(636 days)
No
The document describes a standard in vitro diagnostic test and analyzer for measuring HbA1c. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The focus is on the chemical assay and the analyzer's function in processing the test cartridges and transferring data.
No
Explanation: The device is explicitly stated to be an "in vitro diagnostic test" and "for in vitro diagnostic use only," which means it is used for diagnostic purposes outside of a living organism, rather than for direct treatment or prevention of a disease in a patient.
Yes
The device is described as an "in vitro diagnostic test" for quantitative determination of glycated hemoglobin, which is used as a "marker of long-term metabolic control in persons with diabetes mellitus," indicating its use in diagnosing or monitoring a medical condition.
No
The device description clearly states it includes hardware components: the Afinion™ AS100 Analyzer, the Afinion™ 2 analyzer, Afinion™ Test Cartridges, and Afinion™ Controls. The ADCC is also described as a "small device".
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Afinion™ HbA1c is an in vitro diagnostic test..." and "Afinion™ 2 system, consisting of Afinion™ test cartridges is for in vitro diagnostic use only." and "Alere Afinion™ AS100 Analyzer System... is for in vitro diagnostic use only,".
- Nature of the Test: The device performs a quantitative determination of glycated hemoglobin (HbA1c) in human whole blood. This is a laboratory test performed on biological samples outside of the body to provide information about a person's health status.
- Purpose: The measurement of HbA1c is used as a marker for long-term metabolic control in persons with diabetes mellitus, which is a diagnostic and monitoring purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LCP, JQT
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
- 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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Page 1 of 8
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 |
| Kjelsaasveien 161 | |
| PO Box 6863 Rodeloekka | |
| NO-0504 Oslo | |
| Norway | |
| Establishment #9613069 | |
| Company Contact: | Nathifa Bradshaw |
| Regulatory Affairs Manager | |
| Phone: +1-561-428-2203 | |
| Email: nathifa.bradshaw@abbott.com | |
| 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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Page 2 of 8
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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Page 3 of 8
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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Page 4 of 8
COMPARISON WITH PREDICATE
| Attribute | Predicate Device - K171650
Afinion™ HbA1c | Predicate Device-K151809
Alere Afinion™HbA1c | Candidate Device
Modified Afinion™ HbA1c |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | | |
| Intended use | 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. | 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 | 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. |
| Assay principle | Afinion™ HbA1c is a fully automated
boronate affinity assay for the determination of
the percentage of hemoglobin A1c in human
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
labeling | Same | Same |
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Page 5 of 8
| Attribute | Predicate Device - K171650
Afinion™ HbA1c | Predicate Device-K151809
Alere Afinion™HbA1c | Candidate Device
Modified Afinion™ HbA1c |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Differences | | |
| Test Procedure | IMPORTANT!
Do not use test cartridges that have been accidentally dropped on the floor or lab bench after specimen collection. | IMPORTANT!
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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Page 6 of 8
| Attribute | Predicate Device - K171650
Afinion™ HbA1c | Predicate Device-K151809
Alere Afinion™HbA1c | Candidate Device
Modified Afinion™ HbA1c |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytical
specificity | The following hemoglobin (Hb)
variants have been analyzed and
found not to affect the Alere
Afinion™ HbA1c test result: HbAC,
HbAD, HbAE, HbF, HbAJ and HbAS.
Carbamylated hemoglobin does not
affect the Alere Afinion™ HbA1c test
result. Pre-glycated hemoglobin does
not affect the Alere Afinion™ HbA1c
result. | The following hemoglobin (Hb)
variants have been analyzed and
found not to affect the Alere
Afinion™ HbA1c test result: HbAC,
HbAD, HbAE, HbF, HbAJ and HbAS.
Carbamylated hemoglobin does not
affect the Alere Afinion™ HbA1c test
result. Pre-glycated hemoglobin does
not affect the Alere Afinion™ HbA1c
result. | No significant interference (≤ 7%) was observed for
samples with hemoglobin (Hb) variants and
hemoglobin derivatives up to the following
concentrations:
• HbA2 5.7%
• HbAC 36%
• HbAD 42%
• HbAE 26%
• HbAS 42%
• HbF 10.4%
• Acetylated Hb 4.6 mg/mL
• Carbamylated Hb 13.8 mg/mL
• Labile (pre-glycated) Hb 11.4 mg/mL |
| Limitations | No HbF limitation | No HbF limitation | The highest HbF concentration where no significant
interference (≤ 7%) is observed is 10.4% HbF. Above
10.4% HbF, a negative interference is observed. |
| Limitations | Do not analyze hemolyzed or coagulated
samples. | Do not analyze hemolyzed or coagulated
samples. | Coagulated or hemolyzed samples cannot be used
with Afinion™ HbA1c. Samples with >14% (2000
mg/dL) hemolysis may return an information code. |
| Interference | No significant interference (in vitro ) 14 % |
| | | | • Anticoagulants (EDTA, heparin and citrate) at
concentrations normally used in blood collection
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.
Page 7 of 8
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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.