Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

K214117 · Abbott Diagnostics Technologies AS · LCP · Sep 27, 2023 · Hematology

Device Facts

• Record ID: K214117
• Device Name: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
• Applicant: Abbott Diagnostics Technologies AS
• Product Code: LCP · Hematology
• Decision Date: Sep 27, 2023
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. 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 Afinion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only.

Device Story

Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of % HbA1c in human whole blood; used with Afinion™ AS100 or Afinion™ 2 analyzers. System utilizes boronate affinity assay technology; fully automated. Designed for point-of-care testing; operated by healthcare professionals. Input: venous or capillary whole blood samples in test cartridges. Output: quantitative % HbA1c result displayed on analyzer; data transferable via ADCC to laboratory information systems. Provides clinicians with objective marker for long-term metabolic control in diabetic patients; aids in clinical decision-making regarding diabetes management. Modification involves updated labeling with expanded analytical specificity data for hemoglobin variants, derivatives, and potential interfering substances.

Clinical Evidence

Bench testing only. Analytical specificity studies evaluated interference from hemoglobin variants (HbAC, HbAD, HbAE, HbAS, HbF), hemoglobin derivatives (acetylated, carbamylated, pre-glycated), and various endogenous/exogenous substances (bilirubin, lipids, glucose, rheumatoid factor, common medications). Results demonstrated no significant interference (≤7%) up to specified concentrations. Hemolysis interference threshold established at >14%.

Technological Characteristics

Fully automated boronate affinity immunoassay. Cartridge contains blue boronic acid conjugate, polyethersulfone membrane, and washing solution. Factory calibrated. Connectivity via ADCC for LIS integration. Software version 21.10 or higher updates result reporting for out-of-range values. ISO 14971 risk management applied.

Indications for Use

Indicated for quantitative determination of glycated hemoglobin (% HbA1c) in venous and capillary human whole blood as a marker of long-term metabolic control in persons with diabetes mellitus.

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 ACR on Afinion™ 2 analyzer (K171650)

Reference Devices

• Afinion™ HbA1c (K050574)
• Afinion™ Data Connectivity Converter (K110056)

Submission Summary (Full Text)

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September 27, 2023

Abbott Diagnostics Technologies AS Nathifa Bradshaw Director Regulatory Affairs Kjelsasveien 161 NO-0884 Oslo Norway

Re: K214117

Trade/Device Name: Afinion™ HbA1c, Afinion™ 2, Alere Afinion™AS100 Analyzer Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, JQT Dated: May 3, 2023 Received: May 3, 2023

Dear Nathifa Bradshaw:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K214117

#### Device Name

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

#### Indications for Use (Describe)

### Afinion™ HbA1c

Afmion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of longterm metabolic control in persons with diabetes mellitus.

#### Afinion™ 2

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™ test cartridges is for in vitro diagnostic use only.

#### Alere Afinion™ AS100 Analyzer

Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system.

Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only,

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(K) SUMMARY

## GENERAL INFORMATION

| Document# : | k214117 & CW210007 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) : | Dual Submission – 510(k) and CLIA waiver |
| Applicant Name: | Abbott Diagnostics Technologies AS<br>Kjelsaasveien 161<br>PO Box 6863 Rodeloekka<br>NO-0504 Oslo<br>Norway<br>Establishment #9613069 |
| Company Contact: | Nathifa Bradshaw<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 26, 2023 |

## DEVICE IDENTIFICATION

Trade or Proprietary Names: Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

Common Name:

HbA1c test

Classification:

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

Predicate Device:

Afinion™ HbA1c (k171650) with Afinion™ 2 and Alere Afinion™ HbA1c ( k151809) with Alere Afinion™ AS100 Analyzer.

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The following are the legally marketed devices covered under the predicate device clearances, k171650 and k151809, and prior clearances:

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

A modification to the Afinion™ HbA1c assay with the Afinion™ AS100 analyzer to add a new accessory, the Afinion™ Data Connectivity Converter, was cleared under k110056.

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

A modification to the Afinion™ HbA1c assay with HbA1c Controls to include use with the Afinion™ 2 Analyzer was cleared under k171650.

## DEVICE DESCRIPTION

The 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 Afinion™ HbA1c assay is designed to be used with the Afinion™ AS100 Analyzer and the Afinion™ 2 analyzer which are compact multi-assay analyzers for point-of-care testing. Quality control using the Afinion™ HbA1c Control is recommended to confirm that the system is working properly and provides reliable results.

## INTENDED USE/INDICATIONS FOR USE

Afinion™ HbA1c

Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

Afinion™ 2

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 Afinion™ test cartridges is for in vitro diagnostic use only.

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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, rounded letter 'a' in a bright blue color. Below the symbol, the company name "Abbott" is written in a bold, sans-serif font.

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Alere Afinion™ AS100 Analyzer

Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only.

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Image /page/6/Picture/0 description: The image shows the logo for Abbott. The logo consists of a stylized, rounded letter "a" in blue, positioned above the company name "Abbott" in bold, black font. The "a" symbol is simple and modern, while the company name is clear and legible.

# Page 4 of 8

# COMPARISON WITH PREDICATE

| Attribute | Predicate Device - k171650<br>Afinion™ HbA1c | Predicate Device-K151809<br>Alere Afinion™HbA1c | Candidate Device<br>Modified Afinion™ HbA1c |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | | |
| Intended use | Afinion™ HbA1c is an <i>in vitro</i> diagnostic test<br>for quantitative determination of glycated<br>hemoglobin (% hemoglobin A1c, % HbA1c) in<br>human whole blood. The measurement of %<br>HbA1c is recommended as a marker of long<br>term metabolic control in persons with<br>diabetes mellitus. | Alere Afinion™HbA1c is an <i>in-vitro</i><br>diagnostic test for quantitative<br>determination of glycated<br>hemoglobin (%<br>hemoglobin A1c, % HbA1c) in<br>human whole blood. The<br>measurement of % HbA1c is<br>recommended as a marker of long<br>term metabolic control in persons<br>with diabetes mellitus | Afinion™ HbA1c is an <i>in vitro</i> diagnostic test for<br>quantitative determination of glycated hemoglobin<br>(% hemoglobin A1c, % HbA1c) in venous and<br>capillary human whole blood. The measurement of<br>% HbA1c is recommended as a marker of long term<br>metabolic control in persons with diabetes mellitus. |
| Assay principle | Afinion™ HbA1c is a fully automated<br>boronate affinity assay for the determination of<br>the percentage of hemoglobin A1c in human<br>whole blood. | Same | Same |
| Blood samples | Venous whole blood and capillary fingerstick | Same | Same |
| Analyzer | Afinion™ 2 | Alere Afinion™ AS100 Analyzer | Alere Afinion™ AS100 Analyzer and Afinion™ 2 |
| User Interface | User display and operating instructions in<br>labeling | Same | Same |

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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 blue, positioned above the company name "Abbott" in bold, black font. The "a" symbol is a rounded, geometric shape, and the overall design is clean and modern.

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| Attribute | Predicate Device - k171650<br>Afinion™ HbA1c | Predicate Device-K151809<br>Alere Afinion™HbA1c | Candidate Device<br>Modified Afinion™ HbA1c |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Differences | | |
| Test Procedure | IMPORTANT!<br>Do not use test cartridges that have been accidentally dropped on the floor or lab bench after specimen collection. | IMPORTANT!<br>Do not use test cartridges that have been accidentally dropped on the floor or lab bench after specimen collection. | Addition to warning and precautions Alterations in the presentation of the test result reporting Text update to align with American Diabetes Association (ADA) recommendations Inclusion of a performance characteristics disclaimer Revisions to bibliography page IMPORTANT! Do not use test cartridges that have been accidentally dropped on the floor or lab bench after sample collection. Do not use cold test cartridges. Use the test cartridge within 10 minutes after opening the foil pouch. |

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Image /page/8/Picture/0 description: The image contains the Abbott logo. The logo consists of a stylized letter 'a' in blue, positioned above the word "Abbott" in bold, black font. The 'a' is designed with rounded edges and a continuous line, giving it a modern and abstract appearance. The overall design is clean and corporate, reflecting the company's brand identity.

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| Attribute | Predicate Device - k171650<br>Afinion™ HbA1c | Predicate Device-K151809<br>Alere Afinion™HbA1c | Candidate Device<br>Modified Afinion™ HbA1c |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytical<br>specificity | The following hemoglobin (Hb)<br>variants have been analyzed and<br>found not to affect the Alere<br>Afinion™ HbA1c test result: HbAC,<br>HbAD, HbAE, HbF, HbAJ and HbAS.<br>Carbamylated hemoglobin does not<br>affect the Alere Afinion™ HbA1c test<br>result. Pre-glycated hemoglobin does<br>not affect the Alere Afinion™ HbA1c<br>result. | The following hemoglobin (Hb)<br>variants have been analyzed and<br>found not to affect the Alere<br>Afinion™ HbA1c test result: HbAC,<br>HbAD, HbAE, HbF, HbAJ and HbAS.<br>Carbamylated hemoglobin does not<br>affect the Alere Afinion™ HbA1c test<br>result. Pre-glycated hemoglobin does<br>not affect the Alere Afinion™ HbA1c<br>result. | No significant interference (≤ 7%) was observed for<br>samples with hemoglobin (Hb) variants and<br>hemoglobin derivatives up to the following<br>concentrations:<br>• HbA2 5.7%<br>• HbAC 36%<br>• HbAD 42%<br>• HbAE 26%<br>• HbAS 42%<br>• HbF 10.4%<br>• Acetylated Hb 4.6 mg/mL<br>• Carbamylated Hb 13.8 mg/mL<br>• Labile (pre-glycated) Hb 11.4 mg/mL |
| Limitations | No HbF limitation | No HbF limitation | The highest HbF concentration where no significant<br>interference (≤ 7%) is observed is 10.4% HbF. Above<br>10.4% HbF, a negative interference is observed. |
| Limitations | Do not analyze hemolyzed or coagulated<br>samples. | Do not analyze hemolyzed or coagulated<br>samples. | Coagulated or hemolyzed samples cannot be used<br>with Afinion™ HbA1c. Samples with >14% (2000<br>mg/dL) hemolysis may return an information code. |
| Interference | No significant interference (<5%) was | No significant interference (<5%) was | No significant interference (≤7%) was observed up |
| | observed up to the following | observed up to the following | to the following concentrations: |
| | concentrations: | concentrations: | |
| | • Bilirubin - 342 µmol/L (20 mg/dL) | • Bilirubin - 342 µmol/L (20 mg/dL) | • Bilirubin conjugated 600 mg/L |
| | • Triglycerides - 15.7 mmol/L (1389 mg/dL) | • Triglycerides - 15.7 mmol/L (1389 mg/dL) | • Bilirubin unconjugated 600 mg/L |
| | • Cholesterol - 9.1 mmol/L (351 mg/dL) | • Cholesterol - 9.1 mmol/L (351 mg/dL) | • Glucose 10 g/L |
| | • Glucose - 27.8 mmol/L (500 mg/dL) | • Glucose - 27.8 mmol/L (500 mg/dL) | • Lipids (as Intralipid) 10 g/L |
| | • Fructosamine - 680 µmol/L | • Fructosamine - 680 µmol/L | • Rheumatoid factor 780 000 IU/L |
| | • Hemolysis - 5.0% | • Hemolysis - 5.0% | • Total protein 15 g/dL |
| | • Anticoagulants (EDTA, heparin and<br>citrate) at concentrations normally<br>used in blood collection tubes. | • Anticoagulants (EDTA, heparin and<br>citrate) at concentrations normally<br>used in blood collection tubes. | • Glycated albumin 7.7 g/L |
| | • Acetaminophen - 1.7 mmol/L (256 µg/mL) | • Acetaminophen - 1.7 mmol/L (256 µg/mL) | • Acetaminophen 200 mg/L |
| | • Ibuprofen - 1.8 mmol/L (372 µg/mL) | • Ibuprofen - 1.8 mmol/L (372 µg/mL) | • Acetylcysteine 1663 mg/L |
| | • Acetylsalicylic acid - 3.3 mmol/L (599 µg/mL) | • Acetylsalicylic acid - 3.3 mmol/L (599 µg/mL) | • Acetylsalicylic acid 1000 mg/L |
| | • Salicylic acid - 4.3 mmol/L (593 µg/mL) | • Salicylic acid - 4.3 mmol/L (593 µg/mL) | • Ampicillin 1000 mg/L |
| | • Glyburide - 3.9 µmol/L | • Glyburide - 3.9 µmol/L | • Ascorbic acid 300 mg/L |
| | • Metformin - 310 µmol/L | • Metformin - 310 µmol/L | • Cefoxitin 2500 mg/L |
| | | | • Cyclosporine A 5 mg/L |
| | | | • Cyclosporine C 5 mg/L |
| | | | • Doxycycline 50 mg/L |
| | | | • Glyburide 1.9 mg/L |
| | | | • Heparin 5000 U/L |
| | | | • Ibuprofen 500 mg/L |
| | | | • Levodopa 20 mg/L |
| | | | • Metformin 40 mg/L |
| | | | • Methyldopa 20 mg/L |
| | | | • Metronidazole 200 mg/L |
| | | | • Phenylbutazone 400 mg/L |
| | | | • Rifampicin 64 mg/L |
| | | | • Salicylic acid 599 mg/L |
| | | | • Theophylline 100 mg/L |
| | | | • Hemolysis ( <i>in vitro</i> ) 14 % |
| | | | • Anticoagulants (EDTA, heparin and citrate) at<br>concentrations normally used in blood collection<br>tubes do not interfere. |

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Image /page/9/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, bold font. The "A" is designed with rounded corners and a gap in the upper right, giving it a modern and distinctive look. The overall design is clean and professional, reflecting the company's focus on health and innovation.

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Afinion™ HbA1c Dual Submission – 510(k) and CLIA waiver k214117 & CW210007 Page 8 of 8

#### DESCRIPTION OF DEVICE MODIFICATION

The Afmion™ HbA1c assay labeling was modified to incorporate information from the previously cleared diagnostic version of the test – Afinion™ HbA1c Dx. Supporting data information on analytical specificity for hemolysis, hemoglobin derivatives, hemoglobin variants and, exogenous and endogenous substances.

## CONCLUSION

The information and data in this 510(k) application demonstrate that the Afinion™ HbA1c assay with modified labeling is substantially equivalent to the unmodified predicate devices.