(457 days)
The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A 1 (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc 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.
The Alc GEAR instrument is a fully automated desktop electric spectrophotometer that measures %HbAlc in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system illuminates a 660 nm LED (Light Emitting Diode) through the test material and quantitatively measures the percent of hemoglobin Alc in the total hemoglobin (%HbA1c) by means of light absorbance changes and a non-linear calibration curve. The system includes the Hemoglobin A Ic Analyzer (Alc GEAR), thermal printer, barcode reader, power cable, and fan filter. MEDIDAS HbAIc is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with reagent; latex (reagent R1), antibody (reagent R2), and sample dilute solution.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Alc GEAR System
Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" in a pass/fail format for each performance study. Instead, the document presents performance data to support the claim of substantial equivalence. The table below interprets the "acceptance criteria" as the performance demonstrated by the device, which is considered sufficient for regulatory clearance by showing equivalence to established methods/devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred from study design and context of substantial equivalence) | Reported Device Performance |
|---|---|---|
| Linearity | High linearity (r^2 near 1.00) and acceptable recovery rate for the specified analytical range. (e.g., within 90-110% recovery) | Range: 4.0 - 13.1% HbA1c Regression line: y = 0.98x + 0.19 r^2: 1.00 Recovery (%): 98 - 103 |
| Method Comparison (Venous to Venous) | Strong correlation (high r^2) and close agreement (slope near 1, intercept near 0) with established HPLC methods and predicate POC analyzer. | HPLC I (N/A): r^2 = 0.98, y = 1.03x - 0.33 (Range: 4.6-10.6% HbA1c) HPLC 2 (N=40): r^2 = 0.98, y = 0.99x + 0.31 (Range: 4.2-9.8% HbA1c) DCA Vantage (N=60): r^2 = 0.99, y = 0.95x - 0.12 (Range: 4.7-11.7% HbA1c) |
| Matrix Comparison | Strong correlation (high r^2) and close agreement (slope near 1, intercept near 0) between different sample matrices. | Finger (y) vs. EDTA-venous (x) (N=78): r^2 = 0.99, y = 0.96x + 0.15 (Range: 4.3-9.0% HbA1c) NaF-venous (y) vs. finger (x) (N=46): r^2 = 0.99, y = 1.04x - 0.06 (Range: 4.8-8.8% HbA1c) NaF-venous (y) vs. EDTA-venous (x) (N=81): r^2 = 0.99, y = 1.01x + 0.01 (Range: 5.3-10.9% HbA1c) |
| Precision (Internal) | Acceptable within-run, between-day, and total CVs for control materials and patient samples across different %HbA1c levels. | Control L (5.2%): Within-run CV=1.26%, Between-day CV=0.51%, Total CV=1.36% Control H (9.0%): Within-run CV=0.85%, Between-day CV=0.26%, Total CV=1.06% Sample 1 (5.5%): Total CV=1.12% Sample 2 (11.1%): Total CV=1.37% Sample 3 (12.1%): Total CV=1.52% |
| Precision (External) | Similar acceptable CVs to internal site, demonstrating reproducibility in different settings. | Control L (5.0%): Within-run CV=1.08%, Between-day CV=0.75%, Total CV=1.31% Control H (8.9%): Within-run CV=0.65%, Between-day CV=0.53%, Total CV=0.90% Sample 1 (5.2%): Total CV=1.34% Sample 2 (8.8%): Total CV=1.05% |
| Reproducibility (Overall) | Acceptable between-site and total CVs. | Control L (5.1%): Between-site CV=2.55%, Total CV=2.81% Control H (9.0%): Between-site CV=0.56%, Total CV=0.94% |
| POC Precision | Acceptable within-site and overall reproducibility CVs across multiple POC sites and multiple levels of controls and patient samples. | Control 1 (approx 5.2%): Reproducibility Total CV=2.26% Control 2 (approx 7.0%): Reproducibility Total CV=2.11% Control 3 (approx 11.0%): Reproducibility Total CV=2.55% Sample Low (approx 5.8%): Reproducibility Total CV=3.12% Sample Middle (approx 8.0%): Reproducibility Total CV=4.16% Sample High (approx 10.8%): Reproducibility Total CV=5.25% |
| POC Method Comparison | Strong correlation (r near 0.99) and close agreement (slope near 1, intercept near 0) with a reference HPLC method. | Site 1 (N=47): r=0.995, Slope=0.968, Intercept=0.04 (Range: 4.9-11.9% HbA1c) Site 2 (N=41): r=0.990, Slope=0.976, Intercept=0.12 (Range: 5.4-10.8% HbA1c) Site 3 (N=46): r=0.990, Slope=0.989, Intercept=0.08 (Range: 5.0-9.6% HbA1c) |
| Interference | No significant interference from common substances within specified concentrations. | No significant interference observed for Free-bilirubin, Conjugated-bilirubin, Rheumatoid factor, Chyle (including triglycerides, phospholipids, free fatty acids), additional Triglycerides, Acetaminophen, Ibuprofen, Glibenclamide, Metformin, Ascorbic acid at tested concentrations. |
| Analytical Specificity (Hb Variants) | Limited or no interference from common hemoglobin variants. (Note: The study revealed significant interference here, which is important for labeling/limitations) | Interference observed: Samples with Hemoglobin C elevated by 24%, Hemoglobin D by 16%, Hemoglobin E by 13%, Hemoglobin S by 14%. Samples with >10% Hemoglobin F decreased by 32%. All variants tested interfered. This results in a limitation specified in the Indications for Use. |
| Analytical Specificity (Modified Hb) | No significant interference from common modified hemoglobins. | No effect found for Carbamylated hemoglobin, Acetylated hemoglobin, Labile hemoglobin. |
| Limit of Detection (LOD) | A detectable range appropriate for HbA1c measurements. | LOD: 2.6% HbA1c. LOB: 2.3% HbA1c. |
| Stability - Real-Time | Reagent cartridge maintains performance for a specified shelf life. | Reagent cartridge can be stored for up to one year at 2-8 °C (36-46 °F). |
2. Sample Sizes and Data Provenance
- Test Set Description / Data Provenance:
- Linearity: Two whole blood samples (low and high HbA1c) mixed in different proportions to obtain 11 samples. Measured in triplicate. Provenance not specified, but implied to be in-house.
- Method Comparisons (Venous): N/A (HPLC 1), N=40 (HPLC 2), N=60 (DCA Vantage). Venous whole blood collected into EDTA tubes from donors. Provenance not specified, but implied to be in-house.
- Matrix Comparison: N=78 (finger vs. EDTA-venous), N=46 (NaF-venous vs. finger), N=81 (NaF-venous vs. EDTA-venous). Samples collected from each donor (finger-stick, EDTA-venous, NaF-venous). Provenance not specified, but implied to be in-house.
- Precision (Internal/External): N=80 for each control material and patient sample (measured for 20 days, in duplicate, twice a day). Tested at an internal site and an external site. Provenance not specified.
- Reproducibility (Overall): N=160 (combining internal and external site data) for each control material. Provenance not specified.
- POC Precision: Control samples (3 levels): N=120 per site (3 sites = 360 total per level). Patient samples (3 levels): N=60 per site (3 sites = 180 total for low), N=120/128 per site (3 sites = 368 total for middle), N=120/128 per site (3 sites = 368 total for high). Provenance not specified, but implied to be across multiple external POC sites.
- POC Method Comparison: N=47 (Site 1), N=41 (Site 2), N=46 (Site 3). Finger-stick blood from donors. Provenance not specified, but implied to be across multiple external POC sites.
- Interference, Analytical Specificity (Hb Variants & Modified Hb), LOD, Stability: Specific sample sizes are not detailed for each substance/variant, but commercial samples or prepared samples were used. Provenance not specified.
3. Number of Experts and Qualifications for Ground Truth
- The document primarily describes analytical performance studies against reference methods or established standards. It does not mention the use of human experts to establish "ground truth" in the way it might for image-based diagnostics.
- For the method comparisons, the "ground truth" or reference values were established by:
- Ion-exchange HPLC methods (specific models not always named, but generally considered gold standard for HbA1c).
- The predicate device, DCA Vantage.
- Tosoh G8 ion-exchange HPLC reference method (for POC method comparison).
- Personnel performing these reference tests are described as "qualified laboratory technicians at a reference laboratory" for the POC method comparison.
- For precision and other analytical studies, the "ground truth" relates to the inherent properties of the control materials or patient samples as measured by the reference techniques.
4. Adjudication Method
- Not applicable. The studies are analytical performance assessments against reference methods or internal calibration, not clinical interpretation requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or other human interpretation tasks, not an automated quantitative assay like HbA1c.
6. Standalone Performance (Algorithm Only)
- Yes, the entire set of performance data represents the standalone performance of the Alc GEAR System. It is an automated instrument that directly measures %HbA1c without a human-in-the-loop interpretation step that would significantly influence the result. Its performance is compared to other analytical methods (like HPLC) which are also standalone assays.
7. Type of Ground Truth Used
- Reference Methods / Gold Standards: Ion-exchange HPLC methods (e.g., Primus Ultra Boronate Affinity HPLC, Tosoh G8, and other unnamed HPLC systems) are frequently used as the reference "ground truth" for HbA1c measurements (e.g., in linearity, method comparison, and analytical specificity studies).
- Predicate Device: The DCA Vantage was used as a comparison method in some studies.
- Expected Values: For linearity, expected values were created by mixing known low and high samples.
- Commercial Controls: Commercial control materials were used in precision studies, for which expected values would be established by the manufacturer through rigorous testing.
8. Sample Size for the Training Set
- The document describes the performance testing of the device. It does not provide information about a "training set" in the context of machine learning algorithms. The Alc GEAR System is described as using light absorbance changes and a non-linear calibration curve, typical of an immunoassay/photometric system rather than a machine learning model that would require a distinct training set. If "calibration" is considered training, the master calibration card (mentioned in Section 11) would set the initial parameters, but the data used to develop that calibration curve is not provided.
9. How the Ground Truth for the Training Set was Established
- As noted above, no "training set" in the machine learning sense is described. The device's operation relies on a "non-linear calibration curve" and a "master calibration card". The ground truth for this calibration would be established by measuring a series of known HbA1c concentration standards (likely traceable to a primary reference method like HPLC) to define the relationship between absorbance and %HbA1c. The details of this calibration process and the data used are not provided in this 510(k) summary.
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Phone: +81-274-52-3126, Fax: +81-274-52-4240
510(k) Summary
APR 0 4 2014
1 Applicant SAKAE CORPORATION 239 Onishi, Fujioka, Gunma, 370-1401 JAPAN Phone: (81)-274-52-3126 Fax: (81)-274-52-4240
2 Contact Information:
Erika B. Ammirati, R. A. C., MT (ASCP) Regulatory Consultant to SAKAE CORPORATION Phone: (650) 949-2768 E-mail: erikaba@pacbell.net
3 Device Trade Name: Alc GEAR System
4 Device Common Name:
Glycated hemoglobin assay and discrete photometric chemistry analyzer for clinical use
5 Manufacturer Address
SAKAE CORPORATION 239 Onishi, Fujioka, Gunma, 370-1401 JAPAN Phone: (81)-274-52-3126 Fax: (81)-274-52-4240
6 Device Classification:
SAKAE CORPORATION A1c GEAR System (new) is a Class II device and reagent, and is classified by FDA under 21 CFR 864.7470 Glycosylated hemoglobin assay and the FDA Product Code is LCP.
A lc GEAR (the instrument) is a Class I device and is classified by FDA under 21 CFR 862.2160, Discrete photometric chemistry analyzer for clinical use, and the FDA Product Code is JJE.
7 Device Description:
The Alc GEAR instrument is a fully automated desktop electric spectrophotometer that measures %HbAlc in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system illuminates a 660 nm LED (Light Emitting Diode) through the test material and quantitatively measures the percent of hemoglobin Alc in the total hemoglobin (%HbA1c) by means of light absorbance changes and a non-linear calibration curve. The system includes the Hemoglobin A Ic Analyzer (Alc GEAR), thermal printer, barcode reader, power cable, and fan filter.
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Phone: +81-274-52-3126,
MEDIDAS HbAIc is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with reagent; latex (reagent R1), antibody (reagent R2), and sample dilute solution.
8 Indications for Use
The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A 1 (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc 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.
9 Limitations
- This test should not be used in monitoring daily glucose control. ●
- . Should not be used to replace daily home testing of urine and blood glucose levels.
- 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.
10 Expected Values and Reference (non-diabetic) Level
The American Diabetes Association (ADA) expected value range is 4.0-6.0% HbA1c for people without diabetes.
The American Diabetes Association's (ADA) most recent Clinical Practice recommendation for diabetes specified a treatment goal of less than 7% and suggests additional action when HbA1c is above 8%
| HbA1c Value | Glycemic Goal |
|---|---|
| <8% HbA1c | Less stringent |
| <7% HbA1c | General (Non-Pregnant Adults) |
| <6.5% HbA1c | More stringent |
American Diabetes Association Standards of Medical Care in Diabetes 2012. 35 (Supplement1), S11-S63
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239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan Phone: +81-274-52-3126, Fax: +81-274-52-4240
11 Predicate Device
DCA Vantage, a test system for hemoglobin A1c by Siemens Medical Solutions Diagnostics, K071466. The predicate device has the same intended use, uses substantially the same assay methodology, and is substantially equivalent to the A 1c GEAR System.
| Manufacturer | SAKAE CORPORATION | Siemens Medical Solutions Diagnostics |
|---|---|---|
| Trade Name | A1c GEAR System | DCA Vantage |
| 510(k) Number | K130014 | K071466 |
| Product Code | LCP | LCP |
| Regulation Number | 864.7470 | 864.7470 |
| Indications for use: | Quantitative measurement of percenthemoglobin A1c in human wholeblood | Quantitative measurement of percenthemoglobin A1c in human whole blood |
| Methodology | Immuno-turbidimetric | Immuno-turbidimetric (inhibition) |
| Sample | Finger-stick blood or venous wholeblood collected in K2 EDTA orsodium fluoride | Finger-stick blood or venous whole bloodcollected in EDTA, heparin,fluoride/oxalate, and citrate |
| Visual Display | LCD | LCD |
| Hemolysate preparation | Automatic | Automatic |
| Detection Method | Transmission | Transmission |
| Calibration | User; calibration card | User; calibration card |
| Recommended testingenvironment | Professional use; point of care | Professional use; point of care |
| Throughput | 6-7 minutes per sample | 6-7 minutes per sample |
| Analytical Range | 4.3-12.5% | 2.5-14.0% |
| Reagent Storage | 2-8 degrees Celsius (36-46 degreesFahrenheit) | 2-8 degrees Celsius (36-46 degreesFahrenheit) |
| Accuracy (Comparison) | Versus HPLC method$Y=1.03x-0.33$ , $R=0.99$ N=158 | Versus DCCT reference method (HPLC)$Y=1.02x-0.00$ , $R=0.98$ N=100 |
| NGSP Certification Status | Certified | Certified |
| Complies with IEC 60601-1 | Yes | Yes |
| Complies with IEC 60601-1-2 | Yes | Yes |
Device Comparison Chart
12 Performance Data
12.1 Linearity
Linearity of the Alc GEAR System was verified with the use of two whole blood samples collected into EDTA tubes. Sample low (L: 4.0% HbA1c, result from ion-exchange HPLC) and high (H: 15.0% HbA1c, result from ion-exchange HPLC) were mixed in different proportions to obtain a series of 11 samples were measured in triplicate. Recovery rate was used as an indicator for the degree of the deviation of expected values. The linear regression analysis was performed.
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Phone: +81-274-52-3126, Fax: +81-274-52-4240
Table 1 Linearity of the Alc GEAR System. Y: observed value, X: expected value, r': squared coefficient of correlation, recovery (%) = observed value / expected value x 100.
| Range (% HbA1c) | Regression line | r2 | Recovery (%) |
|---|---|---|---|
| 4.0 - 13.1 | y = 0.98x + 0.19 | 1.00 | 98 - 103 |
12.2 Method Comparisons (venous to venous sampling, in-house)
Method comparison studies were performed with three comparison methods: two different ion-exchange HPLC methods and one point of care (POC, DCA Vantage) method were each compared to the Alc GEAR System. Venous whole blood collected into EDTA tubes were prepared from donors and analyzed.
Table 2 Linear regression analysis data of method comparison. Y: A1c GEAR, X: comparison method, N: number of samples, r2: squared coefficient of correlation.
| Comparison Method | र | HbA1c (%) | Regression Line | |
|---|---|---|---|---|
| HPLC I | ા રેક | 4.6-10.6 | y = 1.03x - 0.33 | 0.98 |
| HPLC 2 | 40 | 4.2-9.8 | v=0.99x+0.31 | 0.98 |
| Another POC analyzer (DCAVantage) | 60 | 4.7-11.7 | y = 0.95x - 0.12 | 0.99 |
12.3 Matrix Comparison
Matrix comparison studies were performed to evaluate the effect of the sample matrix. A finger-stick sample and venous whole blood samples with anticoagulants EDTA or sodium fluoride (NaF), were collected from each donor and analyzed with the Alc GEAR System.
Table 3 Linear regression analysis data of matrix comparison. N: number of samples, r: squared coefficient of correlation.
| Matrix | N | HbA1c (%) | Regression line | r2 |
|---|---|---|---|---|
| finger (y) vs. EDTA-venous (x) | 78 | 4.3-9.0 | y = 0.96x + 0.15 | 0.99 |
| NaF-venous (y) vs. finger (x) | 46 | 4.8-8.8 | y = 1.04x - 0.06 | 0.99 |
| NaF-venous (y) vs. EDTA-venous (x) | 81 | 5.3-10.9 | y = 1.01x + 0.01 | 0.99 |
12.4 Precision
Precision studies were performed at both internal and external sites. The studies followed CLSI (Clinical and Laboratory Standards Institute) Guideline EP5-A2.
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PORATION
239 Onishi, Fujioka-shi, Gunma, 3 Phone: +81-274-52-3126, Fax: +81-274-52-4240
Within-run (repeatability), between-day, and total precision were determined for two control materials (control L and H) and three EDTA whole blood samples at the internal site, and with two control materials (control L and H) and two EDTA whole blood samples at the external site. The samples were analyzed for 20 days, in duplicate, twice a day (n = 80).
| Sample | N= | Mean | Within-run CV (%) | Between-day CV (%) | Total CV (%) |
|---|---|---|---|---|---|
| Control L | 80 | 5.2 | 1.26 | 0.51 | 1.36 |
| Control H | 80 | 9.0 | 0.85 | 0.26 | 1.06 |
| Sample 1 | 80 | 5.5 | 0.73 | 0.80 | 1.12 |
| Sample 2 | 80 | 11.1 | 1.11 | 0.70 | 1.37 |
| Sample 3 | 80 | 12.1 | 1.14 | 1.01 | 1.52 |
Table 4 Results from the internal site. %CV: %coefficient of variation.
Table 5 Results from the external site. %CV: %coefficient of variation.
| Sample | N= | Mean | Within-run CV (%) | Between-day CV (%) | Total CV (%) |
|---|---|---|---|---|---|
| Control L | 80 | 5.0 | 1.08 | 0.75 | 1.31 |
| Control H | 80 | 8.9 | 0.65 | 0.53 | 0.90 |
| Sample 1 | 80 | 5.2 | 1.18 | 0.56 | 1.34 |
| Sample 2 | 80 | 8.8 | 0.82 | 0.47 | 1.05 |
Table 6 Reproducibility estimated from the results of two sites. %CV: %coefficient of variation.
| Sample | N | Overall mean | Between-site CV (%) | Total CV (%) |
|---|---|---|---|---|
| Control L | 160 | 5.1 | 2.55 | 2.81 |
| Control H | 160 | 9.0 | 0.56 | 0.94 |
12.5 Point of Care (POC) Studies
External validation of the AIc GEAR System was performed at POC sites to evaluate precision and method comparisons.
In the precision study, three levels of controls were analyzed for 20 days and three levels of patient samples were analyzed for 10 days by POC operators.
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239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan Phone: +81-274-52-3126, Fax: +81-274-52-4240
| Sample | N = | Site | Mean | Within-siteCV (%) | Overall mean | ReproducibilityTotal CV (%) |
|---|---|---|---|---|---|---|
| Control 1 | 120 | 1 | 5.19 | 2.85% | 5.22 | 2.26% |
| 120 | 2 | 5.21 | 1.92% | |||
| 120 | 3 | 5.27 | 1.46% | |||
| Control 2 | 120 | 1 | 7.01 | 2.53% | 7.06 | 2.11% |
| 120 | 2 | 7.07 | 1.73% | |||
| 120 | 3 | 7.10 | 1.73% | |||
| Control 3 | 120 | 1 | 11.05 | 3.37% | 11.04 | 2.55% |
| 120 | 2 | 11.09 | 2.48% | |||
| 120 | 3 | 11.00 | 1.35% | |||
| Sample Low | 60 | 1 | 5.80 | 3.14% | 5.84 | 3.12% |
| 60 | 2 | 5.83 | 3.28% | |||
| 60 | 3 | 5.89 | 2.63% | |||
| Sample Middle | 120 | 1 | 8.01 | 3.31% | 8.07 | 4.16% |
| 128 | 2 | 7.87 | 2.30% | |||
| 120 | 3 | 8.34 | 2.91% | |||
| Sample High | 120 | 1 | 10.55 | 3.22% | 10.84 | 5.25% |
| 128 | 2 | 10.59 | 2.46% | |||
| 120 | 3 | 11.38 | 3.21% |
Table 7 Results of precision study at three external sites. %CV: %coefficient of variation.
In the method comparison study, a finger-stick sample and a venous EDTA sample were collected from each donor. The finger-stick blood samples were analyzed with the AIc GEAR System by POC operators and the venous blood samples were analyzed with an ion-exchange HPLC (Tosoh, G8) reference method by qualified laboratory technicians at a reference laboratory.
Table 8 Linear regression analysis of method comparison study at three external sites. N: number of samples, r: coefficient of correlation.
| Studysite | N | Min | Max | Slope(95% confidence interval) | Intercept(95% confidence interval) | r |
|---|---|---|---|---|---|---|
| 1 | 47 | 4.9 | 11.9 | 0.968(0.941 to 0.994) | 0.04(-0.16 to 0.24) | 0.995 |
| 2 | 41 | 5.4 | 10.8 | 0.976(0.936 to 1.015) | 0.12(-0.15 to 0.40) | 0.990 |
| 3 | 46 | 5.0 | 9.6 | 0.989(0.952 to 1.027) | 0.08(-0.18 to 0.35) | 0.990 |
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239 Onishi, Fujioka-shi, G Phone: +81-274-52-3126, Fax: +81-274-52-4240
12.6 Interference
No significant interference was observed up to the following concentrations in both EDTA and NaF whole blood samples, or commercial controls:
| • | Free - bilirubin | 37.0 mg/dl |
|---|---|---|
| • | Conjugated - bilirubin | 40.4 mg/dl |
| • | Rheumatoid factor | 550 IU/ml |
| • | Chyle (mixture of lipids)includes: | 3120 FTU (Formazine Turbidity Unit) |
| Triglycerides | 170 mg/dl | |
| Phospholipids | 182 mg/dl | |
| Free fatty acids | 124 μEq/dl (approx. 1.24 mmol/l) | |
| • | Triglycerides (separate study) | 2,000 mg/dl |
| • | Acetaminophen | 20.0 mg/dl |
| • | Ibuprofen | 50.0 mg/dl |
| • | Glibenclamide | 0.2 mg/dl |
| • | Metformin | 5.1 mg/dl |
| • | Ascorbic acid | 6.0 mg/dl |
NOTE: It is possible that other substances and/or factors not listed above may interfere with the test and cause false results.
12.7 Analytical Specificity 12.7.1 Hemoglobin (Hb) Variants
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 %HbA1c at concentrations from 4.6-11.6%. These variant samples were tested in duplicate using the A1c GEAR System versus a reference method (Primus Ultra Boronate Affinity HPLC). 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.
12.7.2 Modified Hemoglobin
The following modified hemoglobin was prepared by incubating with the substance in parentheses and found not to affect the A1c GEAR System for both EDTA and NaF whole blood samples:
- . Carbamylated hemoglobin (sodium cyanate, 10 mg/dl)
- . Acetylated hemoglobin (acetylsalicylic acid. 200 mg/dl)
- Labile hemoglobin 트 (D-glucose, 2000 mg/dl)
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239 Onishi, Fujioka-shi, Gunma, 1 401 Japan Phone: +81-274-52-3126, Fax: +81-274-52-4240
12.8 Limit of Detection
To estimate the lowest detectable value of %HbA1c for the A1c GEAR System, limit of detection (LOD) studies were performed and LOD was calculated to be 2.6% and LOB was calculated to be 2.3%.
12.9 Stability- Real-Time
A real time shelf life stability study was performed for MEDIDAS HbA Ic using the A1c GEAR analyzer. From these results, it was concluded that the reagent cartridge can be stored for up to one year at 2-8 °C (36-46 °F).
13 Conclusions
Performance studies were conducted and the data obtained indicate the AIc GEAR System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
SAKAE CORPORATION C/O ERICA AMMIRATI 575 SHIRLYNN COURT LOS ALTOS CA 94022
Re: K130014
Trade/Device Name: A 1c Gear System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE Dated: March 28, 2014 Received: March 31, 2014
Dear Ms. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Ammirati
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance 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" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
Courtney H. Lias -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K130014
Device Name Alc GEAR System
Indications for Use (Describe)
The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A le (%HbA lc) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbA 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.
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 FOR FDA USE ONLY CONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
§ 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).