. Classification Name

Plasma, Coagulation Control 21 CFR 864.5425 Class II Product Code: GGN

C. Predicate Devices

Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3 (K032017)

D. Device Description and Intended Use

The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.

The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

E. Conclusion

The information provided in the premarket notification demonstrates that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are substantially equivalent to previously approved predicate devices. The information provided assures

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that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird.

JUN 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rachael S. Williamson Regulatory Affairs Specialist Biosite Incorporated 11030 Roselle Street San Diego, California 92121

K050799 Re:

Trade/Device Name: Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma coagulation control Regulatory Class: II Product Code: GGN Dated: May 17, 2005 Received: May 18, 2005

Dear Ms. Williamson:

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). 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.

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Page 2 –

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 (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

lobatz Beckerich

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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): K050799

Device Name: Triage® D-Dimer Test

Indications For Use:

The Triage D-Dimer Controls are assayed materials to be used with the The Thage D-Dimer Test and Triage MeterPlus 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)

Josephine Bautista

(Division Sign-Øff)

510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of Clinical Laboratory Devices
510(k) Number K050799

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.