(90 days)
The Primidone Calibrators are in-vitro diagnostic medical devices intended to be used for calibration of DRI Primidone EIA Assay for quantitative determination of Primidone in human serum or plasma.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding "Primidone Calibrators." This type of document is a regulatory approval for a medical device and does not contain the detailed study information generally associated with artificial intelligence/machine learning (AI/ML) device approvals, which would discuss acceptance criteria based on performance metrics like sensitivity, specificity, AUC, etc.
The device discussed here, "Primidone Calibrators," is an in-vitro diagnostic (IVD) medical device used for the calibration of a specific immunoassay (DRI Primidone EIA Assay) to quantitatively determine Primidone levels in human serum or plasma. This is a chemical calibrator, not an AI/ML powered diagnostic device that analyzes images or complex data and therefore the questions in the prompt are largely not applicable.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. For calibrators, acceptance criteria would typically relate to their accuracy, precision, stability, and linearity in calibrating an assay. The document confirms the device is substantially equivalent to legally marketed predicate devices, implying it meets similar performance standards, but specific criteria and reported performance values are not detailed.
2. 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 present. Calibrator performance is typically evaluated through analytical studies using controlled samples rather than clinical test sets with data provenance.
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. The concept of "ground truth established by experts" is not relevant for a chemical calibrator. The "truth" for a calibrator is its chemical concentration and its ability to establish a reliable standard curve for an assay.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present. Adjudication methods are typically associated with human reviewer variability in AI/ML performance evaluation, which is not applicable here.
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 information is not present. This type of study is entirely irrelevant for a chemical calibrator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present. This question relates to AI/ML software performance, which is not applicable to a chemical calibrator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a chemical calibrator, the "ground truth" would be the certified or precisely measured concentrations of Primidone in the calibrator solutions. This information is not explicitly detailed in the provided document, but it's an inherent requirement for such a product.
8. The sample size for the training set:
This information is not present. Chemical calibrators do not use training sets in the AI/ML sense. Their manufacturing involves highly controlled processes and quality checks to ensure accuracy and consistency.
9. How the ground truth for the training set was established:
This information is not present, for the same reason as point 8.
In summary, the provided document is a regulatory approval letter for a chemical calibrator and does not contain the detailed performance study information typically found for AI/ML powered diagnostic devices. The questions posed in the prompt are mostly not applicable to this type of device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Lakshmi Anne, Ph. D. Director, Product Development Microgenics Corporation 46360 Fremont Boulevard Fremont, CA 94538
Re: K023780 Trade/Device Name: Primidone Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DLJ Dated: November 10, 2002 Received: November 12, 2002
Dear Dr. Anne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.
FEB I 0 2003
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K 023780 510(K) Number (if known): _
Primidone Calibrators. Device Name:
Indications For Use:
The Primidone Calibrators are in-vitro diagnostic medical devices intended to be used for calibration of DRI Primidone EIA Assay for quantitative determination of Primidone in human serum or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K023780 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.