FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

K052082 · Beckman Coulter, Inc. · JMG · Aug 19, 2005 · Immunology

Device Facts

• Record ID: K052082
• Device Name: FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
• Applicant: Beckman Coulter, Inc.
• Product Code: JMG · Immunology
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Indications for Use

The Beckman Coulter Ferritin assay is an in vitro diagnostic test for the quantitative determination of ferritin in human serum and plasma using the Access Immunoassay Systems. Ferritin measurements are used in the diagnosis and management of diseases involving iron metabolism such as hemochromatosis and iron deficiency anemia.

Device Story

Automated immunoassay system for ferritin quantification in serum/plasma; utilizes Access Immunoassay Analyzers (Access, Access 2, SYNCHRON LXi 725, UniCel Dxl 800). Modification adds auto-dilution feature (1:10 ratio using Access Wash Buffer) to extend reportable range to 1300–15,000 ng/mL; includes automated mixing step in dilution vessel. Protocol modification ensures main pipettor depth adjustment for improved reagent mixing/aspiration. Operated by laboratory personnel in clinical settings. Output provides quantitative ferritin levels to clinicians for iron metabolism assessment and disease management.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance of auto-dilution feature and pipettor depth adjustments. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Two-site immunoenzymatic (sandwich) assay. Solid phase: paramagnetic particles coated with goat anti-mouse IgG. Conjugate: goat anti-ferritin-alkaline phosphatase. System includes automated dilution feature (1:10) and updated pipettor depth control via assay protocol file. Operates on Access Immunoassay Systems (Access, Access 2, SYNCHRON LXi 725, UniCel DxI 800).

Indications for Use

Indicated for the quantitative determination of ferritin levels in human serum and plasma (heparin) using Access Immunoassay Systems. For prescription use only.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Beckman Coulter Ferritin on the Access® Immunoassay Systems (K926221)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K_052082

Beckman Coulter Ferritin on the Access® Immunoassay Systems

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. Beckman Coulter Ferritin on the Access® Immunoassay Systems (K926221).
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes were 1) Addition of an auto-dilution feature that allows a 1:10 on-board system dilution of serum and plasma samples using the Access Wash Buffer. The auto-dilution feature is for all Access Immunoassay Analyzers (Access, Access 2, SYNCHRON LXi 725 and UniCel Dxl 800) and this modification requires addition of a second assay protocol file to all Access Immunoassay Analyzer. The reportable range using the auto-dilution feature is 1300 ng/mL to ~ 15,000 ng/mL (10 times the highest calibrator value). A mix step is included in the dilution vessel for Access, Access 2 and LXi. 2) Modification of the assay protocol file to ensure the main pipettor drops to a certain depth in the reagent pack to improve particle mixing and sufficient aspiration of reagents for transfer to the reaction vessel. 3) Addition of a description of the auto-dilution feature in the package insert.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, indication for use, methodology, sample matrix, kit component specification and analytical performance.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis - Failure mode and effects analysis (see Section G, p.38)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (see Section G, p. 38)
c) A declaration of conformity with design controls (see Section H, p. 40). The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurrate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.