EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200

K091991 · Medica Corp. · CIG · Sep 4, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091991
• Device Name: EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
• Applicant: Medica Corp.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Indications for Use

The EasyRA direct bilirubin reagent is intended for the quantitative determination of Direct Bilirubin (DBIL) in the human serum of adults, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in-vitro diagnostic use only.

Device Story

In vitro diagnostic device; measures clinical analytes in patient samples. Modification involves transition from single-wavelength to dual-wavelength measurement; purpose: improve precision and reduce lipemic interference. Modification includes increased sample reaction time. Device operates in clinical laboratory settings; used by laboratory technicians/pathologists. Output provides quantitative analyte results for clinical decision-making. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided; device is an in-vitro diagnostic reagent system evaluated via bench testing for analytical performance.

Technological Characteristics

In-vitro diagnostic reagent for use on the Medica EasyRA Chemistry Analyzer. Quantitative colorimetric/spectrophotometric assay principle. Designed for human serum analysis. Standalone reagent kit for use within an automated clinical chemistry analyzer platform.

Indications for Use

Indicated for use as a diagnostic device for clinical laboratory testing, consistent with the previously cleared device (K80810).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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 k091991

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.) k80810
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.

The device has been modified from the use of one spectral wavelength to two wavelength measurements to improve precision and reduce lipemic interference.

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

The differences are, addition of a secondary wavelength and increase of sample reaction time.

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 90 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 included:

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.