Search Results

This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

For in vitro diagnostic use only.

The CODA GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing B-nicotinamide adenine dinucleotide phosphate (NADP), galactose-1-phosphate, uridine-5diphosphoglucose (UDPG), and a tetrazolium salt. During the manual elution step, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.

After elution, the samples are placed on the CODA instrument and an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added.

During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.

The CODA instrument is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use.

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each performance test in the "Testing To Establish Substantial Equivalence" section. It primarily focuses on comparing the new CODA assay's performance against the existing Microplate Neonatal GALT Assay.

• Sample Size: Not explicitly stated for the test set.
• Data Provenance: The document does not provide details on the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a device modification, the studies were likely conducted internally by Bio-Rad Laboratories, Inc.

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

This information is not provided in the document. The study primarily involves analytical performance comparisons rather than clinical evaluation requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. The study focuses on analytical performance characteristics and concordance with a predicate device, not clinical outcomes requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, and the evaluation focuses on its analytical performance and equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done for the CODA Neonatal GALT Assay, as indicated by the "CODA Assay (Reported Performance)" column in the table. The reported values for Analytical Sensitivity, Within-run Precision, Total Precision, and Interference are measurements of the device's performance in isolation.

7. Type of Ground Truth Used

The "ground truth" for the performance tests appears to be established by:

• Concordance: Comparison to a "Manual" method (likely a reference laboratory method or a prior established manual GALT assay).
• Analytical Sensitivity, Precision, and Interference: These are quantitative measurements against established analytical standards and internal controls. The document states a "unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃," indicating a well-defined chemical/enzymatic basis for measurement.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of developing the CODA Neonatal GALT Assay. This assay is a modification to an existing one, not a novel AI/machine learning algorithm that typically requires a distinct training phase.

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this device modification. The device's underlying principles are based on established biochemical reactions, not on learning from a dataset.

Ask a specific question about this device