(52 days)
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.
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.
This 510(k) submission pertains to the Abbott ARCHITECT™ Total T3 assay, a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (total T3) in human serum and plasma. The study conducted aimed to demonstrate substantial equivalence to a legally marketed predicate device, the AxSYM® Total T3 assay.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for correlation, slope, or intercept. Instead, it presents the results of the comparison study to demonstrate substantial equivalence to the predicate device. The performance is reported in comparison to the AxSYM Total T3 assay.
| Metric | Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance (ARCHITECT Total T3 vs. AxSYM Total T3) |
|---|---|---|
| Correlation Coefficient (Least Squares) | Expected high correlation (implied from goal of substantial equivalence) | 0.950 |
| Slope (Least Squares) | Expected close to 1 (implied from goal of substantial equivalence) | 0.86 |
| Y-axis Intercept (Least Squares) | Expected close to 0 ng/mL (implied from goal of substantial equivalence) | 0.22 ng/mL |
| Correlation Coefficient (Passing-Bablok) | Expected high correlation (implied from goal of substantial equivalence) | 0.950 |
| Slope (Passing-Bablok) | Expected close to 1 (implied from goal of substantial equivalence) | 1.08 |
| Y-axis Intercept (Passing-Bablok) | Expected close to 0 ng/mL (implied from goal of substantial equivalence) | -0.04 ng/mL |
Note: The acceptance criteria are implicitly derived from the objective of showing substantial equivalence to the predicate device, meaning the new device should perform very similarly to the predicate.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 1120 specimens
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This type of in vitro diagnostic device (IVD) submission typically relies on a comparator method (the predicate device) as the reference for "ground truth" or a well-established clinical assay. There is no mention of human experts being used to establish ground truth for individual test cases in the context of this 510(k) submission.
4. Adjudication Method for Test Set
Not applicable. The ground truth was established by comparison to a predicate device, not by expert interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images. This submission is for an in vitro diagnostic assay.
6. Standalone Performance Study
Yes, a standalone performance study was done for the ARCHITECT Total T3 assay in the sense that its performance was assessed independently by comparing its results against a predicate device. This is a common approach for IVDs to demonstrate performance for regulatory clearance. The "algorithm only" in this context refers to the assay's performance itself, independent of human interpretation of the results.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the results obtained from the AxSYM® Total T3 assay, which is the legally marketed predicate device. The study aimed to show strong agreement between the new device and this established method.
8. Sample Size for Training Set
The document does not specify a separate "training set" or its sample size. For an IVD like this, the development and optimization of the assay would typically involve extensive internal testing during the R&D phase, but this information is usually not detailed in the 510(k) summary, which focuses on validation data. The 1120 specimens mentioned are for the comparison study, effectively acting as the validation or test set against the predicate.
9. How Ground Truth for Training Set Was Established
As there is no explicit mention of a separate training set in the context of the 510(k) summary, how its "ground truth" was established is not provided. If a training phase existed for the assay's development, it would likely involve comparisons to reference methods or clinically validated samples during the assay optimization process.
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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
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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.
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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
§ 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.