ACCESS THYROGLOBULIN ANITBODY

K112933 · Beckman Coulter, Inc. · JNL · Dec 27, 2011 · Immunology

Device Facts

• Record ID: K112933
• Device Name: ACCESS THYROGLOBULIN ANITBODY
• Applicant: Beckman Coulter, Inc.
• Product Code: JNL · Immunology
• Decision Date: Dec 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

The Access Thyroglobulin Antibody II Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin autoantibodies (TgAb) in human serum and plasma using the Access Immunoassay Systems.

Device Story

The Access Thyroglobulin Antibody II assay is an automated, paramagnetic particle, chemiluminescent immunoassay used on Access Immunoassay Systems. It measures thyroglobulin antibody levels in human serum or plasma samples. The system utilizes a sandwich immunoassay format to quantify the analyte. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a quantitative concentration value (IU/mL) provided to the clinician, which assists in the diagnosis of thyroid-related autoimmune conditions such as Hashimoto's disease, nontoxic goiter, and Graves' disease.

Clinical Evidence

Bench testing only. Validation studies confirmed that the reagent pack modification did not impact assay performance. Analytical sensitivity (LoB/LoD) was recalculated per CLSI EP17-A guidelines and remains 0.9 IU/mL. Risk analysis (FMEA) demonstrated that all performance criteria were met.

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Automated system. Measuring range 0.9 - 2500 IU/mL. Standardized to NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93. Calibration utilizes a stored calibration curve.

Indications for Use

Indicated for the quantitative determination of thyroglobulin autoantibodies (TgAb) in human serum and plasma to aid in the clinical assessment of patients with thyroid disease.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Predicate Devices

• Access Thyroglobulin Antibody II Assay (k062516)

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 k112933 Beckman Coulter
Access Thyroglobulin Antibody II Assay

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
Access Thyroglobulin Antibody II Assay, k062516

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 (labeling changes are permitted as long as they do not affect the intended use).
There are no changes in the intended use or indications of use.

3. A description of the device MODIFICATIONS, 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. The assay reagent pack configuration was changed from three reagent wells (R1a, R1b, R1c) to four reagent wells (R1a, R1b, R1c, R1d) with R1d containing a TRIS buffer plus a blocking polymer.

2. Revisions to the labeling were made to reflect results of design change validation studies for the following changes:

a. Additional analyzers in the Access instrument family added (UniCel Dxl 600, UniCel Dxl 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i) using the Reagent replacement policy.

b. Dilution of over range Tg Ab samples is no longer recommended due to some samples not diluting linearly.

c. The "hook" effect warning was decreased from 350,000 IU/mL to 50,000 IU/mL.

d. The analytical sensitivity was recalculated using CLSI EP17-A guidelines. The analytical sensitivity still remains at 0.9 IU/mL. Both LoB and LoD are defined as 0.9 IU/mL.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics. The results provided indicate no substantial change in device 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
Beckman Coulter used Failure Mode and Effect Analysis (FMEA) to assess the impact of the addition of TRIS buffer plus blocking polymer into the reagent pack design and was included in their Risk Analysis Report, all results met predetermined acceptance criteria and no performance changes were observed (see Risk Analysis Document 2 and TgAb II dFMEA 2011 Design Change Document).

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
Detailed description of device modifications was included. The assay reagent pack (cartridge) configuration was modified to address issues that lead to a product recall. The modifications do not affect the intended use or device performance criteria (see Reason for Submission document).

c) A declaration of conformity with design controls. The declaration of conformity should include:

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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.

A declaration of conformity with design controls was included, please see statements in file.

6. A Truthful and Accurate 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 (or their preamendment) device.