(91 days)
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No
The summary describes a calibrator for a lactate test system, which is a chemical reference standard, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a calibrator used to standardize measurements in a diagnostic test system, rather than directly treating a condition.
No
The device is a calibrator for a lactate test system. Its purpose is to establish a standardized reference point for determining lactate values, not to diagnose a condition itself.
No
The summary describes a "lactate calibrator" which is a physical component used in a test system, not a software application.
Based on the provided information, the Olympus lactate calibrator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's 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." This clearly indicates it's used in vitro (outside the body) to analyze human specimens (plasma and cerebrospinal fluid) for diagnostic purposes (determining lactate values).
- Medical Purposes: The intended use also states it's "intended for medical purposes."
- Prescription Use: The "Intended User / Care Setting" indicates "Prescription Use," which is common for IVD devices used in a clinical setting.
While the "Device Description" is not found, the intended use alone is sufficient to classify this device as an IVD. Calibrators are essential components of many IVD test systems, used to ensure the accuracy and reliability of the test results.
N/A
Intended Use / 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.
Product codes
JIT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
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