(81 days)
Prestiae Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
Prestige Aqueous Glucose Control Low Prestige Agueous Glucose Control High
Here's an analysis of the provided text regarding acceptance criteria and a study for the "Prestige Aqueous Glucose Controls" device:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not contain any specific acceptance criteria or detailed device performance data. The document is an FDA 510(k) clearance letter, which states that the device has been found "substantially equivalent" to predicate devices. This means it has met the regulatory requirements for marketing based on a comparison to an already legally marketed device, but the letter itself does not typically detail the specific performance metrics or acceptance thresholds used in the underlying studies.
Therefore, without more information, I cannot create this table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The 510(k) clearance letter is a summary of the FDA's decision, not a detailed scientific report of the studies performed.
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)
The document does not mention the number of experts or their qualifications used to establish ground truth. As this device is a glucose control solution, the "ground truth" would likely be established through analytical reference methods, not human expert interpretation in the way it would be for imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This concept is typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), not for the analytical performance of a control solution.
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
No MRMC comparative effectiveness study was done or mentioned. This type of study is completely irrelevant for a glucose control solution, which is an in vitro diagnostic product used to verify the accuracy of a blood glucose monitoring kit, not an AI-powered diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The "Prestige Aqueous Glucose Controls" is a chemical solution used for quality control, not an algorithm. Therefore, the concept of "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that this is an aqueous glucose control solution, the ground truth for its performance would typically involve reference analytical methods for glucose concentration. This would involve precise laboratory measurements using highly accurate and calibrated instruments (e.g., YSI glucose analyzer, hexokinase method) to determine the true glucose concentration of the control solution. This is not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic devices.
8. The sample size for the training set
The document does not provide any information regarding a "training set." Training sets are relevant for machine learning algorithms. This device is a biochemical control, not an AI model.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
Summary of what the document does provide:
- Device Name: Prestige Aqueous Glucose Control Low, Prestige Aqueous Glucose Control High
- Indication for Use: "Ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit." They are used by individuals with diabetes and healthcare professionals to monitor and treat fluctuations in blood glucose levels.
- Regulatory Status: Cleared under 510(k) as substantially equivalent to predicate devices. Classified as Regulatory Class: I, Product Code: JJX.
- Approval Date: December 16, 1997.
Crucially, the provided text is an FDA clearance letter, which confirms regulatory approval based on demonstrating substantial equivalence. It does not provide the detailed study reports, performance data, or methodology that would be found in a scientific publication or the full 510(k) submission. To answer most of your questions, one would need to review the actual 510(k) submission document (K973676) that Sorrento Biochemical, Inc. submitted to the FDA, which would contain the study details.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC I 6 1997
Zak Hassanein President Sorrento Biochemical, Inc. 3443 Tripp Court, Suite A San Diego, California 92121
Re : K973676 Prestige Aqueous Glucose Controls Regulatory Class: I Product Code: JJX Dated: September 19, 1997 Received: September 26, 1997
Dear Mr. Hassanein:
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 Requlations, Title 21, Parts 800 to 895. ರ್ಕ 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/dsmamain.html".
Sincerely yours,
Steven Sitman
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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510(k) Number (if known): _unknown
Device Name: Prestige Aqueous Glucose Control Low Prestige Agueous Glucose Control High
Indication for Use:
Prestiae Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
PAPS
Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood gluccse concentrations from patients in the ER, ICU, CCU, OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Device | |
| 510(k) Number | 972676 |
| Prescription Use(Per 21 CFR 801-109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.