The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Device Description

Dimension® Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 9, 25, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device: Dimension® RxL Cardiac Troponin-I (TROP) Calibrator.

Based on the document, this is a calibrator (a lab reagent used to set the scale of an instrument), not a diagnostic device that directly measures a patient's condition or relies on expert interpretation of images or other data. Therefore, many of the typical questions related to diagnostic device studies (like expert consensus, adjudication, MRMC studies, or standalone performance for an algorithm) do not apply to this type of product.

The study described is a comparison to a predicate device to establish substantial equivalence.

Here's the information extracted from the provided text:

Table of Acceptance Criteria and Reported Device Performance:

The document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) because it is a calibrator, not a diagnostic test with an output about a patient's condition. Instead, the "acceptance" for this submission is demonstrating substantial equivalence to a previously cleared predicate device based on its intended use, analyte, matrix, form, volume, values, and levels.

Characteristic	Predicate Device: Dimension® RxL TROP Calibrator	Modified Device: Dimension® RxL TROP Calibrator
Intended Use	Calibrator	Calibrator
Analyte	Cardiac troponin-I	Native human troponin-I complex
Matrix	Buffered bovine protein	Buffered bovine protein
Form	Frozen	Frozen
Volume	2.0 mL per vial	3.0 mL per vial
Values	Assigned	Assigned
Levels	5 levels	5 levels

Reported Device Performance: The conclusion states: "The modified Dimension® RxL Cardiac Troponin I Calibrator is substantially equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently marketed by Dade Behring based on the comparison summarized above."

Sample size used for the test set and the data provenance:

Not applicable in the typical sense for a diagnostic device. The "test" here is a comparison of product specifications (physical characteristics and intended use) between the new and predicate calibrator. There is no mention of patient samples or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a calibrator, not a diagnostic device relying on expert interpretation of images or clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.
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 a calibrator, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a calibrator, not an algorithm or an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for a device that is a calibrator. The "ground truth" for showing substantial equivalence relies on comparing the characteristics and functional aspects of the new calibrator against those of an already cleared predicate calibrator. The "truth" is whether the characteristics (analyte, matrix, form, values, levels) are sufficiently similar or justified in their differences (like volume or specific analyte source) to achieve the same intended use.
The sample size for the training set:

Not applicable. This device does not use machine learning or require a "training set."
How the ground truth for the training set was established:

Not applicable.

Summary

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NOV 4 1998

DADE BEHRING

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

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:	10/20/98
Device Name:	Dimension® RxL Cardiac Troponin-I (TROP) Calibrator
Classification Name:	Calibrator, secondary
Predicate Device:	Dimension® RxL Cardiac Troponin-I Calibrator(K973668)

Device Description: Dimension® Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 9, 25, and 55 ng/mL containing native human troponin complex in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

Intended Use: TROP Calibrator is intended to be used to calibrate the TROP Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Comparison to Predicate Device:

Dimension® RxL TROP Calibrator (Modified)	Dimension® RxL TROP Calibrator
Intended Use	Calibrator	Calibrator
Analyte	Native human troponin-I complex	Cardiac troponin-I
Matrix	Buffered bovine protein	Buffered bovine protein
Form	Frozen	Frozen
Volume	3.0 mL per vial	2.0 mL per vial
Values	Assigned	Assigned
Levels	5 levels	5 levels

Comments on Substantial Equivalence: Modified Dimension® RxL Cardiac Troponin I Calibrator is equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently

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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 Dimension® RxL Cardiac Troponin-I assay.

Conclusion: The modified Dimension® RxL Cardiac Troponin I Calibrator is substantially equivalent to the Dimension® RxL Cardiac Troponin-I Calibrator currently marketed by Dade Behring based on the comparison summarized above.

Rebecca S. Ayash

Rebecca Regulatory Affairs and Compliance Manager Date: 10/20/98

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its head turned to the left and its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

NOV 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: кавзеяз Dimension® RxL Cardiac Troponin-I (TROP) Trade Name: Requlatory Class: II Product Code: JIT Dated: October 20, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 misbrandinq 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 requlations 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 yerify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.

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Page 2

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 regulation (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 Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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Enclosure

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Indications Statement

Device Name: Dimension® RxL Cardiac Troponin-1 (TROP) Calibrator

Indications for Use: The Cardiac Troponin-I (TROP) Calibrator is intended to be used to calibrate the Cardiac Troponin-I Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Rebecca S. Ayash

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 10/20/98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K 983693
510(k) Number

510(k) Number

Division Sign-Off
Office of Device Evaluation

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.