EASYRA GLU-H REAGENT, MODEL 10200

K092506 · Medica Corp. · CFR · Sep 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092506
• Device Name: EASYRA GLU-H REAGENT, MODEL 10200
• Applicant: Medica Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Sep 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyRA Glucose-Hexokinase Reagent is intended for the quantitative determination of glucose in human serum and plasma on the EasyRA clinical chemistry analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Story

EasyRA Glucose-Hexokinase Reagent; in vitro diagnostic reagent for use on EasyRA clinical chemistry analyzer. Modification involves splitting reagent into two compartments and altering sequence of readings to reduce interference from lipemia, bilirubin, and hemoglobin. Device measures glucose levels in human serum/plasma samples. Used in clinical laboratory settings by trained personnel. Output provides quantitative glucose concentration to assist clinicians in diagnosing/managing carbohydrate metabolism disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to the predicate device.

Technological Characteristics

In vitro diagnostic reagent; hexokinase-based enzymatic assay. Reagent split into two compartments for sequential reading. Designed for use on EasyRA clinical chemistry analyzer. No changes to fundamental scientific technology.

Indications for Use

Indicated for the measurement of glucose in serum for the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• EasyRA Glucose-Hexokinase Reagent (k080823)

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: k092506

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.) EasyRA Glucose-Hexokinase Reagent k080823

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: Modifying the procedure and the sequence of readings in the Glucose-Hexokinase test. The EasyRA Glu-H reagent was split into two separate compartments and order of the sequence of readings was altered to reduce interference from lipemia, bilirubin and hemoglobin.

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, method comparison between predicate and candidate devices. Accuracy, Linearity, Extension of Linearity, Precision, Imprecision, Limit of Blank, Limit of detection and Interference testing were also performed.

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.