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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November 29, 2018

Alere Technologies AS Monica Vallestad Regulatory Affairs Manager Kielsaasveien 161 Oslo, NO-0884 Norway

Re: K182988

Trade/Device Name: Afinion HbA1c Dx on Afinion 2 Regulation Number: 21 CFR 862.1373 Regulation Name: Hemoglobin A1c test system Regulatory Class: Class II Product Code: PDJ, JQT Dated: October 26, 2018 Received: October 29, 2018

Dear Monica Vallestad:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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.

# Kellie B. Kelm -S

for 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) k182988

Device Name Afinion HbA1c Dx on Afinion 2

#### Indications for Use (Describe)

Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% homoglobin Alc, HbAlc) in human venous and capillary whole blood.

This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion™ 2 System consisting of the Afinion™ 2 Analyser and the Afinion™ Test Cartridges is for in vitro diagnostic use only. The Afinion™ 2 Analyzer is a compact multi-of-care testing and is designed to analyze the Afinion™ Test Cartridges.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

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 shows the logo for Abbott Laboratories. The logo consists of a stylized letter 'a' in blue, with the word "Abbott" written in black below it. The 'a' is made up of thick, rounded lines, giving it a modern and clean look. The overall design is simple and recognizable.

#### 510(K) SUMMARY k182988

#### GENERAL INFORMATION

- Applicant Name:
Alere Technologies AS Kjelsaasveien 161 PO Box 6863 Rodeloekka NO-0504 Oslo Norway Establishment #9613069

- Company Contact: Monica Vallestad Regulatory Affairs manager Phone: [phone] Email: [e-mail]
- November 28, 2018 Date Prepared:

### DEVICE IDENTIFICATION

Trade or Proprietary Names: Afinion™ HbA1c Dx on Afinion™ 2

Common Name: HbA1c test Analyzer

Classification:

| Product Code | Classification | Regulation Section | Classification Panel |
|--------------|----------------|--------------------|----------------------|
| PDJ | Class II | 21 CFR 862.1373 | Hematology |
| JQT | Class I | 21 CFR 862.2400 | Chemistry |

Predicate Device:

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

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Image /page/4/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized, rounded square shape in blue, resembling an abstract letter 'A'. Below the symbol, the company name "Abbott" is written in a bold, sans-serif font. The overall design is clean and modern, reflecting the company's focus on innovation and health.

The following are the legally marketed devices covered under the predicate device clearance, k180296, and their prior clearances:

The original Alere Afinion™ AS100 Analyzer was cleared under premarket notification k050574 for use with the Alere Afinion™ HbA1c assay and Alere Afinion™ HbA1c Controls.

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.

The Alere Afinion™ ACR assay with ACR controls for use with the Afinion™ AS100 Analyzer was cleared under k171650.

HbA1c Dx for use with Alere Afinion™ AS100 Analyzer was cleared under k180296

### DEVICE DESCRIPTION

The Afinion™ HbA1c Dx test system is a CLIA moderate complexity test for diagnosing diabetes and identifying patients who may be at risk for developing diabetes, as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion 2 is a multi-assay analyzer for point-of-care testing, designed for use with Afinion assay test cartridges and Afinion controls. It has the same functionality as the Afinion AS100 analyzer performing identical assay processing.

### INTENDED USE/INDICATIONS FOR USE

Afinion™ HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human venous and capillary whole blood.

This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.

The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

The Afinion™ 2 system, consisting of Afinion™ 2 analyzer and the Afinion™ test cartridges is for in vitro diagnostic use only. The Afinion™ 2 Analyzer is a compact

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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 a light blue color, positioned above the company name "Abbott" written in black, bold letters. The design is simple and modern, with a focus on the company's name and a recognizable symbol.

multi-assay analyzer for point-of-care testing and is designed to analyze the Afinion™ Test Cartridges.

| Attribute | Predicate Device - k180296<br>Afinion HbA1c Dx with Afinion<br>AS100 Analyzer | Candidate Device<br>Afinion HbA1c Dx with<br>Afinion 2 analyzer |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Similarities | | |
| Intended use | Afinion™ HbA1c Dx is an <i>in vitro</i><br>diagnostic test for quantitative<br>determination of glycated hemoglobin<br>(% hemoglobin A1c, % HbA1c) in human<br>whole blood. The measurement of %<br>HbA1c is recommended as a marker of<br>long term metabolic control in persons<br>with diabetes mellitus. | Same |
| Assay principle | Afinion HbA1c Dx is a fully automated<br>boronate affinity assay for the<br>determination of the percentage of<br>hemoglobin A1c in human whole blood. | Same |
| Standardization | Afinion HbA1c Dx is traceable to the<br>International Federation of Clinical<br>Chemistry and Laboratory Medicine<br>(IFCC) Reference Method for<br>Measurement of HbA1c. HbA1c values<br>are reported according to the NGSP<br>recommendations at DCCT (Diabetes<br>Control and Complications Trial) level.<br>Afinion HbA1c Dx is certified by NGSP. | Same |
| Analyzer<br>function | Assay cartridge processing including<br>pumping, heating, image processing | Same |
| Cartridge<br>interface | Physical processing of cartridge (locking,<br>docking, splitting, foil penetration,<br>merging) | Same |
| User Interface | User display and operating instructions<br>in labeling | Same |

# COMPARISON WITH PREDICATE

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Image /page/6/Picture/1 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, bold font. The 'A' symbol is a rounded, geometric shape, and the overall design is clean and modern.

| Differences | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Instrument components | Most components in metal | Several metal components replaced with injection molded plastics with more sub-assemblies |
| Electronics | Obsolete components or components that will be obsolete in near future, e.g. CPU and memory<br>14 PCBs in use | Obsolete components replaced by those with more current technology<br>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 Ethernet plug | Ethernet plug incorporated into the analyzer and connectivity software incorporated in the software |

#### DESCRIPTION OF DEVICE MODIFICATION

The Afinion 2 analyzer is a modification of the cleared Afinion AS100 analyzer for use with Afinion assays with no change in intended use. The Afinion™ 2 analyzer has the same functionality and user interface as the Alere Afinion™ AS100 Analyzer. The primary modifications are changes in component materials and other minor changes in component design in order to make a more robust analyzer. 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 to maintain assay sequence timing as 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 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).

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Image /page/7/Picture/0 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized letter "a" in a blue color. Below the symbol is the company name, "Abbott", in a bold, sans-serif font.

The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Afinion™ HbA1c Dx 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. The Afinion HbA1c Dx on the Afinion 2 is found to be substantially equivalent to the predicate device, Afinion HbA1c Dx on the Alere Afinion AS100.