EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020

K100673 · Medica Corp. · JGS · Apr 6, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100673
• Device Name: EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
• Applicant: Medica Corp.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Apr 6, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

The EasyLyte analyzers are used for the in-vitro diagnostic testing of Sodium (Na+), Potassium (K+), chloride (C1-), and Lithium (Li) in clinical laboratories by trained technicians. Sodium test: The sodium (Na+) assay is intended to measure sodium in serum, plasma, whole blood and urine. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (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, whole blood and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride test: The chloride (Cl-) assay is intended to measure the level of chloride in plasma, serum, whole blood, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Lithium test: The lithium (Li+) assay is intended to measure lithium (from the drug lithium carbonate) in serum, plasma and whole blood. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Device Story

Medica EasyLyte analyzer measures sodium, potassium, chloride, and lithium in human serum, plasma, or whole blood; utilizes ion-selective electrode (ISE) technology; modified version updates hardware components including electronics, display, printer, and power supply; intended for clinical laboratory use; provides quantitative electrolyte results to assist in patient diagnosis and management.

Clinical Evidence

No clinical data provided; the submission relies on bench testing and substantial equivalence to existing predicate devices.

Technological Characteristics

Ion-selective electrode (ISE) technology; measures potential differences proportional to ion activity. Analyzes serum, plasma, whole blood, and urine. Standalone benchtop analyzer.

Indications for Use

Indicated for the measurement of sodium, potassium, chloride, and lithium in human serum, plasma, or whole blood.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k100673

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Medica EasyLyte Na/K/Cl/Li analyzer, k963763.

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 (labeling changes are permitted as long as they do not affect the intended use).

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, physical characteristics, analytes and performance characteristics. Studies include precision, linearity and method comparison.

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. ISO 14971
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.