(52 days)
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.
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.
Here's an analysis of the provided 510(k) summary regarding the Abbott ARCHITECT™ Free T4 assay, structured to address your specific questions.
It's important to note that the provided document is a 510(k) summary, which is a high-level overview. Detailed study protocols and full results are typically found in the complete 510(k) submission, which is not included here. Therefore, some information might be missing or inferred based on common practices for such submissions.
Acceptance Criteria and Study Details for Abbott ARCHITECT™ Free T4
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit performance acceptance criteria in the way one might for a novel classification. For substantial equivalence, the key acceptance criteria revolve around showing comparable analytical performance.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (ARCHITECT™ Free T4 vs. AxSYM® Free T4) |
|---|---|
| Correlation Coefficient (r): Demonstrate strong linear relationship | 0.932 (for both least squares and Passing-Bablok analysis) |
| Slope (Least Squares Linear Regression): Close to 1 | 0.81 |
| Y-axis Intercept (Least Squares Linear Regression): Close to 0 | 0.23 ng/dL |
| Slope (Passing-Bablok Linear Regression): Close to 1 | 0.98 |
| Y-axis Intercept (Passing-Bablok Linear Regression): Close to 0 | 0.01 ng/dL |
Interpretation: The reported performance metrics (high correlation, slopes close to 1, and intercepts close to 0, especially with Passing-Bablok) indicate a strong agreement between the new ARCHITECT™ Free T4 assay and the predicate AxSYM® Free T4 assay, signifying comparable analytical performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1250 specimens
- Data Provenance: Not explicitly stated in the provided summary (e.g., country of origin, specific demographics). It is listed as "human serum or plasma."
- Retrospective or Prospective: Not explicitly stated. For a 510(k) submission comparing a new device to a predicate, it is common to use retrospectively collected samples, or a mix, to cover a broad range of clinically relevant analyte concentrations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and therefore not provided in the 510(k) summary for this type of device and study.
For assays like this, which measure an analyte quantitatively, the "ground truth" for the test set is established by running the samples on the predicate device (AxSYM® Free T4 assay). The AxSYM® Free T4 assay itself serves as the reference against which the new ARCHITECT™ Free T4 assay is compared. There isn't typically a need for human experts to establish ground truth in the same way they would for image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable for this type of study. Adjudication methods (like 2+1, 3+1) are typically used when there is subjective interpretation involved, such as in clinical trials or image analysis where multiple readers might disagree. For quantitative assays comparing a new device to a predicate, the results from the predicate device serve as the direct comparator, and no human adjudication of results is described or necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted and is not applicable for this type of in vitro diagnostic device (IVD). MRMC studies are primarily used for diagnostic imaging devices or other human-interpreted diagnostics to assess the impact of AI assistance on human reader performance. This submission is for a quantitative chemical assay.
6. Standalone (Algorithm Only) Performance
The study implicitly represents standalone performance in the context of an IVD. The ARCHITECT™ Free T4 assay (the "algorithm" or device under review) was run on its own, and its results were directly compared to the predicate device. There is no "human-in-the-loop" component in the operation of this automated assay itself.
7. Type of Ground Truth Used
The "ground truth" used for comparison was the results obtained from the predicate device, the AxSYM® Free T4 assay. This is a comparative analytical performance study where the well-established predicate serves as the reference standard.
8. Sample Size for the Training Set
This information is not provided in the summary. For IVDs, "training sets" are distinct from "test sets" and might refer to samples used during the development and calibration of the assay. The 1250 specimens mentioned are specifically for the comparison (test) phase. The summary does state the ARCHITECT Free T4 is "calibrated with ARCHITECT Free T. Calibrators" but does not give sample sizes for this calibration process.
9. How Ground Truth for the Training Set Was Established
This information is not provided in the summary. For the development and calibration of the assay (what might be considered "training"), ground truth would typically be established using:
- Reference materials/standards: Traceable to international or national standards for free T4.
- Highly characterized samples: Often involving methods with higher analytical rigor (e.g., mass spectrometry) if available and necessary to establish target values for calibrators.
- Consensus values: For in-house calibrators, a set of highly reliable measurements from multiple runs on the developed assay and/or comparison to established reference methods could be used.
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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".
§ 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.