ARCHITECH AFP MASTERCHECK, MODEL 6C01-05

K992781 · Bio-Rad · JJX · Apr 5, 2000 · Clinical Chemistry

Device Facts

• Record ID: K992781
• Device Name: ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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.

Device Story

Architect AFP MasterCheck is a quality control material used in clinical laboratory settings. It serves to verify the performance of the AFP assay on the Abbott Architect i System, specifically assessing sensitivity, calibration linearity, and reportable range. The device is used by laboratory technicians to ensure the accuracy and reliability of AFP assay results. By confirming that the assay is operating within specified parameters, the device helps clinicians maintain confidence in diagnostic testing, ultimately supporting accurate patient monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic quality control material for use with the Abbott Architect i System. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as a quality control material to verify sensitivity, calibration linearity, and reportable range of the AFP assay on the Abbott Architect i System.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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(Concurrence of CDRH, Office of Device Evaluation)


(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993781

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