(52 days)
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No
The summary describes a standard immunoassay for measuring free thyroxine and does not mention any AI or ML components.
No
This device is an in vitro diagnostic assay used for quantitative determination of free thyroxine to aid in the assessment of thyroid status, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to be used as an aid in the assessment of thyroid status," which is a diagnostic purpose.
No
The device description clearly indicates it is a Chemiluminescent Microparticle Immunoassay (CMIA), which is a laboratory-based assay 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 free thyroxine (free T) in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "Chemiluminescent Microparticle Immunoassay (CMIA)" which is a laboratory technique used to measure substances in biological fluids. It also mentions using calibrators and controls, which are standard components of IVD assays.
- Performance Studies: The performance studies describe comparisons with another assay using "specimens," further indicating the testing of biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The ARCHITECT™ Free T (FT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (free T ) in human serum and plasma. The ARCHITECT Free T assay is to be used as an aid in the assessment of thyroid status.
Product codes
CEC, JIT, JX
Device Description
ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum or plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T, is calibrated with ARCHITECT Free T. Calibrators. ARCHITECT Free T. Controls are assaved for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
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
Least squares linear regression analysis of an ARCHITECT Free T, vs. AxSYM Free T, comparison, using 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.81 and y-axis intercept = 0.23 ng/dL. Passing-Bablok linear regression analysis of an ARCHITECT Free T , vs. AxSYM Free T , comparison, using 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.98 and y-axis intercept = 0.01 ng/dL.
Key Metrics
Correlation coefficient = 0.932, slope = 0.81 and y-axis intercept = 0.23 ng/dL (Least squares linear regression)
Correlation coefficient = 0.932, slope = 0.98 and y-axis intercept = 0.01 ng/dL (Passing-Bablok linear regression)
Predicate Device(s)
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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.
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510(k) Summary Abbott ARCHITECT™ Free Ta
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Free T, constitutes data supporting a substantially equivalent determination.
ARCHITECT Free T, is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T, in human serum or plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T, is calibrated with ARCHITECT Free T. Calibrators. ARCHITECT Free T. Controls are assaved for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Substantial equivalence has been demonstrated between the ARCHITECT Free T, assay and the AxSYM® Free T, assay. The intended use of both assays is for the quantitative determination of free T , in human serum and plasma. Least squares linear regression analysis of an ARCHITECT Free T, vs. AxSYM Free T, comparison, using 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.81 and y-axis intercept = 0.23 ng/dL. Passing-Bablok linear regression analysis of an ARCHITECT Free T , vs. AxSYM Free T , comparison, using 1250 specimens, gave the following parameter estimates: correlation coefficient = 0.932, slope = 0.98 and y-axis intercept = 0.01 ng/dL.
In conclusion, these data demonstrate that the ARCHITECT Free T, assay is as safe and effective as, and is substantially equivalent to, the AxSYM Free T, assay.
Prepared and Submitted September 28, 1998 by: April Veoukas, J.D. Senior Regulatory Specialist ADD Regulatory Affairs (847) 937-8197 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
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Public Health Service
Image /page/1/Picture/1 description: The image shows the Department of Health & Human Services logo and text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" and "NOV 20 1998". The logo is a stylized image of three human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. April Veoukas, J.D. Senior Requlatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983417 Abbott ARCHITECT™ Free T4 Trade Name: Product Code: Regulatory Class: II
CEC JIT II JX I Dated: September 28, 1998 September 29, 1998 Received:
Dear Ms. Veoukas:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
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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"(21 CFR 807.97). Other general information on your 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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510(k) Number (if known): 1983417
Abbott ARCHITECT™ Free T4 Device Name: _________
Indications For Use:
The ARCHITECT™ Free T (FT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (free T ) in human serum and plasma. The ARCHITECT Free T assay is to be used as an aid in the assessment of thyroid status.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/3/Figure/5 description: The image shows a form with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use" and "Over-The-Counter Use". The "Prescription Use" option is checked, and the 510(k) Number is "K983417".