(79 days)
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Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No.
The device is a control solution intended to verify the performance of a blood glucose test system, not to directly treat or diagnose a medical condition.
No
Explanation: The device is described as "Control Solutions" used to verify the performance of a blood glucose test system. It helps ensure the accuracy of a diagnostic device (the blood glucose test system) rather than directly diagnosing a condition itself.
No
The device description clearly states "Supreme II Control Solutions," which are physical solutions used to verify a blood glucose test system. This indicates a physical product, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The solutions are intended for in-vitro use only." This is a key characteristic of IVD devices, which are used to examine specimens derived from the human body in vitro (outside the body).
- Purpose: The purpose is to "verify the performance of the Supreme II Blood Glucose Test System." This indicates the control solutions are used in conjunction with a diagnostic test (blood glucose testing) to ensure its accuracy and reliability.
Therefore, the Supreme II Control Solutions fit the definition of an IVD device.
N/A
Intended Use / Indications for Use
The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose
The solutions are intended for in-vitro use only.
Product codes
JJX
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEC 17 1998
Mr. Jeffrey P. Heaton Manager, Quality Assurance and Requlatory Affairs Chronimed. Inc. 10900 Red Circle Drive Minnetonka, Minnesota 55343
K983432 Re: Supreme II Control Solutions Trade Name: Requlatory Class: I Product Code: JJX Dated: September 25, 1998 Received: September 29, 1998
Dear Mr. Heaton:
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 legally marketed predicate 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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandinq 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1
Paqe 2
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 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/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
K983432
510(k) Number (if known): unknown
Device Name: Supreme II Control Solutions
Indications for Use:
The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose
The solutions are intended for in-vitro use only.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Device
510(k) Number K983432
Over-the-Counter Use
Prescription Use (Per 21 CFR 801.109) OR
(Optional Format 1-2-96)