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510(k) Data Aggregation
(81 days)
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.
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.
This document describes the performance of the A1c iGear System, a device for quantitative measurement of percent hemoglobin A1c (%HbA1c).
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the A1c iGear System are not explicitly listed as a separate table with specific pass/fail thresholds in the provided document. However, the performance data presented, particularly related to precision and method comparison, implies the acceptance criteria were met given the conclusions stated for each study.
Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the conclusions:
| Performance Metric | Inferred Acceptance Criteria (Based on Study Conclusions) | Reported Device Performance |
|---|---|---|
| Precision (Internal) | All %CVs for repeatability 0.97), linear regression lines nearly Y=X, and very small biases. | Site 1 (n=42): Slope 0.95, y-intercept 0.10, R^2 0.99, Bias -0.25 |
| Site 2 (n=44): Slope 0.95, y-intercept 0.20, R^2 0.99, Bias -0.18 | ||
| Site 3 (n=40): Slope 0.94, y-intercept 0.34, R^2 0.97, Bias -0.09 | ||
| Limit of Detection (LoD) | LoD should be less than the lower end of the analytical range (4.3%) and clinically acceptable. | LoB 2.3%, LoD 2.6% |
| Linearity | R^2 close to 1.00 (e.g., >0.99) and slope close to 1.00. | y=0.98x+0.19, r^2=1.00 (across 4.0% to 15.0% HbA1c) |
| Matrix Comparison | High squared correlation coefficients (R^2 > 0.99) and slopes close to 1.00. | Fingerstick vs EDTA (n=78, 4.3-9.0% HbA1c): y=0.96x+0.15, r^2=0.99 |
| NaF vs. Fingerstick (n=46, 4.8-8.8% HbA1c): y=1.04x-0.06, r^2=0.99 | ||
| NaF vs. EDTA (n=81, 5.3-10.9% HbA1c): y=1.01x+0.01, r^2=0.99 | ||
| Interference (Common substances) | No significant interference observed at relevant concentrations. | Bilirubin (unconjugated 37 mg/dL, conjugated 40.4 mg/dL), Triglycerides (2000 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) showed no significant interference. |
| Interference (Labile, Carbamylated, Acetylated Hb) | No significant interference observed. | No significant interference with D-glucose (up to 2000 mg/dL), sodium cyanate (up to 10 mg/dL), acetylsalicylic acid (up to 200 mg/dL). |
| Interference (Hemoglobin Variants) | Device performance should be characterized, and labeling should reflect any interferences. | Hemoglobin C increased results by 24%, Hemoglobin D by 16%, Hemoglobin E by 13%, Hemoglobin S by 14%. Hemoglobin F (>10%) decreased results by 32%. A boxed warning is included in the labeling. |
Study Information
The document describes several studies conducted to demonstrate the performance of the A1c iGear System. Note that the A1c iGear System is stated to be a modified version of the previously cleared A1c GEAR System (K130014), and some performance data (Limit of Detection, Linearity, Matrix Comparison, Interference/Analytical Specificity) were generated with the A1c GEAR analyzer and repeated for completeness.
1. Precision Studies (Internal and External)
- Sample Size:
- Internal Precision:
- Control Material: 3 levels, each tested in duplicate for 10 days on each of two A1c iGear instruments. Total 40 results per control level.
- Whole Blood Samples: 3 levels, each tested in duplicate for 10 days on each of two A1c iGear instruments. Total 40 results per sample level.
- External Precision (Controls): 3-level control set, tested in duplicate for 20 days by each of three different operators at three separate sites. Total N=360 per control level.
- External Precision (Whole Blood): 3 whole blood samples (low, middle, high %HbA1c) tested two tests per day for 10 days by three operators at three separate sites. Total N=360 per whole blood sample.
- Internal Precision:
- Data Provenance: The internal precision study likely occurred at the manufacturer's facility. The external precision study was conducted at "three external POC sites" for the A1c iGear System. The data generated is prospective for the A1c iGear system.
- Number of Experts/Ground Truth: Not applicable for precision studies, as these evaluate the device's consistency, not accuracy against a true value.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No. This section describes device precision (reproducibility and repeatability).
- Standalone Performance: Yes, this describes the standalone performance of the A1c iGear System.
- Type of Ground Truth: Not applicable for precision studies.
- Training Set Sample Size/Ground Truth: Not specified/applicable, as this describes a performance validation study, not an AI model.
2. Method Comparison Study (Accuracy)
- Sample Size:
- Site 1: 42 patient samples
- Site 2: 44 patient samples
- Site 3: 40 patient samples
- Total: 126 patient samples
- Data Provenance: Patient samples (both fingerstick and venous whole blood) were collected at "three external POC sites" and compared against a reference laboratory. This is prospective data originating from these POC sites.
- Number of Experts/Ground Truth: Not applicable in the typical sense of expert review for imaging data. The ground truth (reference method) was High-Performance Liquid Chromatography (HPLC) testing performed at a reference laboratory.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No. This compares the device to a reference method, not human readers.
- Standalone Performance: Yes, this describes the standalone performance of the A1c iGear System against a reference method.
- Type of Ground Truth: Reference method (HPLC).
- Training Set Sample Size/Ground Truth: Not specified/applicable.
3. Limit of Detection (LoD)
- Sample Size:
- LoB: 90 replicates of a zero sample (blank)
- LoD: 27 replicates of three low HbA1c samples
- Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), which is the predicate device. Therefore, the provenance is likely internal testing by the manufacturer.
- Number of Experts/Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes.
- Type of Ground Truth: Controlled samples (blank, low HbA1c samples).
- Training Set Sample Size/Ground Truth: Not specified/applicable.
4. Linearity
- Sample Size: Two EDTA whole blood samples (normal and elevated HbA1c) were inter-mixed to make 11 intermediate samples. All intermediate dilutions were analyzed in replicates of three.
- Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), which is the predicate device. Likely internal testing by the manufacturer.
- Number of Experts/Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes.
- Type of Ground Truth: Serially diluted samples (prepared from known normal and high HbA1c blood).
- Training Set Sample Size/Ground Truth: Not specified/applicable.
5. Matrix Comparison
- Sample Size:
- Fingerstick vs EDTA: 78 donor samples (Site 1)
- NaF vs. Fingerstick: 46 donor samples (Site 2)
- NaF vs. EDTA: 81 donor samples (Site 3)
- Total: 205 donor samples.
- Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), the predicate device. Donor samples were collected from three different sites. This is retrospective data relative to the A1c iGear, but prospective for the original A1c GEAR validation.
- Number of Experts/Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes.
- Type of Ground Truth: Comparative analysis between different sample matrices (Fingerstick, EDTA whole blood, NaF whole blood) measured by the device.
- Training Set Sample Size/Ground Truth: Not specified/applicable.
6. Interference and Analytical Specificity (Variant Hemoglobins)
- Sample Size:
- Common Interferents: Human EDTA and NaF whole blood samples with different %HbA1c levels (~6.3% and ≥9.0% HbA1c values) spiked with interferents, tested in quadruplicate. Specific number of samples not given for each interferent.
- Labile, Carbamylated, Acetylated Hb: EDTA and NaF whole blood samples with different %HbA1c levels (~6.3% and > 9.0% HbA1c) incubated with the substance, analyzed for a total of four replicates per sample.
- Hemoglobin Variants: Commercial samples known to contain Hemoglobin C, D, E, S, and F (at concentrations from 4.6-11.6% HbA1c) tested in duplicate. Specific number of samples not given for each variant.
- Data Provenance: This data was generated with the A1c GEAR System (K130014), the predicate device. Likely internal laboratory testing.
- Number of Experts/Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes.
- Type of Ground Truth: Controlled samples (spiked with known interferents/variants) measured by the device and compared to reference samples (without interferent).
- Training Set Sample Size/Ground Truth: Not specified/applicable.
Note: No information regarding AI or machine learning algorithms, training sets, or expert adjudication for ground truth (beyond using laboratory reference methods) is provided in this document as it pertains to a medical device for quantitative measurement rather than an AI/ML diagnostic software. The questions concerning "Number of experts," "Adjudication method," and "MRMC comparative effectiveness study" are typically relevant for AI/ML-based diagnostic devices. This submission does not describe such a device.
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(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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