(76 days)
The IDS Gamma-B 1,25-Dihydroxy Vitamin D kit is a complete assay system intended for the purification of 1,25-dihydroxyvitamin D (1,25D) in human serum or plasma by immunoextraction followed by quantitation by 1251 radioimmunoassay. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in,the assessment of 1,25D deficiency associated with renal disease in adult populations. For In Vitro Diagnostic Use Only.
Not Found
This is an FDA Premarket Notification (510(k)) letter for the device "Gamma-B 1, 25-Dihydroxy Vitamin D." This document is a clearance letter and does not contain the detailed study results or acceptance criteria that would typically be found in a submission document or a medical publication.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the document:
1. A table of acceptance criteria and the reported device performance:
- Cannot be determined from this document. This document is a clearance letter, not a detailed study report. It states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device met the necessary performance criteria submitted in the original 510(k) application, but these specific criteria and the reported performance are not present in this letter.
2. Sample size used for the test set and the data provenance:
- Cannot be determined from this document. The document does not provide details about sample sizes or the origin of the data used for the substantial equivalence determination.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be determined from this document. This information is not part of the FDA clearance letter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be determined from this document. Adjudication methods are typically detailed in study protocols, which are not included 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:
- Not applicable. The device described is an "in vitro diagnostic" (IVD) test system (specifically, a radioimmunoassay for 1,25-dihydroxyvitamin D). It is not an AI-assisted diagnostic imaging device, so MRMC studies and human reader improvement with AI are not relevant for this type of product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. This is an IVD kit, which provides a quantitative result. Its performance is evaluated through analytical and clinical studies, not typically as a "standalone algorithm" in the way an AI medical imaging algorithm would be. The device itself is the "standalone" indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be determined from this document. For an IVD, ground truth would typically refer to a reference method or clinical diagnosis based on established criteria and other laboratory and clinical data. However, the specific method used for this device's validation is not described here. The indications for use state "Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations." This implies that the ground truth would be a clinical diagnosis informed by multiple data points.
8. The sample size for the training set:
- Not applicable / Cannot be determined. This device is an immunoassay kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its development involves optimization and validation using various samples, but not a distinct "training set" for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As above, the concept of a "training set" ground truth isn't directly relevant to this type of IVD device.
In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device. It does not provide the detailed scientific study information requested as part of the 510(k) application.
{0}------------------------------------------------
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 (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 1 2004
Mr. Paul Puntin Head of Quality & Regulatory Affairs Immunodiagnostic Systems Limited 10 Didcot Way Boldon Business Park Boldon, Tyne & Wear, NE35 9PD United Kingdom
Re: K042519
Trade/Device Name: Gamma-B 1, 25-Dihydroxy Vitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: September 13, 2004 Received: September 16, 2004
Dear Mr. Puntin:
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 (OS) regulation (21 CFR Part 820).
{1}------------------------------------------------
Page 2 -
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,
Sincerely yours,
Cornelius B. Looker
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
8.0 INDICATIONS FOR USE
510(k) Number (if known): K_04251
Device Name:
Gamma-B 1,25-Dihydroxy Vitamin D
Indications For Use:
The IDS Gamma-B 1,25-Dihydroxy Vitamin D kit is a complete assay system intended for the purification of 1,25-dihydroxyvitamin D (1,25D) in human serum or plasma by immunoextraction followed by quantitation by 1251 radioimmunoassay. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in,the assessment of 1,25D deficiency associated with renal disease in adult populations.
For In Vitro Diagnostic Use Only.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of Iri Vii: Diagnostic Device Evaluation and Safety
510(k) K042519
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.