The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of troponin complex per well is 40 ng/mL. The CalPak is a single-use product.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Stratus® CS Troponin I Calibrator (TROP CalPak). It is not a study report that includes acceptance criteria and performance data for a device in the way you've described for an AI/algorithm-based device.

The document primarily focuses on establishing "substantial equivalence" of a modified calibrator to a previously marketed calibrator. This regulatory process does not typically involve the kinds of performance studies, acceptance criteria, ground truth, or expert review that would be associated with a new diagnostic algorithm or device determining a medical outcome.

Therefore, I cannot extract the information you requested because it is not present in this document. Here's why and what kind of information is contained:

Why the requested information is not present:

Nature of the Device: The device is a "calibrator," meaning it's a reference material used to ensure the accuracy of an analyzer (the Stratus® CS analyzer) that measures Cardiac Troponin I. It's not a diagnostic device that directly interprets patient data, makes a diagnosis, or an AI/algorithm.
Regulatory Goal: The purpose of this 510(k) submission is to demonstrate that the modified calibrator is "substantially equivalent" to an already cleared calibrator. This relies on demonstrating that their intended use, operating principles, design, materials, etc., are similar enough that the new device is as safe and effective as the predicate. It does not require a de novo performance study against a ground truth as would be needed for a new diagnostic claim or an AI algorithm.
"Acceptance Criteria" for a Calibrator: For a calibrator, "acceptance criteria" would typically relate to its manufacturing specifications, stability, and its ability to consistently produce expected values on the analyzer. These are internal manufacturing and quality control parameters, not performance metrics against a clinical ground truth.

What is available in the document:

Predicate Device: Stratus® CS TROP CalPak (K981100)
Differences from Predicate: The main difference is the "Analyte" source (Native human troponin complex vs. Troponin-I peptide fragment). Target Concentration also differs (40 ng/mL vs. 45 ng/mL).
Conclusion: The modified calibrator is "substantially equivalent" based on the comparison provided.

In summary, this document is a regulatory submission for a laboratory calibrator, not a study evaluating an AI/algorithmic device's diagnostic performance. Therefore, it does not contain the information you asked for regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert review for diagnostic accuracy.

Summary

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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

Dade Behring

Summary of Safety and Effectiveness Information

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

Submitter's Name:	Rebecca S. AyashDade Behring Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101Phone: (302) 631-6276FAX: (302) 631-6299
Date of Preparation:	10/21/98
Device Name:	Stratus® CS Troponin I Calibrator (TROP CalPak)
Classification Name:	Calibrator, secondary
Predicate Device:	Stratus® CS TROP CalPak (K981100)

Device Description: The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of troponin complex per well is 40 ng/mL. The CalPak is a single-use product.

Intended Use: The TROP CalPak is intended to be used for calibration of the Cardiac Troponin I method on the Stratus® CS analyzer.

Comparison to Predicate Device:

	Stratus® CS TROP CalPak(Modified)	Stratus® CS TROP CalPak(K981100)
Intended Use	Calibrator	Calibrator
Analyte	Native human troponin complex	Troponin-I peptide fragment
Matrix	Buffered bovine protein	Buffered bovine protein
Form	Frozen	Frozen
Target Concentration	40 ng/mL	45 ng/mL
Values	Assigned	Assigned
Packaging Configuration	Single use plastic cartridge	Single use plastic cartridge
Levels	One	One

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Comments on Substantial Equivalence: The Stratus® CS TROP CalPak (modified) is equivalent to the Stratus® CS TROP CalPak currently marketed. Both products are manufactured using a buffered bovine protein matrix but differ in analyte source. Both products are intended to be used as calibrators for the Stratus® CS Cardiac Troponin I method.

Conclusion: The modified Stratus® CS TROP CalPak is substantially equivalent to the Stratus® CS TROP CalPak currently marketed by Dade Behring based on the companson summarized above.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 10/21/98

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NOV 4 1998

Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager DADE BEHRING, INC. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re : K983722 Trade Name: Stratus® CS Troponin-I Calibrator (TROP CalPak) Requlatory Class: II Product Code: JIT Dated: October 21, 1998 Received: October 21, 1998

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indications Statement

Device Name: Stratus® CS Troponin I Calibrator (TROP CalPak)

Indications for Use: The Cardiac Troponin-I Calibrator (TROP CalPak) is intended to be used to calibrate the Cardiac Troponin I method on the Stratus® CS analyzer.

Rebecca S. Ayash

Rebecca S. Ayas Regulatory Affairs and Compliance Manager Date: 10/21/98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K983722
510(k) Number

signature

Division Sign-Off Office of Device Evaluation

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/ prescription use

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.