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This Astoria-Pacific SPOTCHECK® Undyttransferase 50-Hour Reagent Kit is for the qualifative determination of galactose-1-phosphate uridyttransferase, EC 2.7.12 (GALT) activity in whole blood saturated filter paper disks (S&S 903 filter paper or equivalent), using the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate undyttransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants. This method is not for monitoring purposes.

The proposed device, Unidyttransferase 50-Hour Reagent Kit, is a set of reagents to be used with the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System for the quantitative determination of the enzyme galactose-1-phosphate uridyttransferase (UT) in whole blood saturated filter paper disks. The amount of unidyltransferase activity is determined by measuring the fluorescent compound produced in the reaction of UT with galactose and UDP Glucose, followed by NADP reduction at 37°C. The excitation wavelength of the reaction product is 450 nm, and it's emission is measured at 550 nm. The method is specific for uridy transferase.

The method is designed for mass screening, with enough reagents in each 50-Hour Reagent Kit for 1 week plus start-up (50 hours total) of run time. It is packaged to reduce space and to require a minimum of time to prepare. Each component is packaged with the correct weight to prepare the required volume of reagent. The standard is in a concentrated form, to permit easy dikition to prepare a standard curve.

This document describes the Astoria-Pacific Uridyltransferase 50-Hour Reagent Kit, a device for in vitro diagnostic use to screen for decreased levels of GALT activity in infants. The information provided is sparse regarding detailed acceptance criteria and study particulars, particularly from a modern regulatory submission perspective.

Here's an attempt to extract and interpret the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, it relies on a qualitative assessment of "correlation" with known samples.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 27 specimens
  • 20 normal neonatal blood samples
  • 7 deficient samples from juveniles and adults
• Data Provenance: Not specified, but implied to be from a clinical setting, given the use of "normal neonatal blood samples" and "deficient samples from juveniles and adults." It is highly likely to be retrospective given the submission date and the limited details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information regarding the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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 not applicable. The device is a reagent kit for assaying enzyme activity, not an AI or imaging diagnostic device requiring human reader interpretation in the context of an MRMC study.

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

This is not applicable in the typical sense of algorithm-only performance for an AI/CADe device. The device itself is an in vitro diagnostic assay kit. Its performance is measured by its ability to accurately detect GALT activity, which is a "standalone" measurement in its own right, without human interpretation of complex outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the deficient samples and normal samples would likely have been established by a reference method for GALT deficiency diagnosis or existing clinical records for those individuals. The document does not explicitly state the specific method used for ground truth establishment, but it implies a pre-existing clinical classification ("normal neonatal blood samples" and "deficient samples").

8. The sample size for the training set

The document does not mention a separate training set. The "clinical tests" described appear to be the entirety of the evaluation. For a reagent kit, the development and calibration process would typically involve internal studies, but these are not disclosed as a "training set" in the context of this summary.

9. How the ground truth for the training set was established

Not applicable, as a separate training set is not explicitly mentioned. If the 27 clinical samples were used for both development and "testing" (which is common in older 510(k) submissions but not ideal by current standards), then the ground truth would have been established as described in point 7.

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