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), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls is for in vitro diagnostic use only.

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

Alere Afinion™HbA1c Controls have been designed for use with the Alere Afmion™AS100 Analyzer System. Quality control using the Alere Afinion™HbA1c Control should be done to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable result.

The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine using the Alere Afinion™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

The Alere Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Alere Afinion™AS100 Analyzer System is working properly and provides reliable results.

The Afinion™ Lipid Panel is an in vitro diagnostic test for quantitative determination of total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig) in serum. Values for low-density lipoprotein (LDL) cholesterol and Chol/HDL ratio are calculated by the Afinion™ AS100 Analyzer. Chol, HDL cholesterol, Trig, and calculated LDL cholesterol, non-HDL cholesterol and Chol/HDL ratio) are used in the diagnosis and treatment of disorders involving excess or low cholesterol in the blood and lipid and lipoprotein metabolism disorders. Afinion™ Lipid Panel Control has been designed for use with the Afinion™ AS100 Analyzer and Afinion™ Lipid Panel. Afinion™ Lipid Panel Control is intended for use as assayed control material for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

For use in clinical laboratories and point of care laboratory settings. For prescription use only.

Device Description

The Alere Afinion HbA1c test cartridge contains all of the reagents necessary for the determination of % HbA1c. The sample material is collected from a fingerstick or a sample tube with the integrated sampling device before the test cartridge is placed in the cartridge chamber of the Alere Afinion AS100 Analyzer. The blood sample is then automatically diluted and mixed with a solution that releases hemoglobin from the erythrocytes. The hemoglobin precipitates. This sample mixture is transferred to a blue boronic acid conjugate, which binds to the cis-diols of glycated hemoglobin. This reaction mixture is soaked through a filter membrane and all precipitated hemoglobin, conjugate-bound and unbound (i.e. glycated and non-glycated hemoglobin) remains on the membrane. Any excess of conjugate is removed with a washing reagent. The analyzer evaluates the precipitate on the membrane. By measuring the reflectance, the blue (glycated hemoglobin) and the red (total hemoglobin) color intensities are evaluated, the ratio between them of which is proportional to the percentage of HbA1c in the sample. The % HbA1c is displayed on the Alere Afinion™ AS100 Analyzer.

The analyzer uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology to perform a variety of diagnostic assays.

A test cartridge with patient sample or control is placed in the cartridge chamber of the analyzer. By manually closing the lid, the test cartridge is transported into the analysis compartment of the analyzer. There is no further user intervention or activity required to perform the assay. Test and lot specific information are obtained from the test cartridge barcode label, which then initiates the processing of the test. The sample and reagents are automatically transferred between the wells of the test cartridge.

A monochrome solid-state camera monitors the entire process. When the assay is completed, lightemitting diodes (LEDs) illuminate the final reaction area, which can be either a colored membrane or a reaction well. The camera detects the reflected or transmitted light, which is converted to a test result and displayed on the touch screen. When the user accepts the result, the lid covering the cartridge chamber opens automatically and the used test cartridge can be removed and discarded. The analyzer is then ready for the next run.

The current sampling device integrated in the test cartridge is made of plastic with a glass capillary tube glued into the sampling device. The new, modified plastic sampling device will be manufactured in one piece of plastic of the same base material (polystyrene) as the plastic part of the current sampling device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Alere Afinion HbA1c and Alere Afinion AS100 Analyzer. The modification specifically concerns the sampling device capillary, changing it from glass to plastic. The document outlines the study (design control activities) performed to demonstrate that the modified device meets acceptance criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "acceptance criteria were set to maintain the efficiency and safety of the assay in the hands of waived users" and that the verification/validation program included studies of "precision, accuracy, robustness and potential interference of plastic additive as well as external waived user studies." However, the specific quantitative acceptance criteria and the detailed reported device performance against these criteria are not provided in the publicly available summary. The document only offers a general statement: "all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "in-house studies" and "external waived user studies."

Sample Size for Test Set: The specific number of samples (e.g., number of patient samples, number of replicates) used in these studies is not explicitly stated in the provided text.
Data Provenance: The document implies the studies were conducted by Alere Technologies AS. The location of "in-house" studies is likely Norway (where Alere Technologies AS is based). "External waived user studies" suggests data collected from various waived user sites, but no specific countries or locations are mentioned. It is retrospective in the sense that the data proving the device meets acceptance criteria has already been collected and is being used to support the premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures glycated hemoglobin, the ground truth would likely be established using a reference method in a clinical laboratory.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study, which typically involves human readers and assesses the impact of AI assistance, is not applicable to this device. This device is an in-vitro diagnostic assay and analyzer, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only performance) was conducted. The "in-house studies of precision, accuracy, robustness and potential interference of plastic additive" and "external waived user studies" would assess the Alere Afinion AS100 Analyzer's performance with the modified sampling device independently. The entire premise of this 510(k) is to demonstrate the modified device's performance when used alone.

7. Type of Ground Truth Used

The ground truth for the HbA1c measurement would be established by a reference method for glycated hemoglobin in human whole blood, typically performed by a laboratory instrument following established clinical laboratory standards. The document doesn't explicitly state the specific reference method used, but it's implied by the nature of the device (in-vitro diagnostic for quantitative determination of % HbA1c).

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/machine learning model. This is an IVD device, and the verification and validation studies are typically used to confirm the performance characteristics rather than to train an algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of AI/machine learning for this IVD device, this question is not applicable. The "ground truth" for evaluating the device's accuracy would be established by comparing its results to a recognized reference method.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2015

ALERE TECHNOLOGIES AS KARI SKINNEMOEN REGULATORY AFFAIRS MANAGER KJELSAASVEIEN 161 OSLO, NO NO-0884

Re: K151809

Trade/Device Name: Alere Afinion Hba1c and Alere Afinion AS100 Analyzer Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: II Product Code: LCP, JOT Dated: June 26, 2015 Received: July 2, 2015

Dear Dr. Skinnemoen:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -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) K151809

Device Name

Alere Afinion HbA1c and Alere Afinion™AS100 Analyzer

Indications for Use (Describe)

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

This summary of 510(k) safety and efficacy information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K151809

Submission type:	Special 510(k)
Submitter/Owner:	Alere Technologies ASVisiting address: Kjelsaasveien 161, NO-0884 Oslo, NorwayPostal address: P.O. Box 6863 Rodeloekka, NO-0504 Oslo, Norway
Contact person:	Ms. Kari Skinnemoen, Regulatory Affairs ManagerE-mail: kari.skinnemoen@alere.com
Preparation date:	24 June 2015

Device Name: Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer

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

Predicate Devices:

The predicate devices are the following legally marketed devices:

Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer

The Alere Afinion™ HbA1c test system consists of the Alere Afinion™ AS100 Analyzer and the Alere Afinion HbA1c test cartridge. The system was initially cleared under Pre-Market Notification K050574 and later cleared under Pre-Market Notification K110056. The test is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA '88) for current indications for use (CR140337).

Alere Afinion™ AS100 Analyzer is cleared under K110056 also for use with other analyte assay and controls, which are not affected by this modification: Alere Afinion™ ACR, Alere Afinion™ HbA1c Control and Alere Afinion™ ACR Control.

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Alere Technologies AS Special 510(k)

Alere Afinion™ Lipid Panel and Alere Afinion™ Lipid Panel Control are cleared under K132031 for use with Alere Afinion™ AS100 Analyzer.

Intended use/Indications for use (K110056)

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

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

Alere Afinion™ HbA1c Controls have been designed for use with the Alere Afinion™AS100 Analyzer System. Quality control using the Alere Afinion™ HbA1c Control should be done to confirm that the Alere Afinion™ AS100 Analyzer System is working properly and provides reliable result.

Intended use/Indications for use (K132031)

for total cholesterol (Chol), high-density lipoprotein (HDL) cholesterol and triglycerides (Trig). The controls should be used to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.

For use in clinical laboratories and point of care laboratory settings. For prescription use only.

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Principle of the assay

Alere Afinion™ HbA1c

Alere Afinion™ AS100 Analyzer

The analyzer uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology to perform a variety of diagnostic assays.

Description of Device Modification

Comparison Information

The design and appearance of the plastic sampling device will be very similar to the current sampling device and the user handling will be the same as for the current sampling device.

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Similarities
Attribute	Alere Afinion HbA1csystem (predicate)	Modified device
Intended use	Measurement of %HbA1c inhuman whole blood as amarker of long termmetabolic control in personswith diabetes mellitus.	Same
Test principle	Automated boronate affinityassay.	Same
Type of test	Quantitative in-vitrodiagnostic test	Same
Intended users	Prescription use.Waived users.	Same
Blood sampling	Standard phlebotomytechniques for obtainingvenous blood samples.Fingerstick by use of lancet.	Same
Procedure for filling ofsampling device capillary	Touch the surface or bringthe tip of the capillary justbeneath the surface of theblood drop/sample. Do notwipe off the capillary afterfilling.	Same
Fill volume of samplingdevice capillary	1.5 µL	Same
Design of sampling device	Grip for pulling up andinserting the sampling deviceinto the cartridge	Same

Differences
Attribute	Alere Afinion HbA1c system (predicate)	Modified device
Sampling device capillary material and appearance	Glass	PlasticSlightly different shape and appearance.
Cartridge barcode	For analyzer identification of HbA1c test with glass capillary sampling device.	For analyzer identification of HbA1c test with plastic capillary sampling device
Package Insert and Quick Guide	Illustrations of cartridge and sampling device with glass capillary.	Illustrations of cartridge and sampling device with plastic capillary.

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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 efficiency and safety of the assay in the hands of waived users. The verification/validation program included in-house studies of precision, accuracy, robustness and potential interference of plastic additive as well as external waived user studies.

Conclusion

As required by the risk analysis, all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met. The modified devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).