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

Intended 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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November 21, 2017

Abbott Rapid Diagnostics Annie Wright Senior Regulatory Affairs Manager 9975 Summers Ridge Road San Diego, California 92121

Re: K171650

Trade/Device Name: Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JFY, JQT Dated: June 2, 2017 Received: June 5, 2017

Dear Annie Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171650

#### Device Name

Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer

Indications for Use (Describe)

Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afmion™ 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 the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, rounded letter "a" in a bright blue color. Below the symbol, the company name "Abbott" is written in a bold, black font. The logo is simple and modern, conveying a sense of trust and reliability.

# K171650 510(k) SUMMARY

# GENERAL INFORMATION

| Submitter: | Abbott Rapid Diagnostics |
|-----------------|-----------------------------------|
| | 9975 Summers Ridge Road |
| | San Diego, CA 92121 USA |
| | Annie Wright |
| | Senior Manager, Regulatory Affair |
| | Phone: [phone] |
| | Email: [e-mail] |
| Applicant Name: | Abbott Rapid Diagnostics |
| | Kjelsaasveien 161 |
| | PO Box 6863 Rodeloekka |
| | NO-0504 Oslo |
| | Norway |
| | Establishment #9613069 |

Date Prepared: November 20, 2017

# DEVICE IDENTIFICATION

Trade or Proprietary Names: Alere Afinion™ HbA1c Alere Afinion™ ACR Afinion™ 2

Common Name: HbA1c test ACR test Analyzer

Classification:

| Product Code | Classification | Regulation Section | Classification Panel |
|--------------|----------------|--------------------|----------------------|
| LCP | Class II | 21 CFR 864.7470 | Hematology |
| JFY | Class II | 21 CFR 862.1225 | Chemistry |
| JQT | Class I | 21 CFR 862.2400 | Chemistry |

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Image /page/4/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter 'a' in blue, positioned above the company name "Abbott" in black, sans-serif font. The 'a' is designed with a rounded, modern look, and the overall design is clean and professional.

Predicate Device:

Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer (k151809)

The following are the legally marketed devices covered under the predicate device clearance, k151809, and their prior clearances:

The Alere Afinion™ HbA1c assay with HbA1c controls for use with the Alere Afinion™ AS100 Analyzer was cleared under k050574.

The Alere Afinion™ ACR assay with ACR controls for use with the Alere Afinion™ AS100 Analyzer was cleared under k072409.

The system, including both HbA1c and ACR assays and the Afinion AS100 Analyzer, was cleared under k110056 for the addition of a new accessory, the Afinion Data Connectivity Converter.

A modification to the Afinion HbA1c assay with the Afinion AS100 Analyzer was cleared under k151809.

# DEVICE DESCRIPTION

The Afinion™ 2 analyzer is a multi-assay analyzer for point-of-care testing, designed for use with Alere Afinion™ assays. The Afinion™ 2 analyzer is a modification, a new model, of the previously cleared device Alere Afinion™ AS100 Analyzer.

# INTENDED USE/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.

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Image /page/5/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized letter 'A' in blue, positioned above the company name 'Abbott' in bold, black font. The 'A' is designed with rounded edges, giving it a modern and approachable look. The overall design is clean and professional, reflecting the company's focus on health and innovation.

### COMPARISON WITH PREDICATE

| Attribute | Predicate Device<br>Alere Afinion™ AS100<br>Analyzer<br>k151809 | Candidate Device<br>Alere Afinion™ HbA1c and<br>ACR on Afinion™ 2 analyzer |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <b>Similarities</b> | | |
| Intended use | Alere Afinion™ 2 is a compact<br>multi-assay analyzer for point-of-<br>care testing, designed to analyze the<br>Afinion™ test cartridges. | Same |
| Analyzer function | Assay cartridge processing<br>including pumping, heating, image<br>processing | Same |
| Cartridge interface | Physical processing of cartridge<br>(locking, docking, splitting, foil<br>penetration, merging) | Same |
| User Interface | User display and operating<br>instructions in labeling | Same |
| Peripheral units | A barcode reader and printer can be<br>connected | Same |
| <b>Differences</b> | | |
| Components | Most components in metal | Several metal components replaced<br>with injection molded plastics |
| Electronics | Obsolete components or<br>components that will be obsolete in<br>near future, e.g. CPU and memory. | Obsolete components replaced by<br>those with more current technology |
| | 14 PCBs in use | 9 PCBs in use |
| Dimensions | 190 mm W x 170 mm H x 340 mm D<br>5 kg | 200 mm W x 186 mm H x 328 mm D<br>3.4 kg |
| Connectivity | Separate connectivity unit with<br>Ethernet plug | Ethernet plug incorporated into the<br>analyzer and connectivity software<br>incorporated in the software |

# DESCRIPTION OF DEVICE MODIFICATION

The Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer has the same functionality and user interface as the Alere Afinion™ AS100 Analyzer. The intended use/indications for use and fundamental scientific technology have not changed. The primary modifications are changes in component materials and other minor changes in component design in order to make a more robust analyzer. Electronic components that

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Image /page/6/Picture/0 description: The image shows the logo for Abbott Laboratories. The logo consists of a stylized, rounded letter "a" in blue, positioned above the word "Abbott" in a bold, sans-serif font. The color of the text is black.

are obsolete or expected to become obsolete in the near future were changed. Software overall architecture and high-level requirements remain unchanged from the Alere Afinion™ AS 100 Analyzer to the Afinion™ 2 analyzer. Software design in the Afinion™ 2 analyzer was modified from the Alere Afinion™ AS 100 Analyzer wherever needed to adapt to changes made to electronics and mechanics in order to maintain assay sequence timing as it is in the Alere Afinion™ AS100 Analyzer.

# DESIGN CONTROL ACTIVITIES

The design development and verification/validation of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the performance and safety of the Afinion™ system using the applicable Alere Afinion™ tests with the device. All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software). The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Alere Afinion™ HbA1c and Alere Afinion™ ACR are not adversely affected by using the modified device.

# CONCLUSION

Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met. This device is found to be substantially equivalent to the predicate device.