Afinion HbA1c Dx on Afinion 2

K182988 · Alere Technologies AS · PDJ · Nov 29, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182988
• Device Name: Afinion HbA1c Dx on Afinion 2
• Applicant: Alere Technologies AS
• Product Code: PDJ · Clinical Chemistry
• Decision Date: Nov 29, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1373
• Device Class: Class 2

Intended Use

The AfinionTM A1c Dx is a multi-assay analyzer for in vitro diagnostic use. The AfinionTM A1c Dx is a compact, rapid, multi-assay analyzer that provides in vitro diagnostic tests. The AfinionTM A1c Dx is intended for professional use in clinical settings. The AfinionTM A1c Dx is intended for use by healthcare professionals.

Device Story

Afinion 2 is a compact, point-of-care, multi-assay analyzer for quantitative HbA1c measurement. It processes Afinion test cartridges containing human venous or capillary whole blood. The device performs automated boronate affinity assay processing, including pumping, heating, and image processing. It physically manipulates cartridges via locking, docking, splitting, foil penetration, and merging. The system provides HbA1c results to clinicians to assist in diabetes diagnosis and metabolic monitoring. It is designed for use in clinical settings by healthcare professionals. The Afinion 2 replaces the AS100 analyzer, featuring updated electronics, injection-molded plastic components, and integrated connectivity, while maintaining the same assay sequence timing and core functionality as the predicate.

Clinical Evidence

Bench testing only. Verification and validation studies were performed based on risk analysis to confirm that the modified device (Afinion 2) maintains the performance and safety of the Afinion system. All acceptance criteria were met.

Technological Characteristics

Compact multi-assay analyzer; boronate affinity assay principle; automated cartridge processing (pumping, heating, image processing); injection-molded plastic and metal components; 9 PCBs; integrated Ethernet connectivity; traceable to IFCC reference method; NGSP certified.

Indications for Use

Indicated for quantitative determination of HbA1c in human venous and capillary whole blood to aid in diabetes diagnosis, identify at-risk patients, and monitor long-term metabolic control in patients with diabetes mellitus.

Regulatory Classification

Identification

A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.

Special Controls

(b) Classification. Class II (special controls). Hemoglobin A1c test systems must comply with the following special controls: 1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. 2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity and interference, including the following: i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0%, 6.5%, 8.0% and 12% hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least 3 lots of the device and 3 instruments, as applicable. ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the new device and compare results of the new device to results of the standardized test method. Results must demonstrate little or no bias versus the standardized method. iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6%. iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2 and Hemoglobin S. 3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.

*Classification.* Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. (2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following: (i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable. (ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method. (iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent. (iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S. (3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.

Predicate Devices

• Afinion™ HbA1c Dx on Alere Afinion™ AS100 Analyzer (k180296)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k182988

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: AfinionTM A1c Dx with Alere AS100 Analyzer (k180296).

2. Applicant’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 analyzer from Alere Afinion AS100 Analyzer to Afinion 2
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, components 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.

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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 applicant’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 applicant 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.

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