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The Quantase Total Galactose Screening Assay is an enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme.

The test is intended as a screening the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received.

The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

enzymatic colorimetric end-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens

The provided text is a 510(k) clearance letter from the FDA for the Quantase™ Total Galactose Screening Assay, 2000 Test Kit. This document does not contain the acceptance criteria or details of a study proving the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It mentions the intended use of the device: an enzymatic colorimetric end-point method for the determination of total D(+)galactose in dried blood spot specimens from newborn human infants as part of a newborn screening program. It also states that elevated results indicate the urgent need for further study, and the kit is not intended for monitoring galactosaemic patients or detecting ante-natal galactosaemia.

Since the provided document does not contain the requested information about acceptance criteria and study details, I cannot populate the table or answer the specific questions. A separate study report or regulatory submission document would be required to provide the information requested.

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The Quantase Total Calactose Screening Assay is an enzymatic colorimetric cad-point method for the determination of total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme.

The test is intended as a screening measuring the total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of galactosaemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received.

The kit is NOT intended for use in monitoring the circulating concentrations of total D(+)galactose in galactosaemic patients nor to detect ante-natal galactosaemia.

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The provided text is a 510(k) clearance letter from the FDA for the "Quantase Total Galactose Screening Assay 500 Test Kit." It confirms substantial equivalence to a legally marketed predicate device but does not contain a detailed study report or specific acceptance criteria and performance data for the device itself.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study types (MRMC, standalone) because this information is not present in the provided document. The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed technical study analysis.

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The Quantase Phe/Gal Screening Assay is an eazymatic colorinetic cast-point mechod for the decired blood more maciment I he Quantist Parcelling Possy is an enzintate e. siactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening programme The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose I he ust is miched is a screening meason for messaring are not diagnostic per se of phenylkstomuria or galactosemia, but indicate the urgent need for further study of the newborn from which the presumptive positive specimen was received. The lit is NOT intended for use in monitoring the circulating concentrations of L-phenylalanine and total I be an is NOT measurer and galactosenic patients respectively, nor to detect ante-natal phenylketonucia and galactosemia or maternal phenylketonuria

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The perfect answer would include all the information listed in the prompt. However, based on the input provided, I cannot answer all parts fully. Here's a breakdown of what can and cannot be answered:

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document is a 510(k) clearance letter, not a study report. It does not contain acceptance criteria or performance data.
• Sample size used for the test set and the data provenance: Not mentioned in the provided text.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, as this is a diagnostic assay, not an imaging AI.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: While the device is a screening assay performed in a lab, the concept of "standalone performance" as it applies to an AI algorithm is not directly applicable or discussed in this context.
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Information that CAN be extracted and inferred:

This document is primarily a 510(k) clearance letter for an in-vitro diagnostic device, specifically the "Quantase™ PHE/GAL Screening Assay." It confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This type of document typically does not include detailed study results, acceptance criteria, or ground truth methodologies for the device's validation. Those details would be found in the original 510(k) submission and supporting documentation, which is not provided here.

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