(37 days)
AxSYM® 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma on the AxSYM System. The AxSYM 3rd Generation TSH assay is used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.
AxSYM 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of TSH in human serum or plasma. AxSYM 3rd Generation TSH is calibrated with Abbott AxSYM 3rd Generation TSH Calibrators. Abbott AxSYM 3rd Generation TSH Controls are assayed for the verification of the accuracy and precision of the AxSYM System.
This document describes the 510(k) summary for the Abbott AxSYM® 3rd Generation TSH, an in vitro diagnostic device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, the AxSYM Ultrasensitive hTSH II assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as distinct thresholds against which the new device's performance is measured. Instead, the study aims to show substantial equivalence to a predicate device. The performance is reported in terms of statistical correlation and agreement between the new device and the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (AxSYM 3rd Generation TSH vs. AxSYM Ultrasensitive hTSH II) |
|---|---|---|
| Pearson Correlation Coefficient | High correlation (close to 1) indicating similar results | 0.977 |
| Slope of Least Squares Regression | Slope close to 1, indicating proportional agreement | 1.033 (95% confidence interval: 1.018, 1.047) |
| Y-axis Intercept of Least Squares Regression | Intercept close to 0, indicating minimal constant bias | 0.538 uIU/mL (95% confidence interval: 0.387, 0.690) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 921 specimens were used to compare the AxSYM 3rd Generation TSH assay with the AxSYM Ultrasensitive hTSH II assay.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It refers to "human serum or plasma" specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis. Instead, the "ground truth" for comparison is the measurement obtained from the predicate device, the AxSYM Ultrasensitive hTSH II assay. Therefore, this section is not applicable in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. The study compares the results of two assays directly on the same specimens. There is no adjudication process involving human reviewers for discrepancies between different measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This is not an MRMC study. It is a method comparison study evaluating the performance of a new assay against a predicate assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in essence. This is a standalone performance evaluation of the analytical capabilities of the in vitro diagnostic device (the immunoassay) itself, as it compares the results generated by the device to those of a predicate device. It is not evaluating a human-in-the-loop scenario.
7. The Type of Ground Truth Used
The "ground truth" for this study is the analytical measurement provided by the predicate device, the AxSYM Ultrasensitive hTSH II assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic assays. It is not based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. This type of submission (510(k) for an IVD) typically focuses on demonstrating the analytical performance of the final device against a predicate, rather than detailing the machine learning (ML) model development process which would include a training set. The term "calibration" is used in relation to the AxSYM 3rd Generation TSH Calibrators, but this refers to the routine calibration of the instrument and assay, not a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is described, this question is not applicable. The device is calibrated using "Abbott AxSYM 3rd Generation TSH Calibrators," which would involve reference materials with known TSH concentrations.
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APR 2 9 1998
510(k) Summary Abbott AxSYM® 3rd Generation TSH
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for the Abbott AxSYM® 3rd Generation TSH constitutes data supporting a substantially equivalent determination.
AxSYM 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of TSH in human serum or plasma. AxSYM 3rd Generation TSH is calibrated with Abbott AxSYM 3rd Generation TSH Calibrators. Abbott AxSYM 3rd Generation TSH Controls are assayed for the verification of the accuracy and precision of the AxSYM System.
Substantial equivalence has been demonstrated between the AxSYM 3rd Generation TSH assay and the AxSYM Ultrasensitive hTSH II assay. The intended use of both assays is for the quantitative determination of TSH in human serum or plasma. Both assays are automated, in vitro immunoassays that use antibodies specific for TSH. The fluorescent signal measured by both assays is directly related to the concentration of TSH in the sample. The Least Squares regression analysis between these two assays, using 921 specimens, yielded a Pearson correlation coefficient of 0.977, slope of 1.033 (95% confidence interval of 1.018, 1.047), and Y-axis intercept of 0.538 uIU/mL (95% confidence interval of 0.387, 0.690).
In conclusion, these data demonstrate that the AxSYM 3rd Generation TSH assay is as safe and effective as, and is substantially equivalent to, the AxSYM Ultrasensitive hTSH II assay.
Prepared and Submitted March 20, 1998 by: April Veoukas Senior Regulatory Specialist ADD Regulatory Affairs (847) 937-8197 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
AxSYM 3rd Generation TSH 510(k) March 1998 aTSH-510k.lwp
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 1998
April Veoukas, J.D. . Senior Regulatory Specialist Abbott Laboratories 200 Abbott Park Road, Dept. 9V6, Bldg. AP31 Abbott Park, Illinois 60064-3537
Re: K981060 Abbott AxSYM® 3rd Generation TSH Regulatory Class: I & II Product Code: JLW, JIS, JJX Dated: March 20, 1998 March 23, 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 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 The general controls provisions of the Act 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 Regulations, Title 21, Parts 800 to 895. ರ್ಥ 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 regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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/dsmamain.html".
Sincerely yours,
Steven Litman
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):
Abbott AxSYM® 3rd Generation TSH Device Name:
Indications For Use:
AxSYM® 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma on the AxSYM System. The AxSYM 3rd Generation TSH assay is used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.
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Division of Cimca) Laboratory Devices
510(k) Number K981060
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.