Search Results

The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.

The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The kit contains Neonatal Total Galactose Assay Reagent 1, Neonatal Total Galactose Assay Reagent 2, Neonatal Total Galactose Assay Buffer, Neonatal Total Galactose Assay Reconstitution Solution, and Neonatal Extraction Solution. Calibrators and Controls are also included.

1. Table of Acceptance Criteria and Reported Device Performance

• Conjugated Bilirubin: Concentrations above 16.6 mg/dL caused a significant decrease (>15%) in measured total galactose. At 24.9 mg/dL and above, the decrease was 100% at some total galactose concentrations.
• Intralipid: Concentrations above 250 mg/dL (at 5 and 10 mg/dL total galactose) or 375 mg/dL (at 15 mg/dL total galactose) caused a significant increase (>15%) in measured total galactose. Maximum tested (1500 mg/dL) caused an increase of ~52-77%.
• Hemoglobin (with Bilirubin): Hemoglobin levels at 198 g/L and above in combination with an elevated bilirubin level of 15 mg/dL caused a significant increase (>15%) in measured total galactose at certain total galactose concentrations. For example, at 5 mg/dL total galactose, 198 g/L Hb led to a 26.3% increase.
• Non-Interfering Substances: Unconjugated bilirubin (20 mg/dL), ß-Nicotinamide adenine dinucleotide (100 µmol/L), Glutathione (3 mmol/L), Human Serum Albumin (30 mg/mL), Ascorbate (6 mg/dL), D-glucose (1000 mg/dL), D-mannose (100 mg/dL), D-fructose (18 mg/dL), Ampicillin (152 µmol/L), and Lithium heparin (0.375 mg/ml), and Hematocrit levels from 30% to 66% (102-230 g/L Hemoglobin) were found not to interfere. |
  | Screening Performance vs. Predicate (95th percentile) | Overall percent agreement = 96.0%
  Positive percent agreement = 63.6%
  Negative percent agreement = 97.9% |
  | Screening Performance vs. Predicate (99th percentile) | Overall percent agreement = 98.8%
  Positive percent agreement = 53.3%
  Negative percent agreement = 99.4% |

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

• Sample Size for Precision Study: 7 samples, with 216 total measurements per sample (4 replicates per sample, in 27 runs over 21 days using 3 kit lots and 3 GSP instruments).
• Sample Size for LoD: 216 determinations of 4 low-level samples.
• Sample Size for LoB: 150 blank samples.
• Sample Size for Recovery: 3 contrived dried blood spot samples.
• Sample Size for Interference Studies: Not explicitly stated for each concentration, but involved various concentrations of interfering substances at three total galactose concentrations (5, 10, and 15 mg/dL).
• Sample Size for Internal Method Comparison: 141 routine screening and spiked blood spot specimens.
• Sample Size for Screening Performance Study: 2320 samples (6 confirmed positive samples and 2314 routine samples).
• Data Provenance: The screening performance study was conducted at "one newborn screening laboratory in the United States." Other non-clinical studies (precision, linearity, LoB/LoD/LoQ, recovery, interference) appear to be internal laboratory studies without specific geographic provenance mentioned, but presumably also conducted in the US or Finland (Wallac Oy headquarters). The studies were retrospective, using banked samples and contrived samples.

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

The document does not mention the use of experts to establish ground truth for the test set. For the screening performance study, "6 confirmed positive samples" are mentioned, implying prior clinical diagnosis as the ground truth. The qualifications of who confirmed these positive cases or how the "routine samples" were classified as normal are not specified.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe any expert adjudication process for the test set. Ground truth for confirmed positive samples likely came from clinical diagnosis.

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 device is an in-vitro diagnostic test kit (laboratory assay) for quantitative determination, not an imaging device or AI-assisted diagnostic tool that would involve human readers interpreting results in a MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the assay itself. The entire submission details the standalone performance of the GSP Neonatal Total Galactose kit (assay only) without human-in-the-loop interpretation beyond standard laboratory procedures and reporting. The "GSP® instrument" is automated, as stated in the comparison chart ("GSP instrument, automated").

7. The Type of Ground Truth Used

• For Analytical Performance (Precision, LoB, LoD, LoQ, Linearity, Recovery, Interference): Ground truth was established by preparing samples with known concentrations of total galactose or specific interfering substances. For example, for recovery, the "recovery of galactose, galactose-1-phosphate, and both combined was determined from three contrived dried blood spot samples," meaning these samples were prepared with known amounts.
• For Screening Performance Study: The ground truth for the 6 positive samples was "confirmed positive." This implies a clinical diagnosis of galactosemia, likely through follow-up diagnostic testing. The other 2314 samples are referred to as "routine samples" and classified as "normal" in the context of screening performance, likely based on either their negative predicate device result or their actual clinical status. The document also compares the new device's results against the predicate device's results as a reference for "Manual result."

8. The Sample Size for the Training Set

Not applicable in the conventional sense of machine learning training sets. This is a chemical assay, not an AI/ML device that requires a distinct training set for model development. The development and optimization of the assay would involve various experiments, but these are not referred to as "training sets" in this context.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this chemical assay. The development of the calibrators and controls (which are prepared with known concentrations of galactose and galactose-1-phosphate) serves an analogous function in ensuring accuracy and consistency of the assay.

Ask a specific question about this device

The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood on filter paper disks. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.

The provided text describes a 510(k) premarket notification for the AutoDELFIA Neonatal IRT kit. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. As such, many of the requested fields for AI/ML device studies are not directly applicable or explicitly stated in this document.

However, I can extract information related to the device's analytical performance characteristics, which serve as a form of acceptance criteria for this type of in-vitro diagnostic device.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available.

1. Table of Acceptance Criteria and the Reported Device Performance

For this in-vitro diagnostic device, "acceptance criteria" are generally established by demonstrating performance characteristics that are comparable to or better than a legally marketed predicate device, and that meet the required analytical performance for its intended use.

Ask a specific question about this device

The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.

The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the GSP Neonatal Thyroxine (T4) kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and ground truth for disease diagnosis in the same way an AI/ML powered device might.

Therefore, the requested information regarding "acceptance criteria" for an AI device, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training/testing" in the context of an AI/ML study does not directly apply to this submission.

However, I can extract the closest analogous information available within this document, focusing on the performance characteristics presented to demonstrate equivalence.

Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" as performance metrics for this diagnostic kit.

1. Table of Acceptance Criteria and Reported Device Performance

For an in-vitro diagnostic kit like this, "acceptance criteria" are typically defined by demonstrating that the new device performs comparably to or within acceptable ranges relative to a predicate device and established analytical performance specifications. The document provides a comparison of various features and performance characteristics between the new GSP Neonatal T4 kit and its predicate device, AutoDELFIA Neonatal T4 Kit.

• Intra-assay variation 14.9 %
• Inter-assay variation 10.0 %
• Total variation 18.0 %
  Control 2; 8.08 µg/dL serum
• Intra-assay variation 10.6 %
• Inter-assay variation 7.1 %
• Total variation 12.7 %
  Control 3; 18.2 µg/dL serum
• Intra-assay variation 8.2%
• Inter-assay variation 4.3%
• Total variation 9.3 % | Sample 1; 2.0 µg/dL
• Within run 1.0%
• Within lot 15.5%
• Total variation 15.8%
  Sample 2; 4.8 µg/dL
• Within run 7.3%
• Within lot 10.7%
• Total variation 11.4%
  Sample 3; 7.5 µg/dL
• Within run 6.5%
• Within lot 8.4%
• Total variation 8.6%
  Sample 4; 16.6 µg/dL
• Within run 4.5%
• Within lot 7.8%
• Total variation 8.5%
  Sample 5; 19.8 µg/dL
• Within run 7.2%
• Within lot 9.9%
• Total variation 10.3%
  Sample 6; 21.4 µg/dL
• Within run 7.1%
• Within lot 9.8%
• Total variation 10.1% |
  | Measuring Range | 1.5 µg/dL to the highest level calibrator | 1.6 to 30 µg/dL serum |
  | Limit of Blank (LoB) |

Ask a specific question about this device