Alere Afinion HbA1c and ACR on Afinion 2 analyzer

K171650 · Abbott Rapid Diagnostics · LCP · Nov 21, 2017 · Hematology

Device Facts

• Record ID: K171650
• Device Name: Alere Afinion HbA1c and ACR on Afinion 2 analyzer
• Applicant: Abbott Rapid Diagnostics
• Product Code: LCP · Hematology
• Decision Date: Nov 21, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Alere Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afinion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus. The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

Device Story

Afinion™ 2 analyzer is a compact, point-of-care, multi-assay system for processing Alere Afinion™ test cartridges. It accepts whole blood (HbA1c) or urine (ACR) samples. The device performs automated cartridge processing, including mechanical operations (locking, docking, splitting, foil penetration, merging), fluid pumping, heating, and image processing. It provides quantitative diagnostic results to clinicians to support diabetes management and nephropathy diagnosis. The system is designed for use in clinical settings. It features integrated Ethernet connectivity and updated electronic/mechanical components compared to the predicate. The device maintains the same fundamental scientific technology and assay sequence timing as the Alere Afinion™ AS100.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of physical/component modifications.

Technological Characteristics

Point-of-care analyzer; materials changed from metal to plastic; PCB count reduced from 14 to 9; dimensions 200 mm W x 186 mm H x 328 mm D; weight 3.4 kg; integrated Ethernet connectivity.

Indications for Use

Indicated for quantitative determination of HbA1c in human whole blood for long-term metabolic control monitoring in patients with diabetes mellitus, and for quantitative determination of albumin, creatinine, and ACR in human urine to aid in early diagnosis of nephropathy.

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 (k151809)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER k171650

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:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. Alere Afinion HbA1c and Alere Afinion AS100 Analyzer, k151809
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 following:

a. Change the name of the analyzer from Alere Afinion AS100 Analyzer to Afinion 2 Analyzer
b. Change several internal analyzer components from metal to plastic
c. Change from 14 printed circuit boards (PCBs) to 9 PCBs
d. Change in analyzer dimensions from 190 mm W x 170 mm H x 340 mm D to 200 mm W x 186 mm H x 328 mm D and weight from 5 kg to 3.4 kg
e. Change in Ethernet connectivity from using a separate unit to incorporating the Ethernet plug into the analyzer.

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