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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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(31 days)
The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.
The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip. The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.
To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.
Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change – the red sample color changes to a brown / black color on the upper half of the reaction pad.
Here's a breakdown of the acceptance criteria and study details for the BinaxNOW® G6PD Test, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Heparin Samples: | ||
| Deficient Result Percent Agreement | > 90% (Commonly accepted for diagnostic tests, though not explicitly stated as an "acceptance criterion" in this document) | 98.0% (CI = 89.3 - 99.6%) |
| Normal Result Percent Agreement | > 90% | 97.9% (CI = 94.8 - 99.2%) |
| Overall Percent Agreement | > 90% | 97.9% (CI = 95.3 - 99.1%) |
| EDTA Samples: | ||
| Deficient Result Percent Agreement | > 90% | 98.0% (CI = 89.5 - 99.6%) |
| Normal Result Percent Agreement | > 90% | 97.4% (CI = 94.2 - 98.9%) |
| Overall Percent Agreement | > 90% | 97.6% (CI = 94.8 - 98.9%) |
| Agreement between Heparin and EDTA | > 95% (Indicates consistency in performance across different anticoagulants) | 99% |
| Interfering Substances | No interference from specified endogenous blood components or copper sulfate; Performance may be affected by extreme hematocrit levels. | None of the endogenous blood components (bilirubin, triglycerides, total cholesterol, lactate dehydrogenase, glucose) affected test performance. Copper sulfate also did not affect performance. Performance was affected by abnormally low (17-18%) and high (54-65%) hematocrit levels. |
| Reproducibility (Across sites/operators) | High agreement with expected results (e.g., >95%) | 98.4% (123/125) agreement with expected test results, with no significant differences within run, between run, between sites, or between operators. |
| Precision (Single operator) | Consistent results over time for known normal/deficient samples (e.g., 100% agreement) | Normal samples interpreted as normal 100% of the time over 10 days. Deficient samples interpreted as deficient 100% of the time over 10 days. |
Note: The document doesn't explicitly state numerical acceptance criteria for agreement percentages, but the reported performance levels clearly exceed commonly accepted efficacy thresholds for diagnostic devices (typically >90% sensitivity and specificity, or equivalent agreement).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 246 subjects.
- Data Provenance:
- Country of Origin: U.S.
- Retrospective or Prospective: Prospective study conducted in 2007-2008.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish the ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth was established by a "commercially available quantitative G6PD test."
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
This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The "reading" of the BinaxNOW test is a visual interpretation of a color change by a single operator.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The BinaxNOW® G6PD Test is a visual screening test, which inherently involves a "human-in-the-loop" for interpretation of the color change. It is not an algorithm-only device. Therefore, a standalone performance study in the context of an algorithm-only device is not applicable in the typical sense for this product. The studies presented are the standalone performance of the test as it is intended to be used (visually read).
7. The Type of Ground Truth Used
The ground truth was established by a "commercially available quantitative G6PD test." This is a reference method, often considered a "gold standard" for determining the actual G6PD activity levels.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" in the context of machine learning or AI. The BinaxNOW® G6PD Test is a lateral flow assay, not a machine learning algorithm that requires training data in the typical sense. The "performance summary" sections describe clinical validation studies rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
As noted above, there isn't a "training set" for an algorithm in the context of this device. The development of the device itself would have involved laboratory optimization using known samples (with ground truth established by quantitative G6PD assays), but this is part of product development and not typically referred to as an "algorithm training set" in the regulatory submission for this type of IVD.
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(295 days)
The BinaxNOW® G6PD (Glucose-6-Phosphate Dehydrogenase) Test is an in vitro enzyme chromatographic test for the qualitative detection of G6PD enzyme activity in human venous whole blood, collected in heparin or ethylenediaminetetraacetic acid (EDTA). The BinaxNOW® G6PD Test is a visual screening test used for differentiating normal from deficient G6PD activity levels in whole blood and is intended to aid in the identification of people with G6PD deficiency. Samples which generate deficient results should be assayed using a quantitative G6PD test method to verify the deficiency.
The BinaxNOW® G6PD test device consists of a lateral flow test strip comprised of a white sample pad and a reaction pad, which is located at the top of the strip (2 U.S. patents pending). The reaction pad contains the reagents necessary for the G6PD enzymatic reaction and the subsequent reduction of a nitro blue tetrazolium dye into its concomitant blue formazan product. The resulting color change on the strip indicates enough G6PD activity is present to presume the sample is not deficient.
To perform the test, a whole blood sample is mixed with red blood cell (RBC) lysing reagent in a sample preparation vial and then transferred to the test device sample pad. The lysed blood sample migrates up the test strip, reconstituting reagents in the reaction pad. When the sample front (or liquid migration) covers the entire reaction pad, the device is closed.
Test results are read visually. If no change in the red color of the sample front is observed at the test read time, the sample is presumed to be deficient in G6PD enzyme activity. Samples normal in G6PD activity produce a distinct color change - the red sample color changes to a brown / black color on the upper half of the reaction pad.
Here's a breakdown of the acceptance criteria and the study details for the BinaxNOW® G6PD Test, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criteria revolve around the agreement of the BinaxNOW® G6PD Test results with a commercially available quantitative G6PD test, particularly for identifying G6PD deficiency and normal activity.
| Acceptance Criteria (Implicit) | Reported Device Performance (BinaxNOW® G6PD Test) |
|---|---|
| Agreement with Quantitative G6PD Test for Deficient Results (Heparin Samples): High percentage of agreement for deficient results compared to the quantitative method. | Deficient result percent agreement (Heparin Samples): 98.0% (CI = 89.3 - 99.6%) |
| Agreement with Quantitative G6PD Test for Normal Results (Heparin Samples): High percentage of agreement for normal results compared to the quantitative method. | Normal result percent agreement (Heparin Samples): 97.9% (CI = 94.8 - 99.2%) |
| Overall Agreement with Quantitative G6PD Test (Heparin Samples): High overall percentage of agreement. | Overall percent agreement (Heparin Samples): 97.9% (CI = 95.3 - 99.1%) |
| Agreement with Quantitative G6PD Test for Deficient Results (EDTA Samples): High percentage of agreement for deficient results compared to the quantitative method. | Deficient result percent agreement (EDTA Samples): 98.0% (CI = 89.5 - 99.6%) |
| Agreement with Quantitative G6PD Test for Normal Results (EDTA Samples): High percentage of agreement for normal results compared to the quantitative method. | Normal result percent agreement (EDTA Samples): 97.4% (CI = 94.2 - 98.9%) |
| Overall Agreement with Quantitative G6PD Test (EDTA Samples): High overall percentage of agreement. | Overall percent agreement (EDTA Samples): 97.6% (CI = 94.8 - 98.9%) |
| Consistency between Heparin and EDTA Samples: High agreement between the two sample types. | Percent agreement between heparin and EDTA samples: 99% (for 240/243 subjects) |
| Reproducibility Across Operators and Sites: High agreement with expected test results across multiple operators, days, and sites. | Reproducibility Agreement: 98.4% (123/125) with no significant differences within run, between run, between sites, or between operators. |
| Precision (Single Operator): Consistent results by a single operator over multiple days. | Demonstrated 100% consistent results for both normal and deficient samples over ten successive days by a single operator. |
| Absence of Interference from Endogenous Substances: Test performance not affected by high levels of various endogenous blood components. | Interference Testing: None of the tested endogenous blood components (bilirubin, triglycerides, total cholesterol, lactic acid, lactate dehydrogenase, glucose, copper sulfate) affected test performance. |
| Performance with Abnormally Low/High Hematocrit Levels: Performance maintained within defined limits (though limitations existed as per package insert). | Test performance was affected by abnormally low and high hematocrit levels (17-18% and 54-65%), as described in the Limitations section of the package insert (details not provided in this summary). |
Study Details:
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Sample Size used for the test set and the data provenance:
- Sample Size: 246 subjects (for the initial clinical sample performance study).
- Data Provenance: Prospective study conducted in 2007-2008 in the U.S.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth. The "ground truth" was established by a "commercially available quantitative G6PD test," implying a quantitative laboratory assay rather than human expert interpretation of the BinaxNOW® test results.
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Adjudication method for the test set:
- Adjudication method for the test set results is not explicitly mentioned. The BinaxNOW® G6PD Test is a visual screening test. The comparison was made against a "commercially available quantitative G6PD test," implying a direct numerical comparison against the quantitative assay's results.
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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 a rapid diagnostic test (lateral flow, enzyme chromatographic) for G6PD deficiency, read visually, not an AI-powered diagnostic imaging tool. It involves a single visual reading of the color change on the strip.
- The closest "multi-reader" equivalent mentioned is the Reproducibility Study, which involved "multiple operators" (6 operators) across "3 separate sites." However, this was to assess the consistency of the device's output and interpretation, not to compare human performance with/without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in effect, a standalone performance was done for comparing the device's output against the quantitative method. The BinaxNOW® G6PD Test is designed to be a standalone visual screening test. The "performance summary" directly compares its qualitative output (deficient/normal) to the quantitative method's results, indicating its performance as a standalone diagnostic tool. Human readers are involved in the interpretation of the visual result of the BinaxNOW® test, but the device itself is a qualitative biochemical assay, not an AI algorithm.
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The type of ground truth used:
- Quantitative Assay Results: The ground truth was established using results from a "commercially available quantitative G6PD test." This serves as the reference standard. A specific cut-off value of 4.2 U/gHb from the comparative method was used to define "deficient" and "normal" for comparison purposes.
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The sample size for the training set:
- The document does not explicitly mention a separate "training set" as would be typical for machine learning models. For this type of in-vitro diagnostic device, development and optimization often involve internal studies, but specific details on a "training set" size for a machine learning context are not provided because it's not an AI device. The clinical performance study used 246 subjects.
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How the ground truth for the training set was established:
- As noted above, a distinct "training set" with established ground truth in the context of an AI algorithm is not applicable here. The development and validation of the BinaxNOW® G6PD Test would have involved establishing performance characteristics against known G6PD activity levels, likely using quantitative methods, but this is a product development process rather than an AI model training process.
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(117 days)
For the quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
Not Found
This document is a 510(k) premarket notification acceptance letter and an Indications for Use statement for a medical device. It does not contain information about acceptance criteria, study details, or device performance as requested in the prompt. Therefore, I cannot provide the requested information based on this input.
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