MODIFICATION TO AVIE A1C TEST SYSTEM

K091400 · Mec Dynamics Corp · LCP · Jun 11, 2009 · Hematology

Device Facts

• Record ID: K091400
• Device Name: MODIFICATION TO AVIE A1C TEST SYSTEM
• Applicant: Mec Dynamics Corp
• Product Code: LCP · Hematology
• Decision Date: Jun 11, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Avie A1C test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in patients with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.

Device Story

Point-of-care system for quantitative measurement of % A1C (glycated hemoglobin) in capillary or venous whole blood; used for monitoring glycemic control in diabetic patients. Intended for prescription use and physician-directed home use. Device provides quantitative results to assist healthcare providers and patients in managing diabetes. Contraindicated for patients with specific hemoglobinopathies (HbF, HbC, HbD).

Clinical Evidence

No clinical data; bench testing and design verification/validation activities performed per 21 CFR 820.30.

Technological Characteristics

RFID technology for lot information scanning; increased cartridge capacity. Fundamental scientific technology unchanged from predicate. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of % A1C in capillary or venous whole blood to monitor glycemic control in patients with diabetes mellitus. Contraindicated for patients with hemoglobinopathies HbF, HbC, and HbD.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

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 k091400

MEC Dynamics Corp. Avie™ A1C Test System

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. k081269, MEC Dynamics Corp. Avie™ A1C Test System.
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 the addition of RFID technology to scan cartridge lot information and to increase the number of test cartridges per vial.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, software validation and verification activities, and risk analysis.
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. FMEA
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.