(529 days)
No
The summary describes a standard chemiluminescent immunoassay for measuring thyroglobulin levels. There is no mention of AI, ML, or any computational analysis beyond standard data processing for calculating results from the immunoassay signals. The performance studies focus on analytical characteristics of the assay itself, not on the performance of an AI/ML algorithm.
No
The device is an in vitro diagnostic (IVD) immunoassay designed to quantitatively determine thyroglobulin levels in human serum to aid in monitoring for persistent or recurrent disease; it is not intended to treat or prevent a disease, which would classify it as a therapeutic device.
Yes
The device is described as an "immunoassay for the quantitative determination of thyroglobulin levels in human serum" intended to "aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer." This directly states its purpose is to provide information for diagnosis or monitoring of a disease state.
No
The device is a paramagnetic particle, chemiluminescent immunoassay, which is a laboratory test system involving chemical reagents and physical components, not solely 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 levels in human serum." This involves testing a biological sample (human serum) outside of the body.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and lists reagents used in the test. This is a typical description of an in vitro diagnostic test system.
- Care Setting: The device is designed for use in a "clinical laboratory setting," which is where IVD tests are performed.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Reproducibility, Linearity, Limits of Detection/Quantitation, Analytical Specificity) are all standard types of studies conducted to validate the analytical performance of an IVD.
- Predicate Device: The mention of a "predicate currently marketed Access Thyroglobulin assay" with a K number (K002905) indicates that this device is being compared to a previously cleared IVD.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 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.
Product codes
MSW
Device Description
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 thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
Well: R1a: Ingredients: Dynabeads* paramagnetic particles coated with streptavidin and coupled to biotinylated mouse monoclonal antithyroglobulin antibodies, suspended in a TRIS buffer with protein (bovine),
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
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.(b)
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.
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September 15, 2023
Beckman Coulter, Inc. Adam Viitala Senior Manager Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K220972
Trade/Device Name: Access Thyroglobulin Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: MSW Dated: January 26, 2023 Received: January 26, 2023
Dear Adam Viitala:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao-S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220972
Device Name Access Thyroglobulin
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular shape with two curved lines inside, resembling a stylized wave or heartbeat. To the right of the circular shape, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Access Tg 510(K) Summary
Immunodiagnostic Development Center
1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a)(1).
The assigned 510(k) number is K220972
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-1142 Fax: (952) 246-1860
Contact Person:
Adam Viitala 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: +1 (520) 496-4517
Alternate Contact:
Muhammad Sheikh Office Phone: (952) 368-1142
Date Prepared:
September 14, 2023
Device Name:
Proprietary / Trade Name: Access Thyroglobulin Common Name: Thyroglobulin Chemiluminescence Immunoassay Classification Description: Tumor-associated antigen immunological test system Classification Regulation: 21 CFR 866.6010 Classification Product Code: MSW
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Predicate Device:
The modified Access Thyroglobulin assay claims substantial equivalence to previously cleared Access Thvroglobulin assay. FDA 510(k) Number K002905, cleared October 19, 2000.
Device Description:
Access Thyroqlobulin 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 thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidin |
| and coupled to biotinylated mouse monoclonal | |
| antithyroglobulin antibodies, suspended in a TRIS buffer with | |
| protein (bovine), 10 | |
| ng/mL can lead to significant (> 10%) | |
| negative bias in Thyroglobulin results. | No significant |
| interference (≤± 10%) | |
| observed in samples | |
| containing up to 3,510 | |
| ng/mL of biotin. |
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Summary of Studies:
Method Comparison: A comparison of 102 serum samples with thyroglobulin concentrations within the assay's measuring range were run on both the modified Access Thyroglobulin assay and the predicate currently marketed Access Thyroglobulin assay. The results were compared using Passing-Bablok reqression and Pearson's correlation with the predicate on the x-axis. The results of the method comparison study met the acceptance criteria of R ≥ 0.90 and slope 1.00 ± 0.09.
Imprecision: A study based on CLSI EP05-A3 performed on an Access Immunoassay System tested multiple samples in duplicate in 2 runs per day for 20 days. The representative imprecision data is provided in the following table.
| Sample | N | Mean
(ng/mL) | Within-Run | | Between-Run | | Between-Day | | Total | |
|--------|----|-----------------|------------|-----|-------------|------|-------------|-----|-------|------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 80 | 0.11 | 0.01 | 8.4 | 0.01 | 4.7 | 0.00 | 0.0 | 0.01 | 9.6 |
| 2 | 80 | 0.17 | 0.01 | 6.2 | 0.02 | 14.0 | 0.01 | 4.3 | 0.03 | 15.9 |
| 3 | 80 | 4.5 | 0.09 | 2.1 | 0.06 | 1.3 | 0.05 | 1.0 | 0.12 | 2.6 |
| 4 | 80 | 21 | 0.4 | 1.9 | 0.0 | 0.0 | 0.2 | 0.9 | 0.5 | 2.2 |
| 5 | 80 | 133 | 2.2 | 1.6 | 1.7 | 1.2 | 0.0 | 0.0 | 2.7 | 2.1 |
| 6 | 80 | 431 | 7.2 | 1.7 | 8.5 | 2.0 | 18.4 | 4.3 | 21.5 | 5.0 |
Reproducibility: Two reproducibility studies based on CLSI EP05-A3 performed on the Access Immunoassay System tested multiple samples in replicates of 3 or 5 over a 5 day period of time. Study 1 consisted of 3 replicates of 2 samples tested with 2 runs per day for 5 days on 3 instruments. Study 2 consisted of 5
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replicates of 3 samples with 3 runs per day over 5 days one 1 instrument. The representative reproducibility data is provided in the following table.
| | Mean | | Repeatability
(within-run) | | Between-day | | Between-
instrument | | Reproducibility | |
|-------|---------|----|-------------------------------|---------|---------------|---------|------------------------|---------|-----------------|------|
| Study | (ng/mL) | N | SD
(ng/mL) | %
CV | SD
(ng/mL) | %
CV | SD
(ng/mL) | %
CV | SD
(ng/mL) | % CV |
| 1 | 4.3 | 90 | 0.07 | 1.7 | 0.04 | 1.0 | 0.10 | 2.3 | 0.15 | 3.6 |
| | 20 | 90 | 0.27 | 1.3 | 0.00 | 0.0 | 0.57 | 2.8 | 0.74 | 3.6 |
| 2 | 0.48 | 75 | 0.01 | 2.9 | 0.01 | 2.2 | 0.01 | 2.0 | 0.02 | 4.2 |
| | 136 | 75 | 2.44 | 1.8 | 1.43 | 1.1 | 3.01 | 2.2 | 4.13 | 3.0 |
| | 446 | 75 | 10.74 | 2.4 | 8.15 | 1.8 | 0.00 | 0.0 | 13.48 | 3.0 |
High-dose Hook Effect: The Access Thyroglobulin assay demonstrated no highdose hook effect at concentrations up to at least 40,000 ng/mL.
Linearity: The Access Thyroglobulin assay has been demonstrated to be linear across the range of the assay (0.1 to approximately 500 ng/mL) in serum samples.
Dilution Recovery: The Access Thyroglobulin assay has been demonstrated to dilute recover across and above the range of the assay in serum samples.
Limit of Blank (LoB): The Access Thyroglobulin assay was designed to have a Limit of Blank of ≤ 0.03 ng/mL. In one study, LoB testing determined the LoB for Access Thyroglobulin to be 0.02 ng/mL.
Limit of Detection (LoD): The Access Thyroglobulin assay was designed to have a Limit of Detection (LOD) of ≤ 0.05 ng/mL in serum samples. In one study, LoD testing determined the LoD for Access Thyroglobulin to be 0.05 ng/mL.
Limit of Quantitation (LoQ): The Access Thyroqlobulin assay was designed to have a Limit of Quantitation (LOD) of ≤ 0.1 ng/mL in serum samples. In one study, the LoQ for Access Thyroglobulin was determined to be 0.05 ng/mL.
Analytical Specificity: Potential cross-reactive substances were added to serum patient samples at two concentrations of thyroglobulin (approximately 20 ng/mL and 100 ng/mL). Stock solutions of potential cross-reactants were prepared and added directly to the serum in no more than 5% (v/v) final concentration. Control samples were prepared in the same manner without the cross-reactant added. Testing of 3,3',5-Triiodo-L-thyronine (T3), L-Thyroxine (T4), Thyroxine Binding Globulin (TBG) and Thyroid Stimulating Hormone (TSH) with Access Thyroglobulin found that there is no significant cross-reactivity, as defined by a change in concentration between the diluent control and the test samples within ± 10%.
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Potential interferents were tested at one concentration and compared to control samples without potential interferents. The results were reported as a percent difference between test and control sample. Testing was completed on patient serum samples containing two levels of Thyroglobulin at clinically relevant concentrations of approximately 25.0 ng/mL and 100.0 nq/mL. Testing of all potential interferents, including biotin at a concentration of 3510 ng/mL, with Access Thyroqlobulin found that there is no significant interference, as defined by a change in concentration between the diluent control and the test samples within