(346 days)
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.
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This document is a 510(k) premarket notification acceptance letter and does not contain the detailed study information needed to fully answer the request. The letter only confirms that the LXN Fructosamine Test System is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide concrete answers to most of the specific questions. However, based on the limited information available, here's what can be inferred or stated:
1. A table of acceptance criteria and the reported device performance
- This information is not present in the provided document. The 510(k) letter confirms substantial equivalence but does not detail the specific performance criteria or the results from the studies demonstrating that performance.
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not present in the provided document. The letter does not describe the test set or its origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not present in the provided document as it pertains to the details of the performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- The device is a "Fructosamine Test System," which is an in vitro diagnostic (IVD) quantitative blood test. This type of device does not typically involve "human readers" in the context of interpretation of images or complex data in the same way an AI-powered diagnostic imaging system would. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This refers to the performance of the analytical instrument itself. While a standalone analytical performance study would have been conducted as part of the 510(k) submission, the results and methodology are not detailed in this acceptance letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a quantitative diagnostic test like a fructosamine system, the "ground truth" would typically be established by a reference method or another highly validated, perhaps more precise, laboratory method for measuring fructosamine in blood samples. This information is not present in the provided document.
8. The sample size for the training set
- This information is not present in the provided document. For an IVD device, the concept of a "training set" might apply to calibration curves or algorithm development, but the specifics are not disclosed here.
9. How the ground truth for the training set was established
- This information is not present in the provided document. Similar to point 7, it would likely involve a reference method, but the details are missing.
In summary: The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not elaborate on the specific studies, performance metrics, or methodologies that were part of the submission. To obtain the detailed information requested, one would need to access the full 510(k) submission summary or associated performance studies, which are not included here.
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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)
§ 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).