(35 days)
No
The summary describes a standard immunoassay for measuring free thyroxine levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical performance characteristics of the assay and instrument, not on the performance of an AI/ML algorithm.
No
This device is an in vitro diagnostic (IVD) immunoassay that measures free thyroxine levels to aid in the diagnosis and treatment of thyroid diseases. It does not directly treat or interact with the patient's body for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the diagnosis and treatment of thyroid diseases." This directly indicates its use as a diagnostic device.
No
The device description clearly indicates that the device is an in vitro diagnostic assay consisting of reagent packs and calibrators, which are physical components. It is designed for use with Access Immunoassay Systems, which are also hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases." This clearly indicates that the device is intended to be used in vitro (outside the body) to analyze biological samples (serum and plasma) for diagnostic purposes.
- Device Description: The description details the components of the assay, including reagents and calibrators, which are typical for an in vitro test. It also mentions its use with "Access Immunoassay Systems in a clinical laboratory setting," further supporting its use in a laboratory environment for analyzing samples.
- Anatomical Site: The "Anatomical Site" is listed as "Not Applicable (In vitro diagnostic)," which is a direct confirmation that the device is an IVD.
N/A
Intended Use / Indications for Use
The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.
Product codes
CEC
Device Description
Assay type: two-step, competitive
The Access Free T4 assay is a two-step enzyme immunoassay. The Access Free T4 assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Free T4 reagent pack, Access Free T4 calibrators, along with Wash Buffer II are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The Access Free T4 contains the following components:
- R1a: Dynabeads paramagnetic particles coated with streptavidin and mouse monoclonal anti-Thyroxine (T4) coupled to biotin; preservative
- R1b: TRIS buffered saline with protein (avian), surfactant, preservative
- R1c: TRIS buffered saline with protein (avian), surfactant, preservative.
- R1d: Triiodothyronine-alkaline phosphatase (bovine) conjugate in a TRIS buffer with protein (avian), surfactant, preservative.
- R1e: TRIS buffer with protein (avian and murine), surfactant, preservative
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
Not Found
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 method comparison study was performed to compare the Access FT4 assay on Access 2 and Dxl 9000 Immunoassay system to the predicate device. A total of one hundred and sixty three (163) serum samples falling within the measuring range of the Access FT4 assay were evaluated. The results of the within range method comparison study met the acceptance criteria of slope 1.00 ± 0.12.
A study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression compared the Access 2 Immunoassay System and predicate device.
N: 163, Concentration Range (ng/dL): [0.27 - 5.32], Slope: 1.02, Slope 95% Cl: [1.00 to 1.04], Intercept: - 0.04, Intercept 95% Cl: [-0.06 to -0.02], Correlation Coefficient R: 0.98
A study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression compared the Dxl 9000 Access Immunoassay Analyzer and predicate device.
N: 163, Concentration Range (ng/dL): 0.25 - 5.31, Slope: 1.02, Slope 95% CI: 0.99 to 1.05, Intercept: 0.03, Intercept 95% CI: 0.01 - 0.06, Correlation Coefficient R: 0.95
Imprecision: On the Access 2 Immunoassay Analyzer and Dxl 9000 Access Immunoassay Analyzer the within-laboratory (total) %CV ≤ 10.0% for values ≥ 0.61 ng/dL. The within-laboratory (total) SD was ≤ 0.06 for Free T4 concentrations
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
0
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March 6, 2024
Muhammad Sheikh Staff Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K240273
Trade/Device Name: Access Free T4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC Dated: January 31, 2024 Received: January 31, 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" (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).
1
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,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240273
Device Name Access Free T4
Indications for Use (Describe)
The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.
| 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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3
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: K240273
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Muhammad Sheikh, Staff Regulatory Affairs Phone: +1 (201) 335 0632 Email: msheikh@beckman.com
Alternate Contact:
Kate M. Oelberg, Senior Staff Quality and Regulatory Affairs Phone: +1 (612) 431-7315 Email: kmoelberg@beckman.com
Date Prepared: 3/06/2024
Device Name Trade Name: Access Free T4 Common Name: Free Thyroxine Assay Classification Name: Free Thyroxine Test system Classification Regulation: 21 CFR 862.1695 Classification Product Code: CEC
Predicate Device: Device Name: Access Free T4 Assay on the Access Immunoassay Analyzer 510(k) Numbers: K982250
Device Description
Assay type: two-step, competitive
The Access Free T4 assay is a two-step enzyme immunoassay. The Access Free T4 assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Free T4 reagent pack, Access Free T4 calibrators, along with Wash Buffer II are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
4
The Access Free T4 contains the following components:
- R1a: Dynabeads paramagnetic particles coated with streptavidin and mouse monoclonal anti-Thyroxine (T4) coupled to biotin; preservative
- R1b: TRIS buffered saline with protein (avian), surfactant, preservative
- R1c: TRIS buffered saline with protein (avian), surfactant, preservative.
- R1d: Triiodothyronine-alkaline phosphatase (bovine) conjugate in a TRIS buffer with protein (avian), surfactant, preservative.
- R1e: TRIS buffer with protein (avian and murine), surfactant, preservative
Intended Use
The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.
| Parameter | Predicate Device
Access Free T4 Assay
on the Access Immunoassay
Analyzer (K982250) | Modified Device
Access Free T4 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access Free T4 assay is a
paramagnetic particle,
chemiluminescent immunoassay
for the quantitative determination
of free thyroxine levels in human
serum and plasma (heparin) using
the Access Immunoassay
Systems. | The Access Free T4 assay is a
paramagnetic particle,
chemiluminescent immunoassay for
the quantitative determination of
free thyroxine levels in human
serum and plasma (heparin) for the
diagnosis and treatment of thyroid
diseases using the Access
Immunoassay Systems. |
| Analyte Measured | Free Thyroxine | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Technology | Chemiluminescent | Same |
| Format | Two-step competitive enzyme
Immunoassay | Same |
| Method | Automated | Same |
| Sample Type | Human serum or plasma | Same |
| Sample Volume | 30 μL | Same |
| Reagent Stability | Stable at 2 to 10°C for 28 days
after initial use | Same |
| Antibody | Mouse monoclonal anti-Thyroxine
(T4) | Same |
| Measuring Range | 0.25 - 6.0 ng/dL | 0.40 – 6.0 ng/dL (Access 2)
0.32 – 6.0 ng/dL (Dxl 9000 Access
Immunoassay Analyzer) |
Comparison of Technological Characteristics to the Predicate (Assay)
5
| Parameter | Predicate Device
Access Free T4 Assay
on the Access Immunoassay
Analyzer (K982250) | Modified Device
Access Free T4 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay architecture | Biotinylated mouse monoclonal
anti-thyroxine antibodies not pre-
coupled to paramagnetic particles
coated with streptavidin | Biotinylated mouse monoclonal anti-
thyroxine antibodies pre-coupled to
paramagnetic particles coated with
streptavidin |
| Linearity | Not applicable | A study based on CLSI EP06-Ed2
performed on the Access 2
Immunoassay System determined
the assay demonstrated linearity
across the measuring interval. |
| Biotin Interference | Specimens with biotin
concentrations $\leq$ 10 ng/mL
demonstrated non-significant bias
( $\leq$ 10%) in results. Biotin
concentrations > 10 ng/mL can
lead to significant (> 10%) positive
bias in Free T4 results. | No significant interference (± 10%)
observed in samples containing up
to 3,510 ng/mL of biotin. |
| Substrate | Access Substrate | Same (Access 2)
Lumi-Phos PRO substrate (Dxl
9000 Access Immunoassay
Analyzer) |
| Instrument | Access® Immunoassay Analyzer | Access 2 Immunoassay Analyzer
Dxl 9000 Access Immunoassay
Analyzer |
Summary of Studies
Method Comparison: A method comparison study was performed to compare the Access FT4 assay on Access 2 and Dxl 9000 Immunoassay system to the predicate device. A total of one hundred and sixty three (163) serum samples falling within the measuring range of the Access FT4 assay were evaluated. The results of the within range method comparison study met the acceptance criteria of slope 1.00 ± 0.12.
A study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression compared the Access 2 Immunoassay System and predicate device.
| N | Concentration
Range* (ng/dL) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | Correlation
Coefficient
R |
|-----|---------------------------------|-------|-------------------|-----------|----------------------|---------------------------------|
| 163 | [0.27 - 5.32] | 1.02 | [1.00 to
1.04] | - 0.04 | [-0.06 to -
0.02] | 0.98 |
*Values are from predicate device.
6
A study based on CLSI EP09c, 3rd Edition20 using Passing-Bablok regression compared the Dxl 9000 Access Immunoassay Analyzer and predicate device.
| N | Concentration
Range*
(ng/dL) | Slope | Slope
95% CI | Intercept | Intercept
95% CI | Correlation
Coefficient
R |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|---------------------------------|
| 163 | 0.25 - 5.31 | 1.02 | 0.99 to 1.05 | 0.03 | 0.01 - 0.06 | 0.95 |
*Values are from predicate device.
Imprecision: On the Access 2 Immunoassay Analyzer and Dxl 9000 Access Immunoassay Analyzer the within-laboratory (total) %CV ≤ 10.0% for values ≥ 0.61 ng/dL. The within-laboratory (total) SD was ≤ 0.06 for Free T4 concentrations