(52 days)
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No
The summary describes a standard immunoassay for measuring total T3 levels and does not mention any AI or ML components. The performance studies use standard statistical methods (linear regression) for comparison, not AI/ML metrics.
No.
The device is for in vitro diagnostic (IVD) use, providing quantitative determination of total T3, which aids in assessing thyroid status; it is not directly involved in treating or preventing a disease, injury, or condition.
Yes
The device quantitatively determines total T3 in human serum and plasma, which is used as an aid in the assessment of thyroid status. This fits the definition of a diagnostic device as it provides information for diagnosis.
No
The device is a Chemiluminescent Microparticle Immunoassay (CMIA), which is a laboratory-based assay requiring physical reagents and instrumentation, 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 total triiodothyronine (total T3) in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Aid in Assessment of Thyroid Status: The assay is used "as an aid in the assessment of thyroid status," which is a diagnostic purpose.
- Device Description: The description confirms it's a "Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T3 in human serum and plasma." This further reinforces the in vitro nature of the testing.
The core function of the device is to analyze biological samples (serum and plasma) to provide information for diagnosis or assessment of a medical condition (thyroid status), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total T, assay is to be used as an aid in the assessment of thyroid status.
Product codes
CDP
Device Description
ARCHITECT Total T2 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T. Calibrators. ARCHITECT Total T2 Controls are assayed for 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 Total T, vs. AxSYM Total T, comparison, using 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 0.86 and v-axis intercept = 0.22 ng/mL. Passing-Bablok linear regression analysis of an ARCHITECT Total T2 vs. AxSYM Total T2 comparison, using 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 1.08 and yaxis intercept = - 0.04 ng/mL.
Key Metrics
correlation coefficient = 0.950, slope = 0.86 and v-axis intercept = 0.22 ng/mL.
correlation coefficient = 0.950, slope = 1.08 and yaxis intercept = - 0.04 ng/mL.
Predicate Device(s)
AxSYM® Total T3 assay
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.
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510(k) Summary Abbott ARCHITECT™ Total T3
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™ Total T, constitutes data supporting a substantially equivalent determination.
ARCHITECT Total T2 is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total T, in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Total T, is calibrated with ARCHITECT Total T. Calibrators. ARCHITECT Total T2 Controls are assayed for verification of the accuracy and precision of the Abbott ARCHITECT i System.
Substantial equivalence has been demonstrated between the ARCHITECT Total T, assay and the AxSYM® Total T3 assay. The intended use of both assays is for the quantitative determination of total T, in human serum and plasma. Least squares linear regression analysis of an ARCHITECT Total T, vs. AxSYM Total T, comparison, using 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 0.86 and v-axis intercept = 0.22 ng/mL. Passing-Bablok linear regression analysis of an ARCHITECT Total T2 vs. AxSYM Total T2 comparison, using 1120 specimens, gave the following parameter estimates: correlation coefficient = 0.950, slope = 1.08 and yaxis intercept = - 0.04 ng/mL.
In conclusion, these data demonstrate that the ARCHITECT Total T2 assay is as safe and effective as, and is substantially equivalent to, the AxSYM Total T2 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™ Total T, 510(k) September 1998
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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 human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. April Veoukas, J.D. Senior Regulatory Specialist ADD Regualtory Affairs Abbott Laboratories 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983434 Trade Name: Abbott ARCHITECT™ Total T3 Product Code: CDP Regulatory Class: II JIT II JJX I September 28, 1998 Dated: 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 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 regulatory 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, "Misbrandinq 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): 1 983434
Abbott ARCHITECT™ Total T2 Device Name:
Indications For Use:
The ARCHITECT™ Total T3 (TT) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The ARCHITECT Total 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)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983434