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510(k) Data Aggregation
(448 days)
ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.
HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.
ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.
The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide.
The device for this submission is available as kit only. It consists of 4 different levels of calibrator at 0.5 mL volume. Each level consists of lyophilized hemolysates prepared from human erythrocytes. HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors teste individually and found to be negative for HbsAg and to antibodies to HCV and HI according to FDA-approved methods.
ELITech Clinical Systems HbA1c Control L + H is a two level quality control products consisting of lyophilized hemolysates prepared from human erythrocytes containing constituents at desired levels. HbA1c CONTROL L+ H is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
The provided document is a 510(k) summary for the ELITech Clinical Systems HbA1c reagent, calibrator set, and control set. It details the substantial equivalence of these devices to a predicate device, focusing on their intended use, assay principle, composition, and performance characteristics. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for training/test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).
The document is a regulatory submission for in vitro diagnostic (IVD) assays, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., test set sample size, data provenance, expert-established ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, how training ground truth was established) are not applicable or typically reported in this type of submission. Performance for IVD devices is usually evaluated through analytical studies (precision, accuracy/method comparison, linearity, interference) rather than clinical studies with expert-adjudicated ground truth as seen in AI/ML device submissions.
Here's an attempt to answer based on the provided text, highlighting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table for accuracy. Instead, it compares the proposed device's performance to the predicate device's performance and clinical utility. The "Conclusion" sections uniformly state that the device "met all acceptance criteria" without detailing what those criteria were. However, we can infer some performance metrics:
| Performance Metric | Acceptance Criteria (Not explicitly stated, but implied by comparison/predicate) | Reported Device Performance (ELITech Clinical Systems HbA1c) |
|---|---|---|
| Measuring Range | Comparable to predicate (2 to 16 %) | 2.5 to 16 % |
| Limit of Blank (LoB) | Established and comparable to predicate | 0.6 % |
| Limit of Detection (LoD) | Established and comparable to predicate | 0.7 % |
| Within-Run Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 1.1 %Level 6.7 %: CV= 0.9 %Level 9.5 %: CV= 1.0 % |
| Total Precision (CV) | Expected to be low and comparable to predicate for various HbA1c levels | Level 4.4 %: CV= 2.3 %Level 6.7 %: CV= 1.9 %Level 9.5 %: CV= 2.9 % |
| Method Comparison (Correlation to Predicate) | Strong correlation (high 'r' value) and good agreement (slope close to 1, intercept close to 0) to predicate. | y = 0.926x + 0.1 %r = 0.984 |
| Interference | No significant interference from common interfering substances (bilirubin, triglycerides, Hb variants, etc.) | No significant interference reported for: Unconjugated bilirubin (up to 30 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Triglycerides (up to 2000 mg/dL), Acetylsalicylic acid (up to 200 mg/dL), Rheumatoid factor (up to 1000 IU/mL), Ascorbic acid (up to 20 mg/dL), HbC, HbS, HbD, HbE, HbA2. High HbF leads to underestimation. No significant interference from carbamylated or acetylated hemoglobin, or labile HbA1c. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the method comparison (accuracy) study. It provides the regression equation and correlation coefficient (r = 0.984) derived from this study, but not the 'n' value.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This type of detail is not typically included in a 510(k) summary for an IVD reagent. The study would have been an analytical validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For an IVD assay like HbA1c, "ground truth" for individual samples is typically established by comparative methods (e.g., a reference method like HPLC or a legally marketed predicate device) rather than expert adjudication. The study is a method comparison study against the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As this is an IVD assay comparison, not an AI/ML image-based diagnosis, expert adjudication methods are not used.
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 is not an AI/ML device, and no MRMC study or evaluation of human reader improvement is relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a quantitative diagnostic reagent kit for an automated analyzer. Its performance is inherently "standalone" in the sense that the instrument processes the sample and the reagent measures the HbA1c level without direct human interpretive intervention beyond running the assay and interpreting the numerical result. There is no "algorithm" in the AI/ML sense to be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the method comparison study, the "ground truth" (or reference) for evaluation appears to be the predicate device (Pointe Scientific Hemoglobin A1c Reagent Set). The study compares the ELITech device's results (Y) against the predicate device's results (X) using regression analysis ($y=0.926x + 0.1 %$).
8. The sample size for the training set
- Not Applicable. This is an IVD diagnostic reagent, not an AI/ML algorithm that undergoes "training." The device's performance is characterized through analytical validation studies.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or establishment of ground truth for training in the context of this type of device.
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