(636 days)
Afinion™ 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 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 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,
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.
The provided text is a 510(k) premarket notification for a medical device, specifically an in-vitro diagnostic test. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical performance study for an AI/ML-based medical device.
The document discusses analytical performance characteristics but does not present clinical performance data with a test set, ground truth established by experts, or MRMC studies. The core of this submission is about demonstrating equivalence to existing, cleared devices rather than providing novel clinical efficacy data for a new type of device or an AI algorithm.
Therefore, I cannot provide all the requested information for an AI/ML device study. I can extract the analytical performance characteristics that serve as "acceptance criteria" for this IVD and the reported device performance within the scope of this regulatory submission.
Here's an attempt to answer the questions based on the provided document, noting the limitations of the document's content for AI/ML specific criteria:
Device: Afinion™ HbA1c, Afinion™ 2, Alere Afinion™ AS100 Analyzer
The device is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used as a marker for long-term metabolic control in persons with diabetes mellitus. This is a chemical assay, not an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to analytical performance specifications, not clinical performance for an AI/ML algorithm. The document presents a comparison of the "Candidate Device" (Modified Afinion™ HbA1c) with predicate devices, highlighting improvements or more detailed specifications for analytical specificity and interference.
| Category | Acceptance Criteria (Implied by Predicate/New Specificity) | Reported Device Performance (Candidate Device - Modified Afinion™ HbA1c) |
|---|---|---|
| Analytical Specificity: Hemoglobin Variants & Derivatives | Predicate: HbAC, HbAD, HbAE, HbF, HbAJ, HbAS, Carbamylated Hb, Pre-glycated Hb do not affect result. | No significant interference (≤ 7%) 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 (HbF) | Predicate: 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 (Sample Condition) | Predicate: 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 (Endogenous/Exogenous Substances) | Predicate: No significant interference (<5%) up to specified concentrations for Bilirubin, Triglycerides, Cholesterol, Glucose, Fructosamine, Hemolysis, Anticoagulants, Acetaminophen, Ibuprofen, Acetylsalicylic acid, Salicylic acid, Glyburide, Metformin. | No significant interference (≤7%) was observed up to the following concentrations: • Bilirubin conjugated 600 mg/L• Bilirubin unconjugated 600 mg/L• Glucose 10 g/L• Lipids (as Intralipid) 10 g/L• Rheumatoid factor 780 000 IU/L• Total protein 15 g/dL• Glycated albumin 7.7 g/L• Acetaminophen 200 mg/L• Acetylcysteine 1663 mg/L• Acetylsalicylic acid 1000 mg/L• Ampicillin 1000 mg/L• Ascorbic acid 300 mg/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 (in vitro) 14 %• Anticoagulants (EDTA, heparin and citrate) at concentrations normally used in blood collection tubes do not interfere. |
2. Sample size used for the test set and the data provenance
The document describes analytical performance characteristics, meaning substances were tested to determine their interference with the assay. It does not mention a "test set" in the context of an AI/ML algorithm evaluation with patient data. The specifics of sample size and data provenance (country, retrospective/prospective) for these analytical studies are not provided in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/provided. For an in-vitro diagnostic assay like Afinion™ HbA1c, the ground truth for analytical performance is established by known concentrations of substances or reference methods, not by expert consensus on clinical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies involving interpretation (e.g., radiology for AI/ML), which is not the nature of this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. An MRMC study is relevant for AI/ML imaging devices that assist human readers. This device is an automated diagnostic assay.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided, as this is not an AI/ML algorithm. The device "stand-alone" performance is its analytical performance as an automated assay, as detailed in the interference and specificity sections.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for this type of IVD testing would typically involve:
- Reference methods: Comparing the device's results to established, highly accurate laboratory methods for HbA1c measurement.
- Known concentrations: Spiking samples with known concentrations of interfering substances or hemoglobin variants to determine the assay's specificity and interference profile.
The document does not explicitly state the reference method used but implies the use of controlled laboratory conditions and specific substance concentrations for interference testing.
8. The sample size for the training set
This information is not applicable/provided. The Afinion™ HbA1c is a chemical assay, not an AI/ML device, and therefore does not have a "training set" in the sense of machine learning. The "training" of such a device involves assay development, reagent formulation, and calibration using established chemical and biological principles.
9. How the ground truth for the training set was established
This information is not applicable/provided. Similar to the above, as this is not an AI/ML device, there is no "training set" in the context of ground truth establishment for machine learning. The calibration and validation of the chemical assay would be based on certified reference materials and established metrological traceability.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/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 bold, black font. The 'a' symbol is a rounded, geometric shape, and the overall design is clean and modern.
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 ASKjelsaasveien 161PO Box 6863 RodeloekkaNO-0504 OsloNorwayEstablishment #9613069 |
| Company Contact: | Nathifa BradshawRegulatory Affairs ManagerPhone: +1-561-428-2203Email: 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.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized lowercase "a" in blue, positioned above the company name "Abbott" in black, bold font. The "a" is designed with rounded edges and a gap in the upper right, giving it a modern and recognizable appearance.
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.
{5}------------------------------------------------
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.
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.
{6}------------------------------------------------
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 - K171650Afinion™ HbA1c | Predicate Device-K151809Alere Afinion™HbA1c | Candidate DeviceModified Afinion™ HbA1c |
|---|---|---|---|
| Similarities | |||
| Intended use | Afinion™ HbA1c is an in vitro diagnostic testfor quantitative determination of glycatedhemoglobin (% hemoglobin A1c, % HbA1c) inhuman whole blood. The measurement of %HbA1c is recommended as a marker of longterm metabolic control in persons withdiabetes mellitus. | Alere Afinion™HbA1c is an in-vitrodiagnostic test for quantitativedetermination of glycatedhemoglobin (%hemoglobin A1c, % HbA1c) inhuman whole blood. Themeasurement of % HbA1c isrecommended as a marker of longterm metabolic control in personswith diabetes mellitus | Afinion™ HbA1c is an in vitro diagnostic test forquantitative determination of glycated hemoglobin(% hemoglobin A1c, % HbA1c) in venous andcapillary human whole blood. The measurement of% HbA1c is recommended as a marker of long termmetabolic control in persons with diabetes mellitus. |
| Assay principle | Afinion™ HbA1c is a fully automatedboronate affinity assay for the determination ofthe percentage of hemoglobin A1c in humanwhole 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 inlabeling | Same | Same |
{7}------------------------------------------------
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.
Page 5 of 8
| Attribute | Predicate Device - K171650Afinion™ HbA1c | Predicate Device-K151809Alere Afinion™HbA1c | Candidate DeviceModified 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. |
{8}------------------------------------------------
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.
Page 6 of 8
| Attribute | Predicate Device - K171650Afinion™ HbA1c | Predicate Device-K151809Alere Afinion™HbA1c | Candidate DeviceModified Afinion™ HbA1c |
|---|---|---|---|
| Analyticalspecificity | The following hemoglobin (Hb)variants have been analyzed andfound not to affect the AlereAfinion™ HbA1c test result: HbAC,HbAD, HbAE, HbF, HbAJ and HbAS.Carbamylated hemoglobin does notaffect the Alere Afinion™ HbA1c testresult. Pre-glycated hemoglobin doesnot affect the Alere Afinion™ HbA1cresult. | The following hemoglobin (Hb)variants have been analyzed andfound not to affect the AlereAfinion™ HbA1c test result: HbAC,HbAD, HbAE, HbF, HbAJ and HbAS.Carbamylated hemoglobin does notaffect the Alere Afinion™ HbA1c testresult. Pre-glycated hemoglobin doesnot affect the Alere Afinion™ HbA1cresult. | No significant interference (≤ 7%) was observed forsamples with hemoglobin (Hb) variants andhemoglobin derivatives up to the followingconcentrations:• 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 significantinterference (≤ 7%) is observed is 10.4% HbF. Above10.4% HbF, a negative interference is observed. |
| Limitations | Do not analyze hemolyzed or coagulatedsamples. | Do not analyze hemolyzed or coagulatedsamples. | Coagulated or hemolyzed samples cannot be usedwith Afinion™ HbA1c. Samples with >14% (2000mg/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 andcitrate) at concentrations normallyused in blood collection tubes. | • Anticoagulants (EDTA, heparin andcitrate) at concentrations normallyused 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 ( in vitro ) 14 % | |||
| • Anticoagulants (EDTA, heparin and citrate) atconcentrations normally used in blood collectiontubes do not interfere. |
{9}------------------------------------------------
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
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, sans-serif letter 'A' in a light blue color. Below the symbol is the company name, "Abbott," written in a bold, sans-serif font. The text is black, providing a strong contrast against the white background.
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.
§ 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).