(55 days)
Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Not Found
This letter is a 510(k) clearance for the SYNCHRON CX Systems Glucose Reagent (GLU) and does not contain the detailed study information required to fully answer the request. The document states that the device is "substantially equivalent" to predicate devices, but it does not provide acceptance criteria, performance data, or details about the studies conducted. Therefore, I cannot extract the information requested in points 1 through 9.
Here's why some of the specific points cannot be addressed:
- 1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only grants clearance based on substantial equivalence.
- 2. Sample sized used for the test set and the data provenance: Not available in this document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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: This is a glucose reagent, not an AI-assisted diagnostic imaging device for human readers. This question is not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a reagent, it functions in conjunction with a laboratory instrument, not as a standalone algorithm in the sense of AI.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
- 8. The sample size for the training set: Not available. This is a reagent, not typically "trained" in the AI sense.
- 9. How the ground truth for the training set was established: Not available.
To get the requested information, one would need to refer to the original 510(k) submission document (K971467) itself, which would contain the scientific and clinical data supporting the substantial equivalence claim.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 6 1997
Cynthia Shugart President Carolina Liquid Chemistries Corporation -----------451 West Lambert Road, Suite 207 Brea, California 92821
K971467 Re : SYNCHRON CX Systems Glucose Reagent (GLU) Requlatory Class: II Product Code: CFR Dated: April 17, 1997 Received: April 22, 1997
Dear Ms. Shugart:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in 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 requlations.
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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 requlation (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
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Page 3 of 36
510(k) Number (if known):__
Device Name: Glucose Reagent
Indications For Use:
Glucose Reagent is intended for the quantitative સ્ determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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Concurrence of CDRH, Office of Device Evaluation (ODE) On Sion-
Prescription Use_ Per 21 CFR 801.109
3 -
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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§ 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.