(137 days)
Not Found
No
The description focuses on standard optical measurements (reflection and transmission) and self-calibration, with no mention of AI/ML terms or methodologies.
No.
The device is an in-vitro diagnostic system for quantitative determination of glycated hemoglobin, used as a marker for long-term metabolic control in people with diabetes, rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is for in-vitro diagnostic use only" and is designed for the "quantitative determination of glycated hemoglobin in human blood," which is used as a "marker of long-term metabolic control in persons with diabetes mellitus." These functions clearly define it as a diagnostic device.
No
The device description clearly states it includes hardware components such as a digital camera and Light Emitting Diodes, and is part of a system with an analyzer and test cartridges.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section:
- "Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only."
- "Afinion™ HbA Ic is an in-vitro test for quantitative determination of glycated hemoglobin in human blood."
These statements clearly indicate that the device is intended for use in examining specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of -care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.
Afinion™ HbA Ic is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS100 Analyzer System. Quality control using the Afinion™ HbA 1c Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJX, JQT
Device Description
Instrument read, single usc in-vitro test for quantitative determination of glycated hemoglobin in human whole blood.
Afinion™ AS100 Analyzer utilizes a digital camera and Light Emitting Diodes to perform two kinds of measurements; reflection mcasurement (amount of light rcflected from a membrane) and transmission measurement (amount of light propagating through a liquid). The analyzer is self-calibrated and no calibration by user is needed.
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 substantial equivalence, safety and efficacy of the Axis-Shield PoC Afinion™ HbA1c assay to Bayer DCA 2000® Hemoglobin A1c assay (K951361), 510(k) cleared 05/05/1995, CLIA Waived 11/12/1997, was evaluated internally and externally at three study sites.
Forty (40) venous EDTA blood samples were analyzed internally on both Afinion™ AS100 Analyzer and Bayer DCA 2000 . The Bland-Altman method comparison showed acceptable agreement with a bias of -0.3 % HbA1c and 95 % limit of agreement from -1.0 to 0.4 % HbA1c.
At three external study sites 75 venous EDTA blood samples were analyzed on both Afinion™ AS100 Analyzer and Bayer DCA 2000". The linear regression comparison method showed acceptable agreement with; slope = 0.91, y-intercept = 0.2 % HbA1c and r2 = 0.96.
39 venous EDTA blood samples from the European Reference Laboratory for glycohemoglobin (ERL) wcre analyzed internally by the Afinion™ HbA1c assay and by ERL with their reference method Primus CLC385. The Bland-Altman method comparison showed excellent agreement with a bias of 0.0 % HbA 1 c and 95 % limit of agreement from -0.3 to 0.3 % HbA1c.
Capillary and venous blood samples from 74 donors were analyzed externally with the Afinion™ HbA1c assay. The Bland-Altman comparison showed excellent agreement with a bias of 0.0 % and 95 % limit of agreement from -3.5 to 3.6 %. Linear regression; slope = 0.99, y-interccpt = 0.1 % HbA1c and r2 = 0.99.
Precision studies were performed according to Clinical and Laboratory Standards NCCLS guideline EP5-A by using two levels of blood samples (5,6 and 10,0 % HbAlc) and two Afinion™ HbA1c Controls (6,5 and 9,1 % HbA1c). The withinrun CV was
§ 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).
0
First response to K050574 Afinion™; HbA1c, Control & Analyzer; Appendix 5 Page 1 of 5 Axis-Shield PoC AS
510(k) Summary
Afinion™ HbA1c, Afinion™ HbA1c Control &
Afinion™ AS100 Analyzer
1. Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for determination of substantial equivalence.
2. Submitter
Manufacturer/Owner Axis-Shield PoC AS Marstrandgata 6 P.O. Box 5863 Rodelokka N-0504 Oslo Norway Tel: +47 22 042 000 Fax: +47 22 042 001 Contact person: Jorunn Grevle Lolland Title: Manager Quality Assurance and Regulatory Affairs E-mail: JGL(@no.axis-shicld.com
Date prepared: March 3rd 2005
3. Device name
Trade name: Afinion™ HbA1c Common name: Glycated Hemoglobin Assay Classification name: Glycosylated Hemoglobin assay Regulation Number: 21 CFR § 864.7470
4. Predicate Device
Predicate device name: DCA2000® Hemoglobin A1c Reagent kit
1
5. Device Description
Instrument read, single usc in-vitro test for quantitative determination of glycated hemoglobin in human whole blood.
6. Intended Use
Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer Afinion™ Test Cartridges and Afinion™ Controls is for in-vitro diagnostic use only. Afinion™ AS100 Analyzer is a compact multi-assay analyzer for point-of -care testing, designed to analyze the Afinion™ Test Cartridges. The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.
Afinion™ HbA1c is an in-vitro test for quantitative determination of glycated hemoglobin in human blood. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.
Afinion™ HbA1c Controls have been designed for use with the Afinion™ AS100 Analyzer System. Quality control using the Afinion™ HbA1c Control should be done to confirm that the Afinion™ AS100 Analyzer System is working properly and provides reliable results.
7. Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The formation of glycohemoglobins is principally a function of the concentration of glucose to which the erythrocytes are exposed. Glycated hemoglobin is a clinically useful index of mean glycemia during the preceding 6-8 weeks. Chronic elevated blood sugar level of persons with diabetes mellitus will over time cause damage to the small vessels of the body. The damages develop slowly over years and are known to cause late complications. Depending on the assay method, HbA1c is approximately 3-6 % in non-diabetics, 6-8 % in controlled diabetics and can be as much as 18 % or higher in poorly controlled diabetics.
The Afinion™ HbA1c is a fully automated assay for the determination of the percentage of HbA1c in human whole blood, by use of Afinion™ AS100 Analyzer.
Afinion™ AS100 Analyzer utilizes a digital camera and Light Emitting Diodes to perform two kinds of measurements; reflection mcasurement (amount of light rcflected from a membrane) and transmission measurement (amount of light propagating through a liquid). The analyzer is self-calibrated and no calibration by user is needed.
000089
2
Several fail-safe functions are provided to ensure the quality of assay results, to ensure that no erroneous results are presented to the user and to prevent mechanical damage to the analyzer itself. If an error should occur, an information code described in the User Manual is displayed.
Verification of the Afinion™ AS100 Analyzer has been performed and the results demonstrate compliance with specifications.
The results from the Afinion™ HbAlc assay are traceable to the International Federation of Clinical Chemistry (IFCC) Reference Method for measurement of HbA1c in human blood. NGSP (National Glycohemoglobin Standardization Program, US) recommends that HbA1c values are reported at DCCT-level (Diabetes Control and Complications Trial, US). The IFCC Working Group on Standardization of HbA1c has established a Master Equation for the Designated Comparison Method (the method used in the DCCT study, referred to as the NGSP Master Equation by the Working Group). This master equation (NGSP = 0.9148 IFCC + 2.152) is implemented in the Afinion™ AS100 Analyzer software and the Analyzer displays values at DCCT level.
The substantial equivalence, safety and efficacy of the Axis-Shield PoC Afinion™ HbA1c assay to Bayer DCA 2000® Hemoglobin A1c assay (K951361), 510(k) cleared 05/05/1995, CLIA Waived 11/12/1997, was evaluated internally and externally at three study sites.
Forty (40) venous EDTA blood samples were analyzed internally on both Afinion™ AS100 Analyzer and Bayer DCA 2000 . The Bland-Altman method comparison showed acceptable agreement with a bias of -0.3 % HbA1c and 95 % limit of agreement from -1.0 to 0.4 % HbA1c.
At three external study sites 75 venous EDTA blood samples were analyzed on both Afinion™ AS100 Analyzer and Bayer DCA 2000". The linear regression comparison method showed acceptable agreement with; slope = 0.91, y-intercept = 0.2 % HbA1c and r2 = 0.96.
39 venous EDTA blood samples from the European Reference Laboratory for glycohemoglobin (ERL) wcre analyzed internally by the Afinion™ HbA1c assay and by ERL with their reference method Primus CLC385. The Bland-Altman method comparison showed excellent agreement with a bias of 0.0 % HbA 1 c and 95 % limit of agreement from -0.3 to 0.3 % HbA1c.
Capillary and venous blood samples from 74 donors were analyzed externally with the Afinion™ HbA1c assay. The Bland-Altman comparison showed excellent agreement with a bias of 0.0 % and 95 % limit of agreement from -3.5 to 3.6 %. Linear regression; slope = 0.99, y-interccpt = 0.1 % HbA1c and r2 = 0.99.
000090
3
Precision studies were performed according to Clinical and Laboratory Standards NCCLS guideline EP5-A by using two levels of blood samples (5,6 and 10,0 % HbAlc) and two Afinion™ HbA1c Controls (6,5 and 9,1 % HbA1c). The withinrun CV was