(28 days)
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No
The summary describes a calibrator for a laboratory assay, which is a chemical reagent used for calibration, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.
No
This device is a calibrator for an in vitro diagnostic test, used to ensure the accuracy of measurements. It does not directly treat or diagnose a disease.
No
Explanation: The device is a calibrator for an assay, not a diagnostic device itself. It provides suitable calibration levels for determining Prealbumin, but it does not directly diagnose any condition.
No
The device description clearly identifies it as a "Calibrator," which is a physical substance used to calibrate analytical instruments. The intended use also describes its function in calibrating an "analyzer," implying a hardware component. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to provide calibration levels for an assay used to determine Prealbumin in human serum. This indicates that the device is used to analyze a biological sample taken from the human body.
- Device Description: While simple, the description "Olympus Prealbumin Calibrator" aligns with the type of reagents and materials used in in vitro diagnostic testing.
- Context: Calibrators are essential components of many in vitro diagnostic assays. They are used to establish a known relationship between the signal measured by the analyzer and the concentration of the analyte (in this case, Prealbumin) in the patient sample.
Therefore, based on the provided information, the Olympus Prealbumin Calibrator fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.
AUG 2 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Campbell Senior Manager, RA/QC Olympus 3131 West Royal Lane Irving, TX 75063-3104
K032285 Re:
Trade/Device Name: Olympus Prealbumin Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 24, 2003 Received: July 24, 2003
Dear Mr. Campbell:
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. Iisting 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 (OS) 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 vours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Olympus Prealbumin Calibrator 510(K) Premarket Notification
Indications for Use Statement
510(k) Number (if known):
Device Name:
Olympus Prealbumin Calibrator
Indications for Use:
The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidimetric assay for Prealbumin determinations in human serum.
Carol C Benson for Jean Cooper, DYI
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032285
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
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