(30 days)
Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
Architect Testosterone MasterCheck Level 0 contains bovine serum Architect Testosterone MasterCheck Levels 1, 2 and 3 contain testosterone prepared in bovine serum. Preservative: Antimicrobial agent.
The provided document is a 510(k) summary for a medical device called "Architect Testosterone MasterCheck." This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of analytical performance.
Instead, the document primarily addresses:
- Device Description: What the Architect Testosterone MasterCheck is (bovine serum with testosterone).
- Intended Use: Verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System.
- Substantial Equivalence Comparison: A table comparing its characteristics (intended use, form, matrix, storage, analytes, open vial claim) to a predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set).
- Regulatory Classification: Class I device.
- FDA Clearance: Notification of clearance for marketing based on substantial equivalence.
Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as this type of information is not present in the provided 510(k) summary.
In summary, the document does not contain the information needed to answer the questions about acceptance criteria and a study proving device performance.
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NOV 1 2 1998
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
4983578
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 November 2, 1998
Device (Trade & Common Name) Architect Testosterone 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 Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott Architect i System
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Image /page/1/Picture/0 description: The image shows the Bio-Rad logo. The logo is white text on a black background. The text is in a bold, sans-serif font.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Testosterone MasterCheck Level 0 contains bovine serum Architect Testosterone MasterCheck Levels 1, 2 and 3 contain testosterone prepared in bovine serum.
Preservative: Antimicrobial agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect Testosterone MasterCheck and the devices to which substantial equivalence is claimed.
| Architect TestosteroneMasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range 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 | Bovine serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Testosterone | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect testosterone assay | Calibration verifier formultiple analytes. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three profiles facing right, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories, Irvine Facility Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re : K983578 Architect Testosterone MasterCheck Trade Name: Product Code: Regulatory Class: F JJX צביר I Dated: October 9, 1998 Received: October 13, 1998
Dear Ms. Platt:
NOV 1 2 1998
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 Requlations, 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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Page 2
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 Routman
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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Page 1 of 1
510(k) Number: K983578
Device Name: Architect Testosterone MasterCheck
Indications for Use:
Architect Testosterone MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range 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)
Prescription Use
OR Over-The Counter Use _
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number k98557
25
§ 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.