(105 days)
The Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control intended for use in the verification of calibration linearity and reportable range of the Glycated Hemoglobin assay on the Abbott ARCHITECT® i system.
Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control for the verification of calibration linearity and reportable range of the ARCHITECT® Glycated Hemoglobin assay on the Abbott ARCHITECT® i System.
The provided text is a 510(k) summary for a medical device called Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed information necessary to complete the requested table and study information.
The document states: "Substantial equivalence has been demonstrated between the ARCHITECT® Glycated Hemoglobin MasterCheck 10 and the Bio-Rad Lyphochek® Diabetes Control Level 1 and 2." This implies that the device is a control substance, not an analytical device that measures a patient's glycemic control directly. As a control, its performance is evaluated based on its stability, consistency, and ability to challenge the assay's performance over a range, rather than diagnostic accuracy against a ground truth of patient disease.
Therefore, many of the requested categories, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set," are not applicable or cannot be extracted from this type of regulatory submission concerning a control material.
The document confirms that it is a control material for verifying calibration linearity and reportable range for an existing assay system (Abbott ARCHITECT® i System). Its "performance" would be related to its assigned values and how precisely and accurately it challenges the assay within its intended range, not its diagnostic accuracy in a clinical setting.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or reported device performance data in the way one would expect for an diagnostic algorithm. It only states that "Substantial equivalence has been demonstrated." This typically means that the control material performs similarly to the predicate control material in terms of its intended use (verifying calibration linearity and reportable range).
2. Sample sized used for the test set and the data provenance:
Not applicable. The device is a control material, not an analytical device tested on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for a control material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a control material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The ground truth for a control material would be its assigned value, which is typically established through a reference method or validated against a reference material with known concentrations. This information is not in the provided text.
8. The sample size for the training set:
Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable.
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K992710
510(k) Summarv Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™
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® Glycated Hemoglobin MasterCheck™ constitutes information supporting a substantially equivalent determination.
Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control for the verification of calibration linearity and reportable range of the ARCHITECT® Glycated Hemoglobin assay on the Abbott ARCHITECT® i System.
Substantial equivalence has been demonstrated between the ARCHITECT® Glycated Hemoglobin MasterCheck 10 and the Bio-Rad Lyphochek® Diabetes Control Level 1 and 2. The intended use of the ARCHITECT® Glycated Hemoglobin MasterCheck™ is for use in the verification of calibration linearity and reportable range of the Glycated Hemoglobin assay on the Abbott ARCHITECT® i system. The intended use of the Bio-Rad Lyphochek® Diabetes Control Level 1 and 2 is monitoring the precision of laboratory testing procedures.
In conclusion, the information demonstrates that the ARCHITECT® Glycated Hemoglobin MasterCheck™ is as safe and effective as, and is substantially equivalent to the Bio-Rad Lyphochek® Diabetes Control Level 1 and 2.
Prepared and Submitted August 10, 1999, edited November 5, 1999 by:
Katherine M. Wortley, Ph.D. Regulatory Specialist ADD Regulatory Affairs (847) 938-7707
Abbott Laboratories Dept. 9YC, Bldg. AP31 200 Abbott Park Road Abbott Park, IL 60064-6200
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 4 1999
Katherine M. Wortley, Ph.D. Regulatory Specialist ADD Regulatory Affairs Dept. 9V6. Bldg. AP31 200 Abbott Park Road Abbott Park, Illinois 60064-6200
Re: K992710
Trade Name: Abbott ARCHITECT™ Glycated Hemoglobin MasterCheckTM Regulatory Class: I Product Code: JJY Dated: November 5, 1999 Received: November 8, 1999
Dear Dr. Wortely:
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 Regulations, 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 (OS) 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 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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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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 K992710
Device Name: Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™
Indications For Use:
The Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an assayed control intended for use in the verification of calibration linearity and reportable range of the Glycated Hemoglobin assay on the Abbott ARCHITECT® i system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 1992710 |
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- | -- |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.