FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.