(49 days)
Not Found
No
The summary describes a standard immunoassay system for measuring antibody levels and does not mention any AI or ML components.
No.
This device is an in-vitro diagnostic device used for quantitative determination of TPOAb levels as an aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The detection of TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders." and the device is an "immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels".
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 thyroperoxidase antibody (TPOAb) levels in human serum and plasma." This is a test performed in vitro (outside the body) on a biological sample (serum and plasma).
- Aid in Diagnosis: The intended use also states that the detection of TPO antibodies is an "aid in the diagnosis of thyroid autoimmune disorders." This clearly indicates a medical purpose for the test results.
- Device Description: The description details the reagents, calibrators, and analyzers used to perform the test on human serum and plasma.
- Performance Studies: The document includes performance studies like imprecision, dilution recovery, methods comparison, analytical specificity, stability, expected values, and clinical sensitivity, which are typical evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K991096 Immulite 2000 Anti-TPO Ab) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. The detection of TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders.
Product codes
JZO, JIT
Device Description
The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of thyroperoxydase antibody (TPO) levels in human serum and plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Imprecision: Imprecision was tested for concentrations from approximately 0.6 to 809 IU/mL. The within run imprecision ranged from 2.6% CV to 7.9% CV. Between-run assay imprecision ranged from 1.3% CV to 4.9% CV. Total imprecision ranged from 3.1% CV to 8.7% CV.
Dilution Recovery (Linearity): Multiple dilutions of serum samples were analyzed. Mean % recovery ranged from 86.4% to 94.9%. The following statement has been added to the TPOAD directional insert: "Due to varying antigen specificity, and avidity of TPOAb in their epitope reactions, some samples may not dilute linearly."
Methods Comparison: A comparison of 119 values using the Access TPOAb assay and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=5-1000, Slope=1.0207 (95% confidence interval 0.9722 to 1.0693), Intercept=-10.9123 (95 % confidence interval -24.6421 to 2.8175), Correlation coefficient (r)=0.97. The results of the study indicate that the slope and intercept are not significantly different from one and zero respectively.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides).
Stability: TPOAb reagents are stable for 56 days after opening. TPOAb calibrators are stable for 120 days after opening. The calibration is stable for 56 days.
Expected Values: Sera samples were obtained in the United States from a healthy male population
§ 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
JUL - 6 2006
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: K061382
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1383 Fax: (952) 368-7610 Contact: Valynda Machen
Date Prepared: June 19, 2006
Device Names
| Proprietary Name: | TPO Antibody and TPO Antibody Calibrators on the
Access® Immunoassay Systems |
|----------------------|---------------------------------------------------------------------------------|
| Common Name: | Immunoassay for the determination of thyroperoxydase antibodies |
| Classification Name: | System, Test, Thyroid Autoantibody |
Predicate Device
·
Immulite 2000 Anti-TPO Ab Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
510(k) Number: K991096
1
Device Description
The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of thyroperoxydase antibody (TPO�) levels in human serum and plasma.
Intended Use
The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxydase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. The detection of TPO antibodies is on id in the diagnosis of autoimmune thyroid disorders.
Comparison of Technological Characteristics
| Attribute | Immulite 2000 Anti-TPO Ab | Access TPO Antibody |
|---|---|---|
| Intended | ||
| Use | For the in vitro diagnostic use with the | |
| Immulite 2000 Analyzer-for the | ||
| quantitative measurement of | ||
| antithyroid peroxidase (TPO) | ||
| antibodies in serum and EDTA | ||
| plasma, as an aid the clinical | ||
| diagnosis of thyroid disease. | For the quantitative determination of | |
| TPO antibody levels in human serum | ||
| and plasma. | ||
| Assay | ||
| Principles | Immulite 2000 Anti-TPO Ab is a solid- | |
| phase, enzyme-labeled, | ||
| chemiluminescent sequential | ||
| immunometric assay. | The Access TPO Antibody assay is a | |
| sequential two-step | ||
| immunoenzymatic ("sandwich") | ||
| assay. | ||
| Solid | ||
| Support | Beads coated with highly purified | |
| human TPO. | Paramagnetic particles coated with | |
| streptavidin and coupled to | ||
| biotinylated human recombinant | ||
| TPO. | ||
| Detection | ||
| System | Chemiluminescent substrate. | Utilizes dioxetane-based |
| chemiluminescent substrate; | ||
| Measures light production from a | ||
| chemiluminescent reaction. | ||
| Calibrator | Two levels (low and high) of | |
| lyophilized TPO autoantibodies in a | ||
| human serum/buffer matrix, with | ||
| preservatives. | Six levels (0, ~5, ~20, ~75, ~300, and | |
| ~1000 IU/mL) of rabbit TPO | ||
| antiserum in a buffered protein | ||
| solution with preservatives. |
2
Summary of Analytical Studies
Imprecision: Imprecision was tested for concentrations from approximately 0.6 to 809 IU/mL. The within run imprecision ranged from 2.6% CV to 7.9% CV. Between-run assay imprecision ranged from 1.3% CV to 4.9% CV. Total imprecision ranged from 3.1% CV to 8.7% CV.
Dilution Recovery (Linearity): Multiple dilutions of serum samples were analyzed. Mean % recovery ranged from 86.4% to 94.9%. The following statement has been added to the TPOAD directional insert: "Due to varying antigen specificity, and avidity of TPOAb in their epitope reactions, some samples may not dilute linearly."
Methods Comparison: A comparison of 119 values using the Access TPOAb assay and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=5-1000, Slope=1.0207 (95% confidence interval 0.9722 to 1.0693), Intercept=-10.9123 (95 % confidence interval -24.6421 to 2.8175), Correlation coefficient (r)=0.97. The results of the study indicate that the slope and intercept are not significantly different from one and zero respectively.
Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides).
Stability: TPOAb reagents are stable for 56 days after opening. TPOAb calibrators are stable for 120 days after opening. The calibration is stable for 56 days.
Summary of Clinical Studies
Expected Values: Sera samples were obtained in the United States from a healthy male population