(43 days)
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No
The summary describes a standard in vitro diagnostic device for glucose measurement and contains no mention of AI, ML, or related concepts.
No
The device is used for the "In Vitro, quantitative determination of glucose" for diagnostic purposes, not for treating a condition directly.
Yes
The text explicitly states that glucose measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders".
No
The intended use describes an in vitro diagnostic device for measuring glucose in human serum using automated chemistry analyzers, which are hardware devices. The summary does not mention any software component that operates independently of this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers." The phrase "In Vitro" is the key indicator that the device is used to examine specimens taken from the human body, rather than being used directly on the body.
- Purpose: The purpose of the device is to measure glucose in human serum, which is a biological sample. This measurement is used for diagnostic and treatment purposes related to carbohydrate metabolism disorders.
Therefore, based on the provided information, the device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers.
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.
Product codes
CGA
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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 3 1 2001
Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166
510(k) Number: K011900 Re: Trade/Device Name: Glucose Reagent Regulation Number: 862.1345 Regulatory Class: II Product Code: CGA Dated: May 21, 2001 Received: June 18, 2001
Dear Mr. Johnston:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerate of mixes 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 the Echarate 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 ( Femanet I ripps of ally of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing A substantally cquiralism (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perioure GMP mith the GMP regulation may result in 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 reemer 1 rease wou might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510K) prematket This letter will allow you to begin manculig your do not of your device to a legally marketed
notification. The FDA finding of substantial equivale normits your device to notification. The FDA Inding of substantial equivaliation of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in vide diagnostions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on (301) 594-4639. Also, please note the regulation please contact the Office of Compitation at (301) 3 + Tesals of (21CFR 807.97). Other general entitled, "Misbranding by telefice to premanted in the Act may be obtained from the Division of Small
information on your responsibilities under the Act 2011 443 6507 or stit information on your responsibilities must and 11 (800) 638-2041 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 Manufacturers 7135156af100 av 1da.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
JUL 3 1 2001
Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ N/A Device Name: __ Glucose REAGENT Indications for Use:
Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers.
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.
Fred Lacy
(vision Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011900
(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)