Access Thyroglobulin

K241423 · Beckman Coulter, Inc. · MSW · Jun 7, 2024 · Immunology

Device Facts

• Record ID: K241423
• Device Name: Access Thyroglobulin
• Applicant: Beckman Coulter, Inc.
• Product Code: MSW · Immunology
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

Device Story

Access Thyroglobulin is a paramagnetic particle, chemiluminescent immunoassay for quantitative thyroglobulin measurement in human serum and plasma. Used in clinical laboratories on Access Immunoassay Systems; operated by laboratory technicians. Input: patient serum or plasma sample. Principle: sandwich immunoassay using biotinylated mouse monoclonal anti-thyroglobulin antibodies coupled to streptavidin-coated paramagnetic particles and mouse monoclonal anti-thyroglobulin-alkaline phosphatase conjugate. Output: quantitative thyroglobulin concentration. Healthcare providers use results to monitor for persistent or recurrent/metastatic disease in post-surgical differentiated thyroid cancer patients. Benefits include standardized monitoring of disease status in patients lacking thyroglobulin antibodies.

Clinical Evidence

Bench testing only. Matrix comparison study performed using 45 matched sets of serum, lithium heparin plasma, and sodium heparin plasma. Results showed high correlation (r=0.999) with slopes near 1.0 (1.000 for Li-heparin, 1.021 for Na-heparin). No clinical prospective or retrospective studies were required as performance characteristics were transferred from the predicate device (K220972).

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Reagents: Dynabeads (streptavidin-coated paramagnetic particles), biotinylated mouse monoclonal anti-thyroglobulin antibodies, mouse monoclonal anti-thyroglobulin-alkaline phosphatase conjugate. Measuring range: 0.1–500 ng/mL. Sample volume: 40 μL. Automated operation on Access Immunoassay Systems. Standard: CLSI EP35 for specimen type equivalence.

Indications for Use

Indicated for monitoring persistent, recurrent, or metastatic disease in patients with differentiated thyroid cancer (DTC) post-thyroid surgery (with/without ablation) who lack serum thyroglobulin antibodies.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Access Thyroglobulin (K220972)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K241423

B Applicant

Beckman Coulter, Inc

C Proprietary and Established Names

Access Thyroglobulin

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| MSW | Class II | 21 CFR 866.6010 - Tumor-Associated Antigen Immunological Test System | IM - Immunology |

## II Submission/Device Overview:

A Purpose for Submission:

Addition of plasma sample type to the previously cleared Access Thyroglobulin

B Measurand:

Thyroglobulin

C Type of Test:

Quantitative, Chemiluminescent Immunoassay

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

K220972 - Page 1 of 6

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
K220972 - Page 2 of 6

# III Intended Use/Indications for Use:

## A Intended Use(s):

See Indications for Use below.

## B Indication(s) for Use:

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only
For In Vitro Diagnostic Use Only

The Instructions for Use of the device contains the following warning statement:

"The presence of serum autoantibodies to thyroglobulin (TgAb) can interfere with assays for thyroglobulin (Tg). Therefore, sera which contain TgAb, even at very low levels, should not be tested for Tg.

The concentration of thyroglobulin in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the Tg assay used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining Tg levels serially is changed, additional sequential testing should be carried out to confirm baseline values."

## D Special Instrument Requirements:

Access Immunoassay Systems (Access Immunoassay System and Access 2 Immunoassay System)

# IV Device/System Characteristics:

## A Device Description:

Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma (heparinized) using the Access Immunoassay Systems.

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Materials included in the Access Thyroglobulin assay

Reagent Pack (2 packs, 50 tests/pack) contains:

- R1a (3.25 mL): Dynabeads paramagnetic particles coated with streptavidin and coupled to biotinylated mouse monoclonal antithyroglobulin antibodies in TRIS buffer with protein (bovine) and preservatives
- R1b (3.10 mL): Mouse monoclonal anti-thyroglobulin-alkaline phosphatase (bovine) conjugate in a TRIS buffer with protein (bovine, murine) and preservatives
- R1c (3.10 mL): HEPES buffer with protein (bovine, murine) and preservatives

Materials needed but not supplied

- Access Thyroglobulin Calibrators: Six levels – 0, 1.0, 10, 100, 250, and 500 ng/mL
- Quality control materials: commercial control material
- Access Thyroglobulin Sample Diluent
- Access Substrate
- Access Wash Buffer II / Unicel DxI Wash Buffer II

B Principle of Operation:

The Access Thyroglobulin assay is a simultaneous one-step immunoenzymatic (“sandwich”) assay. A sample is added to a reaction vessel with four biotinylated anti-thyroglobulin antibodies coated on streptavidin paramagnetic particles, and monoclonal anti-thyroglobulin antibody alkaline phosphatase conjugate. The thyroglobulin in the sample binds to the biotinylated antibodies on the solid phase, while the conjugate antibody reacts with a different antigenic site on the thyroglobulin molecule. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of thyroglobulin in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Access Thyroglobulin

B Predicate 510(k) Number(s):

K220972

C Comparison with Predicate(s):

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

K220972 - Page 3 of 6

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| Device & Predicate Device(s): | K241423 | K220972 |
| --- | --- | --- |
| Device Trade Name | Access Thyroglobulin | Access Thyroglobulin |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies. | Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies. |
| Technology | Chemiluminescent immunoassay | Same |
| Analyte | Thyroglobulin | Same |
| Antibodies | Mouse monoclonal antibodies | Same |
| Method | Automated | Same |
| Assay Architecture | Biotinylated mouse monoclonal anti-thyroglobulin antibodies pre-coupled to paramagnetic particles coated with streptavidin. | Same |
| Sample Volume | 40 μL | Same |
| Assay Throughput | ~42 minutes | Same |
| Measuring Range | 0.1 – 500 ng/mL | Same |
| General Device Characteristic Differences | | |
| Sample Matrix | Serum and Plasma | Serum |

VI Standards/Guidance Documents Referenced:

The following Clinical and Laboratory Standards Institute (CLSI) guideline was used:

- CLSI EP35, Assessment of Equivalence or Suitability of Specimen Types for Medical Measurement Procedures – Third Edition

VII Performance Characteristics (if/when applicable):

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

K220972 - Page 4 of 6

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
K220972 - Page 5 of 6

# A Analytical Performance:

1. Precision/Reproducibility:
Refer to K220972

2. Linearity:
Refer to K220972

3. Analytical Specificity/Interference:
Refer to K220972

4. Assay Reportable Range:
Refer to K220972. The assay reportable range for the Access Thyroglobulin is the same as the claimed analytical measuring interval (AMI): 0.1–500 ng/mL.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Refer to K220972

6. Detection Limit:
Refer to K220972

7. Assay Cut-Off:
Not applicable

# B Comparison Studies:

1. Method Comparison with Predicate Device:
Refer to K220972

2. Matrix Comparison:
A study was performed to demonstrate that lithium heparin and sodium heparin plasma matrices yield comparable values as serum for the same patient with the Access Thyroglobulin assay. The study included 45 matched native samples with thyroglobulin concentration covering the measuring range of the assay. Samples were tested in replicates of three for each sample pair using one reagent lot of the Access Thyroglobulin assay on one Access 2 Immunoassay System. Passing-Bablok regression analyses were performed by comparing the results of plasma samples to the results of corresponding serum samples. Representative results of single replicate are summarized in the table below:

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| Plasma/Serum | N | Range (ng/mL) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient (r) |
| --- | --- | --- | --- | --- | --- |
| Li-heparin plasma vs Serum | 45 | 0.227 to 494.070 | 1.000 (0.983; 1.015) | 0.163 (-0.212; 0.712) | 0.999 |
| Na-heparin plasma vs Serum | 45 | 0.227 to 494.070 | 1.021 (1.010; 1.039) | 0.147 (-0.246; 0.952) | 0.999 |

## C Clinical Studies:

1. Clinical Sensitivity:
Refer to K002905

2. Clinical Specificity:
Refer to K002905

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable

## D Clinical Cut-Off:

Refer to K002905

## E Expected Values/Reference Range:

Refer to K220972

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
K220972 - Page 6 of 6