(76 days)
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Not Found
No
The summary describes a radioimmunoassay kit for measuring vitamin D levels, which is a traditional laboratory technique and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic assay system used to quantify 1,25-dihydroxyvitamin D and assist in the assessment of deficiencies; it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kit is used to quantify 1,25-dihydroxyvitamin D and that "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," which is a diagnostic purpose. It also states "For In Vitro Diagnostic Use Only."
No
The device is an in vitro diagnostic (IVD) kit that involves the purification and quantitation of a substance in human samples using radioimmunoassay. This process inherently involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "For In Vitro Diagnostic Use Only." This is a clear indication that the device is intended for use in vitro (outside of the body) to diagnose or aid in the diagnosis of a condition.
Furthermore, the description of the assay system, which involves the purification and quantitation of a substance in human serum or plasma, aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MRG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adult populations
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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).
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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,
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
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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