EASYRA MG REAGENT, MODEL 10220

K092737 · Medica Corp. · JGJ · Nov 17, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092737
• Device Name: EASYRA MG REAGENT, MODEL 10220
• Applicant: Medica Corp.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Indications for Use

The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. For in vitro diagnostic use only.

Device Story

The EasyRA Magnesium Reagent is an in-vitro diagnostic reagent used with the Medica EasyRA clinical chemistry analyzer. It enables quantitative measurement of magnesium levels in serum samples. The system is intended for use in clinical laboratory settings by trained personnel. The analyzer processes the sample with the reagent to produce a photometric measurement, which is then converted into a concentration value. This output assists clinicians in diagnosing and monitoring conditions related to magnesium imbalance, such as renal failure, alcoholism, and pancreatitis. The device provides objective data to support clinical decision-making regarding patient electrolyte management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro diagnostic reagent for use on the Medica EasyRA analyzer. Utilizes photometric measurement principles for quantitative serum magnesium analysis. Class I, reserved device.

Indications for Use

Indicated for the quantitative determination of magnesium in human serum or plasma on the EasyRA clinical chemistry analyzer.

Regulatory Classification

Identification

A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

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 k092737

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.) k080810 (EasyRA Magnesium Reagent).

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:

a. The buffer capacity of the magnesium reagent has been increased and stabilizers were added to extend the on-board stability of the reagent from 7 to 17 days. Device labeling was changed to reflect this change.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies include accuracy, method comparison, precision, interferences, linearity, extended linearity, detection limits, and stability with automated laboratory analyzer.

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.