(81 days)
Not Found
No
The device description and performance studies focus on traditional spectrophotometry and immuno-turbidimetric methods, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic device used for measuring %HbA1c to monitor glycemic control in previously diagnosed diabetic patients. It is not intended for diagnosis or screening, nor does it directly treat or mitigate a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use only."
No
The device is described as a "fully automated, desktop, electrical spectrophotometer" which is a hardware device. It also utilizes a dedicated reagent component. While it likely contains software to control the hardware and process data, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Alc iGear is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A1c (%HbA1c) from fingerstick blood or venous whole blood..."
- Device Description: The description details how the device measures %HbA1c in human whole blood using a dedicated reagent and an immuno-turbidimetric method. This involves analyzing biological samples outside of the body.
- Sample Type: The device uses fingerstick blood or venous whole blood, which are biological specimens.
- Measurement: It performs a quantitative measurement of a specific analyte (%HbA1c) in these samples.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alons is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin I 10 / 10 total 15 montager to 11 / Hood ag venous whole blood collected in either EDTA or sodium fluoride (NaF) for r linical laboratory and point of care use. The measurement of HbA lc is recommended to monitor long-term glycemic control of persons previously diabetes mellitus. This test is not for screening or diagnosis of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJE
Device Description
A1c iGear is a fully automated, desktop, electrical spectrophotometer that measures %HbA1c in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system shines light from a 660 nm light emitting diode (LED) through the test material and measures the percent of hemoglobin A1c in the total hemoglobin (%HbA1c) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.
MEDIDAS HbA1c (the reagent component) is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with the reagent; namely latex (Reagent 1: R1), antibody (Reagent 2: R2), and sample diluent solution. The A1c iGear and MEDIDAS HbA1c assay utilize an immuno-turbidimetric method to determine the percentage of HbA1c in total hemoglobin directly.
1st reaction: The hemolysate is mixed with the latex particles. Total hemoglobin and HbA1c have the same adsorption affinity for these particles, and therefore the percentage of HbA1c presented in the sample is proportional to latex-bound HbA1c.
2nd reaction: Addition of the antibody against human HbA1c creates a complex formed by the interaction between latex-bound HbA1c and the corresponding antibodies, which is agglutinated by goat anti-mouse IgG antibody. The amount of turbidity created by these aggregates is proportional to the amount of latex-bound HbA1c and therefore is proportional to the % of HbA1c in the total hemoglobin. A non-linear calibration curve is used to obtain the % of HbA1c in the total hemoglobin.
To perform with fingerstick or venous blood, the user collects the blood (1uL) into the supplied capillary. The capillary and the pipette tip are inserted into the cartridge, and the cartridge is placed into the analyzer. A1c iGear has the capacity to assay a total of three cartridges at one time. The measurement starts automatically when the ANALYZE button on A 1c iGear is pressed. Upon starting the measurement, a lot-specific barcode on the cartridge is read, and the corresponding calibration information is used. The result(s) are displayed on the screen and printed out in 6 to 7 minutes. The HbA1c measurement range is 4.3-12.5%. Acceptable anticoagulants for venous blood samples include EDTA- 2K and sodium fluoride (NaF).
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
for clinical laboratory and point of care use.
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)
Precision with Control Material and Whole Blood:
Study type: Precision study
Sample size: Control L (n=40), Control M (n=40), Control H (n=40), Sample Low (n=40), Sample Middle (n=40), Sample High (n=40) for internal study. For external study, Control L (N=360), Control M (N=360), Control H (N=360), and 3 whole blood samples (N not explicitly stated for individual samples, but tested for 10 days by 3 operators at 3 sites).
Key results: All %CVs for repeatability were less than 3%, and all %CVs for total precision were less than 6%. For external study, the imprecision for both control material and whole blood demonstrated %CVs of less than 3% across all variables.
Method Comparison Study-external:
Study type: Method comparison (accuracy)
Sample size: Study Site 1 (n=42), Study Site 2 (n=44), Study Site 3 (n=40)
Key results: The slopes, y-intercepts, and squared correlation coefficients were comparable across sites, and the values of the squared coefficients of correlation (R) were high (at least 0.97), indicating excellent correlation between A1c iGear System and the HPLC reference method. In addition, linear regression lines were nearly Y=X at each site, and biases were very small.
Limit of Detection:
LoB was determined at 2.3%. LoD was determined at 2.6%.
Linearity:
Linearity was evaluated according to CLSI-06A. Linear regression: y=0.98x+0.19, r2=1.00.
Matrix Comparison:
Study type: Matrix comparison
Sample size: Fingerstick vs EDTA (n=78), NaF vs. Fingerstick (n=46), NaF vs. EDTA (n=81).
Key results: Linear regression analyses showed strong correlation: Fingerstick vs EDTA (y=0.96x+0.15, r2=0.99), NaF vs. Fingerstick (y=1.04x-0.06, r2=0.99), NaF vs. EDTA (y=1.01x+0.01, r2=0.99).
Interference and Analytical Specificity (variant hemoglobins):
Study type: Interference study
Key results: Identified highest concentrations of various potential interferents where no significant interference was observed (e.g., Unconjugated Bilirubin at 37 mg/dL, Triglycerides at 2,000 mg/dL, etc.). No significant interference with labile hemoglobin (D-glucose, up to 2000 mg/dL), carbamylated hemoglobin (sodium cyanate, up to 10 mg/dL), and acetylated hemoglobin (acetylsalicylic acid, up to 200 mg/dL). Hemoglobin variant study indicates interference from Hemoglobin C (elevated by 24%), Hemoglobin D (elevated by 16%), Hemoglobin E (elevated by 13%), Hemoglobin S (elevated by 14%), and Hemoglobin F (>10% decreased by 32%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SAKAE CORPORATION C/O ERIKA AMMIRATI AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT LOS ALTOS CA 94022
December 16, 2014
Re: K142789
Trade/Device Name: A1c iGear System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP. JJE Dated: September 25, 2014 Received: September 26, 2014
Dear Ms. Erika Ammirati:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : 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)
Device Name Alc iGear
Indications for Use (Describe)
The Alons is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin I 10 / 10 total 15 montager to 11 / Hood ag venous whole blood collected in either EDTA or sodium fluoride (NaF) for r linical laboratory and point of care use. The measurement of HbA lc is recommended to monitor long-term glycemic control of persons previously diabetes mellitus. This test is not for screening or diagnosis of diabetes.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
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.
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"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 shows the logo and contact information for Sakae Corporation. The logo is a blue abstract design. The text includes the company name, address (239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan), phone number (+81-274-52-3126), and fax number (+81-274-52-4240).
510(k) SUMMARY
The assigned 510(k) number is K142789.
| (1): Name: | Sakae Corporation |
|---|---|
| Address: | 239 Onishi, Fujioka-shi, Gunma |
| 370-1401 Japan | |
| Phone: | 011 81-274-52-3126 |
| FAX: | 011 81-274-52-4240 |
| Contact: | Mr. Shinji Nakayama |
| Regulatory Contact: | Erika Ammirati, Consultant to Sakae Corporation |
| Phone: | 650-949-2768 |
| FAX: | 650-949-5347 |
| Date: | November 19, 2014 |
(2): Device name- trade name, common name, classification, product code
Trade name: A1c iGear System Common Name: Glycosylated hemoglobin assay Classification: Assay System: 21 CFR § 864.7470- Product code LCP, Class II Analyzer: 21 CFR § 862.2160- Product code JJE, Class I
(3): Identification of the legally marketed predicate devices
A1c GEAR System, Sakae Corporation, Japan, K130014
(4): Device Description
A1c iGear is a fully automated, desktop, electrical spectrophotometer that measures %HbA1c in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system shines light from a 660 nm light emitting diode (LED) through the test material and measures the percent of hemoglobin A1c in the total hemoglobin (%HbA1c) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.
MEDIDAS HbA1c (the reagent component) is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with the reagent; namely latex (Reagent 1: R1), antibody (Reagent 2: R2), and sample diluent solution. The A1c iGear and MEDIDAS HbA1c assay utilize an immuno-turbidimetric method to determine the percentage of HbA1c in total hemoglobin directly.
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for Sakae Corporation. The logo is a blue stylized "S". The text includes the company name, address (239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan), phone number (+81-274-52-3126), and fax number (+81-274-52-4240).
1st reaction: The hemolysate is mixed with the latex particles. Total hemoglobin and HbA1c have the same adsorption affinity for these particles, and therefore the percentage of HbA1c presented in the sample is proportional to latex-bound HbA1c.
2nd reaction: Addition of the antibody against human HbA1c creates a complex formed by the interaction between latex-bound HbA1c and the corresponding antibodies, which is agglutinated by goat anti-mouse IgG antibody. The amount of turbidity created by these aggregates is proportional to the amount of latex-bound HbA1c and therefore is proportional to the % of HbA1c in the total hemoglobin. A non-linear calibration curve is used to obtain the % of HbA1c in the total hemoglobin.
To perform with fingerstick or venous blood, the user collects the blood (1uL) into the supplied capillary. The capillary and the pipette tip are inserted into the cartridge, and the cartridge is placed into the analyzer. A1c iGear has the capacity to assay a total of three cartridges at one time. The measurement starts automatically when the ANALYZE button on A 1c iGear is pressed. Upon starting the measurement, a lot-specific barcode on the cartridge is read, and the corresponding calibration information is used. The result(s) are displayed on the screen and printed out in 6 to 7 minutes. The HbA1c measurement range is 4.3-12.5%. Acceptable anticoagulants for venous blood samples include EDTA- 2K and sodium fluoride (NaF).
(5): Intended Use
The Alc iGear is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A1c (%HbA1c) from fingerstick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbA1c is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for Sakae Corporation. The logo is a stylized blue symbol. The address is 239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan, and the phone number is +81-274-52-3126, with a fax number of +81-274-52-4240.
(6): Technological Similarities and Differences to the Predicate
The following chart describes similarities and differences between A1c iGear and its predicate.
| Manufacturer | SAKAE CORPORATION | SAKAE CORPORATION |
|---|---|---|
| Trade Name | A1c iGear with MEDIDAS HbA1c | A1c GEAR System (predicate |
| device) | ||
| 510(k) Number | K142789 | K130014 |
| Product Code | LCP | LCP |
| Regulation Number | 864.7470 | 864.7470 |
| Indications for use: | Quantitative measurement of percent | |
| hemoglobin A1c in human whole | ||
| blood | Quantitative measurement of percent | |
| hemoglobin A1c in human whole | ||
| blood | ||
| Methodology | Immuno-turbidimetric | Immuno-turbidimetric |
| Sample | Fingerstick blood or venous whole | |
| blood collected in EDTA-2K or | ||
| sodium fluoride (NaF) | Fingerstick blood or venous whole | |
| blood collected in EDTA-2K or | ||
| sodium fluoride (NaF) | ||
| Visual Display | Color LCD touch panel | LCD |
| Hemolysate preparation | Automatic | Automatic |
| Detection Method | Transmission | Transmission |
| Calibration | User; calibration card | User; calibration card |
| Recommended testing | ||
| environment | Professional use; laboratory and point | |
| of care | Professional use; laboratory and point | |
| of care | ||
| Throughput | 6-7 minutes per sample | 6-7 minutes per sample |
| Analytical Range | 4.3-12.5% | 4.3-12.5% |
| Reagent Storage | 2-8 degrees Celsius (36-46 degrees | |
| Fahrenheit) | 2-8 degrees Celsius (36-46 degrees | |
| Fahrenheit) | ||
| Accuracy (Comparison) | Versus HPLC method | |
| y=0.95x+0.11, R2=0.99, n=48 | Versus HPLC method | |
| y=0.99x+0.31, R2=0.98, n=40 | ||
| Precision | Level 1: 5.6 %A1c, 3.5%CV, n = 40 | |
| Level 2: 7.3 %A1c, 1.2%CV, n = 40 | ||
| Level 3: 10.7 %A1c, 2.4%CV, n = 40 | Level 1: 5.5 %A1c, 1.1%CV, n = 80 | |
| Level 2: 11.1 %A1c, 1.4%CV, n = 80 | ||
| Level 3: 12.1 % A1c, 1.5% CV, n = 80 |
The A1c iGear System is the same device as the A1c GEAR System previously cleared in K130014. The device has been modified to include a change in the name of the test system, the addition of an external connection to enable the analyzer to connect to external PC and USB flash memory, and simplification of the air filter and improvement of air circulation from the front side of the analyzer. Finally, electrical system improvements include: a color LCD touch panel and control. A/D converter, external communication, and operational board integrations. There was no change to the reagent component (MEDIDAS HbA1c cartridge).
(7): Performance Data
Precision with Control Material and Whole Blood
Three levels of control material and three whole blood samples targeted at low, middle and high levels of %HbA1c were each tested in duplicate for 10 days on each of two A1c iGear instruments for a total of 40 results per sample. The summarized data follow.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for Sakae Corporation. The logo is a stylized blue "S". The text includes the address: 239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan, as well as the phone number: +81-274-52-3126, and fax number: +81-274-52-4240.
| Test
sample | # of
iGear | # of
test
days | Mean
(%A1c) | Repeatability | | Between-Day | | Between-iGear | | Total
Precision | |
|-------------------------|---------------|----------------------|----------------|---------------|-------|-------------|-------|---------------|-------|--------------------|-------|
| | | | | SD | CV | SD | CV | SD | CV | SD | CV |
| Control L
n = 40 | 2 | 10 | 5.9 | 0.06 | 0.93% | 0.05 | 0.85% | 0.02 | 0.34% | 0.08 | 1.30% |
| Control M
n = 40 | 2 | 10 | 7.4 | 0.08 | 1.04% | 0.11 | 1.50% | 0.00 | 0.00% | 0.14 | 1.82% |
| Control H
n = 40 | 2 | 10 | 11.7 | 0.10 | 0.87% | 0.13 | 1.10% | 0.09 | 0.75% | 0.19 | 1.59% |
| Sample Low
n = 40 | 2 | 10 | 5.6 | 0.06 | 1.02% | 0.19 | 3.33% | 0.00 | 0.00% | 0.20 | 3.47% |
| Sample Middle
n = 40 | 2 | 10 | 7.3 | 0.06 | 0.78% | 0.03 | 0.37% | 0.07 | 0.88% | 0.09 | 1.24% |
| Sample High
n = 40 | 2 | 10 | 10.7 | 0.09 | 0.83% | 0.24 | 2.24% | 0.05 | 0.45% | 0.26 | 2.43% |
Precision Results with Control Materials and Whole Blood Samples
Conclusions: All %CVs for repeatability were less than 3%, and all %CVs for total precision were less than 6%.
Precision Study-external
Studies for precision with control materials and whole blood, and a method comparison (accuracy), were performed at three external POC sites to evaluate the A1c iGear System in the POC setting. These evaluations also confirmed the usability of the modified instrument.
For the controls portion of the precision study, a 3-level control set was tested in duplicate for 20 days by each of three different operators at three separate sites. The results were analyzed by analysis of variance (ANOVA) under the assumption that the measurement results were independent with each other and followed a Gaussian distribution. Each variation was estimated as standard deviation (SD) and percent coefficient of variation (%CV). The results and the summarized statistics per sample (Table 1) and per site (Table 2) are shown below.
- Control L: Mean HbA1c = 5.9 % ± 0.12 %, CV 1.96 %
- Control M: Mean HbA1c = 7.4 % ± 0.11%, CV 1.42 %
- Control H: Mean HbA1c = 11.4 % ± 0.28 %, CV 2.42 %
| Test
sample | # of
test
days | Mean
(%A1c) | Repeatability | | Between-Day | | Between-Operator | | Between-
Site | Reproducibility | |
|----------------|----------------------|----------------|---------------|-------|-------------|-------|------------------|-------|------------------|-----------------|-------|
| | | | SD | CV | SD | CV | SD | CV | CV | SD | CV |
| Control L | 20 | 5.9 | 0.05 | 0.92% | 0.06 | 1.01% | 0.08 | 1.40% | 0.00% | 0.12 | 1.96% |
| Control M | 20 | 7.4 | 0.06 | 0.81% | 0.08 | 1.01% | 0.02 | 0.24% | 0.54% | 0.11 | 1.42% |
| Control H | 20 | 11.4 | 0.15 | 1.29% | 0.15 | 1.31% | 0.17 | 1.51% | 0.46% | 0.28 | 2.42% |
Table 1 Summary of Control Precision Studies (for each sample, N=360)
7
RPORATION
239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan Phone: +81-274-52-3126, Fax: +81-274-52-4240
| Test
sample | Site | # of | Mean
(%A1c) | Repeatability | | Between-Day | | Between-Operator | | Within-Site | |
|----------------|------|-----------|----------------|---------------|-------|-------------|-------|------------------|-------|-------------|-------|
| | | test days | | SD | CV | SD | CV | SD | CV | SD | CV |
| Control L | A | 20 | 5.9 | 0.07 | 1.12% | 0.05 | 0.85% | 0.00 | 0.00% | 0.08 | 1.40% |
| | B | 20 | 5.8 | 0.05 | 0.86% | 0.03 | 0.57% | 0.00 | 0.00% | 0.06 | 1.03% |
| | C | 20 | 5.9 | 0.05 | 0.77% | 0.08 | 1.32% | 0.03 | 0.48% | 0.09 | 1.59% |
| Control M | A | 20 | 7.5 | 0.06 | 0.85% | 0.08 | 1.02% | 0.00 | 0.00% | 0.10 | 1.32% |
| | B | 20 | 7.4 | 0.06 | 0.86% | 0.04 | 0.54% | 0.00 | 0.00% | 0.07 | 1.01% |
| | C | 20 | 7.4 | 0.06 | 0.76% | 0.10 | 1.32% | 0.03 | 0.38% | 0.12 | 1.56% |
| Control H | A | 20 | 11.6 | 0.09 | 0.74% | 0.16 | 1.42% | 0.00 | 0.00% | 0.19 | 1.60% |
| | B | 20 | 11.3 | 0.22 | 1.93% | 0.12 | 1.03% | 0.00 | 0.00% | 0.25 | 2.19% |
| | C | 20 | 11.4 | 0.09 | 0.80% | 0.17 | 1.48% | 0.06 | 0.55% | 0.20 | 1.78% |
Table 2 Summary of Control Precision Studies (for each site, N= 360)
For the whole blood portion of the precision study, sufficient venous whole blood was collected into EDTA-anticoagulated blood tube from three volunteers (inclusive of low, middle and high levels of %HbAlc) so as to provide each site sufficient test material necessary for 10-days of testing. The testing was performed two tests per day for each sample, for 10 days. Each whole blood set was run independently by three operators at the three separate sites. The results were analyzed by analysis of variance (ANOVA) under the assumption that the measurement results were independent with each other and followed a Gaussian distribution. Each variation was estimated as standard deviation (SD) and percent coefficient of variation (%CV). The results and the summarized statistics per sample (Table 3) and per site (Table 4) are shown below.
| Test
sample | # of
test
days | Mean
(%A1c) | Repeatability | | Between-Day | | Between-
Operator | | Between-Site | | Reproducibility | |
|----------------|----------------------|----------------|---------------|-------|-------------|-------|----------------------|-------|--------------|-------|-----------------|-------|
| | | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| 1 | 10 | 5.4 | 0.08 | 1.52% | 0.08 | 1.54% | 0.02 | 0.43% | 0.03 | 0.54% | 0.12 | 2.29% |
| 2 | 10 | 7.2 | 0.08 | 1.06% | 0.03 | 0.46% | 0.00 | 0.00% | 0.03 | 0.45% | 0.09 | 1.24% |
| 3 | 10 | 10.1 | 0.08 | 0.82% | 0.12 | 1.17% | 0.06 | 0.60% | 0.06 | 0.63% | 0.17 | 1.68% |
| Test
sample | Site | # of
test
days | Mean
(% A1c) | Repeatability | | Between-Day | | Between-Operator | | Within-Site | |
|----------------|------|----------------------|-----------------|---------------|-------|-------------|-------|------------------|-------|-------------|-------|
| | | | | SD | CV | SD | CV | SD | CV | SD | CV |
| 1 | A | 10 | 5.4 | 0.08 | 1.49% | 0.07 | 1.30% | 0.03 | 0.54% | 0.11 | 2.04% |
| | B | 10 | 5.3 | 0.05 | 0.99% | 0.03 | 0.51% | 0.04 | 0.79% | 0.07 | 1.37% |
| | C | 10 | 5.4 | 0.10 | 1.92% | 0.12 | 2.27% | 0.00 | 0.00% | 0.16 | 2.98% |
| 2 | A | 10 | 7.2 | 0.07 | 0.98% | 0.03 | 0.47% | 0.00 | 0.00% | 0.08 | 1.09% |
| | B | 10 | 7.2 | 0.08 | 1.07% | 0.03 | 0.35% | 0.01 | 0.10% | 0.08 | 1.14% |
| | C | 10 | 7.2 | 0.08 | 1.12% | 0.04 | 0.52% | 0.00 | 0.00% | 0.09 | 1.23% |
| 3 | A | 10 | 10.2 | 0.08 | 0.80% | 0.07 | 0.66% | 0.00 | 0.00% | 0.11 | 1.03% |
| | B | 10 | 10.0 | 0.09 | 0.90% | 0.05 | 0.54% | 0.04 | 0.37% | 0.11 | 1.11% |
| | C | 10 | 10.1 | 0.08 | 0.78% | 0.19 | 1.84% | 0.10 | 1.00% | 0.23 | 2.23% |
Page 5 of 8
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Conclusions: The imprecision, for both control material and whole blood, demonstrated %CVs of less than 3% across all variables.
Method Comparison Study-external
For the method comparison study, each site analyzed a minimum of 40 patient samples. Patient samples were representative of the validated range of the test system, capturing low, middle and high ranges. Matched whole blood samples and fingerstick samples were obtained from each individual (non-diabetic and diabetic) using standard technique. The fingerstick samples were analyzed by A1c iGear System by POC operators, and the EDTA samples were shipped to a reference laboratory that performed HPLC testing.
Linear regression analysis was performed where the Alc iGear results at each POC site (y-axis) were compared to the laboratory HPLC method (x-axis), and the slope, y-intercept, squared coefficient of correlation and bias were calculated. The results summary is shown in Table 5.
| Study Site | n | Min | Max | Slope | y-intercept | R2 | Bias |
|---|---|---|---|---|---|---|---|
| 1 | 42 | 5.2 | 11.3 | 0.95 | |||
| (0.93 to 0.98) | 0.10 | ||||||
| (-0.13 to 0.32) | 0.99 | -0.25 | |||||
| 2 | 44 | 5.1 | 11.7 | 0.95 | |||
| (0.91 to 0.98) | 0.20 | ||||||
| (-0.03 to 0.44) | 0.99 | -0.18 | |||||
| 3 | 40 | 5.2 | 9.3 | 0.94 | |||
| (0.88 to 0.99) | 0.34 | ||||||
| (-0.02 to 0.70) | 0.97 | -0.09 |
Table 5 Summary of Comparison Studies at 3 Sites-All units %HbA1c (95% confidence intervals)
The slopes, y-intercepts, and squared correlation coefficients were comparable Conclusions: across sites, and the values of the squared coefficients of correlation (R) were high (at least 0.97), indicating excellent correlation between A1c iGear System and the HPLC reference method. In addition, linear regression lines were nearly Y=X at each site, and biases were very small.
The following performance data were generated with the A1c GEAR analyzer, cleared under K130014. They are repeated here for completeness of the record.
Limit of Detection
The Limit of Blank (LoB) was determined by assaying 90 replicates of a zero sample (blank). The Limit of Detection (LoD) was determined by assaying 27 replicates of three low HbA1c samples. The LoB was determined to be 2.3% and the LoD was 2.6%.
Linearity
Linearity was evaluated according to CLSI-06A. The linearity was verified using two EDTA whole blood samples, including a normal sample with HbA1c concentration of 4.0% and an elevated HbA1c level sample with HbA1c concentration at 15.0%. The normal and high samples were inter-mixed to make a total of 11 intermediate samples covering the assay range. All intermediate dilutions were analyzed in replicates of three. The observed %HbA1c value for each intermediate dilution was plotted versus the expected analyte concentration. The linear regression is as follows: y=0.98x+0.19, r2=1.00.
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Image /page/9/Picture/0 description: The image shows the logo and contact information for Sakae Corporation. The logo is a blue stylized "S". The text below the logo includes the address: 239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan, as well as the phone number: +81-274-52-3126 and fax number: +81-274-52-4240.
Matrix Comparison
A study was performed using fingerstick whole blood, EDTA whole blood, and NaF whole blood. A total of 78 donor samples were collected from Site 1 using fingerstick and venous EDTA, 46 donor samples were collected from Site 2 using fingerstick and venous NaF, and 81 donor samples were collected from Site 3 using venous EDTA and NaF. Samples tested ranged from 4.3-10.9% HbA1c. The linear regression analyses are as follows:
| Matrices | n | HbA1c% | Regression | r2 |
|---|---|---|---|---|
| Fingerstick vs EDTA | 78 | 4.3-9.0 | y=0.96x+0.15 | 0.99 |
| NaF vs. Fingerstick | 46 | 4.8-8.8 | y=1.04x-0.06 | 0.99 |
| NaF vs. EDTA | 81 | 5.3-10.9 | y=1.01x+0.01 | 0.99 |
Interference and Analytical Specificity (variant hemoglobins)
An interference study was performed to assess common or known endogenous and exogenous substances that could interfere with the Alc Gear System. The potential interferents listed below were spiked into human EDTA and NaF whole blood samples with different levels of %HbA1c (~6.3% and ≥9.0% HbA1c values of the spiked samples were compared to reference samples (sample containing no interferent). Samples were tested in quadruplicate to give a total of four replicates per sample. The interferent study results are summarized in the table below:
| Potential Interferent | Highest concentration in which no significant
interference was observed. |
|------------------------|-----------------------------------------------------------------------------|
| Unconjugated Bilirubin | 37 mg/dL |
| Triglycerides | 2,000 mg/dL |
| Conjugated Bilirubin | 40.4 mg/dL |
| Rheumatoid Factor | 550 IU/mL |
| Acetaminophen | 20 mg/dL |
| Ibuprofen | 50 mg/dL |
| Glibenclamide | 0.2 mg/dL |
| Metformin | 5.1 mg/dL |
| Ascorbic Acid | 6.0 mg/dL |
Another interference study was performed to assess the effect of labile hemoglobin, carbamylated hemoglobin and acetylated hemoglobin with the A1c Gear System. Each modified hemoglobin was tested using EDTA and NaF whole blood samples with different levels of %HbA1c (~6.3% and > 9.0% HbA1c). Samples were incubated with the substance in parentheses below and analyzed for a total of four replicates per sample.
There was no significant interference with the following:
- Labile hemoglobin (D-glucose, up to 2000 mg/dL) ●
- Carbamylated hemoglobin (sodium cyanate, up to 10 mg/dL) ●
- Acetylated hemoglobin (acetylsalicylic acid, up to 200 mg/dL) ●
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Image /page/10/Picture/0 description: The image shows the logo and contact information for Sakae Corporation. The logo is a blue stylized "S". The contact information includes the address: 239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan, the phone number: +81-274-52-3126, and the fax number: +81-274-52-4240.
A hemoglobin variant study was performed using commercial samples known to contain hemoglobin variants C, D, E, S and F. Samples contained both low and high levels of % HbAlc at concentrations from 4.6-11.6% HbA1c. These variant samples were tested in duplicate. The results indicated samples containing Hemoglobin C were elevated by 24%. samples containing Hemoglobin D were elevated by 16%, samples containing Hemoglobin E were elevated by 13% and samples containing Hemoglobin S were elevated by 14%. Samples containing >10% Hemoglobin F were decreased by 32%. All variants tested were shown to interfere with this device.
The device labeling contains the following boxed warning:
"Hemoglobinopathies may interfere with glycated hemoglobin analysis. Samples containing the following hemoglobin variants have been shown to interfere with this assay: Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin F (>10%) and Hemoglobin S."
Stability
The system kit (test cartridge) should be refrigerated at 2-8°C (36-46°F) and used immediately after opening. The expiration date of the Master Calibration Card and cartridge as stated on the package is 12 months after the date of manufacture.
Expected Values/Reference Range
The American Diabetes Association (ADA) expected value range is 4.0-6.0% HbA1c for people without diabetes. The ADA's most recent Clinical Practice Recommendation ' for diabetes specified a treatment goal of less than 7% and suggests additional action when HbA1c level is above 8%.
| HbA1c Value | Glycemic Goal |
|---|---|