(83 days)
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No
The description details a standard immunoassay technology and does not mention any AI or ML components.
No
This device is an in vitro diagnostic immunoassay that quantitatively determines thyroglobulin antibody levels to aid in the diagnosis of certain diseases, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease." This directly indicates its use in diagnosing conditions.
No
The device is an in vitro diagnostic immunoassay kit, which involves chemical reagents and physical processes (paramagnetic particles, chemiluminescence) to measure analyte levels. While it uses an "Access Immunoassay System" (likely a hardware analyzer with software), the device itself is the assay kit, not the software controlling the analyzer or interpreting the results.
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 indicates it's used to analyze biological samples in vitro (outside the body).
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" which is a laboratory technique used to measure substances in biological fluids. It also mentions using "human serum and plasma."
- Mechanism: The description of the assay process (adding sample to particles, washing, adding conjugate, adding substrate, measuring light) is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Reproducibility, Linearity, Detection Capability) are standard types of studies conducted to validate the performance of in vitro diagnostic assays.
- Predicate Device: The mention of a predicate device (K213517; Access Thyroglobulin Antibody II) which is also an IVD further supports this classification.
The information provided clearly indicates that this device is designed to perform tests on biological samples outside of the human body to aid in diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Thyroglobulin Antibody II 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 (comma separated list FDA assigned to the subject device)
JNL
Device Description
The Access Thyroglobulin Antibody II 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.
The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb.
After second incubation, 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 analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A study based on CLSI EP09c, 3rd Edition using Passing-Bablok regression and Pearson's correlation compared the Access 2 Immunoassay System and the Dxl 9000 Access Immunoassay Analyzer.
N: 114
Concentration Range (IU/mL): 2.3 – 2,463
Slope: 0.97
Slope 95% CI: 0.95 – 0.99
Intercept: -0.37
Intercept 95% CI: -0.99 – 0.047
Correlation Coefficient R: 1.00
Imprecision: The assay was designed to have within-laboratory imprecision as listed below:
- ≤ 1.5 IU/mL SD at concentrations
§ 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).
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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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
July 3, 2024
Beckman Coulter Inc Kate Oelberg Senior Staff Quality and Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240996
Trade/Device Name: Access Thyroglobulin Antibody II Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JNL Dated: April 11, 2024 Received: April 11, 2024
Dear Kate Oelberg:
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" (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).
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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 (OS) 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) K240996
Device Name Access Thyroglobulin Antibody II
Indications for Use (Describe)
The Access Thyroglobulin Antibody II 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.
| 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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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) Number: K240996
Date Prepared: July 2, 2024
Submitted By:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg Senior Staff Quality and Regulatory Affairs Phone: (612) 431-7315 Email: kmoelberq@beckman.com
Alternate Contact:
Kuljeet Kaur Senior Manager, Requlatory Affairs Phone: (952) 368-7816 Email: kkaur@beckman.com
Device Name
Proprietary/ Trade Name: Access Thyroglobulin Antibody II Common Name: Thyroid autoantibody immunological test system Classification Description: Thyroid autoantibody immunological test system. Classification Regulation: 21 CFR 866.5870 Classification Product Code: JNL
Predicate Device
Device Name: Access Thyroglobulin Antibody II 510(k) Numbers: K213517
Device Description
The Access Thyroqlobulin Antibody II 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.
The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the
4
particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb.
After second incubation, 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 analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
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.
| Characteristic | Predicate Device
Access Thyroglobulin Antibody II
(K213517) | Modified Device
Access Thyroglobulin Antibody II |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | The Access Thyroglobulin Antibody
II 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. | Same |
| Analyte
Measured | Thyroglobulin Antibody | Same |
| Technology | Sandwich immunoassay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Sample Type | Human serum or plasma | Same |
| Sample Volume | 10 uL | Same |
| Measuring
Range | 1.5 -2,500 IU/mL | Same |
| Blocker
reagents | Biotin and alkaline phosphatase
included in reagent pack as blockers | Same |
Comparison of Technological Characteristics to the Predicate
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| Biotin
Interference | No significant interference (± 10%)
observed in samples containing up
to 3,510 ng/mL of biotin. | Same |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Imprecision | SD ≤ 1.5 for values