The Stratus® CS D-dimer CalPak is an in vitro diagnostic product used to calibrate the Stratus® D-dimer method on the Stratus® CS STAT fluorometric analyzer. This calibrator is intended for medical purposes to establish points of reference that are used in the determination of D-dimer concentration in human specimens.

Device Description

The Stratus® CS D-dimer CalPak consists of a plastic cartridge (CalPak) containing human D-dimer in a liquid, buffered bovine protein matrix in each of three wells. The CalPak is designed for use only on the Stratus® CS analyzer.

AI/ML Overview

This document is a 510(k) premarket notification for a calibrator device, not an AI/ML diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for calibrators. The key aspects are the comparison of intended use, design, and performance characteristics (though specific performance data like accuracy or precision of the calibration itself are not detailed in this summary).

Here's an attempt to address the applicable parts of your request based on the provided text:

Acceptance Criteria and Device Performance for Stratus® CS D-dimer CalPak

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from substantial equivalence)	Reported Device Performance
Intended Use	Calibration of corresponding D-dimer method	Calibration of Stratus® D-dimer method on Stratus® CS STAT fluorometric analyzer. Substantially equivalent to predicate's intended use.
Design/Composition	Liquid, buffered bovine protein matrix, human D-dimer.	Liquid, stored frozen; buffered bovine protein matrix with human D-dimer, stabilizers, and sodium azide. Substantially equivalent in design to predicate.
Packaging	Suitable for specific analyzer	Sealed plastic cartridge for use only on the Stratus® CS analyzer.
Calibration Method	Functional calibration system	Calibration curve updated for each lot initially (in triplicate) and every 60 days thereafter using Master lot values. Recovered values automatically calculated from stored calibration coefficients.
Substantial Equivalence	Demonstrated equivalence to predicate device in intended use and design for regulatory approval.	The device is deemed substantially equivalent to the VIDAS® D-dimer Calibrator.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is for a calibrator, which primarily demonstrates substantial equivalence to a predicate device. It does not involve a "test set" in the context of evaluating a diagnostic algorithm's performance against patient data. The "test" mentioned relates to the calibration procedure itself (e.g., "After completion of each test, the recovered values are automatically calculated...").

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

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

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 not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

Not Applicable directly in a diagnostic performance sense. For a calibrator, the "truth" is established by the known concentration of the D-dimer within the calibrator material itself, which is then used to set the instrument's reference points for measuring unknown samples. The document doesn't detail the method of how the D-dimer concentration in the calibrator was precisely determined, but it would involve analytical chemistry and highly controlled reference materials.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

Study Proving Acceptance Criteria:

The "study" that proves the device meets its "acceptance criteria" is the 510(k) premarket notification process itself, specifically the comparison to the predicate device.

The document explicitly states:

"Both the Dade Behring Stratus® CS D-dimer CalPak and the VIDAS® D-dimer calibrator products are intended to calibrate their respective closed system methods utilizing similar designs consisting of human blood products in a buffered, bovine protein-based matrix."

"The Stratus® CS D-dimer CalPak is substantially equivalent in intended use and design to the VIDAS® D-dimer calibrator as noted above."

This statement, reviewed and accepted by the FDA (as indicated by the clearance letter), serves as the evidence that the device meets the regulatory acceptance criteria for market entry as a substantially equivalent device. The underlying details of the analytical performance of the calibrator (e.g., its accuracy, stability, commutability) would have been part of the full 510(k) submission, even if not fully detailed in this summary. However, the core "proof" presented here for regulatory acceptance relies on this substantial equivalence argument.

Summary

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KO22927

NOV 2 7 2002

Summary of Safety and Effectiveness Information

Stratus® CS D-dimer CalPak (calibrator)

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

Submitter's Name:	Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	September 4, 2002
Name of Product:	Stratus® CS D-dimer CalPak (calibrator)
FDA Classification Name:	Calibrator (21 CFR§862.1150); DAP
Predicate Device:	VIDAS® D-dimer (DD) Calibrator
Device Description:	The Stratus® CS D-dimer CalPak consists of a plastic cartridge(CalPak) containing human D-dimer in a liquid, buffered bovineprotein matrix in each of three wells. The CalPak is designedfor use only on the Stratus® CS analyzer
Intended Use:	The Stratus® CS D-dimer CalPak is an in vitro diagnosticproduct used to calibrate the Stratus® D-dimer method on theStratus® CS STAT fluorometric analyzer.

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Comparison to Predicate Device:

	Stratus®CSD-dimer CalPak	VIDAS® D-dimerCalibrator
Intended Use:	Calibration of the Stratus®D-dimer method	Calibration of the VIDAS®D-dimer method
Form:	Liquid, stored frozen	Lyophilized
Matrix:	Buffered bovine proteinmatrix with human D-dimer,stabilizers and sodium azide	Lyophilized fibrin degradationproduct from human plasmawith glycine-albumin bovinebuffer and sodium azide.
Package:	Sealed plastic cartridge for useonly on the Stratus® CS analyzer	Vials; 2 mL reconstituted
Calibration:	Calibration curve updated for eachlot initially, in triplicate and every60 days thereafter using Master lotvalues. After completion of each test,the recovered values are automaticallycalculated from the stored calibrationcoefficients.	One point calibration tested induplicate, with each Master lotinitially by the user. Afterwards,the user recalibrates every 14 days.

Comments on Substantial Equivalence:

Both the Dade Behring Stratus® CS D-dimer CalPak and the VIDAS® D-dimer calibrator products are intended to calibrate their respective closed system methods utilizing similar designs consisting of human blood products in a buffered, bovine protein-based matrix.

Conclusion:

The Stratus® CS D-dimer CalPak is substantially equivalent in intended use and design to the VIDAS® D-dimer calibrator as noted above.

RM Vaught

Richard M. Vaught Regulatory Affairs and Compliance Manager September 4, 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is composed of three curved lines that resemble a bird in flight or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 7 2002

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500. MS 514 P.O. Box 6101 Newark, DE 19714

K022977 · Re:

Trade/Device Name: Stratus® CS D-dimer CalPak (calibrator) Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation products assay Regulatory Class: Class II Product Code: DAP; GHH; JIT Dated: October 30, 2002 Received: November 15, 2002

Dear Mr. Vaught:

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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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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INDICATIONS FOR USE STATEMENT

Device Name:

Koza997

Stratus® CS D-dimer CalPak (calibrator)

Indications for Use:

Rm Van ht
Richard M. Wright

ichard M. Vaught Regulatory Affairs and Compliance Manager

September 4, 2002

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Reeves for J. Bautista

Division Division of Clinical 510(k) Number

Prescription Use > (Per 21 CFR 801.109)

Over-the-counter Use

(Optional format 1-2-96)

Regulation Number and Section

§ 864.7320 Fibrinogen/fibrin degradation products assay.

(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).