SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS

K960485 · Beckman Instruments, Inc. · JMO · May 10, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960485
• Device Name: SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
• Applicant: Beckman Instruments, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

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 Story

The SYNCHRON Systems Iron (FE) and Total Iron Binding Capacity (IBCT) reagents are in vitro diagnostic assays for use on Beckman SYNCHRON CX clinical chemistry analyzers. The FE assay measures serum/plasma iron levels; the IBCT assay measures total iron binding capacity. Both utilize the FerroZine iron reagent in a timed endpoint reaction. The IBCT assay incorporates an alumina column to remove unbound ferric ions, replacing the magnesium carbonate method used in previous iterations. The system processes samples automatically; results are provided to clinicians to assist in diagnosing iron-related disorders. The device is intended for use in clinical laboratory settings by trained laboratory personnel.

Clinical Evidence

Bench testing only. Method comparison studies against predicate SYNCHRON CX reagents showed high correlation (FE: r=0.9998, slope=1.0158; IBCT: r=0.9979, slope=1.0736). Within-run imprecision was evaluated over 80 results per level, with %CV ranging from 0.8% to 2.6% for FE and 1.2% to 5.2% for IBCT. Stability studies confirmed 24-month shelf-life, 30-day on-instrument stability, and 14-day calibration stability.

Technological Characteristics

Timed endpoint colorimetric assay using FerroZine iron reagent. IBCT assay utilizes alumina columns for sample preparation. Designed for automated clinical chemistry analyzers (SYNCHRON CX family).

Indications for Use

Indicated for quantitative determination of iron and total iron binding capacity in human serum and plasma samples for clinical diagnostic assessment.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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200 South Kraemer Boulevard, Box 8000, Brea, CA 92622-8000 • [phone]

# 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: [phone]
FAX: [phone]

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:

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.

6.0 Intended Use:

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.

file: feib510k.sse

Beckman Instruments, Inc.

twx 910-592-1260 • telex: 06-78413

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Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Iron and Total Iron Binding Capacity Reagents
Summary of Safety & Effectiveness

# 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 using FerroZine Iron Reagent* | Same as SYNCHRON IRON Reagent |
| | 2-year shelf-life, 30-day open bottle, 14-day calibration stability | Same as SYNCHRON IRON Reagent |
| | Analytic range 5-500 and within-run imprecision claim of 2.5% CV | Same as SYNCHRON IRON Reagent |
| IBCT Reagent | Supernatant from transferrin saturation is measured by FerroZine Iron Reagent reaction | Same as SYNCHRON TIBC Reagent |
| | 2-year shelf-life, 30-day open bottle, 14-day calibration stability | Same as SYNCHRON TIBC Reagent |
| | Analytic range 10-1000 and within-run imprecision claim of 4% CV | Same as SYNCHRON TIBC Reagent |
| DIFFERENCES | | |
| FE Reagent | Sample type for assay | FE reagent modified to utilize serum and plasma samples |
| IBCT Reagent | Sample type for assay | IBCT reagent modified to utilize serum and plasma samples |
| | Sample preparation | IBCT reagent utilizes alumina columns for removal of unbound ferric ion |

* 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 comparison, 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 IRON Reagent |
| IBCT Reagent | 1.0736 | -11.95 | 0.9979 | CX TIBC Reagent |

file: feib510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
SYNCHRON® Systems Iron and Total Iron Binding Capacity Reagents
Summary of Safety & Effectiveness

## Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| FE Reagent | 24 months shelf-life
30 days on-instrument
14 day calibration |
| IBCT Reagent | 24 months shelf-life
30 days on-instrument
14 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.

file: feib510k.sse