(85 days)
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No
The summary describes a standard immunoassay system and performance studies typical for such devices. There is no mention of AI, ML, or related concepts.
No.
This device is an immunoassay for diagnosing certain conditions by measuring antibody levels, not for treating diseases.
Yes
The device aids in the diagnosis of specific diseases by measuring thyroglobulin antibody levels, which is a diagnostic function.
No
The device description explicitly states that the system comprises "reagents, calibrators, and the Access Immunoassay analyzers," indicating the presence of physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of thyroglobulin antibody levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes reagents, calibrators, and analyzers used to perform the test on these biological samples.
- Performance Studies: The performance studies detail analytical characteristics like method comparison, imprecision, linearity, and analytical specificity, which are typical evaluations for IVD devices.
The core function of the device is to analyze components of human biological samples (serum and plasma) to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Thyroglobulin Antibody II (TgAb II) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thryoglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
Product codes (comma separated list FDA assigned to the subject device)
JNL, JIT
Device Description
The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A comparison of thyroglobulin antibody values from 397 samples, ranging from approximately
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
K.112933
DEC 2 7 2011
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, abstract symbol on the left, resembling two curved shapes intertwined within a circle. To the right of the symbol is the company name, "BECKMAN COULTER," with "BECKMAN" appearing above "COULTER" in a bold, sans-serif font. The entire logo is in black and white.
510(k) Summary Prepared December 14, 2011
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact: Geraldine Baglien (952) 368-7645 (952) 368-7610 (fax)
Valynda Machen Alternate Contact: (952) 368-1383 (952) 368-7610 (fax)
Device Name
| Trade Name: | Access Thyroglobulin Antibody II for use on the
Access Immunoassay Systems | |
|----------------------|-------------------------------------------------------------------------------|--|
| Common Name: | Thyroglobulin Antibody Enzyme Immunoassay | |
| Classification Name: | Immunochemical, Thyroglobulin Autoantibody | |
Predicate Device
Access Thyroglobulin Antibody II (K062516) Manufactured by Beckman Coulter, Inc.
1
Device Description
The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Intended Use
The Access Thyroglobulin Antibody II (TgAb II) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thryoglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
| Parameter | Access TgAb II | Predicate Access TgAb II |
|---|---|---|
| (K112933) | (K062516) | |
| Intended use | The Access Thyroglobulin | |
| Antibody II assay is a | ||
| paramagnetic particle, | ||
| chemiluminescent immunoassay | ||
| for the quantitative determination | ||
| of thyroglobulin antibody levels | ||
| in human serum and plasma | ||
| using the Access Immunoassay | ||
| Systems. The measurement of | ||
| thyroid autoantibodies may aid in | ||
| the diagnosis of Hashimoto's | ||
| disease, nontoxic goiter, and | ||
| Graves' disease. | The Access Thyroglobulin | |
| Antibody II assay is a | ||
| paramagnetic particle, | ||
| chemiluminescent immunoassay | ||
| for the quantitative determination | ||
| of thyroglobulin antibody levels in | ||
| human serum and plasma using | ||
| the Access Immunoassay | ||
| Systems. The measurement of | ||
| thyroid autoantibodies may aid in | ||
| the diagnosis of Hashimoto's | ||
| disease, nontoxic goiter, and | ||
| Graves' disease. | ||
| Analyte Measured | Thyroglobulin Antibody | Thyroglobulin Antibody |
| Standardization | NIBSC Anti-Thyroglobulin | |
| Serum, Human First | ||
| International Reference | ||
| Preparation, WHO Coded 65/93 | NIBSC Anti-Thyroglobulin Serum, | |
| Human First International | ||
| Reference Preparation, WHO | ||
| Coded 65/93 | ||
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent | Chemiluminescent |
| Method | Automated | Automated |
| Calibration | Utilizes a stored calibration | |
| curve | Utilizes a stored calibration curve | |
| Sample Type | Serum or plasma | Serum or plasma |
| Measuring Range | 0.9 - 2500 IU/mL | 0.9 - 2500 IU/mL |
Comparison of Technological Characteristics
2
Summary of Studies
Method Comparison: A comparison of thyroglobulin antibody values from 397 samples, ranging from approximately