(53 days)
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No
The summary describes a standard immunoassay system and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) immunoassay system used for the quantitative determination of thyroglobulin antibody levels to aid in the diagnosis of certain thyroid disorders. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "may aid in the diagnosis of certain thyroid disorders." This directly indicates its role in diagnosis.
No
The device description explicitly states that the system comprises reagents, calibrators, and an analyzer, which are all hardware components.
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 indicates it's used to analyze biological samples in vitro (outside the body).
- Device Description: The description mentions "reagents," "calibrators," and an "Immunoassay Analyzer," which are all components typically used in laboratory testing of biological samples.
- Performance Studies: The performance studies describe analytical characteristics like sensitivity, specificity, precision, and method comparison using serum samples. These are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K894203; Kalibre-RTM Thyroglobulin Antibody (TgAb) RIA Kit) is a strong indicator that this device is being compared to a previously cleared IVD device, a common practice in regulatory submissions for IVDs.
All these factors point to the device being used to perform tests on biological samples in vitro to provide information for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Thyroglobulin Antibody (TgAb) 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 certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
Product codes
DDC
Device Description
The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Analytical Specificity: There was no significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides). Additionally, only one discrepancy between interpretations positive and negative was found between the Access and Kronus thyroglobulin assays for samples form persons with autoimmune disease.
Analytical Sensitivity: The lowest detectable level of thyroglobulin antibody distinguishable from zero (Access Thyroglobulin Calibrator Zero) with 95% confidence was determined to be 1.5 IU/mL. An analytical sensitivity of 2.2 IU/mL will be used in the Access Thyroglobulin Antibody labeling.
Dilution Recovery: Various dilutions of serum samples and serum sample pools were analyzed. The overall mean recovery of the samples was 95% with individual mean sample recoveries varying between 90% and 100%.
Precision: Within run imprecision ranged from 3.99 to 5.04 % CV, between run imprecision ranged from 1.95 to 4.66 % CV, and total imprecision ranged from 4.47 to 6.74 % CV at levels ranging between 34.1 and 1,693 IU/ml.
Hook Effect: The Access Thyroglobulin Antibody assay demonstrated no hook to 350,000 IU/ml.
Relative Sensitivity and Specificity: A total of 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals) were used to calculate relative sensitivity and specificity for the Access vs. the Kronus thyroglobulin antibody assays. The study showed good relative sensitivity (79.0%) and relative specificity (87.6%) between the methods.
Method Comparison: A comparison of thyroglobulin antibody values from 276 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
SEP = 7 2001
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name "BECKMAN COULTER" on the right. The circular graphic features a stylized design with curved lines and small dots, resembling a globe or planet. The text is in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".
1.5
510(k) Summary · Prepared July 12, 2001
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K012208
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Denise Thompson Primary Contact: (952) 368-1202
Alternate Contact: Brent Taber (952) 368-1323
Device Name
Trade Name:
Access® Thyroglobulin Antibody for use on the Access® Immunoassay Systems
Thyroglobulin Antibody Enzyme Immunoassay Common Name: Classification name: Immunochemical, Thyroglobulin Autoantibody
Predicate Device
Kalibre-RTM Thyroglobulin Antibody (TgAb) RIA Kit Kronus / Boise Research Center Boise, ID 83713
510(k) Number: K894203
Device Description
The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Intended Use
The Access Thyroglobulin Antibody (TgAb) 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 certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
1
Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic to the left of the company name. The graphic is black with white dots and two white curved lines running through the center. The company name, "BECKMAN COULTER", is written in a bold, sans-serif font to the right of the graphic.
: .... .
Comparison of Technological Characteristics
. . . . .
| Parameter | Access AccuTnl | Dimension RxL TROP |
|---|---|---|
| Intended Use | The Access® Thyroglobulin | |
| Antibody (TgAb) 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 certain thyroid | ||
| disorders, such as | ||
| Hashimoto's disease, nontoxic | ||
| goiter, and Graves' disease. | The KRONUS | |
| Thyroglobulin Antibody kit | ||
| quantitatively measures | ||
| human serum | ||
| autoantibodies to | ||
| thyroglobulin antigen. | ||
| Serve as an aid in the | ||
| diagnosis of certain thyriod | ||
| disorders, such as | ||
| Hashimoto's thyroiditis, | ||
| non-toxic goiter and | ||
| Graves' Disease. | ||
| Analyte | ||
| Measured | Thyroglobulin Antibody | Thyroglobulin Antibody |
| Standarization | 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 | |
| Immunoassay | Radioimmunoassay | |
| Method | Automated | Manual |
| Calibration | Utilizes a stored calibration | |
| curve | Requires calibration with | |
| every run | ||
| Sample type | Serum or plasma | Serum only |
| Measuring range | 2.2-2500 IU/ml | 0.3-30 U/ml (3-300 IU/ml) |
2
Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name "BECKMAN COULTER" on the right. The circular graphic is black with white dots and two white curved lines inside. The text is in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".
Summary of Studies
Analytical Specificity: There was no significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides). Additionally, only one discrepancy between interpretations positive and negative was found between the Access and Kronus thyroglobulin assays for samples form persons with autoimmune disease.
Analytical Sensitivity: The lowest detectable level of thyroglobulin antibody distinguishable from zero (Access Thyroglobulin Calibrator Zero) with 95% confidence was determined to be 1.5 IU/mL. An analytical sensitivity of 2.2 IU/mL will be used in the Access Thyroglobulin Antibody labeling.
Dilution Recovery: Various dilutions of serum samples and serum sample pools were analyzed. The overall mean recovery of the samples was 95% with individual mean sample recoveries varying between 90% and 100%.
Precision: Within run imprecision ranged from 3.99 to 5.04 % CV, between run imprecision ranged from 1.95 to 4.66 % CV, and total imprecision ranged from 4.47 to 6.74 % CV at levels ranging between 34.1 and 1,693 IU/ml.
Hook Effect: The Access Thyroglobulin Antibody assay demonstrated no hook to 350,000 IU/ml.
Relative Sensitivity and Specificity: A total of 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals) were used to calculate relative sensitivity and specificity for the Access vs. the Kronus thyroglobulin antibody assays. The study showed good relative sensitivity (79.0%) and relative specificity (87.6%) between the methods.
Method Comparison: A comparison of thyroglobulin antibody values from 276 samples, ranging from approximately