(80 days)
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No
The summary describes glucose control solutions for blood glucose monitoring kits and does not mention any AI or ML components.
No.
The device is described as glucose controls intended for use with a blood glucose monitoring kit, which helps in measuring and recording blood glucose levels. It aids in monitoring, but does not directly treat or provide therapy for a medical condition.
No
Explanation: The device described is a glucose control solution used to verify the proper functioning of blood glucose monitoring kits. It does not directly diagnose a condition or disease; rather, it ensures the accuracy of another diagnostic device (the blood glucose monitoring kit).
No
The device description clearly states "Diascan Aqueous Glucose Control Low" and "Diascan Aqueous Glucose Control High," which are described as "ready to use solutions." This indicates a physical, liquid control material, not a software-only device.
Based on the provided information, the Diascan Aqueous Glucose Controls are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states that these controls are "intended for use with a blood glucose monitoring kit." Blood glucose monitoring kits are used to measure glucose levels in biological samples (blood), which is a classic example of an in vitro diagnostic test.
- Function: The controls themselves are "ready to use solutions, which contain a specific amount of glucose." These are used to verify the accuracy and performance of the blood glucose monitoring kit, ensuring that the kit is providing reliable results when testing patient samples. This quality control function is a key aspect of IVD testing.
- Care Setting: The description mentions use "at home" by individuals with diabetes and "in the hospital" by health-care professionals. This aligns with the typical use of IVDs for both self-testing and professional use in clinical settings.
While the document doesn't explicitly use the term "In Vitro Diagnostic," the intended use and function of the device clearly fall under the definition of an IVD. They are reagents used in vitro (outside the body) to assess the performance of a diagnostic device that measures a biological analyte (glucose) in a biological sample (blood).
N/A
Intended Use / Indications for Use
Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.
Product codes
JJX
Device Description
Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose.
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
Individuals with diabetes, health-care professional, ER, ICU, CCU, OR, other bedside locations, home.
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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 5 1997
Zak Hassanein President Sorrento Biochemical, Inc. 3443 Tripp Court, Suite A San Diego, California 92121
K973677 Re : Diascan Aqueous Glucose Controls Requlatory Class: I Product Code: JJX September 19, 1997 Dated: Received: September 26, 1997
Dear Mr. Hassanein:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 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 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" (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.qov/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
2
510(k) Number (if known): _unknown
Diescan Aqueous Glucose Control Low Device Name: Diascan Aqueous Glucose Control High
Indication for Use:
Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Divisi Division | |
|---|---|
| 510(k) Nume | K973677 |
| Prescription Use (Per 21 CFR 801-109) | OR Over-The-Counter Use
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| --------------------------------------- | ----------------------------- |
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(Optional Format 1-2-96)
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