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510(k) Data Aggregation
K Number
K173829Device Name
NeoLSD MSMS kit
Manufacturer
Wallac Oy, a subsidiary of PerkinElmer
Date Cleared
2018-07-18
(212 days)
Product Code
PQW, PQT, PQU, PQV, QCL, QCM
Regulation Number
862.1488Why did this record match?
Applicant Name (Manufacturer) :
Wallac Oy, a subsidiary of PerkinElmer
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K133652Device Name
GSP NEONATAL TOTAL GALACTOSE KIT
Manufacturer
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
Date Cleared
2014-04-28
(152 days)
Product Code
JIA
Regulation Number
862.1310Why did this record match?
Applicant Name (Manufacturer) :
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
Device Description
The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The kit contains Neonatal Total Galactose Assay Reagent 1, Neonatal Total Galactose Assay Reagent 2, Neonatal Total Galactose Assay Buffer, Neonatal Total Galactose Assay Reconstitution Solution, and Neonatal Extraction Solution. Calibrators and Controls are also included.
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K Number
K110274Device Name
AUTODELFIA NEONATAL IRT KIT
Manufacturer
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
Date Cleared
2011-06-10
(130 days)
Product Code
JNO, PRE
Regulation Number
862.1725Why did this record match?
Applicant Name (Manufacturer) :
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
Device Description
The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood on filter paper disks. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
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K Number
K103484Device Name
GSP NEONATAL THYROXINE (T4)
Manufacturer
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
Date Cleared
2011-04-22
(147 days)
Product Code
KLI, AUT
Regulation Number
862.1700Why did this record match?
Applicant Name (Manufacturer) :
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
Device Description
The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.
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