EASYRA CREATININE REAGENT

K123586 · Medica Corporation · CGX · May 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123586
• Device Name: EASYRA CREATININE REAGENT
• Applicant: Medica Corporation
• Product Code: CGX · Clinical Chemistry
• Decision Date: May 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

The EasyRA Creatinine (CREA) Reagent is for the measurement of creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only.

Device Story

EasyRA Creatinine Reagent; in vitro diagnostic reagent for creatinine measurement; used on EasyRA clinical chemistry analyzer. Modifications include: sample volume reduction (10 µl to 5 µl); reaction time reduction (10 min to 8 min); on-board stability extension (20 days to 60 days). Device operates via clinical chemistry analysis; provides quantitative creatinine results to clinicians for diagnostic assessment. Used in clinical laboratory settings by trained personnel.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics of the reagent system.

Technological Characteristics

In vitro diagnostic reagent for use on the EasyRA chemistry analyzer. Measures creatinine via chemical reaction in serum and plasma samples.

Indications for Use

Indicated for the measurement of creatinine in serum and plasma to aid in the diagnosis and treatment of renal diseases and monitoring of renal dialysis. For in vitro diagnostic use by prescription only.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k123586

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 for the EasyRA Creatinine Reagent

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.) EasyRA CREA Reagent (k110675).

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. Sample volume reduction (from 10 µl to 5 µl)
B. Reaction time reduction (from 10 minutes to 8 minutes)
C. Extension of on board stability claim (from 20 days to 60 days)

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.

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.