(241 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the quantitative measurement of glucose in capillary whole blood, which is a standard function for blood glucose meters.
No
The device is intended for quantitative measurement of glucose, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the "quantitative measurement of glucose," which is a diagnostic activity used to identify or monitor a medical condition.
No
The device is described as a "BLOOD GLUCOSE SYSTEM" intended for the "quantitative measurement of glucose in capillary whole blood." This strongly implies the use of hardware components (like a meter and test strips) to perform the measurement, which is inconsistent with a software-only device. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only classification.
Yes, this device is an IVD (In Vitro Diagnostic).
The key indicator is the "Intended Use / Indications for Use" statement: "The GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM is intended for the quantitative measurement of glucose in capillary whole blood."
This clearly states that the device is used to test a biological sample (capillary whole blood) in vitro (outside the body) to obtain diagnostic information (quantitative measurement of glucose). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GLUCOCHEK PockETLAB II BLOOD GLUCOSE SYSTEM is intended for the quantitative measurement of glucose in capillary whole blood.
Product codes
CGA
Device Description
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
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
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Key Metrics
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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 image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 2 1996
Rhonda P. Blanton Director, Requlatory Affairs Clinical Diagnostics, Inc. 609 Columbia Road Chester, South Carolina 29706
K971653 Re : Glucochek Pocketlab II Blood Glucose System Regulatory Class: II Product Code: CGA October 9, 1997 Dated: October 14, 1997 Received:
Dear Ms. Blanton:
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 (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you 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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Paqe 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
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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PAB
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): 3 كها 1 9 كل Device Name: GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTE The GLUCOCHEK PockETLAB II BLOOD GLUCOSE SYSTEM The Geachers'.
Is intended for the quantitative measurement of glucose in copillary whole blood.
Alt An Awm
on Sign-Off)
of Clinical Laboratory Devices
Number, #K971653
(FLEASE 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)
年紀年に行使者
OR
Over-The-Counter Use_
(Optional Format 1-2-96)