Search Results

The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes.

The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.

These devices are intended for use by trained, qualified laboratory personnel.

SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate: Four enzyme mediated reactions are employed in the determination of GALT activity. GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color. The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb.

SPOTCHECK Pro: INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay.

This is a 510(k) premarket notification for a medical device, not an AI/ML device, therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set) is not applicable or cannot be extracted from the provided text. The document describes the device's technical characteristics, performance studies performed to demonstrate substantial equivalence to a predicate device, and its intended use.

Here's an analysis of the provided information, tailored to what is available in the regulatory submission format:

1. Table of Acceptance Criteria (Performance Goals) and Reported Device Performance

The acceptance criteria are generally implied by the comparative studies to the predicate device and established CLSI guidelines for analytical performance. The studies aim to show the SPOTCHECK Kit performs comparably or better than the predicate device across various metrics.

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

• Automated and Manual Performance Comparison:

  • Test Set Sample Size: 128 newborn patient dried blood spot samples, plus dried blood spot controls (manufactured to mimic newborn specimens) and dried specimens of mixed adult blood. A total of 216 samples were analyzed.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific state). The samples are referred to as "newborn patient dried blood spot samples" and "mixed adult blood," suggesting they are from human subjects, but the geographical origin is not specified. The study was retrospective, as existing dried blood spots were analyzed.

• Expected Values and Clinical Cutoff Determination (Automated Processing):

  • Test Set Sample Size: 1752 routine samples and 53 known GALT deficient samples (controls, retrospective galactosemic neonates, and galactosemic non-neonates).
  • Data Provenance: From a "state screening laboratory," indicating US origin and retrospective collection.

• Screening Using Manual Processing:

  • Test Set Sample Size: 247 newborn patient dried blood spot samples, plus dried blood spot controls (with newborn hematocrit) and dried specimens of mixed adult blood. A total of 292 samples were analyzed.
  • Data Provenance: Not explicitly stated, likely similar to the automated comparison study (retrospective human samples, likely US state screening program).

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

• Not applicable as this is a chemical reagent kit for GALT activity measurement, not an AI/ML device relying on human expert image interpretation or similar.
• The "ground truth" for GALT deficiency or normal activity was established by:
  • Analysis using the predicate device.
  • "Known GALT deficient samples" which included "retrospective galactosemic neonates and galactosemic non-neonates," meaning their clinical status was previously established.
  • "Routine neonatal screening by the state DOH classified all but one of these specimens (as well as the specimens classified as negative) to be presumptive negative for galactosemia." For some samples, the reference came from a state Department of Health (DOH) screening classification.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" was established based on predicate device results and previously classified clinical samples, not through a consensus or adjudication process among multiple human readers for a primary diagnostic task.

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 is not an AI/ML device, and no human reader study with or without AI assistance was performed.

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

• This device is a standalone diagnostic kit (the "algorithm" here being the chemical assay and spectrophotometric measurement, interpreted by trained lab personnel). The studies described (linearity, sensitivity, precision, comparison to predicate) are effectively standalone performance evaluations. The SPOTCHECK Pro (instrument) automates the process, meaning the "algorithm" (assay) performs without manual intervention during the assay process itself, aside from initial setup and final interpretation.

7. The Type of Ground Truth Used

• Comparative Reference Standard: The primary ground truth for evaluating the SPOTCHECK Kit was the performance of a legally-marketed predicate device (Bio-Rad Quantase Neonatal GALT Test). The studies explicitly compare the SPOTCHECK Kit's results to the predicate device's results.
• Clinical Diagnosis/Known Status: For validation of clinical classification, "known GALT deficient samples" (retrospective galactosemic neonates and non-neonates) were used. This indicates a form of outcomes data or pre-established clinical diagnosis.
• State DOH Screening Classification: In some instances, the "routine neonatal screening by the state DOH" provided a classification (presumptive positive/negative) which served as a reference for comparison.

8. The Sample Size for the Training Set

• Not applicable in the context of AI/ML. The device is a chemical reagent kit. There wasn't a "training set" in the machine learning sense. The device's calibration curve is established using NADH standards, which are analytical controls, not a training dataset for an algorithm.

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

• Not applicable as there is no "training set" in the AI/ML context. The calibration curve is established analytically using NADH standards, which have known concentrations. These standards are foundational to quantifying the GALT activity, not for training a predictive model.

Ask a specific question about this device