CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91

K051757 · Diagnostic Chemicals , Ltd. · CJY · Nov 10, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051757
• Device Name: CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use. Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis

Device Story

Calcium-ADVANCE Assay is a spectrophotometric reagent for total calcium measurement in serum, plasma, and urine. Reagent contains Phosphonazo III, buffer (pH 5.5), stabilizers, and preservative. Principle: Phosphonazo III reacts with calcium to form a blue-purple complex with maximum absorbance at 600 nm; absorbance is proportional to calcium concentration. Used in clinical chemistry settings; operated by laboratory personnel. Output is quantitative calcium concentration (mg/dL). Results assist clinicians in diagnosing and managing calcium-related metabolic disorders. Assay is incompatible with calcium-complexing anticoagulants (citric acid, oxalates, EDTA, NaF).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spectrophotometric assay. Reagent: 60 μmol/L Phosphonazo III, buffer (pH 5.5 at 25°C), stabilizers, preservative. Measurement principle: colorimetric complex formation (600 nm). Linear range: 0.2–20 mg/dL. Storage: 18-26°C. Complies with CLSI guidelines EP05-A2, EP06-A, EP07-A, EP09-A2, and EP17-A.

Indications for Use

Indicated for quantitative determination of total calcium in serum, plasma (Lithium Heparin), and urine for in vitro diagnostic use. Used in diagnosis and treatment of hypercalcemia (hyperparathyroidism, hypervitaminosis D, multiple myeloma, bone neoplasms) and hypocalcemia (hypoparathyroidism, steatorrhea, nephritis, pancreatitis).

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 0 2005

Ms. Penny White, RAC Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6

Re: k051757 Trade/Device Name: Calcium ADVANCE Assay Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: October 27, 2005 Received: October 28, 2005

Dear Ms. White:

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 [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/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. 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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## Indications for Use

510(k) Number (if known): K051757

Device Name:_Calcium-ADVANCE Assay

Indications For Use:

## For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.

Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

SASifford
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k051757

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