The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Device Description

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.

AI/ML Overview

The provided document, K032697, is a 510(k) premarket notification for a medical device (Dimension® Total Triiodothyronine (T3) Calibrator (RC414)). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's an explanation of why the requested information is absent based on the document's content:

Acceptance Criteria and Reported Device Performance: Instead of performance criteria, the document focuses on comparing the proposed device to a predicate device based on characteristics like intended use, analyte, matrix, form, volume, and levels.
Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. Substantial equivalence is concluded based on the comparison table and the similarities in intended use.
Sample Size for Test Set and Data Provenance: Not applicable in a substantial equivalence filing of this type for a calibrator. There isn't a "test set" in the context of evaluating diagnostic accuracy as would be for an AI algorithm.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth for a calibrator is established through its manufacturing process and chemical properties, not by expert interpretation.
Adjudication Method: Not applicable for a calibrator's performance evaluation.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. These studies are relevant for diagnostic devices where human readers interpret medical images or data, and an AI might assist them. This is a calibrator, a chemical product used to standardize measurements.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this device does not involve an algorithm or AI.
Type of Ground Truth Used: The "ground truth" for a calibrator is its accurately determined concentration of the analyte (T3 in this case). This is established through analytical chemistry methods during manufacturing, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
Sample Size for the Training Set: Not applicable. This device is a chemical calibrator, not a machine learning model that requires a training set.
How the Ground Truth for the Training Set Was Established: Not applicable.

In summary, the provided K032697 document is for a medical device calibrator and demonstrates substantial equivalence to a predicate device. It does not involve AI or diagnostic interpretation, and therefore, the requested information regarding performance studies, ground truth establishment for AI models, and human reader-AI interactions is not present.

The crucial information in the document for K032697 relates to its comparison to a predicate device to establish substantial equivalence.

Here's a table based on the comparison provided in the document:

Feature	Proposed Device: Dimension® T3 Calibrator (RC414)	Predicate Device: Opus Total T3 Calibrator (K953160)
Intended Use	Calibrator	Calibrator
Analyte	T3	T3
Matrix	stripped human serum base	stripped human serum base
Form	liquid	liquid
Volume	2 mL per vial @ level 1; 1 mL per vial @ levels 2-5	2 mL per vial @ level 1; 1 mL per vial @ levels 2-6
Levels	5 levels @ 0, 1, 2, 4, 6.5 ng/ml	6 levels @ 0, 0.5, 1, 2, 4, 6 ng/ml

The "acceptance criteria" for this submission are the demonstration of substantial equivalence to the predicate device based on these comparative characteristics. The study demonstrating this is the comparison table and discussion provided in the document, which identifies the similarities and any minor differences. The document concludes that based on this comparison, the Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators.

Summary

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K032697

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:	Lorraine PiestrakDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	August 29, 2003
Name of Product:	Dimension® Total Triiodothyronine (T3) Calibrator (RC414)
FDA Classification Name:	Calibrator
Predicate Device:	Opus Total T3 Calibrator (K953160)

Device Description: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.

Intended use: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Comparison to Predicate Device:

	Dimension®T3 Calibrator	OpusTotal T3 Calibrator
Intended Use	Calibrator	Calibrator
Analyte	T3	T3
Matrix	stripped human serum base	stripped human serum base
Form	liquid	liquid
Volume	2 mL per vial @ level 11 mL per vial @ levels 2-5	2 mL per vial @ level 11 mL per vial @ levels 2-6
Levels	5 levels@ 0, 1, 2, 4, 6.5 ng/ml	6 levels@ 0, 0.5, 1, 2, 4, 6 ng/ml

Comments on Substantial Equivalence: Both the proposed Dade Behring Dimension® Total Triiodothyronine (T3) Calibrator (RC414) and the existing Opus Total T3 calibrator are in vitro diagnostic products intended for calibrating T3 assays.

Conclusion: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators based on the comparison discussed above.

Lorraine Piestrak

Fraine Piestrak Regulatory Affairs and Compliance Manager August 29, 2003

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Larraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community P.O. Box 6101 - Building 500 Newark, Delaware 19714

NOV - 7 2003

Re: K032697

Trade/Device Name: Dimension® Total Triiodothyronine Calibrator (RC414) Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. Piestrak:

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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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). 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/dsma/dsmamain.html.

Sincerely yours,

iteven 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: Dimension® Total Triiodothyronine Calibrator (RC414)

Indications for Use:

Lorraine Piestrak

Regulatory Affairs and Compliance Manager

August 29, 2003

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-counter Use

Carol Benson / Jean Cooper, DVM
Division Sign-Off

$10(k) K032697

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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.