(27 days)
The Olympus Serum Protein Multicalibrator is designed for use in Olympus automated clinical chemistry analyzers for IgG, IgA, IgM, C3, C4, Transferrin, Ferritin, CRP, and ASO determinations.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Olympus Serum Protein Multi Calibrator." This letter generally does not contain detailed information about acceptance criteria or specific study results for device performance as you've requested.
The 510(k) process primarily demonstrates substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. While the submission for a 510(k) would include performance data to support substantial equivalence, the clearance letter itself is a summary of the FDA's decision and does not elaborate on the specific studies.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study that proves the device meets them based solely on the provided text.
To obtain this information, you would typically need to consult the original 510(k) submission documentation, which is often much more extensive than the clearance letter. This documentation would contain the test plans, results, and analyses that supported the claims of the device manufacturer and led to the FDA's clearance.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 MAY
Laura Storms-Tyler . Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747
Re : K981305 Olympus Serum Protein Multi Calibrator Regulatory Class: II Product Code: JIX Dated: April 9, 1998 Received: April 10, 1998
Dear Ms. Storms-Tyler:
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 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 The general controls provisions of the Act 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. ਸ 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 regulatory In addition, FDA may publish further announcements action. 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 onder enc crinical haberauor, a CLIA complexity (Chin 60), chip device may requires, 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 acboring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marroos problems, 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/dsmamain.html".
Sincerely yours,
Steven Litman
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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Indications for Use Statement
510(k) Number (if known): K981305
Device Name:
Olympus Serum Protein Multi Calibrator
Indications for Use:
The Olympus Serum Protein Multicalibrator is designed for use in Olympus automated clinical chemistry analyzers for IgG, IgA, IgM, C3, C4, Transferrin, Ferritin, CRP, and ASO determinations.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21CFR 801 109)
਼ਸ਼
Over-the Counter Use (Optional Formal 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981305
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.