(71 days)
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No
The summary describes a reagent set for glucose determination, which is a chemical assay, and there is no mention of AI or ML in the provided text.
No
The device is described as a "Liquid Glucose (Hexokinase) Reagent Set" intended for "in vitro diagnostic use only" to quantitatively determine glucose for the diagnosis and treatment of diabetes mellitus. It is used in a "diagnostic laboratory setting," indicating its purpose is to diagnose conditions, not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "to be used in a diagnostic laboratory setting" and "It is intended for in vitro diagnostic use only." It also mentions its use for "the diagnosis and treatment of diabetes mellitus."
No
The device description explicitly states "Liquid Glucose (Hexokinase) Reagent Set," which indicates a physical reagent kit, not a software-only device. The intended use also describes a laboratory test using serum or plasma, further supporting a hardware/reagent-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the product is for the "quantitative determination of glucose in serum or plasma" and is "intended for in vitro diagnostic use only."
- Device Description: The device is a "Liquid Glucose (Hexokinase) Reagent Set," which is a common type of reagent used in laboratory diagnostic tests.
- Intended User / Care Setting: The intended user is "qualified laboratory technologists" in a "diagnostic laboratory setting," which is where IVD tests are typically performed.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.
Product codes
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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
diagnostic laboratory setting, by qualified laboratory technologists
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 22 1997
William F. Walters, Jr. Vice President, Technical Operations Pointe Scientific, Inc 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
K971754 Re : Liquid Glucose (Hexokinase) Reagent Set Requlatory Class: II Product Code: CFR Dated: May 6, 1997 Received: May 12, 1997
Dear Mr. Walters:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Requlations.
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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 w 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (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 Litman
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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Page 1 of 1
510 (k) Number (if known):__Unknown at this time
Device Name:_Liquid Glucose (Hexokinase) Reagent Set
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.
| vision Sign-Off) | |
|---|---|
| vision of Clinical Laboratory Devices | |
| 0(k) Number | K971754 |
(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)