(18 days)
IMx® Free T4 Assay
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No
The document describes a standard immunoassay system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is an immunoassay system used for the quantitative determination of free thyroxine levels, which aids in the diagnosis and treatment of thyroid diseases, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases."
No
The device description explicitly states that the system comprises both reagents and an analyzer, indicating a hardware component is essential for its function.
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 free thyroxine levels in human or plasma (heparin)". This involves testing biological samples in vitro (outside the body).
- Purpose: The measurements obtained are "used in the diagnosis and treatment of thyroid diseases." This is a key characteristic of IVD devices, which are used to provide information for medical diagnosis or treatment.
- Device Description: It describes a "paramagnetic particle, chemiluminescent immunoassay" and an "Immunoassay Analyzer," which are components used for performing laboratory tests on biological samples.
- Regulatory Context: The mention of a "Predicate Device(s)" (IMx® Free T4 Assay) strongly suggests this device is undergoing or has undergone regulatory review as an IVD. Predicate devices are used for comparison in the regulatory submission process for new IVDs.
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 or plasma (heparin) using the ACCESS® Immunoassav System.
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). 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.
Product codes
CEC, JIS
Device Description
The ACCESS® Free T4 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free thyroxine in human serum or plasma (heparin).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision studies: Within run precision ranges from 3.11% CV (high control) to 4.13% CV (low control). Total imprecision ranges from 4.56% CV (high control) to 7.42% CV (low control). Correlation: A comparison of Free T4 values from 327 samples run in both the ACCESS® Free T4 assay and the Abbott IMx® Free T4 assay gives the following statistical data using Deming calculations: r = 0.940, y = 1.16x - 0.275.
Analytical Sensitivity: The lowest detectable level of free T4 distinguishable from zero (ACCESS® Free T4 Calibrator S0) with 95% confidence is 0.15 ng/di.
Key Metrics
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Predicate Device(s)
IMx® Free T4 Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
58250
ACCESS® Free T4
Beckman Coulter, Inc.
510(k) Premarket Notification Confidential APPENDIX 4: Summary of Safety and Effectiveness Information
1. General Information
Device Generic Name: Device Trade Name: Applicant's Name and Address: Enzyme Immunoassay, Free T4 ACCESS® Free T4 assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
2. Predicate Device
IMx® Free T4 Assay Abbott Laboratories Diagnostics Division Abbott Park, IL 60064
3. Device Description
The ACCESS® Free T4 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free thyroxine in human serum or plasma (heparin).
4. 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 or plasma (heparin) using the ACCESS® Immunoassay System.
5. Comparison of Technological Characteristics
Both the ACCESS® Free T4 assay and the Abbott IMx® Free T4 assay measure free thyroxine levels in human serum or plasma (heparin). The ACCESS® Free T4 assay and the Abbott IMx® Free T4 assay are competitive binding immunoassays, utilize particle technology and use a sequential format. Both assays use a T3 alkaline phosphatase conjugate which binds to unoccupied/vacant anti-T4 binding sites. Both assays utilize a four parameter logistic curve (4PLC) data reduction method to generate the curve. Both calibrator sets are prepared in human serum, use a six point calibration, provided in liguid form, and range from 0 - 6 ng/dl. The ACCESS® Free T4 assay binds streplavidin to paramagnetic particles where as the Abbott IMx® Free T4 assay binds anti-T4 to microparticles. The ACCESS® Free T4 assay measures light (photon) production from a chemiluminescent reaction while the Abbott IMx® Free T4 assay measures fluorescence. The ACCESS® Free T4 assay separates the solid phase magnetic particles in a magnetic field during the washing, while the Abbott IMx® Free T4 assay separates the solid phase microparticles by irreversible binding to a glass fiber matrix. The ACCESS®Free T4 assay utilizes a T4 antibody produced in mice while the Abbott IMx® Free T4 assay utilizes a T4 antibody produced in sheep.
6. Summary of Studies
Precision studies: Within run precision ranges from 3.11% CV (high control) to 4.13% CV (low control). Total imprecision ranges from 4.56% CV (high control) to 7.42% CV (low control). Correlation: A comparison of Free T4 values from 327 samples run in both the ACCESS® Free T4 assay and the Abbott IMx® Free T4 assay gives the following statistical data using Deming calculations: r = 0.940, y = 1.16x - 0.275.
Analytical Sensitivity: The lowest detectable level of free T4 distinguishable from zero (ACCESS® Free T4 Calibrator S0) with 95% confidence is 0.15 ng/di.
Conclusion 7.
The ACCESS® Free T4 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of free T4 currently in commercial distribution.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 1998
Shellie Gust Requlatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re : K982250 ACCESS® Free T4 Assay on the ACCESS® Immunoassay Analyzer Regulatory Class: II Product Code: CEC, JIS June 24, 1998 Dated: Received: June 26, 1998
Dear Ms. Gust:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655 .
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Page 1
510(k) Number (if known):
Device Name: ACCESS® Free T4 Reagents on the ACCESS® Immunoassay Analyzer
Indications For Use:
The ACCESS® Free T4 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human or plasma (heparin) using the ACCESS® Immunoassav System.
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). 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.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K182250
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The Counter Use