(85 days)
Not Found
No
The document describes a standard in vitro diagnostic immunoassay and does not mention any AI or ML components in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is an in vitro diagnostic test intended to aid in monitoring for disease, not to provide therapy or direct treatment.
Yes
The device is described as "intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC)", which indicates a diagnostic rather than a therapeutic function.
No
The device description explicitly states it consists of a reagent pack and calibrators, which are physical components, not software. It is an in vitro diagnostic test system.
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 and plasma. This is a test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" which is a common method used in in vitro diagnostic tests. It also mentions the use of reagent packs, calibrators, substrate, and wash buffer, all components typical of an IVD system.
- Clinical Laboratory Setting: The intended user/care setting is a "clinical laboratory setting," which is where IVD tests are performed.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Reproducibility, Linearity, Detection Capability) are all analytical performance studies conducted to validate the accuracy and reliability of an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device (K220972; Access Thyroglobulin assay) indicates that this device is being compared to a previously cleared IVD device.
All 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 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.
Product codes
MSW
Device Description
The Access Thyroglobulin assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Thyroglobulin 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.
Lumi-Phos PRO substrate was used with this pack. The modification does not affect the indications of the device or alter the fundamental scientific technology of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory setting
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
Method Comparison: A comparison of values using the Access Thyroglobulin assay on Dxl 9000 Immunoassay Analyzer and Access 2 Immunoassay System gave statistical data. The data was analyzed by Passing-Bablok regression and Pearson's correlation and followed the CLSI EP09c guideline. N=187, Concentration Range* (ng/mL) 0.35 – 4.73, Slope (95% CI) 1.00 (0.99 - 1.00), Intercept (95% CI) 0.0044 (-0.029 - 0.021), Correlation Coefficient R 1.00. Range is Access 2 values.
Imprecision: The Access Thyroglobulin assay exhibits within laboratory (total) imprecision of CV ≤ 10.0% at concentrations > 1.0 ng/mL and standard deviation (SD) ≤ 0.1 ng/mL at concentrations ≤ 1.0 ng/mL. A study based on CLSI EP05-A3 performed on a Dxl 9000 Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for 20 days.
Sample 1 (N=88, Mean=0.30): Repeatability (Within-run) SD=0.02, %CV=5.4; Between-run SD=0.01, %CV=4.7; Between-day SD=0.01, %CV=4.4; Within-Laboratory (Total) SD=0.02, %CV=8.4.
Sample 2 (N=88, Mean=5.5): Repeatability (Within-run) SD=0.26, %CV=4.7; Between-run SD=0.26, %CV=4.7; Between-day SD=0.09, %CV=1.6; Within-Laboratory (Total) SD=0.38, %CV=6.8.
Sample 3 (N=88, Mean=22): Repeatability (Within-run) SD=0.95, %CV=4.4; Between-run SD=0.88, %CV=4.1; Between-day SD=0.41, %CV=1.9; Within-Laboratory (Total) SD=1.36, %CV=6.3.
Sample 4 (N=80, Mean=111): Repeatability (Within-run) SD=2.22, %CV=2.0; Between-run SD=0.64, %CV=0.6; Between-day SD=1.47, %CV=1.3; Within-Laboratory (Total) SD=2.74, %CV=2.5.
Sample 5 (N=80, Mean=376): Repeatability (Within-run) SD=8.91, %CV=2.4; Between-run SD=5.04, %CV=1.3; Between-day SD=9.06, %CV=2.4; Within-Laboratory (Total) SD=13.67, %CV=3.6.
Sample 6 (N=80, Mean=417): Repeatability (Within-run) SD=8.82, %CV=2.1; Between-run SD=6.25, %CV=1.5; Between-day SD=10.13, %CV=2.4; Within-Laboratory (Total) SD=14.82, %CV=3.6.
Reproducibility: A reproducibility study based on CLSI EP05-A316 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in replicates of 5 per day for a minimum of 5 days on 3 instruments.
Sample 1 (N=75, Mean=0.34): Repeatability (Within-run) SD=0.02, %CV=5.9; Between-day SD=0.02, %CV=4.5; Between-instrument SD=0.00, %CV=0.0; Reproducibility SD=0.03, %CV=7.4.
Sample 2 (N=75, Mean=6.2): Repeatability (Within-run) SD=0.20, %CV=3.2; Between-day SD=0.09, %CV=1.5; Between-instrument SD=0.18, %CV=2.9; Reproducibility SD=0.28, %CV=4.6.
Sample 3 (N=75, Mean=21): Repeatability (Within-run) SD=0.82, %CV=3.9; Between-day SD=0.49, %CV=2.3; Between-instrument SD=0.69, %CV=3.3; Reproducibility SD=1.18, %CV=5.7.
Sample 4 (N=75, Mean=109): Repeatability (Within-run) SD=2.98, %CV=2.7; Between-day SD=1.62, %CV=1.5; Between-instrument SD=0.92, %CV=0.8; Reproducibility SD=3.51, %CV=3.2.
Sample 5 (N=75, Mean=370): Repeatability (Within-run) SD=11.84, %CV=3.2; Between-day SD=6.37, %CV=1.7; Between-instrument SD=13.31, %CV=3.6; Reproducibility SD=18.92, %CV=5.1.
Sample 6 (N=75, Mean=402): Repeatability (Within-run) SD=10.18, %CV=2.5; Between-day SD=13.09, %CV=3.3; Between-instrument SD=16.94, %CV=4.2; Reproducibility SD=23.70, %CV=5.9.
Linearity: A study based on CLSI EP06-Ed215 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
Detection Capability: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2. The LoB study included multiple reagent lots and 2 instruments over a minimum of 3 days. The LoQ studies included multiple reagent lots and a minimum of 5 days.
Limit of Blank (LoB): 0.03 ng/mL
Limit of Detection (LoD): 0.05 ng/mL
Limit of Quantitation (LoQ) ≤20% within-lab CV: 0.1 ng/mL
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2024
Beckman Coulter, Inc. Muhammad Sheikh Staff Regulatory Affairs Beckman Coulter Inc 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240927
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: April 4, 2024 Received: April 4, 2024
Dear Muhammad Sheikh:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
510(k) Number (if known) K240927
Device Name Access Thyroglobulin
Indications for Use (Describe)
Access Thyroglobulin assay is a paramagetic particle, chemiluminescent immunossay 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.
| 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 contains the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized wave or heartbeat. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on top of "COULTER". The overall design is clean and corporate.
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.
510(k) assigned number: K240927
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Muhammad Sheikh, Staff Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318 Phone: +1 (201) 335-0632 Email:msheikh@beckman.com
Alternate Contact:
Kate Oelberg, Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, MN 55318 Office Phone: (612) 431-7315 Email:kmoelberg@beckman.com
Date Prepared:
June 20, 2024
Device Name:
Proprietary / Trade Name: Access Thyroglobulin Common Name: Thyroqlobulin Chemiluminescence Immunoassay Classification Description: Tumor-associated antigen immunological test system Classification Requlation: 21 CFR 866.6010 Classification Product Code: MSW
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Predicate Device:
The modified Access Thyroqlobulin assay claims substantial equivalence to previously cleared Access Thyroglobulin assay, FDA 510(k) Number K220972, cleared September 15, 2023.
Device Description:
The Access Thyroglobulin assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Thyroglobulin 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.
Lumi-Phos PRO substrate was used with this pack. The modification does not affect the indications of the device or alter the fundamental scientific technology of the device.
| 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), 1.0 ng/mL and standard deviation (SD) ≤ 0.1 ng/mL at concentrations ≤ 1.0 ng/mL. |
A study based on CLSI EP05-A3 performed on a Dxl 9000 Immunoassay Analyzer tested multiple samples in duplicate in 2 runs per day for 20 days. The representative imprecision data is provided in the following table.
| Concentration (ng/mL) | | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within-
Laboratory
(Total) | |
|-----------------------|----|------|-------------------------------|-----|-------------|-----|-------------|-----|----------------------------------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 88 | 0.30 | 0.02 | 5.4 | 0.01 | 4.7 | 0.01 | 4.4 | 0.02 | 8.4 |
| Sample 2 | 88 | 5.5 | 0.26 | 4.7 | 0.26 | 4.7 | 0.09 | 1.6 | 0.38 | 6.8 |
| Sample 3 | 88 | 22 | 0.95 | 4.4 | 0.88 | 4.1 | 0.41 | 1.9 | 1.36 | 6.3 |
| Sample 4 | 80 | 111 | 2.22 | 2.0 | 0.64 | 0.6 | 1.47 | 1.3 | 2.74 | 2.5 |
| Sample 5 | 80 | 376 | 8.91 | 2.4 | 5.04 | 1.3 | 9.06 | 2.4 | 13.67 | 3.6 |
| Sample 6 | 80 | 417 | 8.82 | 2.1 | 6.25 | 1.5 | 10.13 | 2.4 | 14.82 | 3.6 |
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Reproducibility: A reproducibility study based on CLSI EP05-A316 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple samples in replicates of 5 per day for a minimum of 5 days on 3 instruments.
| Concentration (ng/mL) | | Repeatability
(Within-run) | | Between-day | | Between -
instrument | | Reproducibility | | |
|-----------------------|----|-------------------------------|-------|-------------|-------|-------------------------|-------|-----------------|-------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 75 | 0.34 | 0.02 | 5.9 | 0.02 | 4.5 | 0.00 | 0.0 | 0.03 | 7.4 |
| Sample 2 | 75 | 6.2 | 0.20 | 3.2 | 0.09 | 1.5 | 0.18 | 2.9 | 0.28 | 4.6 |
| Sample 3 | 75 | 21 | 0.82 | 3.9 | 0.49 | 2.3 | 0.69 | 3.3 | 1.18 | 5.7 |
| Sample 4 | 75 | 109 | 2.98 | 2.7 | 1.62 | 1.5 | 0.92 | 0.8 | 3.51 | 3.2 |
| Sample 5 | 75 | 370 | 11.84 | 3.2 | 6.37 | 1.7 | 13.31 | 3.6 | 18.92 | 5.1 |
| Sample 6 | 75 | 402 | 10.18 | 2.5 | 13.09 | 3.3 | 16.94 | 4.2 | 23.70 | 5.9 |
Linearity: A study based on CLSI EP06-Ed215 performed on the Dxl 9000 Access Immunoassay Analyzer determined the assay demonstrated linearity across the measuring interval.
8
Detection Capability: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) studies were conducted on the Dxl 9000 Access Immunoassay Analyzer following CLSI guideline EP17-A2. The LoB study included multiple reagent lots and 2 instruments over a minimum of 3 days. The LoQ studies included multiple reagent lots and a minimum of 5 days.
| | Dxl 9000 Immunoassay
Analyzer |
|------------------------------------------------------|----------------------------------|
| | ng/mL |
| Limit of Blank (LoB) | 0.03 |
| Limit of Detection (LoD) | 0.05 |
| Limit of Quantitation
(LoQ) ≤20% within-lab
CV | 0.1 |
Conclusion:
The modified device has the same intended use and fundamental scientific technology as the predicate device. The modified device is as safe and effective as the predicate device, as demonstrated through verification testing.
The information provided in this submission demonstrates that the modified device is substantially equivalent to the predicate device.