EON CALCIUM REGENT

K120626 · Vital Diagnostics (Manufacturing) Ptyltd · CJY · Aug 22, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120626
• Device Name: EON CALCIUM REGENT
• Applicant: Vital Diagnostics (Manufacturing) Ptyltd
• Product Code: CJY · Clinical Chemistry
• Decision Date: Aug 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum or plasma on an Eon 100 Analyzer. 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).

Device Story

Eon Calcium Reagent is an in vitro diagnostic reagent used with the Eon 100 Analyzer to quantify total calcium levels in human serum and plasma samples. The system is intended for use by healthcare professionals in clinical laboratory settings. The reagent facilitates the measurement of calcium, which aids clinicians in diagnosing and monitoring conditions such as parathyroid disease, bone disorders, chronic renal disease, and tetany. The device provides quantitative results that inform clinical decision-making regarding patient metabolic and endocrine health.

Clinical Evidence

Bench testing only. Precision evaluated over 21 days (42 runs) with total CVs ranging from 1.2% to 1.7%. Linearity confirmed across 1.3–16.0 mg/dL (r²=0.9990). LoB=0.1 mg/dL, LoD=0.3 mg/dL. Interference testing showed no significant impact (<10%) from hemoglobin (1000 mg/dL), lipemia (500 mg/dL), bilirubin (30 mg/dL), ascorbic acid, acetylsalicylic acid, or acetaminophen. Method comparison (n=62) against predicate yielded a slope of 1.054 and R²=0.9787. Matrix comparison (n=49) confirmed Lithium Heparin plasma is equivalent to serum.

Technological Characteristics

Quantitative photometric assay; Arsenazo III colorimetric method; absorbance measured at 630 nm. Reagent contains >0.13mmol/L arsenazo III, buffer, surfactants, and sodium azide. Single-part liquid configuration. Designed for use on the Eon 100 clinical chemistry analyzer. Traceable to NIST SRM 915b.

Indications for Use

Indicated for the quantitative determination of total calcium in serum or plasma to aid in the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany.

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).

Predicate Devices

• Roche Calcium (Ca) Reagent (k871811)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and conveys a sense of authority and responsibility.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Vital Diagnostics (Manufacturing) Pty, Ltd. c/o Melita Lambiris 189-199 Browns Rd Noble Park, Australia 3174

Re: k120626

Trade Name: Eon Calcium Reagent Regulation Number: 21 CFR §862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Codes: CJY Dated: July 4, 2012 Received: July 6, 2012

Dear Melita Lambiris:

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 (1 wr ), it nay of be ac yound in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device 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 mean that I Dr mas mass statutes and regulations administered by other Federal agencies. or the Act of any 1 outs all the Act's requirements, including, but not limited to: registration 1 ou mast compty what an this; labeling (21 CFR Parts 801 and 809); medical device and fishing (21 GFR 807), as other elated adverse events) (21 CFR 803); and good reporting (reporting of nequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

AUG 22 2012

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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): k120626

Device Name: Eon Calcium Reagent

Indications for Use:

Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. 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).

Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign, Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k120626

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