Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

K151809 · Alere Technologies AS · LCP · Sep 25, 2015 · Hematology

Device Facts

• Record ID: K151809
• Device Name: Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
• Applicant: Alere Technologies AS
• Product Code: LCP · Hematology
• Decision Date: Sep 25, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Alere Afinion HbA1c assay is an in vitro diagnostic test for the quantitative determination of glycated hemoglobin (HbA1c) in human whole blood. The Alere Afinion HbA1c test is for use with the Alere Afinion AS100 Analyzer. The Alere Afinion HbA1c test is intended for use as an aid in the diagnosis of diabetes and as an aid in the management of diabetes patients. The Alere Afinion HbA1c test is intended for use in professional healthcare settings.

Device Story

Device: Alere Afinion HbA1c assay and Alere Afinion AS100 Analyzer; modification involves material change of sampling device from glass to plastic. System inputs: human whole blood sample; processes sample via analyzer to quantify HbA1c levels. Used in professional healthcare settings; operated by clinicians/technicians. Output: quantitative HbA1c measurement; used to aid diabetes diagnosis and management. Benefit: provides clinical data for glycemic control monitoring.

Clinical Evidence

Verification and validation program included in-house studies of precision, accuracy, robustness, and potential interference of plastic additives, alongside external waived user studies. Results demonstrated that all predetermined acceptance criteria were met, confirming the modified device maintains the safety and efficacy of the assay.

Technological Characteristics

In vitro diagnostic assay for HbA1c quantification. Modification: sampling device material changed from glass to plastic. System includes Alere Afinion AS100 Analyzer. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for quantitative determination of glycated hemoglobin (% HbA1c) in human whole blood as a marker of long-term metabolic control in persons with diabetes mellitus, and for quantitative determination of albumin, creatinine, and albumin/creatinine ratio (ACR) in human urine to aid in early diagnosis of nephropathy. For use in clinical laboratories and point-of-care settings by professional users.

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.

Predicate Devices

• Alere Afinion HbA1c and Alere Afinion AS100 Analyzer (k110056)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k151809

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.) k110056: Alere Afinion HbA1c and Alere Afinion AS100 Analyzer

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 material change of the sampling device (from glass to plastic).

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

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

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.