The T3 CAL is a liquid, human serum based product containing Ltriiodothyronine. The kit consists of six vials, three vials of Calibrator A (2.0 mL per vial) and three vials of Calibrator B (1.5 mL per vial). T3 CAL is ready for use, no preparation is required.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study details for the Dimension Vista™ System Total Triiodothyronine Calibrator (T3 CAL - KC250), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Shelf-life Stability	Percent change ≤ 8%	Target: 24 months. Method: Results of product stored at 4°C are compared with control stored at -20°C. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Result: "Percent change should be less than or equal to 8 %." (This implies the performance met the criterion.) Note: "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (This indicates that the 24-month target is supported by actual data, but the specific data points are not provided in this summary.)
On-board Stability (Punctured Vial)	Stable for one day.	A vial punctured by the instrument and stored on board is stable for one day. Testing Method: Punctured vials are tested once after at least 25 hours versus freshly opened vials. (The text implies this met the "one day" criterion, as no failure is reported.)
Open Vial Stability (Recapped, Refrigerated)	Stable for 31 days.	An open vial not stored on board of the instrument, but recapped and stored in a refrigerator is stable for 31 days. Testing Method: For opened vials, a quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened vials are tested on days 0, 2, 8, 15, 22, and 32 versus freshly opened vials. (The text implies this met the "31 days" criterion, as no failure is reported. The testing up to day 32 suggests confirmation beyond the 31-day claim.)
Traceability	Traceable to USP L-triiodothyronine (Catalog # 36800)	The assigned values of the Total Triiodothyronine (T3) Calibrator are traceable to the United Stated Pharmacopeia (USP) L-triiodothyronine (USP Catalog # 36800). (This is a statement of fact and directly meets the criterion.)
Value Assignment (Master Pool)	Not explicitly stated as acceptance criteria, but method described.	Master Pool is manufactured by weighing USP L-triiodothyronine into stripped human serum at five levels. The Master Pool is stored frozen. The bottle value for the Master Pool is assigned for each level by testing N = 45 replicates per level on multiple instruments, using a previous Master Pool as a control. (This describes the process for establishing the value, implying the process itself serves as the "acceptance" of the value.)
Value Assignment (Commercial Lot)	Not explicitly stated as acceptance criteria, but method described.	A Commercial Lot is manufactured by weighing Purified T3 into stripped human serum at two levels. The bottle value assignment of each level is tested using multiple instruments calibrated with Master Pool for N = 45 total replicates per level. A previous lot of commercial calibrator is used as control. (This describes the process for establishing the value, implying the process itself serves as the "acceptance" of the value.)

2. Sample Size Used for the Test Set and Data Provenance

Shelf-life Stability: The text states "comparing results of the product stored at 4℃ with control stored at -20°C." It mentions "Recovery versus time is monitored" but does not give a specific sample size (N count of individual measurements per time point or number of vials).
On-board Stability (Punctured Vial): Vials are tested "once after at least 25 hours versus freshly opened vials." (No specific N Count of replicates per vial or instruments is given).
Open Vial Stability (Recapped, Refrigerated): Vials are tested on "days 0, 2, 8, 15, 22, and 32 versus freshly opened vials." (No specific N Count of replicates per vial or instruments is given).
Value Assignment (Master Pool): N = 45 replicates per level.
Value Assignment (Commercial Lot): N = 45 total replicates per level.

Data Provenance: The document does not explicitly state the country of origin for the data or if it's retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would generally be prospective, conducted by Dade Behring Inc., which is located in Newark, DE, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This device is a calibrator for an in vitro diagnostic test, not an imaging or diagnostic AI device that requires expert-established ground truth in the traditional sense (e.g., radiologists interpreting images).
The "ground truth" (or reference standard) for this calibrator is established by its traceability to USP L-triiodothyronine (Catalog # 36800). This is a chemical reference standard. Therefore, explicit human expert interpretation for "ground truth" is not applicable in the way it would be for, say, a medical image diagnosis. The "experts" are more akin to the chemists and quality control personnel who perform the measurements and ensure adherence to USP standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of in vitro diagnostic calibrator. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's disagreement among human readers or expert reviewers, especially in image interpretation. Here, the performance is based on quantitative analytical measurements against a certified chemical standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic systems (especially AI-powered ones) where human readers' performance is being evaluated, often with and without AI assistance, across multiple cases. This submission is for a calibrator, which is a component of a larger diagnostic system and operates analytically, not interpretively by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable. The device is a "calibrator material," which is a physical consumable used by an automated instrument (the Dimension Vista™ System). Its performance is inherently "standalone" in the sense that it provides a specific, measurable output that the instrument reads, without human cognitive input being part of its own operational performance. The "algorithm" for its function is essentially the chemical composition and the reference methods used for its value assignment, which are then used by the instrument's internal algorithms.

7. The Type of Ground Truth Used

The primary ground truth used is a chemical reference standard:
- USP L-triiodothyronine (USP Catalog # 36800).
The value assignment for master pools and commercial lots involves comparing against a "previous Master Pool as a control" or a "previous lot of commercial calibrator as control," which implies a hierarchical traceability rooted in the USP standard.

8. The Sample Size for the Training Set

This concept is not directly applicable in the traditional "training set" sense of machine learning algorithms.
For the calibration material itself, the "training" equivalent would be the processes for manufacturing and value assignment, which consistently produce the material.
Value Assignment of Master Pool: N = 45 replicates per level (across five levels).
Value Assignment of Commercial Lot: N = 45 total replicates per level (across two levels).
These are more akin to validation measurements rather than training data for an algorithm that learns.

9. How the Ground Truth for the Training Set Was Established

Again, the "training set" concept doesn't fit directly. The "ground truth" for the value assignment (which is analogous to establishing the correct behavior of the calibrator) is established as follows:
- Master Pool: Manufactured by precisely weighing USP L-triiodothyronine. Its bottle values are assigned by testing N=45 replicates per level on multiple instruments, using a previously assigned Master Pool as a control. This process ensures the new Master Pool's values are accurately characterized relative to the foundational USP standard.
- Commercial Lot: Manufactured by weighing Purified T3. Its bottle values are assigned by testing N=45 total replicates per level using multiple instruments calibrated with the (validated) Master Pool, and a previous lot of commercial calibrator is used as a control. This ensures a consistent and traceable value assignment from lot to lot, ultimately linked back to the USP standard.

Summary

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510(k) Summary for the Dimension Vista™ System Total Triiodothyronine Calibrator (T3 CAL - KC250)

A. 510(k) Number:	K061885 AUG 1 4 200
B. Analyte:	Total Triiodothyronine (T3)
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101Victor M. Carrio, Regulatory Affairs and Compliance ManagerOffice: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ System Total Triiodothyronine Calibrator (T3 CAL - KC250)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: JIT Calibrator, Secondary
1. Panel: Clinical Chemistry
G. Intended Use: The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista " System.

H. Device Description:

I. Substantial Equivalence Information:

1. Predicate Device: K032697 Dimension® Total Triiodothyronine Calibrator.
1. Comparison with Predicate:

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	Device	Predicate
Item	Dimension Vista™System TotalTriiodothyronineCalibrator	Dimension®Total TriiodothyronineCalibrator
Intended Use	The T3 CAL is an in vitrodiagnostic product for thecalibration of TotalTriiodothyronine (T3) methodon the Dimension Vista™System.	The T3 Calibrator is intended for usein the calibration of TotalTriiodothyronine (T3) method on theDimension® clinical chemistrysystem with the HeterogeneousImmunoassay Module.
Analytes	Total Triiodothyronine (T3).	Total Triiodothyronine (T3).
Form	Liquid	Liquid
Traceability	USP¹ L-triiodothyronine(USP Catalog # 36800)	USP¹ L-triiodothyronine(USP Catalog # 36800)
Matrix	Stripped human serum.base.	Stripped human serum.base.
Levels	Two levels.	Five levels.

1 United States Pharmacopeia

J. Standard/Guidance Document Referenced:

1. Guidance:	Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Diagnostic Calibrators; Final, 02/22/1999Guidance for Industry and FDA Staff - Use of Symbols on Labelsand in Labeling of In Vitro Diagnostic Devices Intended forProfessional Use, 11/30/2004
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1. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices

K. Performance Characteristics:

Target shelf life for the Dimension Vista™ System Total 1. Stability: Triiodothyronine (T3) Calibrator is 24 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 8 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.

A vial punctured by the instrument and stored on board is stable for one day.

An open vial not stored on board of the instrument, but recapped and stored in a refrigerator is stable for 31 days.

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For testing, vials are opened /punctured on day zero. For opened viales, a quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened vials are tested on days 0, 2, 8, 15, 22, and 32 versus freshly opened vials. Punctured vials are tested once after at least 25 hours versus freshly opened vials.

1. Traceability: The assigned values of the Total Triiodothyronine (T3) Calibrator are traceable to the United Stated Pharmacopeia (USP) Ltriiodothyronine (USP Catalog # 36800).
1. Value Assignment:

Master Pool is manufactured by weighing USP L-triiodothyronine (USP Catalog # 36800) into stripped human serum at five levels. The Master Pool is stored frozen, -10 to -20 °C. The bottle value for the Master Pool is assigned for each level by testing N = 45 replicates per level on multiple instruments, using a previous Master Pool as a control.

A Commercial Lot is manufactured by weighing Purified T3 into stripped human serum at two levels. The bottle value assignment of each level is tested using multiple instruments calibrated with Master Pool for N = 45 total replicates per level. A previous lot of commercial calibrator is used as control.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 4 2006

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. PO Box 6101 Newark, DE 19714-6101

Re: K061885

Trade/Device Name: Dimension VistaTM Total Triiodothyronine Calibrator (T3 CAL, KC250) Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. Carrio:

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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Page 2 -

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 (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,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (if known): -

Device Name: K061885

Dimension Vista™ Total Triiodothyronine Calibrator (T3 CAL , KC250) .

Indications for Use:

The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista" System.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 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)

CAC
Division Si

Office of I. 15-2 Dingnostic Device Evaluation and Salety ( 311-)

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.