(133 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
This device is a glucose monitoring system used to quantitatively determine glucose and fructosamine levels; it does not treat or cure any medical condition.
Yes
The device is intended for the "quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens," which are measurements used to diagnose and monitor diabetes. The system is used by "people with diabetes to monitor their blood glucose and fructosamine levels," which falls under the definition of a diagnostic device as it aids in the monitoring and management of a disease.
No
The device description explicitly states it is a "Glucose Monitoring System" and an "in vitro test kit," which strongly implies the presence of hardware components for sample analysis, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is for the "quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens." This involves testing biological samples (whole blood) outside of the body to diagnose or monitor a medical condition (diabetes).
- "In vitro test kit": The "Intended Use / Indications for Use" section also directly labels it as an "in vitro test kit."
- Device Description: The "Device Description" confirms it's a "Glucose Control Monitoring System," which is a common type of IVD.
- Anatomical Site: The "Anatomical Site" is listed as "whole blood specimens," which are samples taken from the body for in vitro testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Duet II Glucose Monitoring System is intended for the colorimetric determination of of glucose and quantitative, fructosamine in whole blood specimens.
The Duet II Glucose Monitoring System is to be used by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).
Product codes (comma separated list FDA assigned to the subject device)
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
people with diabetes / home use setting
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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/0 description: The image shows a partial view of a document featuring the logo of the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. The text is in uppercase and appears to be part of the official branding of the department.
AUG - 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Neda Rashti Director of Clinical and Regulatory Affairs LXN Corporation 6325 Lusk Boulevard San Diego, California 92121
Re: K990942
Trade Name: Duet II Glucose Control Monitoring System Regulatory Class: II Product Code: CGA Dated: June 11, 1999 Received: June 14, 1999
Dear Ms. Rashti:
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 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 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 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.
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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 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Attachment 1
INTENDED USE STATEMENT
510(k) Number:
Duet II Glucose Control Monitoring System Device Name:
The Duet II Glucose Monitoring System is intended for the Intended Use: colorimetric determination of of glucose and quantitative, fructosamine in whole blood specimens.
The Duet II Glucose Monitoring System is to be used by people Indication for Use: with diabetes to monitor their blood glucose and_fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).
Hean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
f Clinical Laboratory Devices
510(k) Number K 990942
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH, Office of the Device Evaluation
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)