EASTLYTE NA/K/CA/PH

K112788 · Medica Corp. · CEM · Oct 20, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112788
• Device Name: EASTLYTE NA/K/CA/PH
• Applicant: Medica Corp.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians. Sodium test The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium test The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium-ionized test The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized 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). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium. pH test The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units,

Device Story

EasyLyte Na/K/Ca/pH Analyzer; automated electrolyte analyzer; measures sodium, potassium, calcium, pH in clinical samples (whole blood, serum, plasma, urine). Modification involves hardware updates: electronic components, display, printer, power supply. Device operates via ion-selective electrode (ISE) technology; provides quantitative results for clinical decision-making. Used in clinical laboratory settings; operated by trained laboratory personnel. Output displayed on integrated screen and printed; assists clinicians in electrolyte and acid-base balance assessment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the electrolyte and pH measurement assays.

Technological Characteristics

Ion-selective electrode (ISE) technology for Na+, K+, and Ca++ measurement; potentiometric pH sensor; automated sample processing; benchtop analyzer form factor.

Indications for Use

Indicated for quantitative measurement of sodium, potassium, calcium, and pH in whole blood, serum, plasma, or urine for clinical diagnostic purposes.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Submission Summary (Full Text)

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Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Medica Corp. c/o Photios Makris Director Regulatory Affairs 5 Oak Park Drive, Bedford, MA 01730

OCT 20 2011

Re: k112788

Trade/Device Name: EasyLyte Na/K/Ca/pH Analyzer Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system. Regulatory Class: II Product Code: CEM, CHL, JFP, JGS Dated: September 23, 2011 Received: September 26, 2011

Dear Mr. Makris:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 Virro 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/MedicalDevices/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] 1951 196-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours.

j

Courtney H. Lias, 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): K112788

Device Name: EasyLyte Na/K/Ca/pH Analyzer

Indications For Use. The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians.

### Sodium test

The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

#### Potassium test

The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

#### Calcium-ionized test

The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized 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). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium.

#### pH test

The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units,

Prescription Use (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k-112788
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