(105 days)
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No
The document describes an assayed control for verifying calibration and range, which is a standard laboratory quality control product and does not mention or imply the use of AI/ML.
No
The device is described as an "assayed control intended for use in the verification of calibration linearity and reportable range of the Glycated Hemoglobin assay." It is a control for laboratory testing, not a device used for diagnosis, treatment, or prevention of disease in a patient.
No
Explanation: The device is described as an "assayed control" intended for "verification of calibration linearity and reportable range" of an assay. It is used to ensure the accuracy of a diagnostic test, rather than directly diagnosing a condition itself. Its function is quality control for a diagnostic assay.
No
The device is described as an "assayed control," which is a physical substance used for quality control in laboratory testing. This indicates it is a tangible product, not solely software.
Based on the provided information, the Abbott ARCHITECT® Glycated Hemoglobin MasterCheck™ is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of calibration linearity and reportable range of the Glycated Hemoglobin assay on the Abbott ARCHITECT® i system." This indicates it's used in the process of performing an in vitro diagnostic test (the Glycated Hemoglobin assay).
- Device Description: The description reinforces its role as an "assayed control for the verification of calibration linearity and reportable range" of the assay.
- Nature of the Device: A control material used to verify the performance of an assay that measures a substance in a biological sample (glycated hemoglobin in this case) is a classic example of an IVD accessory or component.
While the document doesn't explicitly state "This is an IVD," its function and intended use within the context of an in vitro diagnostic assay clearly classify it as such.
N/A
Intended Use / Indications for Use
The 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.
Product codes
JJY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Bio-Rad Lyphochek® Diabetes Control Level 1 and 2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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)