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510(k) Data Aggregation
K Number
K193103Device Name
NeoBase 2 Non-derivatized MSMS Kit
Manufacturer
PerkinElmer Inc.
Date Cleared
2020-02-07
(91 days)
Product Code
NQL, NOL
Regulation Number
862.1055Why did this record match?
Product Code :
NQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Device Description
Each NeoBase 2 Non-derivatized MSMS kit contains reagents for 960 assays. The kit is designed to be used with NeoBase 2 Non-derivatized Assay Solutions consisting of Neo MSMS Flow Solvent and NeoBase 2 Extraction Solution and NeoBase 2 Succinylacetone Assay Solution.
- NeoBase 2 Internal Standards - 1 vial
- NeoBase 2 Controls Low, High - 3 filter paper cassettes (Whatman, no. 903) containing 3 spots of each level per cassette
- Microplate, U-bottomed - 20 plates
- Adhesive microplate covers - 20 sheets
- Barcode labels for the plates - 30 pcs (10 different barcodes, 3 pcs of each)
- Lot-specific quality control certificate
This kit contains components manufactured from human blood. The source materials have been tested by FDA-approved methods for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies and found to be negative.
Instruments used:
- . QSight® 210 MD Screening System is comprised of:
- QSight® 210 MD Mass Spectrometer
- QSight® HC Autosampler MD
- QSight® Binary Pump MD ●
- Simplicity™ 3Q MD Software
- PerkinElmer MSMS Workstation software ●
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K Number
K173568Device Name
NeoBase 2 Non-derivatized MSMS Kit
Manufacturer
Wallac Oy, Subsidiary of PerkinElmer, Inc.
Date Cleared
2018-09-04
(288 days)
Product Code
NQL
Regulation Number
862.1055Why did this record match?
Product Code :
NQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Device Description
Not Found
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K Number
K093916Device Name
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
Manufacturer
PERKINELMER, INC.
Date Cleared
2010-08-23
(244 days)
Product Code
NQL
Regulation Number
862.1055Why did this record match?
Product Code :
NQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neobase Non-derivatized MSMS reagent kit (for use on the PerkinElmer TQD MSMS Screening System) is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Device Description
The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The each analyte relative to their response of internal stable-isotope labeled corresponding standard is proportional to analyte concentration.
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K Number
K083130Device Name
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
Manufacturer
PERKINELMER, INC.
Date Cleared
2009-07-09
(259 days)
Product Code
NQL, NOL
Regulation Number
862.1055Why did this record match?
Product Code :
NQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoBase Non-derivatized MSMS reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Device Description
The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The response of each analyte relative to their corresponding stable-isotope labeled internal standard is proportional to analyte concentration.
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K Number
DEN040002Device Name
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
Manufacturer
PERKINELMER LIFE SCIENCES, INC.
Date Cleared
2004-08-24
(53 days)
Product Code
NQL
Regulation Number
862.1055Why did this record match?
Product Code :
NQL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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