AFINION ANALYZER

K110056 · Axis-Shield Poc AS · LCP · Feb 15, 2011 · Hematology

Device Facts

• Record ID: K110056
• Device Name: AFINION ANALYZER
• Applicant: Axis-Shield Poc AS
• Product Code: LCP · Hematology
• Decision Date: Feb 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Data Connectivity Converter (ADCC) is a small device for automatic transfer of data. including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system or another electronic journal system. Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer with Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only. Afinion™ HbAIc is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin Alc. % HbA Ic) in human whole blood. The measurement of % HbA Ic is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. Afinion™ HbA Ic Controls have been designed for use with the Afinion™ ASI00 Analyzer System. Quality control using the Afinion™ HbA Ic Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable result. The 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™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy. The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ ASI00 Analyzer System is working properly and provides reliable results.

Device Story

Afinion AS100 Analyzer is a compact point-of-care multi-assay system. The Afinion Data Connectivity Converter (ADCC) is an accessory added to the analyzer to enable automatic data transfer. The ADCC extracts patient and control assay results from the analyzer, converts the proprietary protocol into standardized HL7 or ASTM formats, and forwards data via Ethernet to a laboratory information system (LIS) or electronic journal system. The device provides user feedback via LEDs and includes a web interface for configuration and software upgrades. It is intended for use by healthcare professionals in clinical settings. The system benefits patients by facilitating efficient, automated integration of diagnostic test results into electronic health records, supporting clinical decision-making for diabetes and nephropathy management.

Clinical Evidence

Bench testing only. Verification and validation activities were performed according to the design plan, including software code reviews, software module testing, and functional testing. The device was tested for conformity with electrical safety (IEC 61010-1, 61010-2-081, 61010-2-101) and electromagnetic compatibility (EN 61326-1, EN 61326-2-6, FCC Part 15) standards.

Technological Characteristics

The ADCC is an external hardware accessory for the Afinion AS100 Analyzer. It features Ethernet connectivity for data transmission, LED status indicators, and a web-based interface for configuration and software updates. It supports HL7 and ASTM communication protocols. The system complies with IEC 61010-1, IEC 61010-2-081, IEC 61010-2-101, and EN 61326 series standards.

Indications for Use

Indicated for point-of-care quantitative determination of HbA1c in human whole blood for long-term metabolic control monitoring in patients with diabetes mellitus, and for quantitative determination of albumin, creatinine, and albumin/creatinine ratio in human urine to aid in early diagnosis of nephropathy.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• Afinion™ AS100 Analyzer (k050574)

Reference Devices

• Afinion™ ACR and Afinion™ ACR Control (k072409)

Submission Summary (Full Text)

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# FEB 15 2011

Image /page/0/Picture/2 description: The image shows the logo for Axis-Shield. The logo features a stylized figure of a person standing on a globe-like structure, holding a bow and arrow pointed upwards. The text "AXIS-SHIELD" is written to the right of the figure.

Axis-Shicld PoC AS Part of the Axis-Shield Group

> Postal address: P.O.Box 6863 Rodeløkka N-0504 Oslo, Norway Visiting address: Kielsåsveien 161 N-0884 Oslo, Norway Tel: [phone] Fax: +47 24 05 GO 10 www.axis-shield-poc.com Bank account: 6003 06 59883

## Special 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: 1110056

| Submission type: | 510 (k) Special; modification of a previously cleared device |
|-------------------|-----------------------------------------------------------------------------------|
| Submitter/Owner: | Axis-Shield PoC AS<br>P.O. Box 6863 Rodelokka, N-0504 Oslo, Norway |
| Contact person: | Ms. Kari Skinnemoen, Regulatory Affairs Manager<br>E-mail: [e-mail] |
| Preparation date: | 6 January 2011 |

Proprietary and Established Names of Previously Cleared Device:

Afinion™ AS 100 Analyzer Afinion™ HbAlc Afinion™ HbAlc Controls

#### Regulatory Information of Previously Cleared Device

510(k) no .: k050574 Device Classification: Class I, II Product Codes: JQT, LCP, JJX CLIA complexity: Waived

Regulatory Information of Other Cleared Device applicable to this Submission 510(k) no .: k072409 Trade/Device Name: Afinion™ ACR and Afinion™ ACR Control Device Classification: Class II Product Codes: JFY, JIR, JJY

## Intended use/Indications for Use of Previously Cleared Device (k050574)

Afinion™ ASI00 Analyzer System, consisting of Afinion™ ASI00 Analyzer, Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ ASI00 Analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges.

Afinion™ HbA Ic is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A 1c, % HbA 1c) in human whole blood. The measurement of % HbA 1c is recommended as a marker of long-term metabolic control in persons with

Axis-Shield PoC AS, Special 510(k) Summary, dated 6 January 2011

ISO 9001 and ISO 13485 Certified

Image /page/0/Picture/19 description: The image contains two logos and the text "Certificate No. 255". The logo on the left has the letters "TI" inside of a circle with the text "Teknologisk Institutt" underneath. The logo on the right has a crown on top of a symbol that looks like the letter "A" inside of a circle with the text "DANSKE ACCREDITERING QUALITY" underneath.

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diabetes mellitus.

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

#### Description of Device Modification:

The Afinion™ AS100 Analyzer is equipped with a new component/accessory: A finion™ Data Connectivity Converter (ADCC). The ADCC is only for use together with the Afinion™ AS100 Analyzer.

The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Afinion™ Analyzer to a laboratory information system (LIS) or another electronic journal system. It converts the format of the results from the proprietary Afinion™ Analyzer protocol to a standardized protocol (HL7 or ASTM). The main functionality for software contained in the Afinion™ Data Connectivity Converter is to:

- . Extract test result data from the Afinion™A\$100 Analyzer
- . Convert the transmission format to a configurable standard protocol and forward the result data on Ethernet
- Provide user feedback on LEDs .
- Provide user interface for configuration and software upgrade through a web . interface
- Provide functionality to reset device to default/factory software status. .

#### Comparison Information:

Afinion™ AS100 Analyzer equipped with Afinion™ Data Connectivity Converter (ADCC) is substantial equivalent to the predicate device: Afinion™ AS100 Analyzer. There is no change in indication/intended use, fundamental scientific technology, analytical performance or safety of the Afinion™ AS100 Analyzer System, consisting of Afinion™ AS100 Analyzer, Afinion™ Test Cartridges and Afinion™ Controls.

#### Design Control Activities

Level of concern: moderate. The software device is an accessory/component to a medical device that has a moderate level of concern (Afinion™ AS100 Analyzer).

Hazards analysis has been performed during development regarding installation and operation of Afinion™ Data Connectivity Converter together with the Afinion AS100 Analyzer addressing risks for patient, operator and environment. No hazards have been assessed to have unacceptable risk.

The design development and the verification/validation have been performed according to the Design Plan. Software code reviews, software module testing and functional testing have been performed. Based on the results the Afinion™ Data Connectivity Converter is considered to be in agreement with design input/design specifications.

Axis-Shield PoC AS, Special 510(k) Summary, dated 6 January 2011

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## Safety standards for clectrical equipment for laboratory and IVD use

Afinion™ AS100 Analyzer equipped with Afinion™ Data Connectivity Converter has been tested and found to be in conformity with IEC, UL, CAN/CSA-C22.2: 61010-1 "Safety requirements for electrical equipment for measurement, control, and laboratory use", IEC 61010-2-081 "Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes" and IEC 61010-2-101 "Particular requirements for in vitro diagnostic (IVD) medical equipment".

### Electromagnetic compatibility (EMC) standards

Afinion™ ASI00 Analyzer equipped with Afinion™ Data Connectivity Converter has been tested and found to be in conformity with EN 61326-1:2006 "Electrical equipment for measurement, control, and laboratory use - EMC requirements", EN 61326-2-6:2006 "In vitro diagnostic (IVD) medical equipment" and CFR 47: Telecommunications, Chapter I- FCC Part 15 - Radio Frequency Devices - Subpart B: unintentional radiators (2009).

## Labeling

The labeling is updated by providing instructions for installation and use of the Afinion™ Data Connectivity Converter in a separate User Manual, and by placing the ETL mark on the label, stating compliance with relevant safety standards for electrical equipment for laboratory use.

Axis-Shield PoC AS, Special 510(k) Summary, dated 6 January 2011

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". The caduceus is a symbol of medicine and healing, and the text indicates that the logo represents the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

**FEB 15 2011**

Axis Shield PoC AS c/o Ms. Kari Skinnemoen Regulatory Affairs Manager PO Box 6863 Rodelokka, Oslo, N-0504, Norway

k110056 Re: K110050
Trade Name: Afinion™ AS100 Analyzer
Trade Name: Afinion™ AS1000647479 Frade Name: amber: 21 CFR §864.7470 Regulation Number: 21 Orlogel Hemoglobin Assay Regulatory Class: Class II Regulatory Class. Class If
Product Codes: LCP, JQT, JJX, JIR, JFY, JJY, and DCK Dated: January 6, 2011 Received: January 10, 2011

Dear Ms. Skinnemoen:

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 5 IU(K) prematics is substantially equivalent (for
device referenced above and have determined the legally market predicate devices device referenced above and have deternment the arelly morbed in observed at devices
the indications for use stated in the enclosure) to legally marketd predicate of the the indications for use stated in the enclosure) to togans, the enactment date of the enactment date of the marketed in interstate commerce prior to May been reclassified in accordance
Medical Device Amendments, or to devices that have been reclassified in accordance Medical Device Amendments, or to devices than have been the may the may be and require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act the with the provisions of the Federal Food, Drug, and Cosmons (200). Therefore, market the
approval of a premarket approval application (PMA). You may, the Art The enerals approval of a premarket approval apprication (r.m.). The general controls
device, subject to the general controls provisions of the Act. The general controls device, subject to the general controls for annual registration, listing of devices,
provisions of the Act include requirements for annual registrating and provisions of the Act include requirements for almud. Topen and provisions of the provisions and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns If your device is classitied (see above) into entrols. Existing major regulations
(PMA), it may be subject to such additional controls. Existing major regulations (CFF (PMA), it may be subject to such additional controls. Existing may or segments on the maint of the maint of the maint of your affecting your device can be found in Title 21, Code of Peocers. In a
800 to 895. 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
substanting and and tasmination that your device complies with other. Please be advised that FDA issuance of a substantial cour device complies with other.
not mean that FDA has made a determination that your device administered by other not mean that FDA has made a determination that your dovios admisstered by other requirements of the Act or any Federal statutes and regulirements, and mot
requirements of the Act or any with all the Act 's requirements, nut not Federal agencies. You must comply with all the Act 3 requirement.
Imited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and limited to registration and listing (21 CFR Part 807); labeling (21 Cr 11 cm
809); medical device reporting (reporting of medical device related adverse events) (21 809); medical device reporting (reporting of medical device requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in th CFR 803), and good inn (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverseevents 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): k110056 Device Name: Afinion™ AS100 Analyzer

Indications for Use:

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

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

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

Afinion™ HbA Ic Controls have been designed for use with the Afinion™ ASI00 Analyzer System. Quality control using the Afinion™ HbA Ic Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable result.

The 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™ AS100 Analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.

The Afinion™ ACR Control kit contains liquid preparations of albumin and creatinine in citrate buffer. The controls should be used to confirm that the Afinion™ ASI00 Analyzer System is working properly and provides reliable results.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 1<110056