(230 days)
Architect AFP MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Architect AFP MasterCheck". It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML diagnostic devices.
Instead, this letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The "indications for use" state that the device is "intended for use in the verification of sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System." This strongly suggests that the device in question is a quality control material or calibrator for another assay system, not a diagnostic device that directly produces patient results.
Therefore, the specific information requested in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) is not applicable to this document. These details are typically found in study reports for diagnostic algorithms, not 510(k) clearance letters for quality control materials.
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APR | 5 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re: K992781 Trade Name: Architect AFP MasterCheck Regulatory Class: I Product Code: JJX Dated: November 10, 1999 Received: December 10, 1999
Dear Ms. Platt:
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 (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 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, "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 Butman
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: _ K99378/ Device Name: Architect AFP MasterCheck
Indications for Use:
Architect AFP MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993781
| Prescription Use | OR | Over-The Counter Use | ||
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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.