(52 days)
AxSYM® Free T3
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No
The summary describes a standard immunoassay technology and does not mention any AI or ML components.
No
The device is used to quantitatively determine free triiodothyronine (free T3) in human serum and plasma, aiding in the assessment of thyroid status. It is a diagnostic tool, not a therapeutic one.
Yes
The device is described as an "aid in the assessment of thyroid status," which indicates its use in diagnosing or monitoring health conditions.
No
The device description clearly indicates it is a Chemiluminescent Microparticle Immunoassay (CMIA), which is a laboratory-based assay involving reagents and hardware (the ARCHITECT i System), 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 triiodothyronine (free T3) in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes 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 compare the device to another assay using "specimens," which are biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ARCHITECT™ Free T3 (FT3) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 assay is to be used as an aid in the assessment of thyroid status.
Product codes
CDP, JIT, JJX
Device Description
ARCHITECT Free T3 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free T3 in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T3 is calibrated with ARCHITECT Free T3 Calibrators. ARCHITECT Free T3 Controls are assayed 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 T3 vs. AxSYM Free T3 comparison, using 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958. slope = 0.82 and y-axis intercept = 0.94 pg/mL. Passing-Bablok linear regression analysis of an ARCHITECT Free T3 vs. AxSYM Free T3 comparison, using 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958, slope = 1.05 and y-axis intercept = 0.21 pg/mL.
Key Metrics
correlation coefficient = 0.958
Predicate Device(s)
AxSYM® Free T3
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary Abbott ARCHITECT™ Free T2 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 and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Free T, is calibrated with ARCHITECT Free T2 Calibrators. ARCHITECT Free T2 Controls are assayed 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 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958. slope = 0.82 and y-axis intercept = 0.94 pg/mL. Passing-Bablok linear regression analysis of an ARCHITECT Free T, vs. AxSYM Free T, comparison, using 1101 specimens, gave the following parameter estimates: correlation coefficient = 0.958, slope = 1.05 and yaxis intercept = 0.21 pg/mL.
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
ARCHITECT™ Free T3 510(k) September 1998
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Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV 20 1998
Ms. April Veoukas, J.D. Senior Regulatory Specialist ADD Requaltory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983439 Abbott ARCHITECT™ Free T3 Trade Name: Product Code: CDP Requlatory Class: II JIT II JJX I September 28, 1998 Dated: Received: September 29, 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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 reqistration, 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 leqally 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 Sutman
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): K 98343
Abbott ARCHITECT™ Free T3 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ARCHITECT™ Free Ts (FT2) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (free T3) in human serum and plasma. The ARCHITECT Free T3 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
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OR
| Over-The-Counter Use
| (Optional Format 1-2-96) | |
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983439
Format 1-2-96)