(41 days)
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.
Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum. Preservative: Antimicrobial Agent.
The provided text is a 510(k) summary for the Bio-Rad Laboratories' Architect Progesterone MasterCheck. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes the intended use and technological characteristics of the device but does not contain information on acceptance criteria for a study proving device performance, nor details of a study with sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence based on the device's intended use, form, matrix, storage, analytes, and open vial claim, comparing these characteristics to a predicate device. It also includes the FDA's response letter indicating that the device has been found substantially equivalent.
Therefore, I cannot provide the requested information from the given text. The document does not describe a performance study with detailed acceptance criteria and results.
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Image /page/0/Picture/0 description: The image shows a handwritten date, "8/22/99", in black ink. Below the date, there is a faded, illegible stamp or marking, which appears as a blurred, textured area. The date is written with a slightly slanted style, and the stamp is positioned directly beneath it.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation February 8, 1999
Device (Trade & Common Name) Architect Progesterone MasterCheck
Classification Name Class I, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469
Statement of Intended Use
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone assay on the Abbott Architect i System.
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Image /page/1/Picture/0 description: The image is a black and white photograph that appears to be a landscape. The bottom portion of the image contains a series of dark, irregular shapes that could be interpreted as trees or bushes. The upper portion of the image is mostly white, suggesting a sky or a bright, featureless background.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device Architect Progesterone MasterCheck Level 0 contains human serum. Architect Progesterone MasterCheck Levels 1, 2, 3 and 4 contain progesterone prepared in human serum.
Preservative: Antimicrobial Agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Abbott Architect Progesterone MasterCheck and the devices to which substantial equivalence is claimed.
| Architect ProgesteroneMasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of theProgesterone assay on theAbbott Architect i System. | In vitro diagnostic use in thequantitative determination oflinearity, calibrationverification and verificationof reportable range usingautomated, semi-automatedand manual methods. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Progesterone | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect Progesterone assay. | Calibration verifier formultiple analytes. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAR 2 2 1994
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K990393 Trade Name: Architect Progesterone MasterCheck Regulatory Class: I Product Code: JJX Dated: February 8, 1999 February 9, 1999 Received:
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, Druq, 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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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: __ K990 393 Device Name: Architect Progesterone MasterCheck
Indications for Use:
Architect Progesterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Progesterone 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 | K990393 |
| 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.