(65 days)
Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
The provided document describes the 510(k) summary for the Abbott ARCHITECT™ Testosterone assay, which is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than defining and proving arbitrary acceptance criteria.
The acceptance criteria for substantial equivalence are inherently tied to the performance of the predicate device. Therefore, the "acceptance criteria" here is defined by showing comparable performance to the Chiron Diagnostics ACS:180® Testosterone assay.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Device Performance) | Reported Device Performance (ARCHITECT Testosterone vs. ACS:180 Testosterone) |
|---|---|
| Strong correlation coefficient (close to 1) | 0.986 |
| Slope close to 1 | 0.89 (95% CI: 0.88 to 0.90) |
| Y-axis intercept close to 0 ng/mL | -0.02 ng/mL (95% CI: -0.08 to 0.04) |
| Safe and effective | Demonstrated to be as safe and effective as the predicate device |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 607 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's part of a 510(k) submission for a diagnostic device, it's highly likely to be prospective clinical samples or a mix of prospective and banked retrospective samples relevant to the intended use.
- Test Set Description: The "test set" here refers to the 607 specimens used for the comparative method study.
3. Number of Experts and Qualifications for Ground Truth
This type of information is not applicable to this study. The study is a method comparison, not an evaluation of diagnostic accuracy against an expert-determined ground truth for a medical image or clinical diagnosis. The "ground truth" for this purpose is the measurement obtained from the predicate device, the Chiron Diagnostics ACS:180® Testosterone assay.
4. Adjudication Method for Test Set
Not applicable. There was no human adjudication process involved as the comparison was between two automated quantitative assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This was not an MRMC study. MRMC studies are typically used for evaluating human reader performance, often in diagnostic imaging, with and without AI assistance. This study compared the performance of two automated diagnostic assays.
6. Standalone (Algorithm Only) Performance Study
Yes. This study primarily demonstrates the standalone performance of the ARCHITECT Testosterone assay by comparing its quantitative results against a legally marketed predicate device. The output is a numerical value of testosterone concentration, and its performance is evaluated based on its agreement with the predicate. There is no human-in-the-loop interaction described as part of its primary function.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative testosterone measurement obtained from the predicate device, the Chiron Diagnostics ACS:180® Testosterone assay. This is a form of comparative effectiveness against an established method.
8. Sample Size for the Training Set
The document does not explicitly state a separate training set or its size. In a traditional 510(k) for an in vitro diagnostic (IVD) device like this, the "training" analogous to machine learning would be the assay's development and optimization process, which can involve numerous samples for calibration development, reagent formulation, and internal verification. The 607 specimens mentioned are for the final method comparison study used for the 510(k) submission.
9. How Ground Truth for Training Set Was Established
Since a distinct "training set" with ground truth in the machine learning sense is not explicitly described, the method for establishing its ground truth is not provided. For IVD assays, the "ground truth" for developing calibration and control materials is typically established through rigorous analytical methods, often involving reference methods or gravimetric preparation of highly pure analytes, and then validated through extensive testing.
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510(k) Summary Abbott ARCHITECT™ Testosterone
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for The Ionowing ----------------------------------------------------------------------------------------------------------------------------------------------------------------equivalent determination.
ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone 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 Testosterone assay and the Chiron Diagnostics ACS:180® Testosterone assay. The intended use of the ARCHITECT Testosterone assay is for the quantitative determination of testosterone in human serum and plasma. The intended use of the Chiron Diagnostics ACS:180 Testosterone assay is for the quantitative determination of total testosterone (bound and unbound) in serum. Both assay are competitive immunoassays that use antibodies specific for testosterone and are performed on fully automated immunoassay systems. A least squares linear regression analysis between these two assays, using 607 specimens, yielded a correlation coefficient of 0.986, slope of 0.89 (95% Confidence Interval [CI] of 0.88 to 0.90), and y-axis intercept of -0.02 ng/mL (95% CI of -0.08 to 0.04).
In conclusion, these data demonstrate that the ARCHITECT Testosterone assay is as safe and effective as, and is substantially equivalent to, the Chiron Diagnostics ACS:180 Testosterone assay.
Prepared and Submitted September 11, 1998, by: Karen L. Gates, M.S. Sr. Regulatory Specialist ADD Regulatory Affairs (847) 938-0538 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Ms. Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regulatory Affairs NOV 1 8 1998 Abbott Laboratories Diagnostics Division 200 Abbott Park Road Abbott Park, Illinois 60064-3537 Re: K983212 Trade Name: Abbott ARCHITECT™ Testosterone Product Code: CDZ Requlatory Class: I ris II JJX I
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JJE I Dated: September 11, 1998 September 14, 1998 Received:
Dear Ms. Gates:
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (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 requlation 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 Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): K983212 Device Name: Abbott ARCHITECT™ Testosterone
Indications For Use:
Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K-983212
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.