EASTLYTE NA/K/CA/PH

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

Device Facts

Record IDK112788
Device NameEASTLYTE NA/K/CA/PH
ApplicantMedica Corp.
Product CodeCEM · Clinical Chemistry
Decision DateOct 20, 2011
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 862.1600
Device ClassClass 2

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,

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.

Related Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification OIVD Review Memorandum To: THE FILE RE: DOCUMENT NUMBER k112788 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the EasyLyte Na/K/Ca/pH Analyzer: 1. The name and 510(k) number of Medica Corp.'s previously cleared device, Medica EasyLyte Calcium Analyzer (Na/K/Ca/pH), cleared under k943091. (For a preamendments device, a statement to this effect has been provided.) 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. 3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for Update hardware changes including electronic components, display, printer and power supply. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)
Innolitics

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