(91 days)
The Olympus lactate calibrator is a device intended for medical purposes for use in the Olympus lactate test system to establish a standardized point of reference that is used in the determination of lactate values in human plasma and cerebrospinal fluid.
Not Found
This 510(k) summary document from the FDA relates to the Olympus Lactate Calibrator, a device used in an in vitro diagnostic setting. The document confirms substantial equivalence to a predicate device but does not contain the detailed study information typically found in a clinical study report for an AI/CADe medical device.
Therefore, I cannot provide most of the requested information, specifically points 1, 2, 3, 4, 5, 6, 7, 8, and 9, as they pertain to the performance evaluation of a device through clinical studies.
Here's what I can extract and explain:
- Device Name: Olympus Lactate Calibrator
- Intended Use: To establish a standardized point of reference for determining lactate values in human plasma and cerebrospinal fluid using the Olympus lactate test system.
- Regulatory Status: Class II (Special Controls), Product Code JIT.
This document is a regulatory clearance letter, not a scientific study report. It indicates that the FDA has reviewed the device and found it substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The detailed performance data and study design (especially for AI/CADe devices) are typically found in the 510(k) submission itself or in separate scientific publications, which are not part of this letter.
In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria and device performance studies as it's a regulatory clearance letter for an IVD calibrator, not a clinical study report for an AI/CADe imaging device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 3 2004
Ms. Bev Harding Regulatory Affairs Analyst Olympus America Inc. 3131 West Royal Lane Irving, TX 75063-3104
Re: K042406
Trade/Device Name: Olympus Lactate Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 29, 2004 Received: November 30, 2004
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 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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting 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
K042406 510(k) Number (if known):
Olympus Lactate Calibrator Device Name:
Indications for Use:
The Olympus lactate calibrator is a device intended for medical purposes for use in the Olympus lactate test system to establish a standardized point of reference that is used in the determination of lactate values in human plasma and cerebrospinal fluid.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Division Sign-Off
e of in Vitro Diagnos e Evaluation and s
510(k) K042406
§ 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.