GAMMA-B 1,25-DIHYDROXY VITAMIN D

K042519 · Immunodiagnostic Systems , Ltd. · MRG · Dec 1, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042519
• Device Name: GAMMA-B 1,25-DIHYDROXY VITAMIN D
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended 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.

Device Story

The IDS Gamma-B 1,25-Dihydroxy Vitamin D kit is an in vitro diagnostic radioimmunoassay (RIA) system used in high-complexity clinical laboratories. The process involves immunoextraction of 1,25D from patient serum or plasma samples using a solid-phase monoclonal anti-1,25D gel, followed by elution. The purified 1,25D is then incubated with sheep anti-1,25D and 125I-labeled 1,25D. Bound and free fractions are separated via Ac-Cel incubation, centrifugation, and decantation. A gamma counter measures the radioactivity, which is inversely proportional to the 1,25D concentration. Clinicians use these quantitative results alongside other clinical and laboratory data to assess 1,25D deficiency in patients with renal disease.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, including precision (n=20 per control level), linearity, analytical sensitivity (11 pmol/L), and specificity. Method comparison against the predicate device (n=112) yielded a Passing & Bablok regression of y = 0.96x - 6.3 (r=0.82). Reference intervals were established using 143 healthy adults and 44 patients with end-stage renal disease.

Technological Characteristics

Competitive radioimmunoassay (RIA) using 125I isotope. Materials include solid-phase monoclonal anti-1,25D gel and sheep anti-1,25D. Requires centrifuge, sample mixer, vortex, and gamma counter. Standards referenced: NCCLS C28-A2, EP9-A, EP7-P, EP5-A, and EP6-P2. Storage at 4°C.

Indications for Use

Indicated for the quantitative determination of 1,25-dihydroxyvitamin D in human serum or plasma to assist clinicians in assessing 1,25D deficiency associated with renal disease in adult populations.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 (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 [phone]. 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 [phone] or [phone] 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