(161 days)
The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a Glucose Reagent. It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the specific information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.
The details you requested, such as a table of acceptance criteria, device performance, sample size for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth establishment, are typically found in the 510(k) submission summary itself, or in supporting clinical study reports, not in the FDA's clearance letter.
The clearance letter primarily confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to a predicate device for the stated indications for use. It outlines the regulatory class, product code, and general controls provisions but does not delve into the detailed performance data that would support the acceptance criteria.
Therefore,Based on the provided FDA clearance letter (K970664 for Glucose Reagent), the following answers can be given:
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A table of acceptance criteria and the reported device performance:
- This information is not available in the provided document. The document is an FDA clearance letter confirming substantial equivalence, not a summary of the performance study or acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not available in the provided document.
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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 available in the provided document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not available in the provided document.
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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:
- This information is not available in the provided document. Given that the device is a "Glucose Reagent" (an in-vitro diagnostic device, likely a chemical assay), an MRMC study involving human readers assisting with AI is not applicable to this type of medical device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not available in the provided document. For a Glucose Reagent, the "standalone" performance would refer to the reagent's analytical performance (e.g., accuracy, precision) in a lab setting, which would have been part of the substantial equivalence demonstration, but the details are not in this letter.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not available in the provided document. For a Glucose Reagent, the "ground truth" would typically come from reference methods for glucose measurement.
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The sample size for the training set:
- This information is not available in the provided document.
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How the ground truth for the training set was established:
- This information is not available in the provided document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Charles C. Allain, Ph.D. · Director Derma Media Lab, Inc. . . . 7245 Garden Grove Boulevard, Suite E Garden Grove, California 92641
AUG - 1 1997
Re : K970664 Glucose Reagent Regulatory Class: II Product Code: CFR Dated: May 19, 1997 Received: May 22, 1997
Dear Dr. Allain:
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 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 requirement, 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 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 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/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 Radiological Health
Enclosure
0 日 日常第四章 11 1
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510(k) Number (if known):
Device Name: Glucose Reagent
Indications For Use: ......................
The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.
ision Sign-Off)
Clinical Laboratory Devices
K970664
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
|| វិងអោយបាន រី
Over-The-Counter Use
§ 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.