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510(k) Data Aggregation
(498 days)
The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System.
The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.
The hemoglobin A1c system is comprised of a fully automated desktop electric spectrophotometer that measures HbA1c in capillary or venous whole blood samples collected in EDTA (K2 and K3) or sodium heparin using a dedicated cartridge, which is pre-filled with the reagent; latex (reagent 1), antibody and sample dilute solution (reagent 2). The hemoglobin A1c system shines a light through the test material and measures the quantity 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.
Two levels of hemoglobin A1c control are provided for routine quality checks - level 1 in the normal HbA1c range and level 2 in the elevated HbA1c range. The HbA1c controls are lyophilized hemolysates prepared from packed human erythrocytes.
The provided document is a 510(k) Summary for the URight Hemoglobin A1c System and FORA A1c System. It describes the device, its intended use, and performance characteristics in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the performance characteristics. Instead, it presents the results of various validation studies (linearity, precision, accuracy, interference, matrix comparison) which demonstrate the device's performance against a reference method (Tosoh G8 analyzer) or established expectations for diagnostic devices of this type.
Interpretation for Acceptance Criteria and Performance:
For this type of device, "acceptance criteria" are typically implied requirements for analytical performance that are considered acceptable for clinical use and demonstrate substantial equivalence to a predicate device. These criteria often relate to quantitative measures like R-squared values for correlation, percent recovery for linearity, and Coefficients of Variation (CV%) for precision.
Given the context, I will infer the acceptance criteria based on generally accepted standards for HbA1c assays and what is presented as demonstrating acceptable performance for regulatory approval.
| Performance Characteristic | Inferred Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | R² ≥ 0.98 or similar high correlation; Recovery within a tight range (e.g., 90-110%) | R² = 0.9913; Recovery = 95-104% |
| Precision (Within-run %CV) | Should be low, typically < 5% for clinical assays, especially for control solutions and patient samples. | Control solution (Low): 3.75% - 4.32% (across sites) Control solution (High): 3.55% - 3.88% (across sites) Blood sample (Low): 2.87% - 4.14% (across sites) Blood sample (Middle): 3.58% - 4.95% (across sites) Blood sample (High): 3.26% - 3.60% (across sites) |
| Precision (Between day %CV) | Should be low, typically < 5-10% for clinical assays. | Control solution (Low): 3.47% - 3.82% (across sites) Control solution (High): 3.78% - 4.12% (across sites) Blood sample (Low): 3.70% - 4.04% (across sites) Blood sample (Middle): 3.85% - 3.92% (across sites) Blood sample (High): 3.39% - 3.49% (across sites) |
| Accuracy (Regression R²) | R² ≥ 0.95 (strong correlation to reference method) | Capillary blood: 0.9834, 0.9846, 0.9849 (across sites) Venous blood (K2/K3 EDTA): 0.9807, 0.9885, 0.9861 (across sites) |
| Accuracy (Slope & Intercept) | Slope close to 1, intercept close to 0 (indicating good agreement with reference) | Capillary blood: Slopes 0.958-1.015, Intercepts -0.044 to 0.280 Venous blood: Slopes 0.968-1.022, Intercepts -0.101 to 0.160 |
| Interference | < 6% deviation from target | Achieved for listed substances: Acetaminophen, Glibenclamide, Ibuprofen, Metformin, Triglycerides, Bilirubin, Ascorbic acid, Rheumatoid factor, Carbamylated Hb, Acetylated Hb. No significant interference for: HbC ≤37.4%, HbD ≤48.5%, HbE ≤21.4% and HbA2 < 7.0%. Interference noted for: HbF at 21.2% and HbS at 20.3% (lower than expected HbA1c result). |
| Matrix Comparison (R²) | R² ≥ 0.98 (strong correlation between different sample types) | EDTA vs. Capillary: 0.9896 Sodium heparin vs. Capillary: 0.9885 Sodium heparin vs. EDTA: 0.9879 |
2. Sample sizes used for the test set and the data provenance
- Linearity Test Set: 11 samples (varying proportions of 4.3% and 13% HbA1c fresh EDTA blood samples) + 2 spiked samples (14.3% and 15.5% HbA1c).
- Data Provenance: Not explicitly stated, but likely from a laboratory setting as fresh EDTA blood samples are mentioned. No country of origin is specified. Retrospective/Prospective not specified, but the description implies a prospective creation of samples for the study.
- Precision Test Set:
- Control Solutions: 2 levels of HbA1c control solutions.
- Within-run: 20 tests per control level per site.
- Between-run/Between-day: 80 tests (duplicate twice a day for 20 days) per control level per site. Total n=240 combined across 3 sites for combined between-day.
- Blood Samples: 3 levels of blood samples.
- Within-run: 20 tests per blood level per site.
- Between-run/Between-day: 80 tests (duplicate twice a day for 20 days) per blood level per site. Total n=240 combined across 3 sites for combined between-day.
- Data Provenance: Not explicitly stated for samples but tested at "three different sites." No country of origin is specified. Implies prospective testing.
- Control Solutions: 2 levels of HbA1c control solutions.
- Accuracy Test Set:
- Capillary: 49 (site 1), 48 (site 2), 49 (site 3) = Total 146 samples.
- Venous (K2EDTA/K3EDTA): 49 (site 1), 50 (site 2), 50 (site 3) = Total 149 samples.
- Data Provenance: "patient samples in three different sites." No country of origin is specified. Appears to be prospective.
- Interference Test Set:
- Not specified, but tested with a list of "interfering substances at indicated concentrations." Likely controlled laboratory samples rather than patient samples.
- Matrix Comparison Test Set: 135 samples (HbA1c range 4.5-13%).
- Data Provenance: "collected from 3 POC sites." No country of origin is specified. Implies prospective collection and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for all performance studies (Linearity, Precision, Accuracy) was established by comparison to the Tosoh G8 analyzer. The Tosoh G8 is a widely accepted and certified reference method for HbA1c measurement.
- No human "experts" (like radiologists) were used to establish ground truth in the traditional sense of medical imaging.
- The comparison is against another established, automated analytical device. Therefore, no information on the number or qualifications of human experts is provided or relevant in this context.
4. Adjudication method for the test set
Not applicable. The ground truth is an analytical measurement from a reference instrument (Tosoh G8), rather than expert consensus requiring an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automated in vitro diagnostic (IVD) system for measuring HbA1c. It does not involve human readers evaluating images or assisting in diagnostic interpretation in the way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies presented (Linearity, Precision, Accuracy, Interference, Matrix Comparison) are all standalone performance studies for the URight/FORA A1c System. The device directly measures HbA1c levels, and its performance is assessed independently against a reference method and defined criteria, without human intervention in the measurement process itself.
7. The type of ground truth used
The ground truth used for performance evaluation (linearity, precision, accuracy) was established by measurements obtained from the Tosoh G8 analyzer, which serves as a reference method or known comparative standard for HbA1c testing. For interference and matrix comparison, presumed "true" values or the behavior of various matrices were also assessed against this or similar established analytical standards.
8. The sample size for the training set
The document does not provide information about a "training set" in the context of an algorithm. This device is a spectrophotometer-based immunoassay system, not an AI/machine learning algorithm requiring a specific training dataset in the typical sense. The device's operational parameters (e.g., reagent lot-specific parameters) are predetermined and not "trained" on a large dataset of patient results.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" for an algorithm for this type of device.
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