(38 days)
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No
The summary describes a standard immunoassay for measuring thyroglobulin antibody levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance metrics are standard for an immunoassay.
No
This device is an immunoassay system designed for the quantitative determination of thyroglobulin antibody levels, which aids in diagnosis and not in treating or preventing a disease.
Yes
The intended use explicitly states that the "measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease." This indicates its role in identifying or confirming a medical condition, which is the definition of a diagnostic device.
No
The device description explicitly states that the system comprises reagents, calibrators, and immunoassay analyzers, which are 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 involves testing biological samples (serum and plasma) outside of the body.
- Device Description: It describes reagents, calibrators, and analyzers used to perform the test on these biological samples.
- Clinical Studies: The performance studies involve testing human serum samples to establish a reference range and compare results with a commercially available enzyme immunoassay kit.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Access Thyroglobulin Antibody II (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 Hashimoto's disease, nontoxic goiter, and Graves' disease.
Product codes
DDC, JIT, JNL
Device Description
The Access Thryoglobulin Antibody II reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel DxI 800) comprise the Access Immunoassay Systems for the determination of thyroglobulin antibody (TgAb) levels 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
Not Found
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
Imprecision: Imprecision was tested for concentrations from approximately 27,0 to 721,0 IU/mL. The within run imprecision ranged from 4.0% CV to 5.8% CV. Between-run assay imprecision ranged from 2.7% CV to 5.1% CV. Total imprecision ranged from 4.8% CV to 7.0% CV. For low dose imprecision was tested for concentrations from approximately 1.7 to 10.5 IU/mL. The SD for these samples ranged from 0.3 to 0.8 SD.
Dilution Recovery (Linearity): Multiple dilutions of serum samples were analyzed. Mean % recovery ranged from 118% to 127%. Due to varying antigen specificity, affinity, and avidity of thyroglobuulin antibodies in their epitope reactions, some samples may not dilute linearly.
Methods Comparison: A comparison of 832 values using the Access Thyroglobulin Antibody II assay on the Access Immunoassay system and a commercially available enzyme immunoassay kit gave the following results using relative sensitivity, specificity and percent agreement:
Positive % Agreement = 95%
Negative % Agreement = 99.6%
Percent Agreement = 99%
Analytical Sensitivity: The lowest detectable level of TgAb distinguishable from zero (Access Thyroglobulin Antibody Calibrator S0) with 95% confidence is 0.9 IU/mL. This value is determined by processing a complete six point calibration curve, controls and 20 replicates of the zero calibrator in multiple assays. The analytical sensitivity value is calculated from the curve at the point that is two standard deviations from the mean measured zero calibrator signal.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, triglycerides, and autoantibodies).
Summary of Clinical Studies:
Expected Values: Sera samples were obtained in the United States from males
§ 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
510(k) Summary
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: K062516
:
| Applicant: | Beckman Coulter, Inc.
Immunodiagnostics Development Center
1000 lake Hazeltine Drive
Chaska, MN 55318 | OCT - 5 2006 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Tyler Foutch
Regulatory Affairs Specialist
Phone: 952.368.1653
Fax: 952.368.7610 | |
| Date Prepared: | September 26, 2006 | |
| Proprietary Name: | Thyroglobulin Antibody II and Thyroglobulin Antibody II Calibrators
on the Access® Immunoassay Systems | |
| Common Name: | Immunoassay for the determination of thyroglobulin antibodies | |
| Classification Name: | System, Test, Thyroid Autoantibody | |
| Product Classification: | Class II | |
| Product Code: | Reagent- DDC
Calibrator Secondary- JIT | |
| Predicate Device: | Access® Thyroglobulin Antibody Assay - K012208 | |
| Device Description: | The Access Thryoglobulin Antibody II reagents, calibrators, and the
Access Immunoassay Analyzers (Access, Access 2, Synchron LXi
725, UniCel DxC 600i, and UniCel DxI 800) comprise the Access
Immunoassay Systems for the determination of thyroglobulin
antibody (TgAb) levels in human serum and plasma. | |
| Intended Use: | The Access Thyroglobulin Antibody II (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
Hashimoto's disease, nontoxic goiter, and Graves' disease. | |
:
:
1
Comparison of Technological Characteristics
| Attribute | Access Thyroglobulin Antibody | Access Thyroglobulin Antibody II |
|---|---|---|
| Intended | ||
| Use | For the quantitative determination of | |
| Thyroglobulin antibody levels in human | ||
| serum and plasma. | For the quantitative determination of | |
| Thyroglobulin antibody levels in human | ||
| serum and plasma. | ||
| Assay | ||
| Principles | The Access Thyroglobulin Antibody | |
| assay is a sequential two-step | ||
| immunoenzymatic ("sandwich") assay. | The Access Thyroglobulin Antibody | |
| assay is a sequential two-step | ||
| immunoenzymatic ("sandwich") assay. | ||
| Solid | ||
| Support | Paramagnetic particles coated with | |
| streptavidin and coupled to biotinylated | ||
| human thyroglobulin. | Paramagnetic particles coated with | |
| streptavidin and coupled to biotinylated | ||
| human thyroglobulin. | ||
| Detection | ||
| System | Utilizes dioxetane-based | |
| chemiluminescent substrate; | ||
| Measures light production from a | ||
| chemiluminescent reaction. | Utilizes dioxetane-based | |
| chemiluminescent substrate; | ||
| Measures light production from a | ||
| chemiluminescent reaction. | ||
| Calibrator | Six levels (0, ~50, ~250, ~500, ~1000, | |
| and ~2500 IU/mL) Human | ||
| thyroglobulin antibody in human serum | ||
| in a buffered protein solution with | ||
| preservatives. | Six levels (0, ~50, ~250, ~500, ~1000, | |
| and ~2500 IU/mL) Human | ||
| thyroglobulin antibody in human serum | ||
| in a buffered protein solution with | ||
| preservatives. |
Summary of Analytical Studies
Imprecision: Imprecision was tested for concentrations from approximately 27,0 to 721,0 IU/mL. The within run imprecision ranged from 4.0% CV to 5.8% CV. Between-run assay imprecision ranged from 2.7% CV to 5.1% CV. Total imprecision ranged from 4.8% CV to 7.0% CV. For low dose imprecision was tested for concentrations from approximately 1.7 to 10.5 IU/mL. The SD for these samples ranged from 0.3 to 0.8 SD.
Dilution Recovery (Linearity): Multiple dilutions of serum samples were analyzed. Mean % recovery ranged from 118% to 127%. Due to varying antigen specificity, affinity, and avidity of thyroglobuulin antibodies in their epitope reactions, some samples may not dilute linearly.
Methods Comparison: A comparison of 832 values using the Access Thyroglobulin Antibody II assay on the Access Immunoassay system and a commercially available enzyme immunoassay kit gave the following results using relative sensitivity, specificity and percent agreement:
| Commercially Available TgAb Assay | |||||
|---|---|---|---|---|---|
| + | - | Total | |||
| Access | |||||
| TgAb II | |||||
| Assay | 136 | 3 | 139 | Positive % Agreement = | |
| 95% | |||||
| 7 | 686 | 693 | Negative % Agreement = | ||
| 99.6% | |||||
| Total | 143 | 689 | 832 | Percent Agreement = | |
| 99% |
Analytical Sensitivity: The lowest detectable level of TgAb distinguishable from zero (Access Thyroglobulin Antibody Calibrator S0) with 95% confidence is 0.9 IU/mL. This value is determined by processing a complete six point calibration curve, controls and 20 replicates of the zero calibrator in multiple assays. The analytical sensitivity value is calculated from the curve at the point that is two standard deviations from the mean measured zero calibrator signal.
2
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, triglycerides, and autoantibodies).
Summary of Clinical Studies
Expected Values: Sera samples were obtained in the United States from males