K Number

Device Name

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

Manufacturer

AXIS-SHIELD DIAGNOSTICS, LTD.

Date Cleared

2008-03-17

(175 days)

Product Code

LCP JIT JJX

Regulation Number

864.7470

Intended Use

Device Description

The AxSYM HbA1c assay is an immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. In the AxSYM HbA1c assay, whole blood sample is lysed, releasing hemoglobin and HbA1c analyte. Lysed sample is added to the glass fiber matrix that has been coated with Blocking Buffer in a previous step. Hemoglobin and HbA1c analyte are captured on the glass fiber matrix by the binding reaction that occurs between the analyte and the Blocking Buffer. HbA1c is quantified by measuring the amount of HbA1c analyte captured on the matrix cell, using a conjuqate of Anti-HbA1c and Alkaline Phosphatase as the signal-generating molecule, and the substrate, 4-Methylumbelliferyl Phosphate (MUP). The AxSYM HbA1c reagents and sample are pipetted in the following sequence: SAMPLING CENTER - The whole blood samples can be processed from AxSYM sample . cups or from primary blood collection tubes (fluoride oxalate and fluoride EDTA). Potassium EDTA blood collection tubes that have undergone a single freeze-thaw cycle may also be processed from AxSYM sample cups or from the primary blood collection tube. Fresh (non-frozen) potassium EDTA primary whole blood collection tubes may be used if testing is performed in STAT mode and run in groups of eight tubes or less. For further instructions on use of potassium EDTA whole blood samples, refer to the SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS section. The sample and all AxSYM HbA1c reagents required for one test . are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV). The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe. PROCESSING CENTER - The whole blood sample is combined with the Lysis Buffer and . incubated for 450 seconds. - . The matrix cell is coated with Blocking Buffer. The lysed sample is diluted with Sample Diluent and transferred to . the matrix cell. Hemoglobin and the HbA1c analyte are captured on the glass fiber matrix through interactions with the blocking buffer overcoat. - . The matrix cell is washed to remove unbound materials. - . The Anti-HbA1c:Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the analyte, forming an antigen-antibody complex. - . The matrix cell is washed to remove unbound materials. - . The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly. The concentration of HbA1c in the sample is determined using a previously generated calibration curve

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K011434

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay process and mentions a calibration curve, but there is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
This device is for in vitro diagnostic use, specifically for the quantitative determination of percent hemoglobin A1c (HbA1c) to assess the long-term efficacy of diabetic control. It does not directly treat or prevent a disease, but rather provides diagnostic information.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." Additionally, it describes the device as an "immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System," which is used "in the clinical management of diabetes to assess the long-term efficacy of diabetic control." This clearly indicates its role in diagnosing and monitoring a medical condition.

SaMD (Software as a Medical Device)

The device description clearly outlines a complex immunoassay process involving physical reagents, sample handling, and a dedicated hardware system (AxSYM System) for pipetting, incubation, washing, and fluorescence measurement. This is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
Nature of the Test: The device performs an immunoassay on whole blood samples to quantitatively determine percent hemoglobin A1c (HbA1c). This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
Clinical Purpose: The results of the test are used in the "clinical management of diabetes to assess the long-term efficacy of diabetic control." This indicates the test is used for medical purposes in a clinical setting.
Components: The description mentions reagents, calibrators, and controls, which are typical components of an IVD system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LCP, JIT, JJX

Device Description

In the AxSYM HbA1c assay, whole blood sample is lysed, releasing hemoglobin and HbA1c analyte. Lysed sample is added to the glass fiber matrix that has been coated with Blocking Buffer in a previous step. Hemoglobin and HbA1c analyte are captured on the glass fiber matrix by the binding reaction that occurs between the analyte and the Blocking Buffer. HbA1c is quantified by measuring the amount of HbA1c analyte captured on the matrix cell, using a conjuqate of Anti-HbA1c and Alkaline Phosphatase as the signal-generating molecule, and the substrate, 4-Methylumbelliferyl Phosphate (MUP).

The AxSYM HbA1c reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

The whole blood samples can be processed from AxSYM sample cups or from primary blood collection tubes (fluoride oxalate and fluoride EDTA). Potassium EDTA blood collection tubes that have undergone a single freeze-thaw cycle may also be processed from AxSYM sample cups or from the primary blood collection tube. Fresh (non-frozen) potassium EDTA primary whole blood collection tubes may be used if testing is performed in STAT mode and run in groups of eight tubes or less. For further instructions on use of potassium EDTA whole blood samples, refer to the SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS section.

The sample and all AxSYM HbA1c reagents required for one test are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV).

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.

PROCESSING CENTER

The whole blood sample is combined with the Lysis Buffer and incubated for 450 seconds.
The matrix cell is coated with Blocking Buffer.

The lysed sample is diluted with Sample Diluent and transferred to the matrix cell. Hemoglobin and the HbA1c analyte are captured on the glass fiber matrix through interactions with the blocking buffer overcoat.

The matrix cell is washed to remove unbound materials.
The Anti-HbA1c:Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the analyte, forming an antigen-antibody complex.
The matrix cell is washed to remove unbound materials.
The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly.

The concentration of HbA1c in the sample is determined using a previously generated calibration curve

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The AxSYM HbA1c assay demonstrated substantially equivalent performance to the G7 Automated Glycosylated Hemoclobin HPLC Analyzer indicated by a method comparison study. The AxSYM HbA1c bias for all samples against HPLC method is -0.26% HbA1c, with 95% confidence interval of -0.32 to -0.20% HbA1c. Passing-Bablok linear regression method comparison was performed on 300 samples. AxSYM HbA1c versus HPLC gave a slope of 1.02 (95% Confidence interval 0.97 to 1.06) and an intercept of -0.35 (95% Confidence interval -0.63 to -0.07). Correlation coefficient was determined using Pearson Correlation. AxSYM HbA1c versus HPLC gave an r value of 0.96 (95% Confidence interval 0.95 to 0.97).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

AxSYM HbA1c bias for all samples against HPLC method is -0.26% HbA1c, with 95% confidence interval of -0.32 to -0.20% HbA1c.
Passing-Bablok linear regression slope: 1.02 (95% Confidence interval 0.97 to 1.06)
Passing-Bablok linear regression intercept: -0.35 (95% Confidence interval -0.63 to -0.07)
Pearson Correlation coefficient (r value): 0.96 (95% Confidence interval 0.95 to 0.97)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K011434

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

ADMIN 3.0 AxSYM HbA1c 510(k) SUMMARY

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

The assigned 510(k) number is:

Submission correspondent:

Dr Claire Dora Acting Regulatory Affairs Manager Axis-Shield Diagnostics, Ltd. The Technology Park Dundee DD2 1XA, UK

Device Name: AxSYM HbA1c

Reagents:

Classification Name: Assay, Glycosylated Hemoglobin Trade Name: AxSYM HbA1c Common Name: Glycosylated Hemoglobin test Governing Requlation: 21 CFR 864.7470 Device Classification: Class II Classification Panel: Hematology (81) Product Code: LCP

Calibrators:

Classification Name: Calibrator, Secondary Trade Name: AxSYM HbA1c Standard Calibrators

AxSYM Anti-CCP 510(k) Premarket notification submission ADMIN 4.0 510(k) Summary Final v2.0 Last Updated: 2008-03-05

Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

Controls:

Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: AxSYM HbA1c Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX

Legally marketed device to which equivalency is claimed:

G7 Automated Glycosylated Hemoglobin HPLC Analyzer (TSKgel G7 Variant Hsi); K011434.

Intended Use of Device:

The AxSYM HbA1c Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbA1c in whole blood samples.

The AxSYM HbA1c Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM HbA1c assay when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System.

Description of Device:

The AxSYM HbA1c reagents and sample are pipetted in the following sequence:

SAMPLING CENTER

The whole blood samples can be processed from AxSYM sample . cups or from primary blood collection tubes (fluoride oxalate and fluoride EDTA). Potassium EDTA blood collection tubes that have undergone a single freeze-thaw cycle may also be processed from AxSYM sample cups or from the primary blood collection tube. Fresh (non-frozen) potassium EDTA primary whole blood collection tubes may be used if testing is performed in STAT mode and run in groups of eight tubes or less. For further instructions on use of potassium EDTA whole blood

samples, refer to the SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS section.

The sample and all AxSYM HbA1c reagents required for one test . are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV).

The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe.

PROCESSING CENTER

The whole blood sample is combined with the Lysis Buffer and . incubated for 450 seconds.
. The matrix cell is coated with Blocking Buffer.

The lysed sample is diluted with Sample Diluent and transferred to . the matrix cell. Hemoglobin and the HbA1c analyte are captured on the glass fiber matrix through interactions with the blocking buffer overcoat.

. The matrix cell is washed to remove unbound materials.
. The Anti-HbA1c:Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the analyte, forming an antigen-antibody complex.
. The matrix cell is washed to remove unbound materials.
. The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly.

The concentration of HbA1c in the sample is determined using a previously generated calibration curve

Comparison of Technological Characteristics:

AxSYM HbA1c is an automated immunoassay.

G7 Automated Glycosylated Hemoglobin HPLC Analyzer is an automated High Performance Liquid Chromatography system.

Summary of Non-Clinical Performance:

The AxSYM HbA1c assay is substantially equivalent to the G7 Automated Glycosylated Hemoglobin HPLC Analyzer assay in terms of precision, linearity, interferences and stability as demonstrated in non-clinical performance data in this 510(k) submission.

Summary of Clinical Performance:

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Axis-Shield Diagnostics, Ltd. c/o Dr. Claire Dora Regulatory Affairs Officer Luna Place The Technology Park Dundee, Scotland United Kingdom DD2 1XA

MAR 1 7 2008

Re: K072686

Trade Name: AxSYM HbA1c -- Reagent Kit, Standard Calibrator Kit, Control Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIT, JJX Dated: February 27, 2008 Received: February 29, 2008

Dear Dr. Dora:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

ADMIN 5.0 Product Classification - Indications for Use

Statement

510(k) Number (if known):

Device Name: AxSYM HbA1c Reagents, AxSYM HbA1c Standard Calibrators and AxSYM HbA1c Controls

Indications for Use:

Reagents

Calibrators

The AxSYM HbA1c Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbA1c in whole blood samples.

Controls

For in vitro diagnostic use.

Prescription Use ____________

OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

The Office of
The Office of In Vitro Diagnostic Device
Evaluation and Safety
K072686