(197 days)
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Not Found
No
The summary describes a reagent test system for measuring Hemoglobin A1c, which is a chemical assay and does not mention any AI or ML components.
No
This device is an in vitro diagnostic method for measuring Hemoglobin A1c, used for monitoring diabetes. It does not directly treat or prevent a disease, injury, or condition, which is characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" states it is an "In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c" and that measurements "can be used for monitoring the long-term care of people with diabetes." This clearly indicates its purpose is for diagnosis and monitoring of a medical condition.
No
The device description explicitly lists physical components (Reagent, Calibrator & Control, Hemoglobin Denaturant), indicating it is a hardware-based in vitro diagnostic system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "in vitro diagnostic method" for measuring a substance (Hemoglobin A1c) in a human sample (whole blood).
- Device Description: The description lists components typical of an IVD test system (Reagent, Calibrator & Control, Hemoglobin Denaturant).
- Purpose: The measurements are used for "monitoring the long-term care of people with diabetes," which is a diagnostic and monitoring purpose.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment. This device clearly fits that definition.
N/A
Intended Use / Indications for Use
In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers.
Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.
Product codes
LCP, JIS, JJX
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a circular seal or logo. The text around the top half of the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized graphic that resembles a bird in flight or a person reaching upwards. The image is in black and white and appears to be a scan or photocopy.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Campbell Senior Manager, Regulatory Affairs/Quality Assurance Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104
K031380 Re:
Trade/Device Name: Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assays Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: August 4, 2003 Received: September 9, 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, 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). Other general information on your responsibilities under the Act may be obtained 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,
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
2
Indications for Use Statement
Ko31380 510(k) Number (if known):
Device Name:
Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant)
Indications for Use:
In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers.
Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.
(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 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031380### PAGE NUMBER 97