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510(k) Data Aggregation
(876 days)
The FINDER G6PD test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood specimens collected in lithium heparin tubes, for the identification of G6PD deficient samples. The FINDER G6PD test is intended to be used with the FINDER Instrument in point of care or clinical laboratory settings.
The FINDER G6PD test system measures G6PD quantitatively from a 50uL venous whole blood specimen. The blood specimen should be collected in lithium heparin anticoagulant. The G6PD test system is suitable for use in both a point-of-care setting and a clinical laboratory. The time to result is around 16 minutes from sample introduction. The FINDER G6PD test system consists of the FINDER G6PD Test Cartridge and the FINDER Instrument. The cartridge uses electrowetting-based digital microfluidics to integrate and automate all the sample and reagent handling steps. The instrument contains all the hardware and software required to operate the cartridge, providing electrowetting control, thermal control and detection capability, a touch-screen user interface and software necessary to perform the test and report results.
FINDER G6PD Test: Acceptance Criteria and Performance Study
The FINDER G6PD Test is intended for semi-quantitative measurement of glucose-6-phosphate dehydrogenase in venous whole blood to identify G6PD deficient samples. The device is used with the FINDER Instrument in point-of-care or clinical laboratory settings.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance data presented from precision, linearity, interference, sensitivity, and method comparison studies collectively demonstrate the device's acceptable performance in comparison to the predicate device and established guidelines. For the purpose of this analysis, key performance metrics from the non-clinical and clinical studies will be presented as the "reported device performance."
| Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Precision | Single Site Precision (CV%) | |
| (Hemolysate Controls) | Low (1.4 U/gHb) | Repeatability: 4.1%, Reproducibility: 6.5% |
| Intermediate (7.0 U/gHb) | Repeatability: 3.6%, Reproducibility: 5.3% | |
| High (17.4 U/gHb) | Repeatability: 2.4%, Reproducibility: 5.2% | |
| Reproducibility Precision (CV%) | ||
| (Fresh Whole Blood) | Low (1.1 U/gHb) | Repeatability: 5.9%, Reproducibility: 6.0% |
| Intermediate (3.5 U/gHb) | Repeatability: 3.4%, Reproducibility: 4.4% | |
| High (11.2 U/gHb) | Repeatability: 6.6%, Reproducibility: 7.0% | |
| Linearity | Linear Range | 0.8 to 19.7 U/g Hb |
| Interference | Endogenous Substances | Non-interfering at maximum tested concentrations (e.g., Bilirubin 50 mg/dL, Hemoglobin 5 g/L) |
| Common Drugs | Non-interfering at maximum tested concentrations (e.g., Ampicillin 0.16 mM, Ibuprofen 2.5 mM) | |
| Hematocrit | Bias of -15.3% at 29% Hct (normal sample), -11.1% at 30% Hct (MDL sample) compared to 50% Hct. | |
| Sensitivity | Limit of Blank (LoB) | 0.2 U/g Hb |
| Limit of Detection (LoD) | 0.4 U/g Hb | |
| Limit of Quantitation (LoQ) | 1.1 U/g Hb | |
| Method Comparison | Slope (95% CI) | 0.92 (0.89, 0.95) |
| Intercept (95% CI) | 0.28 (0.12, 0.44) | |
| Correlation Coefficient | 0.9 | |
| Bias at 3.1 U/gHb (30% AMM) | 0.0 U/gHb (-0.1, 0.2) or 1.4% (-2.5%, 5.4%) | |
| Bias at 8.4 U/gHb (80% AMM) | -0.4 U/gHb (-0.5, 0.2) or -4.3% (-6.5%, -2.0%) | |
| Categorical Agreement (<30% AMM vs ≥30% AMM) | Agreement: 98.8% (95% CI: 95.7%, 99.7%) | |
| Categorical Agreement (<70% AMM vs ≥70% AMM) | Agreement: 94.0% (95% CI: 89.3%, 96.7%) | |
| Categorical Agreement (<80% AMM vs ≥80% AMM) | Agreement: 90.4% (95% CI: 85.0%, 94.0%) |
2. Sample Size Used for the Test Set and Data Provenance
For the Clinical Method Comparison Study (test set):
- Sample Size: 200 subjects. The results of 167 samples were used in the concordance analysis after the first 36 normal male samples were used to calculate the adjusted male median.
- Data Provenance: Venous whole blood samples were collected from 6 sites, including one biorepository. The samples were collected in lithium heparin tubes. The study design was based on CLSI EP09-c – Measurement Procedure Comparison and Bias Estimation Using Patient Samples. The subjects included 89 males and 92 females with ages ranging from 20 to 72 years. 19 contrived samples were also included in the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. Instead, the "ground truth" for the method comparison study was established by a comparator method: the Pointe Scientific Glucose-6-Phosphate Dehydrogenase Reagent Set (K024006), run on a Cobas Mira instrument. This predicate device served as the reference method.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving human experts for the test set. The comparison was made directly between the FINDER G6PD Test results and the results obtained from the predicate device (Pointe Scientific G6PD Reagent Set on Cobas Mira).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed in this document. The study focuses on the performance of the device (FINDER G6PD Test) compared to a predicate device, not on human readers' improvement with or without AI assistance. The FINDER G6PD Test is an in vitro diagnostic device, not an imaging AI diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was conducted for the FINDER G6PD Test. All the non-clinical and clinical performance data presented (precision, linearity, interference, sensitivity, and method comparison) reflect the performance of the FINDER G6PD Test system (FINDER G6PD Test Cartridge + FINDER Instrument) operating by itself, without human interpretation of the primary result. The results are reported directly by the instrument in U/gHb and as a % of the site-specific Adjusted Male Median (AMM).
7. Type of Ground Truth Used
The ground truth for the clinical method comparison study was established using a comparator method, specifically the Pointe Scientific Glucose-6-Phosphate Dehydrogenase (G6PD) Reagent Set (K024006) run on a Cobas Mira instrument. This serves as a reference standard for measuring G6PD activity.
8. Sample Size for the Training Set
The document does not specify a distinct "training set" sample size for developing the FINDER G6PD Test. This is typical for IVD devices that measure an analyte directly, where the underlying principle is biochemical and validated through analytical and clinical performance studies, rather than a machine learning model that requires a labeled training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" described in the context of a machine learning model for this IVD device, the concept of establishing ground truth for a training set does not directly apply. The "training" for the device's underlying measurement methodology would involve established biochemical principles and extensive internal analytical validation prior to the formal performance studies presented in the 510(k) submission.
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