(144 days)
Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
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The provided text (from {0} to {2}) is a 510(k) clearance letter from the FDA for a medical device called "Diazyme Liquid Stable Enzymatic Lithium Assay." This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain specific information regarding acceptance criteria, study details, or performance metrics in the format requested.
Therefore, most of the information required to populate the table and answer the detailed questions is not present in the provided text. The document is a clearance letter, not a study report or clinical trial summary.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | Not specified in this document |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not specified. This type of study is more common for imaging devices or AI-assisted diagnostics, not a liquid assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an "Enzymatic Lithium Assay," which is a lab test, not an algorithm in the typical sense of AI/ML. The concept of "standalone performance" as it applies to AI without human-in-the-loop is not relevant here. The device itself performs the assay.
7. The type of ground truth used:
- For an assay device, the "ground truth" would typically refer to a reference method or validated comparative method against which the new assay's measurements are compared. This is not specified in the document.
8. The sample size for the training set:
- Not specified. (Note: For a traditional lab assay, "training set" is not a standard term like it is for AI/ML. There would be R&D and validation work, but the concept of a "training set" for an algorithm isn't directly applicable.)
9. How the ground truth for the training set was established:
- Not specified. (As above, "training set" concept is not directly applicable.)
In summary, the provided FDA clearance letter indicates the device's regulatory pathway and its "substantially equivalent" status to a predicate device, but it does not detail the technical performance studies and their specific methodologies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diazyme Laboratories c/o Abhijit Datta, Ph.D., Director, Manufacturing and QC 12889 Gregg Court Poway, CA 92064
DEC 0 5 2008
Re: K082001
Trade/Device Name: Diazyme Liquid Stable Enzymatic Lithium Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium Test System Regulatory Class: II Product Code: JII Dated: July 11, 2008 Received: August 18, 2008
Dear Dr. Datta:
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.
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Pre-market Notification-Diazyme Liquid Stable Enzymatic Lithium Assay
Indication for Use
510(k) Number (if known): K082001
Device Name: Diazyme Liquid Stable Enzymatic Lithium Assay
Indication For Use: Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
CA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safery
510(k) K082501
Page 19
§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.