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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."

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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

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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The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.

Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed.

As with the predicate, this device is microprocessor-based and incorporates:

• traditional electrode technology to measure blood pH, pCO2, pO2 .
• Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
• ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
• enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
• conductivity/Na+ correction for hematocrit .
• multi-wavelength reflectance/conductivity correction for hemoglobin. .

Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated.

Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin.

This 510(k) summary (K110648) describes the Nova Stat Profile pHOx Ultra Analyzer System as substantially equivalent to the predicate device, the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830). The submission primarily focuses on demonstrating equivalence due to component obsolescence, rather than presenting a study to prove new performance criteria.

Therefore, the acceptance criteria are implicitly those established for the predicate device, and the "study" is a comparison and verification that the changes to the Nova Stat Profile pHOx Ultra Analyzer System did not affect the performance and maintain equivalence.

Here's the information broken down based on the provided text, recognizing the nature of this 510(k) (substantial equivalence based on component updates):

1. Table of Acceptance Criteria and Reported Device Performance

(Note: Since this is a substantial equivalence claim based on component changes, explicit acceptance criteria values for each analyte are not provided in this document. Instead, the "acceptance criteria" for the new device is to perform equivalently to the predicate. The reported device performance is that it met this equivalence.)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size or data provenance (country of origin, retrospective/prospective) for the "performance verification testing." Given the nature of a 510(k) for component changes, this testing would typically involve a series of internal laboratory tests comparing the updated device's output to the predicate's output across a range of relevant samples (e.g., blood controls, patient samples).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of 510(k) submission, focused on component equivalence for an in vitro diagnostic device, typically relies on established reference methods or calibrated controls as the "ground truth" rather than expert consensus on individual cases. The document does not specify the use of "experts" to establish ground truth for a test set in the traditional sense of clinical imaging or diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This submission does not describe a process involving adjudication of test results, as it is focused on technical equivalence to a predicate device rather than human interpretation or complex diagnostic assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an IVD device for quantitative measurements, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this submission.

6. Standalone Performance Study

Yes, in essence, a "standalone" performance verification for the new device was implicitly conducted against the predicate device. The submission states: "The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." This indicates that the device was tested to ensure its standalone performance matches that of the predicate.

7. Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

• Traceability to Reference Methods: Calibrators and controls used for the device would be traceable to recognized reference measurement procedures or certified reference materials for each analyte.
• Comparison to Predicate Device: The primary "ground truth" in this context is the established performance of the legally marketed predicate device (Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System). The new device's performance was verified to be equivalent.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that relies on a "training set" to learn. It is a measurement device with established electrochemical and optical principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of IVD device.

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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.

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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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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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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:

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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