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The NeoLSD™ MSMS kit is intended for the quantitative measurement of the activity of the enzymes acid-9glucocerebrosidase (ABG), acid-sphingomyelinase (GAA), 8 galactocerebrosidase (GALC), agalactosidase A (GLA) and a-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Krabbe Disease, Fabry Disease, and Mucopolyaccharidosis Type I (MPS I) Disease.

The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:

1. NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
2. The QSight Instrument is comprised of:
   QSight® 210 MD Mass Spectrometer O
   QSight HC Autosampler MD Instrument Software O
   QSight Binary Pump MD O
   Simplicity Instrument control software: O
   Simplicity Data Processing software (by sample): O
   O PerkinElmer MSMS Workstation Data Processing Software

The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture which contains;

• six substrates, one corresponding to each lysosomal enzyme
• six stable-isotope mass-labeled internal standards (IS) each designed to chemically resemble each product generated
• . a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from competing enzymes if present and additives to enhance the targeted enzyme reactions.

Here's a breakdown of the acceptance criteria and study information for the NeoLSD MSMS Kit, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state acceptance criteria in a dedicated table for screening performance per se, but it details the analytical performance and implies that meeting the predicate device's performance characteristics for screening, along with established analytical limits, constitutes acceptance. The "Comparison Chart" on page 6 includes some comparable metrics between the proposed and predicate device.

Below is a table summarizing the reported analytical performance, with implied acceptance criteria that the device's performance should be within acceptable clinical/analytical ranges and comparable to the predicate device.

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The NeoLSD MSMS Kit is intended for the quantitative measurement of the activity of the enzymes acid-pglucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-a-glucosidase (GAA), B-galactocerebrosidase (GALC), α-galactosidase A (GLA) and α-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Nieman-Pick A/B Disease, Pompe Disease, Fabry Disease, and MPS I Disease.

The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:

1. NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
2. Waters TQD MSMS instrument comprised of,
   a. Waters 1525 sample pump
   b. Waters 2777c autosampler
   c. Waters MassLynx v4.1 firmware C.
   d. Power cables, tubing, syringes, connection cables
3. Waters NeoLynx v4.1 software and computer with monitor
4. PerkinElmer MSMS Workstation Software

The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture which contains;
. six substrates, one corresponding to each lysosomal enzyme
. six stable-isotope mass-labeled internal standards (IS) each designed to chemically resemble each product generated
. a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from competing enzymes if present and additives to enhance the targeted enzyme reactions.

The NeoLSD MSMS Kit is intended for the quantitative measurement of the activity of six lysosomal enzymes (acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-α-glucosidase (GAA), β-galactocerebrosidase (GALC), α-galactosidase A (GLA), and α-L-iduronidase (IDUA)) in dried blood spots (DBS) from newborn babies. The analysis of enzymatic activity serves as an aid in screening newborns for Gaucher Disease, Niemann-Pick A/B Disease, Pompe Disease, Krabbe Disease, Fabry Disease, and MPS I Disease.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance metrics reported, such as linearity ranges, precision (reproducibility %CV), and LoQ values. The screening performance, particularly sensitivity and specificity, are key for a screening tool.

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