(22 days)
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
Photometric clinical chemistry analyzer
This document is a 510(k) clearance letter from the FDA for the Olympus AU400 Clinical Chemistry Analyzer in 1998. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA determines substantial equivalence based on information provided by the manufacturer, but the 510(k) process typically doesn't involve the FDA conducting or requiring detailed studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would.
Therefore, I cannot extract the requested information about acceptance criteria and a study to prove device performance from this document. The document's purpose is to grant clearance for the device to be marketed, not to provide a detailed performance study report.
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a 1998 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747
Re: K981743 Trade Name: Reagents for the Olympus AU400 Clinical Chemistry Analyzer Regulatory Class: I, II CKB, CIX, CJE, JFJ, JHN, CIT, CIG, DCN, CZW, DGI, CIC, Product Codes: CHH, CHJ, CGS, JLB, CGX. DEF, CFR, CEO, JIY, CFQ, JMO, JGS, JGJ, DHR, DOD, CDQ, CDQ Dated: May 14, 1998 Received: May 18, 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 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) ble 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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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 vour 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 at (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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
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Indications for Use Statement
510(k) Number (if known):
Not assigned yet
Device Name:
Olympus AU400 Clinical Chemistry Analyzer
Indications for Use:
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21CFR 801.109) | OR | Over-the Counter Use (Optional Format 1-2-96) | |
|---|---|---|---|
| -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ----------------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981743 |
|---|---|
| --------------- | --------- |
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(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.