(98 days)
The SYNCHRON Systems Iron (FE) and Iron Binding Capacity (IBCT) Reagents, in conjunction with SYCNHRONC Systems Iron/TIBC Calibrator, are intended for use in the quantitative determination of iron and total iron binding capacity in human serum and plasma samples. These assays are designed for use with the family of SYNCHRON Systems such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
The SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) Reagents are modifications of the current SYNCHRON CX Systems Iron (IRON) and Total Iron Binding Capacity (TIBC) Reagents, and are designed for optimal performance on the SYNCHRON Systems. The modifications include formulation changes which allow for the assay of both serum and plasma samples. Additionally, the IBCT assay utilizes an alumina column for the removal of unbound ferric ions as opposed to magnesium carbonate.
This document describes the performance of the Beckman SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) Reagents, which are quantitative tests for iron and total iron binding capacity in human serum and plasma. The study confirms that these new reagents are substantially equivalent to previously cleared devices.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in this document. Instead, the study aims to demonstrate substantial equivalence to existing predicate devices (SYNCHRON CX System Iron and TIBC Reagents). This is inferred from the comparison studies showing similar analytical performance, specifically in terms of method comparison (slope, intercept, correlation coefficient), stability claims, and imprecision.
Here's a table summarizing the reported device performance, with the understanding that "acceptance" is implied by demonstrating substantial equivalence to the predicate devices:
| Study/Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (SYNCHRON FE & IBCT Reagents) |
|---|---|---|
| Method Comparison | FE Reagent: Slope close to 1, intercept close to 0, r close to 1 (when compared to SYNCHRON CX IRON Reagent) | |
| IBCT Reagent: Slope close to 1, intercept close to 0, r close to 1 (when compared to SYNCHRON CX TIBC Reagent) | FE Reagent: Slope = 1.0158, Intercept = -0.92, r = 0.9998 (vs. CX IRON Reagent) | |
| IBCT Reagent: Slope = 1.0736, Intercept = -11.95, r = 0.9979 (vs. CX TIBC Reagent) | ||
| Shelf-Life | 24 months | FE Reagent: 24 months shelf-life |
| IBCT Reagent: 24 months shelf-life | ||
| On-Instrument Stability | 30 days | FE Reagent: 30 days on-instrument |
| IBCT Reagent: 30 days on-instrument | ||
| Calibration Stability | 14 days | FE Reagent: 14 day calibration |
| IBCT Reagent: 14 day calibration | ||
| Analytic Range | FE Reagent: 5-500 | |
| IBCT Reagent: 10-1000 | FE Reagent: Claimed 5-500 (Same as SYNCHRON IRON Reagent) | |
| IBCT Reagent: Claimed 10-1000 (Same as SYNCHRON TIBC Reagent) | ||
| Within-Run Imprecision | FE Reagent: 2.5% CV | |
| IBCT Reagent: 4% CV | FE Reagent: Level 1: 2.6% CV (at 53.5 ug/mL), Level 2: 1.6% CV (at 166.5 ug/mL), Level 3: 0.8% CV (at 270.5 ug/mL) | |
| IBCT Reagent: Level 1: 5.2% CV (at 148.2 ug/mL), Level 2: 1.2% CV (at 370.5 ug/mL), Level 3: 1.9% CV (at 448.2 ug/mL) | ||
| Note: Some IBCT levels (Level 1) exceed the 4% CV claim, but the summary states equivalence is demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of patient samples) used for the method comparison study (test set). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
For the within-run imprecision study, 80 results were generated for each of the three levels for both the FE and IBCT reagents. The nature of these "results" (e.g., replicates from a few samples, or individual samples) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves the comparison of quantitative laboratory reagents. The "ground truth" for the test set is established by the performance of the predicate devices themselves, which are already commercially distributed and accepted. There are no human expert readers or interpretations involved in establishing ground truth for these types of assays.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as this is a chemical assay performance study, not an imaging or diagnostic interpretation study requiring expert consensus.
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 evaluating the impact of AI on human interpretation accuracy, which is not applicable to an assay reagent performance study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (method comparison, stability, imprecision) represent standalone performance of the reagent systems. There is no "human-in-the-loop" in the direct analytical measurement by the SYNCHRON Systems.
7. The Type of Ground Truth Used
The ground truth for this study is essentially the analytical performance of the predicate devices (SYNCHRON CX System Iron and TIBC Reagents). The new SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) Reagents are compared against these established methods to demonstrate substantial equivalence. The validity of the predicate devices themselves would have been established through robust analytical validation studies.
8. The Sample Size for the Training Set
Not applicable. These are chemical reagents, not a machine learning algorithm that requires a "training set." The development of the reagent formulation might involve empirical testing and optimization, but it's not referred to as a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense for these chemical reagents. The formulation changes (e.g., allowing serum and plasma samples, using alumina columns for IBCT) were likely based on chemical principles and empirical testing to achieve desired analytical characteristics, but this isn't analogous to establishing ground truth for an AI training set.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general 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.