ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

K062516 · Beckman Coulter, Inc. · JNL · Oct 5, 2006 · Immunology

Device Facts

• Record ID: K062516
• Device Name: ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
• Applicant: Beckman Coulter, Inc.
• Product Code: JNL · Immunology
• Decision Date: Oct 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended 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 (EDTA) using the Access Immunoassay Systems. The Access Thyroglobulin Antibody II assay is intended for use as an aid in the management of patients with thyroid disease.

Device Story

Paramagnetic particle, chemiluminescent immunoassay; measures thyroglobulin autoantibodies (TgAb) in human serum or EDTA plasma. Modification of Access Thyroglobulin Antibody Assay (K012208); reagent configuration changed from two-well to three-well (R1a, R1b, R1c with TRIS buffer); sample volume reduced from 20 µL to 10 µL; analytical sensitivity improved to 0.9 IU/mL. Used on Access Immunoassay Systems in clinical laboratory settings. Output is quantitative TgAb concentration; assists clinicians in managing thyroid disease patients.

Clinical Evidence

Bench testing only. Design change validation studies performed to verify performance following reagent configuration changes, matrix addition, and sample volume reduction. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Paramagnetic particles coated with streptavidin and biotinylated human thyroglobulin. Sequential two-step immunoenzymatic sandwich assay. Detection via dioxetane-based chemiluminescent substrate. Automated system-based analysis. Compatible with Access Immunoassay Systems. No specific materials standards or software architecture details provided.

Indications for Use

Indicated for the quantitative determination of thyroglobulin antibody levels in human serum and plasma to aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. No specific age or gender contraindications provided.

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

• Beckman Coulter Access Thyroglobulin Antibody Assay (K012208)

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: k062516 Beckman Coulter Access Thyroglobulin Antibody II Assay on the Access Immunoassay Systems

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II device (Beckman Coulter Access Thyroglobulin Antibody Assay (k012208) requiring 510(k). The following items are present and acceptable:

1. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED (page 1) along with the proposed labeling (package insert) which includes instructions for use (pages 29-39).
2. A description of the device MODIFICATION(S), including clearly labeled diagrams, and user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
3. These changes were for
- The name of the device was changed to Access Thyroglobulin Antibody II
- The assay reagent pack configuration was changed from two reagent wells (R1 and R2) to a three well configuration (R1a, R1b, and R1c) with R1c containing a TRIS buffer.
- EDTA plasma was added as an assay matrix.
- Sample size was decreased from 20 µL to 10 µL.
- The analytical sensitivity (limit of detection) was changed from 2.2 IU/mL to 0.9 IU/mL.
- Revisions to the labeling were made to reflect these changes and to reflect results of design change validation studies.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, (pages 23-24 and 26-27); and
5. A Design Control Activities Summary which includes:
- Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components: Failure Modes and Effects Analysis (FMEA), and the results of the analysis (page 25);
- 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 (Table 3, page 25);
- A declaration of conformity with design controls. The declaration of conformity should include:
- 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 (page 62), and

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- 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 (page 62).

6. A Truthful and Accurate Statement (page 59), a 510(k) Summary (additional information received 10/4/06) and the Indications for Use Enclosure (additional information received 10/4/06)

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.