(346 days)
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No
The summary describes a quantitative blood test system and does not mention any AI or ML terms or functionalities.
No
The device is a diagnostic tool used to monitor fructosamine levels, not a device that applies therapy or treatment to a patient.
Yes
The device is described as a "Test System" intended to "measure fructosamine quantitatively in blood" for "diabetics to monitor their blood fructosamine levels." This act of measuring a biomarker to monitor a disease state (diabetes) falls under the definition of a diagnostic device.
No
The description explicitly states the device is a "Test System" intended to "measure fructosamine quantitatively in blood." This strongly implies the use of physical components (e.g., a meter, test strips, reagents) to perform the measurement, which would not qualify it as a software-only device. The lack of a "Device Description" section prevents a definitive confirmation of hardware components, but the nature of the measurement process points away from a software-only solution.
Yes, based on the provided information, the LXN™ Fructosamine Test System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure fructosamine quantitatively in blood." This involves testing a sample taken from the body (blood) outside of the body (in vitro) to provide information about a person's health status (monitoring blood fructosamine levels in diabetics).
- Anatomical Site: The anatomical site is listed as "blood," which is a biological sample tested in vitro.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood.
The LXN™ Fructosamine Test System is intended for use by diabetics to monitor their blood fructosamine levels in a home use setting.
Product codes
LCP
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
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, resembling an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Vivian T. Noetzel Vice President LXN Corporation 5830 Oberlin Drive, Suite 102 San Dieqo, California 92121
JUN 1 3 1097
Re : K962597 LXN Fructosamine Test System Regulatory Class: II Product Code: LCP Dated: June 3, 1997 Received: June 5, 1997
Dear Ms. Noetzel:
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 qeneral 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 Good Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 leqally 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 Radioloqical Health
Enclosure
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5 10(k) Number (if known): K962597 Device Name: LXN Fructosamine Test System
Indications For Use:
Indications for Use
The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood.
Intended Use
- The LXN™ Fructosamine Test System is intended for use by diabetics to 专 monitor their blood fructosamine levels in a home use setting.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 42962597
Over-The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the CDRH, Office of the Device Evaluation
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)