(110 days)
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No
The summary describes a standard in vitro diagnostic test for glucose measurement and contains no mention of AI or ML.
No
This device is an in vitro diagnostic procedure used to measure glucose, which aids in the diagnosis and treatment of conditions, but it does not directly treat or provide therapy to patients.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma" and that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device is described as an "in vitro diagnostic procedure" intended to measure glucose in human serum and plasma "on the Poly-Chem analyzer." This strongly indicates a hardware-based system (the analyzer) is required for the measurement, not just software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer."
This statement directly identifies the device as an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell carcinoma.
Product codes
CFR
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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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL -3 2002
Ms. Helen Landicho, RAC Director Regulatory Affairs Polymedco, Inc. 510 Furnance Dock Road Cortlandt Manor, NY 10567
Re: K020852
Trade/Device Name: The Polymedco Poly-Chem Glucose Test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: May 30, 2002 Received: May 31, 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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SECTION 12.0 INDICATIONS FOR USE STATEMENT
510(k) Number: K020852
Device Name: The Polymedco Poly-Chem Glucose Test
Indications For Use:
The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell carcinoma.
(PLEASE NO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020852
V Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use