(72 days)
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No
The summary describes a reagent and test system for quantitative enzymatic determination of glucose, with no mention of AI or ML technologies.
No.
The device is for in vitro diagnostic use, meaning it measures substances in samples taken from the body, rather than directly treating a condition within the body. Its purpose is for diagnosis and monitoring, not therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders..." indicating its diagnostic purpose.
No
The device description and intended use clearly indicate a "reagent" and "test system" for measuring glucose in serum or plasma, which are physical components and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only."
- "This glucose test system is a device intended to measure glucose quantitatively in serum or plasma."
These statements clearly indicate that the device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of a medical condition (carbohydrate metabolism disorders).
N/A
Intended Use / Indications for Use
This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only.
This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. 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 tumors.
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
The intended patient population may be adult, pediatric, and neonatal.
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)
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Reference Device(s)
Not Found
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 Department of Health & Human Services USA. The seal features an abstract eagle design with three stylized wing strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 3 0 2004
Mr. James J. Miller Official Correspondent General Manager Hemagen Diagnostics, Inc. Raichem Division 9033 Red Branch Road Columbia, MD 21045
K041052 Re:
Trade/Device Name: Glucose test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: March 5, 2004 Received: April 19, 2004
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conner of the 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). and Cosmetic For (10) that the device, subject to the general controls provisions of the Act. The I ou may, morelor, mains of the Act include requirements for annual registration, listing of general vontrols proficiouring 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In additions (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 I least of advised that I Dr brissantly wour device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must or any 1 cataled and the Act's requirements, including, but not limited to: registration and listing (21 Comply with and the tree (21 CFR Parts 801 and 809); and good manufacturing practice Of It I art 807), 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). 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 yours,
Jean M. Cooper, MS, DVM.
MS, DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041052
Device Name: Glucose test system
Indications For Use:
This reagent is intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only.
This glucose test system is a device intended to measure glucose quantitatively in I his glucose tool oyotom to a casurements are used in the diagnosis and treatment of Scrum or plasma. Glass and idiopathic hypoglycemia, and of pancreatic islet cell tumors.
The intended patient population may be adult, pediatric, and neonatal.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510/k)
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