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.

Device Description

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.

AI/ML Overview

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.

Summary

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BECKMAN

Summary of Safety & Effectiveness SYNCHRON Systems Iron (FE) & Total Iron Binding Capacity (IBCT) Reagents

1.0 Submitted By:

Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92621 Telephone: (714) 993-8916 FAX: (714) 961-4457

K960485

MAY 10 1996

2.0 Date Submitted:

31 December 1996

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON Systems Iron (FE) Reagent SYNCHRON Systems Total Iron Binding Capacity (IBCT) Reagent

3.2 Classification Names

Iron (non-heme) test system (21 CFR 862.1410) Iron-binding capacity test system (21 CFR 862.1415)

4.0 Predicate Device(s):

SYNCHRON CX System Iron (IRON) Reagent, K870986 SYNCHRON CX Systems Total Iron Binding Capacity (TIBC) Reagent, K870986 J&S Medical Associates Micro Column, K893662

5.0 Description:

6.0 intended Use:

EBECHINDIK JIGGEN MINERES, ROC..

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7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
FE Reagent	Timed endpoint reaction usingFerroZine Iron Reagent*	Same as SYNCHRON IRONReagent
	2-year shelf-life, 30-day openbottle, 14-day calibration stability	Same as SYNCHRON IRONReagent
	Analytic range 5-500 and within-run imprecision claim of 2.5% CV	Same as SYNCHRON IRONReagent
IBCT Reagent	Supernatant from transferrinsaturation is measured byFerroZine Iron Reagent reaction	Same as SYNCHRON TIBCReagent
	2-year shelf-life, 30-day openbottle, 14-day calibration stability	Same as SYNCHRON TIBCReagent
	Analytic range 10-1000 andwithin-run imprecision claim of4% CV	Same as SYNCHRON TIBCReagent
DIFFERENCES
FE Reagent	Sample type for assay	FE reagent modified toutilize serum and plasmasamples
IBCT Reagent	Sample type for assay	IBCT reagent modified toutilize serum and plasmasamples
	Sample preparation	IBCT reagent utilizesalumina columns forremoval of unbound ferricion

FerroZine Reagent is a trademark of Hach Chemical Co.

8.0 Summary of Performance Data:

The data In the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companison, stability, and imprecision experiments that relate results obtained from the SYNCHRON FE and IBCT Reagents to the SYNCHRON CX IRON and TIBC Reagents.

Method Comparison Study Results SYNCHRON FE & IBCT Reagents vs. SYNCHRON IRON & TIBC Reagents

Analyte	Slope	Intercept	r	Predicate
FE Reagent	1.0158	-0.92	0.9998	CX IRONReagent
IBCT Reagent	1.0736	-11.95	0.9979	CX TIBCReagent

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Stability Study Results

Reagent	Product Claim
FE Reagent	24 months shelf-life30 days on-instrument14 day calibration
IBCT Reagent	24 months shelf-life30 days on-instrument14 day calibration

Estimated Within-Run Imprecision

MATERIAL	MEAN (ug/mL)	SD (ug/mL)	%CV	Number of Results
FE Reagent
Level 1	53.5	1.41	2.6	80
Level 2	166.5	2.61	1.6	80
Level 3	270.5	2.24	0.8	80
IBCT Reagent
Level 1	148.2	7.8	5.2	80
Level 2	370.5	4.3	1.2	80
Level 3	448.2	8.7	1.9	80

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Regulation Number and Section

§ 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.