(153 days)
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No
The document describes standard optical signal analysis algorithms and does not mention AI or ML.
No
The device is an in-vitro diagnostic system used to measure % HbA1c, which is a diagnostic and monitoring tool, not a therapeutic intervention.
Yes
The device is intended for "quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood" for "in-vitro diagnostic use by healthcare professionals."
No
The device description clearly states the system includes hardware components: the Aina 2 Automated HbA1c Device, the Aina Device (a reflectance-based colorimetric sensor device), and Aina HbA1c Test Kits. While the Aina Mobile Application is software, it is part of a larger system that relies on physical hardware for sample processing, optical readout, and reagent delivery.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment..."
- Measurement of Biomarkers: The system is designed for the "quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood." HbA1c is a biomarker measured in a biological sample (blood) to provide information about a person's health status (long term glycemic control).
- Sample Type: It uses "human anticoagulated venous whole blood," which is a biological specimen.
- Purpose: The purpose is to "monitor long term glycemic control of persons previously diagnosed with diabetes," which is a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of tissues or organs, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not in the diagnosis of or screening for diabetes or for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
The system consists of the Aina 2 Automated HbA1c Device for sample processing that connects to a smartphone via Bluetooth, the Aina Device for optical test strip readout, Aina HbA1c Test Kits which contain all the reagents necessary for running each HbA1c test, and the Aina Mobile Application. The Aina Device is a reflectance-based colorimetric sensor device that connects to the mobile device through the audio jack. The smartphone runs the Aina Mobile Application, which is software that allows for user interaction and illustrates the step-by-step testing process on its touchscreen. The Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading. In addition, the Aina Mobile Application controls the functioning of the Aina 2 Automated HbA1c Device by sending it commands via Bluetooth. Streck A1c-Cellular control solutions can be used for regular quality control checking of the system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
This test is not intended for use on neonates.
Intended User / Care Setting
It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Blood Sample Repeatability: A 20-day repeatability study was conducted to evaluate the performance of the Aina system as per CLSI EP05-A3.
Sample Sizes: Normal (240), Elevated (240), High (240)
Key Results:
Normal: Mean HbA1c %: 5.4, Total SD: 0.2, Total CV%: 4.2
Elevated: Mean HbA1c %: 6.1, Total SD: 0.2, Total CV%: 3.7
High: Mean HbA1c %: 11.1, Total SD: 0.4, Total CV%: 3.2
Control Repeatability: A 20-day repeatability study was conducted to evaluate the performance of the Aina system as per CLSI EP05-A3. The study was performed using two commercial quality controls with target values of 10% HbA1c.
Sample Sizes: Level 1 (80), Level 2 (80)
Key Results:
Level 1: Mean HbA1c %: 5.9, Total SD: 0.22, Total CV%: 3.7
Level 2: Mean HbA1c %: 13.4, Total SD: 0.38, Total CV%: 2.8
Linearity/Assay Reportable Range: A linearity study was conducted in accordance with CLSI EP06-A. Testing was conducted using venous whole blood specimens collected in K₂-EDTA.
Key Results: A linear regression was calculated: y(%HbA1c) = 1.01x - 0.08; R=0.998. The Aina system has a linear range from 4.4% to 13.4%.
Interfering Substances: This study was performed as per CLSI EP07-A3 to assess known endogenous and exogenous substances.
Key Results: No significant interference was observed for various substances up to listed concentrations (Bilirubin, Triglycerides, Cholesterol, Glucose, Rheumatoid Factor, Total Protein, Fructosamine, Acetylsalicylic acid, Ascorbic Acid, Acetaminophen, Glyburide, Ibuprofen, Metformin, Rifampicin, Salicylic Acid).
Cross Reactivity with Hemoglobin Derivatives: Results demonstrated that Acetylated Hb up to 126.1 mg/dL acetylsalicylic acid, Carbamylated Hb up to 32.5 mg/dL sodium cyanate, and Labile A1c up to 1000 mg/dL glucose do not interfere with this assay.
Hemoglobin Variants: The objective of this study was to evaluate the interference effect of hemoglobin variants.
Key Results: No significant interference for samples containing Hemoglobin C (≤50%), Hemoglobin D (≤43%), Hemoglobin E (≤31%), Hemoglobin S (≤ 42%), and Hemoglobin A2 (≤ 6.5%). WARNING: Significant negative interference from Hemoglobin F (HbF).
Specimen Stability: A study was conducted to evaluate the stability of venous whole blood samples when stored at 2 to 8°C.
Key Results: Whole blood samples are stable for use on the system when stored for up to 10 days within 2 to 8°C.
Clinical Studies: To demonstrate accuracy of the system, fresh prospective venous whole blood was collected with K₂-EDTA as an anticoagulant from study participants at three (3) clinical sites and then tested on the Aina HbA1c Monitoring System 2 by trained healthcare professionals in a laboratory environment. Clinical performance of the Aina HbA1c Monitoring System 2 was compared to the Tosoh G8 reference method. Regression analysis was performed.
Sample Size: n=132
Key Results:
Passing-Bablok: Slope = 1.0, 95% CI (0.9792 - 1.041); y-Intercept = -0.20, 95% CI (-0.4929 - 0.0377)
Weighted Deming: Slope = 1.003, 95% CI (0.9679 - 1.038); y-Intercept = -0.1924, 95% CI (-0.4465 - 0.0618)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found in the provided text.
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.
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.
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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
§ 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
Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 26, 2020
Jana Care, Inc. % Fran White President MDC Associates. Inc. 180 Cabot St Beverly, MA 01915
Re: K192987
Trade/Device Name: Aina HbA1c Monitoring System 2 Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: February 20, 2020 Received: February 21, 2020
Dear Fran White:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192987
Device Name Aina HbA1c Monitoring System 2
Indications for Use (Describe)
The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not in the diagnosis of or screening for diabetes or for use on neonates.
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) Number: | K192987 |
|---|---|
| Date of Summary: | March 26, 2020 |
| Product Name: | Aina HbA1c Monitoring System 2 |
| Sponsor: | Jana Care, Inc. |
| 8 Saint Mary's St., Suite 936 | |
| Boston, MA 02215 | |
| Correspondent: | MDC Associates, Inc. |
| Fran White, President | |
| 180 Cabot Street | |
| Beverly, MA 01915 | |
| Phone: (978) 705 5011 | |
| Fax: (866) 540 3448 | |
| Email: regulatory@mdcassoc.com | |
| Common Name: | Assay, glycosylated hemoglobin |
| Regulation Number: | 864.7470 |
| Classification: | LCP, Class II |
510(k) SUMMARY
Substantial Equivalency
| Characteristic | Jana Care, Inc.
Aina HbA1c Monitoring System 2
(New Device) | Alere Technologies AS
Afinion HbA1c, Afinion AS100 Analyzer
K151809
(Predicate Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Aina HbA1c Monitoring System 2
consists of the Aina 2 Automated HbA1c
Device, the Aina Device, Aina HbA1c
Test Kits, mobile device, and the Aina
Mobile Application. It is intended to be
used for quantitative measurement of
%HbA1c (DCCT/NGSP) and mmol/mol
HbA1c (IFCC) in human anticoagulated
venous whole blood. It is intended for
in-vitro diagnostic use by healthcare
professionals in a laboratory
environment to monitor long term | 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. |
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Page 2 of 7
| Characteristic | Jana Care, Inc.
Aina HbA1c Monitoring System 2
(New Device) | Alere Technologies AS
Afinion HbA1c, Afinion AS100 Analyzer
K151809
(Predicate Device) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | glycemic control of persons previously
diagnosed with diabetes. This test is not
intended for use in the diagnosis of or
screening for diabetes or for use on
neonates. | |
| Indications for Use | Same as Intended Use. | Measurement of %HbA1c in
human whole blood as a
marker of long term
metabolic control in persons
with diabetes mellitus. |
| Assay Method | Boronate affinity | Same |
| Assay target | Glycosylated hemoglobin (HbA1c) | Same |
| Measuring Range | 4.4-13.4% HbA1c | 4-15% HbA1c |
| Differences | | |
| Sample Type | Anticoagulated venous whole blood in
K2-EDTA | Capillary blood (from finger prick),
Anticoagulated venous whole blood in
EDTA, heparin, or citrate. |
| Sample Volume | 5 µL | 1.5 µL |
| Test Time | 3 minutes | 3.5 minutes |
| Total Hemoglobin
Range | 7.2-20 g/dL | 6-20 g/dL |
| Testing Temperature | 18 to 40°C | 18 to 30°C |
Intended Use/Indications for Use
The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, the Aina Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of %HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not intended for use in the diagnosis of or screening for diabetes or for use on neonates.
Device Description
The system consists of the Aina 2 Automated HbA1c Device for sample processing that connects to a smartphone via Bluetooth, the Aina Device for optical test strip readout, Aina HbA1c Test Kits which contain all the reagents necessary for running each HbA1c test, and the Aina Mobile Application. The Aina Device is a reflectance-based colorimetric sensor device that connects to the mobile device through the audio jack. The smartphone runs the Aina Mobile Application,
5
Jana Care, Inc. Aina HbA1c Monitoring System 2 510(k) Summary
Page 3 of 7
which is software that allows for user interaction and illustrates the step-by-step testing process on its touchscreen. The Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading. In addition, the Aina Mobile Application controls the functioning of the Aina 2 Automated HbA1c Device by sending it commands via Bluetooth. Streck A1c-Cellular control solutions can be used for regular quality control checking of the system.
Methodology
The Aina HbA1c Test utilizes the boronate affinity method. The Aina HbA1c Test Kit consists of test strips, reagents, wash buffers, capillary tubes for sample collection, and pipette tips. The reagent contains a lysing agent and a blue boronic acid conjugate. When blood is added to the reagent, the erythrocytes are lysed and all hemoglobin precipitates. The boronic acid conjugates binds to the glycosylated hemoglobin. An aliquot of the reaction mixture is applied to the test strip and all the precipitated hemoglobin, conjugate-bound and unbound, remains on top of the filter. Any unbound boronate is removed with the wash buffer. The precipitate is evaluated by measuring the blue (glycosylated hemoglobin) and the red (total hemoglobin) color intensity respectively with the Aina Device, the ratio between them being proportional to the percentage of the glycosylated hemoglobin in the sample.
Limitations of the Test
- The allowed operating temperature range is 18 to 40°C (64 to 104°F). The recommended range is 20 to 25°C (68 to 77°F)
- The Aina HbA1c Monitoring System 2 is intended to be used at altitudes of up to 2000 meters (6562 feet). The HbA1c readings may be affected at an altitude above 2000 meters (6562 feet).
- The reagent and wash buffer must be stored in the designated temperature range (2 to 8°C). Test results may be inaccurate if they are stored outside of this temperature range for more than 2 hours.
- Do not use the reagent and wash buffer if kept at room temperature for more than 2 hours.
- · Use only fresh venous whole blood. Do not use serum or plasma.
- · The Aina HbA1c Monitoring System 2 is not intended for point-of-care use.
- This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels.
- This test is not intended for use in the diagnosis of or screening for diabetes.
- This test is not intended for use on neonates.
- This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss.
- Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the Aina HbA1c Monitoring System 2 show that there is no significant interference for samples containing Hemoglobin C (≤ 50%), Hemoglobin D (≤ 43%), Hemoglobin E (≤ 31%), Hemoglobin S (≤ 42%), and Hemoglobin A2 (≤ 6.5%).
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- Acetylated, carbamylated, and labile-glycated hemoglobin derivatives generated with normal and diabetic specimens by incubation with acetylsalicylic acid, sodium cyanate, and glucose at concentrations up to 126.1, 32.5, and 1000 mg/dL respectively do not interfere with the assay.
- Samples with a hemoglobin concentration lower than 7.2 g/dL or higher than 20 g/dL can cause inaccurate test results.
WARNING: The Aina HbA1c assay has significant negative interference from Hemoglobin F (HbF). HbA1c results are invalid for patients with abnormal amounts of HbF, including those with known Hereditary Persistence of Fetal Hemoglobin.
Reference Range
| NGSP | IFCC | |
|---|---|---|
| Target in Diabetes | 10% HbA1c. |
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| Control
Level | N | Mean
HbA1c % | Repeatability
(Within-Run) | | Between Run | | Between Day | | Total | |
|------------------|----|-----------------|-------------------------------|-----|-------------|-----|-------------|-----|-------|-----|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| Level 1 | 80 | 5.9 | 0.14 | 2.4 | 0.07 | 1.2 | 0.15 | 2.6 | 0.22 | 3.7 |
| Level 2 | 80 | 13.4 | 0.26 | 2.0 | 0.21 | 1.5 | 0.18 | 1.3 | 0.38 | 2.8 |
Tahlo 2: Panaatability of the Aina cuctom
Linearity/Assay Reportable Range
A linearity study was conducted in accordance with CLSI EP06-A. Testing was conducted using venous whole blood specimens collected in K₂-EDTA.
A linear regression was calculated based on the theoretical vs measured % HbA1c values: y(%HbA1c) = 1.01x - 0.08; R=0.998
Based on the results of this study, the Aina system has a linear range from 4.4% to 13.4%.
Interfering Substances
The objective of this study was to assess the known endogenous and exogenous substances that could interfere with the assay. This study was performed as per CLSI EP07-A3. Results demonstrated that no significant interference was observed for the following substances up to the listed concentrations.
| Interferent | Concentration | ||
|---|---|---|---|
| Bilirubin (conjugated) | 35 mg/dL | ||
| Bilirubin (unconjugated) | 66 mg/dL | ||
| Triglycerides | 2000 mg/dL | ||
| Cholesterol | 500 mg/dL | ||
| Glucose | 1500 mg/dL | ||
| Rheumatoid Factor | 1000 IU/mL | ||
| Total Protein | 9.3 g/dL | ||
| Fructosamine | 750 umol/L |
Table 3: Potential endogenous interfering substances
8
| Interferent | Concentration |
|---|---|
| Acetylsalicylic acid | 65 mg/dL |
| Ascorbic Acid | 30 mg/dL |
| Acetaminophen | 30 mg/dL |
| Glyburide | 20 mg/dL |
| Ibuprofen | 50 mg/dL |
| Metformin | 5.1 mg/dL |
| Rifampicin | 6 mg/dL |
| Salicylic Acid | 60 mg/dL |
Cross Reactivity with Hemoglobin Derivatives
Results demonstrated that Acetylated Hb up to 126.1 mg/dL acetylsalicylic acid, Carbamylated Hb up to 32.5 mg/dL sodium cyanate, and Labile A1c up to 1000 mg/dL glucose do not interfere with this assay.
Hemoglobin Variants
The objective of this study was to evaluate the interference effect of hemoglobin variants, as found in patients with natural hemoglobinopathies, in the quantitative measurement of HbA1c using the Aina system on venous whole blood samples.
The results from the Aina HbA1c Monitoring System 2 show that there is no significant interference for samples containing Hemoglobin C (≤50%), Hemoglobin D (≤43%), Hemoglobin E (≤31%), Hemoglobin S (≤ 42%), and Hemoglobin A2 (≤ 6.5%).
WARNING: The Aina HbA1c assay has significant negative interference from Hemoglobin F (HbF). HbA1c results are invalid for patients with abnormal amounts of HbF, including those with known Hereditary Persistence of Fetal Hemoglobin.
Specimen Stability
A study was conducted to evaluate the stability of venous whole blood samples when stored at 2 to 8°C. The results show that whole blood samples are stable for use on the system when stored for up to 10 days within 2 to 8°C.
9
Performance Data: Clinical Studies
To demonstrate accuracy of the system, fresh prospective venous whole blood was collected with K₂-EDTA as an anticoagulant from study participants at three (3) clinical sites and then tested on the Aina HbA1c Monitoring System 2 by trained healthcare professionals in a laboratory environment. Clinical performance of the Aina HbA1c Monitoring System 2 was compared to the Tosoh G8 reference method. Regression analysis (n=132) was performed to compare the results from the Aina HbA1c Monitoring System 2 to the Tosoh G8 using both Passing-Bablok and Weighted Deming analysis.
| Method | Slope | 95% CI | y-Intercept | 95% CI |
|---|---|---|---|---|
| Passing-Bablok | 1.0 | 0.9792 - 1.041 | -0.20 | -0.4929 - 0.0377 |
| Weighted Deming | 1.003 | 0.9679 - 1.038 | -0.1924 | -0.4465 - 0.0618 |
| Table 5: Summary of regression results | |||
|---|---|---|---|
Conclusion
The clinical and analytical tests performed for the Jana Care Aina HbA1c Monitoring System 2 demonstrate that the system is safe, effective, and substantially equivalent to the legally marketed predicate device based on intended use, principle and the performance characteristics presented above.