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 Alere Afmion™ test cartridges 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.

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 the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

Device Description

The Afinion™ 2 analyzer is a multi-assay analyzer for point-of-care testing, designed for use with Alere Afinion™ assays. The Afinion™ 2 analyzer is a modification, a new model, of the previously cleared device Alere Afinion™ AS100 Analyzer.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and study information related to the Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer:

Due to the nature of the provided document (a 510(k) summary), the level of detail you're requesting, especially concerning specific numerical acceptance criteria, detailed study designs, and ground truth establishment for training sets, is generally not fully disclosed. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design modifications and verification/validation.

However, I will extract all available information and highlight what is not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria alongside reported device performance for analytical studies. Instead, it states that "All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software)." and "Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met."

This implies that the acceptance criteria for the Afinion™ 2 analyzer were established to ensure its performance was equivalent to, or did not degrade from, the predicate Afinion™ AS100 Analyzer. The specific performance metrics (e.g., accuracy, precision) for HbA1c and ACR assays would have been assessed, but their numerical targets are not detailed in this summary.

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

The document does not explicitly state the sample sizes for the test sets used in the verification and validation studies.

Regarding data provenance: studies were "in-house analytical performance verification studies." This suggests the data was collected by the manufacturer. The location of Abbott Rapid Diagnostics for the applicant is listed as Kjelsaasveien 161, PO Box 6863 Rodeloekka, NO-0504 Oslo, Norway, which implies data collection might have occurred there or at other internal Abbott facilities. The document does not specify if the data was retrospective or prospective, though "verification studies" often involve prospective collection or use of specific samples to test performance.

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

This information is not provided. For device performance verification, ground truth typically refers to reference measurements from established, highly accurate methods or external laboratories. The document doesn't detail how this reference standard was obtained or if human experts were involved in establishing it beyond standard laboratory practices.

4. Adjudication Method for the Test Set

This information is not provided. Since the device measures quantitative biomarkers (HbA1c and ACR), "adjudication" in the context of expert consensus for subjective interpretations (like in imaging) is not directly applicable here. Performance is typically compared against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret outputs with and without AI assistance. The Alere Afinion™ 2 analyzer is a quantitative measurement device, not an interpretative AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are inherently standalone performance tests for the device. The device measures HbA1c and ACR values independently. The purpose of these verification and validation studies was to confirm that the modified device (Afinion™ 2 analyzer) performs comparably to the predicate device with respect to its analytical capabilities.

7. The Type of Ground Truth Used

While not explicitly stated, for quantitative assays like HbA1c and ACR, the ground truth would typically be established by:

Reference laboratory methods: Highly accurate and precise laboratory-based methods (e.g., HPLC for HbA1c, or established clinical chemistry methods for albumin and creatinine) often traceable to international standards.
Certified reference materials: Use of materials with known, certified concentrations of HbA1c, albumin, and creatinine.
Comparative testing: Measuring samples on a recognized, cleared reference device (in this case, likely the predicate Afinion™ AS100 Analyzer itself, or another gold standard).

The document mentions "analytical performance verification studies," which would rely on such established reference standards.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its size. This device is a quantitative diagnostic instrument, not an AI/ML algorithm that undergoes a distinct training phase. Its design modifications were verified through standard engineering and analytical performance testing, not machine learning training.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm in this context.

Summary of Available Information from the Provided Text:

Acceptance Criteria & Performance: "All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software). The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Alere Afinion™ HbA1c and Alere Afinion™ ACR are not adversely affected by using the modified device. Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met." Specific numerical criteria are not provided.
Sample Size (Test Set): Not specified.
Data Provenance (Test Set): "in-house analytical performance verification studies." Implies internal data, potentially from Norway where the applicant is located. Retrospective/Prospective not specified.
Experts (Ground Truth): Not specified.
Adjudication Method: Not applicable for a quantitative assay.
MRMC Study: No.
Standalone Performance: Yes, the device's analytical performance was assessed.
Ground Truth Type: Likely reference laboratory methods or certified reference materials, compared to the predicate device.
Sample Size (Training Set): Not applicable (not an AI/ML device with a distinct training phase).
Ground Truth (Training Set): Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2017

Abbott Rapid Diagnostics Annie Wright Senior Regulatory Affairs Manager 9975 Summers Ridge Road San Diego, California 92121

Re: K171650

Trade/Device Name: Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JFY, JQT Dated: June 2, 2017 Received: June 5, 2017

Dear Annie Wright:

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

{1}------------------------------------------------

803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171650

Device Name

Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer

Indications for Use (Describe)

X 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 contains the logo for Abbott Laboratories. 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, black font. The logo is simple and modern, conveying a sense of trust and reliability.

K171650 510(k) SUMMARY

GENERAL INFORMATION

Submitter:	Abbott Rapid Diagnostics
	9975 Summers Ridge Road
	San Diego, CA 92121 USA
	Annie Wright
	Senior Manager, Regulatory Affair
	Phone: (858) 805-2316
	Email: annie.wright@alere.com
Applicant Name:	Abbott Rapid Diagnostics
	Kjelsaasveien 161
	PO Box 6863 Rodeloekka
	NO-0504 Oslo
	Norway
	Establishment #9613069

Date Prepared: November 20, 2017

DEVICE IDENTIFICATION

Trade or Proprietary Names: Alere Afinion™ HbA1c Alere Afinion™ ACR Afinion™ 2

Common Name: HbA1c test ACR test Analyzer

Classification:

Product Code	Classification	Regulation Section	Classification Panel
LCP	Class II	21 CFR 864.7470	Hematology
JFY	Class II	21 CFR 862.1225	Chemistry
JQT	Class I	21 CFR 862.2400	Chemistry

{4}------------------------------------------------

Image /page/4/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, sans-serif font. The 'a' is designed with a rounded, modern look, and the overall design is clean and professional.

Predicate Device:

Alere Afinion™ HbA1c and Alere Afinion™ AS100 Analyzer (K151809)

The following are the legally marketed devices covered under the predicate device clearance, K151809, and their prior clearances:

The Alere Afinion™ HbA1c assay with HbA1c controls for use with the Alere Afinion™ AS100 Analyzer was cleared under K050574.

The Alere Afinion™ ACR assay with ACR controls for use with the Alere Afinion™ AS100 Analyzer was cleared under K072409.

The system, including both HbA1c and ACR assays and the Afinion AS100 Analyzer, was cleared under K110056 for the addition of a new accessory, the Afinion Data Connectivity Converter.

A modification to the Afinion HbA1c assay with the Afinion AS100 Analyzer was cleared under K151809.

DEVICE DESCRIPTION

INTENDED USE/INDICATIONS FOR USE

Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Alere Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afinion™ test cartridges is for in vitro diagnostic use only.

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 Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

{5}------------------------------------------------

Image /page/5/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' is designed with rounded edges, giving it a modern and approachable look. The overall design is clean and professional, reflecting the company's focus on health and innovation.

COMPARISON WITH PREDICATE

Attribute	Predicate DeviceAlere Afinion™ AS100AnalyzerK151809	Candidate DeviceAlere Afinion™ HbA1c andACR on Afinion™ 2 analyzer
Similarities
Intended use	Alere Afinion™ 2 is a compactmulti-assay analyzer for point-of-care testing, designed to analyze theAfinion™ test cartridges.	Same
Analyzer function	Assay cartridge processingincluding pumping, heating, imageprocessing	Same
Cartridge interface	Physical processing of cartridge(locking, docking, splitting, foilpenetration, merging)	Same
User Interface	User display and operatinginstructions in labeling	Same
Peripheral units	A barcode reader and printer can beconnected	Same
Differences
Components	Most components in metal	Several metal components replacedwith injection molded plastics
Electronics	Obsolete components orcomponents that will be obsolete innear future, e.g. CPU and memory.	Obsolete components replaced bythose with more current technology
	14 PCBs in use	9 PCBs in use
Dimensions	190 mm W x 170 mm H x 340 mm D5 kg	200 mm W x 186 mm H x 328 mm D3.4 kg
Connectivity	Separate connectivity unit withEthernet plug	Ethernet plug incorporated into theanalyzer and connectivity softwareincorporated in the software

DESCRIPTION OF DEVICE MODIFICATION

The Alere Afinion™ HbA1c and ACR on Afinion™ 2 analyzer has the same functionality and user interface as the Alere Afinion™ AS100 Analyzer. The intended use/indications for use and fundamental scientific technology have not changed. The primary modifications are changes in component materials and other minor changes in component design in order to make a more robust analyzer. Electronic components that

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Abbott Laboratories. The logo consists of a stylized, rounded letter "a" in blue, positioned above the word "Abbott" in a bold, sans-serif font. The color of the text is black.

are obsolete or expected to become obsolete in the near future were changed. Software overall architecture and high-level requirements remain unchanged from the Alere Afinion™ AS 100 Analyzer to the Afinion™ 2 analyzer. Software design in the Afinion™ 2 analyzer was modified from the Alere Afinion™ AS 100 Analyzer wherever needed to adapt to changes made to electronics and mechanics in order to maintain assay sequence timing as it is in the Alere Afinion™ AS100 Analyzer.

DESIGN CONTROL ACTIVITIES

The design development and verification/validation of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the performance and safety of the Afinion™ system using the applicable Alere Afinion™ tests with the device. All requirements for Alere Afinion™ AS100 Analyzer have been re-verified for Afinion™ 2 analyzer through tests both at system level and discipline level (electronics, mechanics and software). The risk analysis identified the appropriate in-house analytical performance verification studies to demonstrate that the analytical performance and risk of erroneous results for Alere Afinion™ HbA1c and Alere Afinion™ ACR are not adversely affected by using the modified device.

CONCLUSION

Verification and validation studies were performed as required by risk analysis and all acceptance criteria were met. This device is found to be substantially equivalent to the predicate device.

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).