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510(k) Data Aggregation
(50 days)
JBL
The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is intended for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes using the Astoria-Pacific SPOTCHECK Analyzer. Measurements of glucose-6-phosphate dehydrogenase activity are used primarily in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a G6PD deficiency. It is for in vitro diagnostic use primarily as an aid in screening for decreased levels of G6PD enzyme activity. This device is for use by trained, qualified laboratory personnel.
The Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit is a reagent kit used for the semi-quantitative determination of glucose-6-phosphate dehydrogenase activity in erythrocytes. The method is based on the spectrophotometric method where enzyme activity is measured by observing NADP+ reduction to NADPH when glucose-6-phosphate is present as a substrate. Maleimide is added to inhibit the production of NADPH by 6-phosphogluconate dehydrogenase. The fluorescent NADPH produced is proportional to the G6PD enzyme activity. The kit contains Extraction Buffer, Tris Buffer, G6PD Substrate, and NADH Stock Std reagents.
The provided text describes the G6PD 50-Hour Reagent Kit and its performance characteristics. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" for regulatory approval in the typical sense of numerical thresholds for sensitivity, specificity, etc., that the device had to meet to be cleared. Instead, it presents performance characteristics that demonstrate the device is substantially equivalent to a predicate. The key performance aspects highlighted are:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Semi-quantitative determination of G6PD activity for screening decreased levels in erythrocytes, aiding diagnosis/treatment of G6PD deficiency. | Semi-quantitative determination of G6PD activity in erythrocytes for screening decreased levels of G6PD enzyme activity. |
| Chemical Principle | NADP+ Reduction to NADPH. | NADP+ Reduction to NADPH. |
| Temperature | Operation at a specific temperature. | 37° C. |
| Stability | Reagent stability. | 8 hours. |
| Expected Value Range | Ability to delineate normal, intermediate, and deficient G6PD activity ranges in the tested populations. | Normal Population: 40 - 224 µM NADPH (Average 150 µM, Range 42-224 µM). Deficient Population: 4 - 40 µM NADPH (Average 18 µM, Range 4-40 µM). Intermediate Population: 28 - 69 µM NADPH (Average 49 µM, Range 28-69 µM). |
| Sensitivity | Ability to discern low levels of NADPH (reflecting G6PD activity). | As little as 2 µM NADPH is discernible from no response. |
| Detection Limit | Lower limit of quantifiable activity. | 9 µM NADPH. |
| Detection Method | Method of detecting NADPH. | Fluorescence of NADPH (λ excit. = 350 nm, λ emiss. = 450 nm). |
| Linearity | Correlation between response and known NADPH concentrations. | Response standards from 0 to 75 µM NADH gave a correlation coefficient r > .999. |
| Carryover | Minimal sample-to-sample interference. | Less than 2%; corrected by CARRYOVER cup. |
| Specificity | Specific for G6PD activity. | Achieved by using specific substrate (glucose-6-phosphate). Small NADPH production in absence of substrate. |
| Within-run Precision | Consistency of results within a single run. | G6PD Deficient: CV 3.2%. Intermediate: CV 4.4%. G6PD Normal: CV 3.1%. |
| Total Precision | Overall consistency of results across runs and days. | G6PD Deficient: CV 5.4%. Intermediate: CV 6.0%. (Normal not provided for total precision but within-run is similar to other levels.) |
| Correlation Study/Agreement with Predicate | No false positives or false negatives compared to predicate. | 0 of 20 false positives, 0 of 10 false negatives (compared to competitive device for normal/deficient samples). |
| Interference | Minimal interference from common substances/conditions. | Bilirubin to 25 mg/dl and lipemia to 1000 mg/dl do not interfere. Hemoglobin is removed by dialysis. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation/Comparison Study: 30 samples (16 normal, 4 intermediate, 10 G6PD deficient).
- Sample Size for Expected Values:
- Normal population of neonates: 17 observations
- G6PD deficient population: 10 observations
- Intermediate G6PD activity population: 4 observations
- Data Provenance: Not explicitly stated (e.g., country of origin). It's reasonable to infer these were collected for the purpose of the study. The study design (clinical samples, comparison to a competitive device) suggests prospective collection or at least retrospective use of stored clinical samples specifically for this performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not mention the use of "experts" in the sense of clinicians or radiologists adjudicating results.
- The ground truth for the comparison study (normal, intermediate, G6PD deficient) was established by analyzing samples "known to be normal (16), intermediate (4), and G6PD deficient (10)". It implies these classifications were based on prior clinical diagnosis or established laboratory methods, rather than real-time expert consensus for the purpose of this specific study.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The study compares the device's results to a "competitive device" and pre-classified samples, rather than an adjudication process among multiple readers for image interpretation or similar tasks.
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
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic reagent kit, not an AI-powered diagnostic system involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance characteristics described are for the Astoria-Pacific SPOTCHECK G6PD 50 Hour Reagent Kit as a standalone device, for use by trained laboratory personnel. Its output (µM NADPH) is a quantitative measurement, and its interpretation (e.g., normal, deficient) is based on established ranges. There is no "human-in-the-loop" AI component.
7. The Type of Ground Truth Used
- The ground truth for the performance studies was based on:
- Prior clinical classification/diagnosis: Samples were "known to be" normal, intermediate, or G6PD deficient before being tested by the device.
- Comparison to a predicate/competitive device: The device's results were compared against an existing, legally marketed G6PD assay.
- Controlled conditions for precision and linearity: Known concentrations of NADH for linearity, and samples with stable activity levels for precision.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a "training set." It's a chemical reagent kit with established biochemical principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
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