(34 days)
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No
The summary describes a reagent for quantitative determination of myoglobin, which is a chemical assay and does not mention any AI/ML components or image processing.
No.
This device is an in vitro diagnostic reagent used for the quantitative determination of myoglobin, aiding in diagnosis. It does not provide any form of therapy or treatment to a patient.
Yes
The device is intended for the quantitative determination of myoglobin, which "aids in the rapid diagnosis of heart or renal disease." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device.
Yes, based on the provided information, the Olympus Myoglobin reagent is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended to be utilized for the quantitative determination of myoglobin in human serum". This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide diagnostic information.
- Diagnostic Purpose: The intended use also states that the measurement "aids in the rapid diagnosis of heart or renal disease". This clearly indicates a diagnostic purpose.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Olympus Myoglobin reagent fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
Product codes
DDR
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
DEC 23 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Laura Storms-Tyler Director, Requlatory Affairs Olympus Diagnostica GMBH C/O Olympus Corp. of America Two Corporate Center Drive Melville, NY 11747
K984145 Re: Trade Name: Olympus Myoglobin Turbidimetric Reagent Requlatory Class: II Product Code: DDR November 17, 1998 Dated: Received: November 19, 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) will 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 requlations.
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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 your 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) Additionally, for questions on the promotion and 594-4588. 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K984145
Device Name:
Olympus Myoglobin Reagent
Indications for Use:
The Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 81.109) | OR | Over-the Counter Use (Optional Format 1-2-96) | |
|---|---|---|---|
| -------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | ---- | ----------------------------------------------- |
Veronica Q. Calvin for awm
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number: K984145