(120 days)
OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers.
Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Olympus Calcium Arsenazo Reagent
This is a 510(k) clearance letter for the Olympus Calcium Arsenazo Reagent, a calcium test system. This document grants market clearance based on substantial equivalence to a predicate device, not on specific performance data and acceptance criteria detailed in the letter itself. Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, expert details, adjudication methods, and MRMC/standalone studies, cannot be found in the provided text.
The document only states the device's indications for use: "OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms)."
To obtain the detailed study information, one would typically need access to the full 510(k) submission, which is not provided here.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Bev Harding RA Analyst Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104
CT - 5 2006
K061575 Re:
Trade/Device Name: Olympus Calcium Arsenazo Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: August 17, 2006 Received: August 18, 2006
Dear Ms. Harding:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto Garcia
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K061575
Olympus Calcium Arsenazo Reagent Device Name:
Indications for Use:
OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers.
Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
and the control control control controlled in the consideration of the consistence in
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.