(64 days)
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No
The summary describes a standard in vitro diagnostic assay for HbA1c, with no mention of AI or ML technologies.
No.
The document explicitly states it is an "in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood", indicating it is used for diagnosis and monitoring, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro diagnostic assay" used for "quantitative determination of percent HbA1c in anticoagulated whole blood," which is then used for "monitoring long-term glucose control in individuals with diabetes mellitus." This directly indicates its role in diagnosing and monitoring a medical condition.
No
The device is an in vitro diagnostic assay, which is a chemical test performed on biological samples. This inherently involves reagents and potentially hardware components (analyzers) to perform the test, making it a hardware-dependent device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood."
This statement clearly identifies the device as an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.
Product codes
LCP
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
Not Found
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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 or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Adminis 098 Gaither Road Rockville MD 20850
Ms. Helen Landicho, RAC Director, Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, New York 10567
APR 24 2002
Re: K020532
Trade/Device Name: Polymedco™ HbA1c Test Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycated Hemoglobin Assay Regulatory Class: II Product Code: LCP Dated: February 5, 2002 Received: February 19, 2002
Dear Ms. Landicho:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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) 594-4588. Additionally, for questions on the promotion and 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" (21CFR 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 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
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510(k) submission
Polymedco HbA1c Test
SECTION 12.0 INDICATIONS FOR USE STATEMENT
510(k) Number: _ 020532
Device Name:
Indications For Use:
The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.
Josephine Bautista
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K020532
(PLEASE NO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
V Prescription Use (Per 21 CFR 801.109) OR