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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Wallac Oy, Subsidiary of PerkinElmer, Inc.
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
K161966Device Name
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
Manufacturer
PerkinElmer, Inc.
Date Cleared
2016-09-08
(52 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
PerkinElmer, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XRpad2 4336 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
Device Description
The XRpad2 4336 HWC-M is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460.0 mm × 383.6 mm × 15.5 mm, which fits into a standard X-ray cassette Bucky.
The detector can be integrated into a fixed room X-ray system to enable digital radiography.
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K Number
K161942Device Name
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
Manufacturer
PERKINELMER, INC.
Date Cleared
2016-09-01
(48 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
PERKINELMER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XRpad2 3025 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammonfions .
Device Description
standard X-ray cassette Bucky
- topad IPU-2 (Interface and Power Un
- KRpad LPT2 Detector Cable
- XRpad Protective Insert 307
- OV Cable IEC 60320 C13
- ........ Cable IEC 60320 CLS
- frigger Cable 5 m/16.5
- ger Cable 20 m/65
- GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
- E Interface Cable 30.5 m/100
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K Number
K140551Device Name
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
Manufacturer
PERKINELMER, INC.
Date Cleared
2014-08-01
(150 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
PERKINELMER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XRpad 4336 MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
Device Description
The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography. The XRpad 4336 MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.
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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
K121864Device Name
PERKINELMER 226 SAMPLE COLLECTION DEVICES
Manufacturer
PERKINELMER, INC.
Date Cleared
2013-03-12
(259 days)
Product Code
PJC
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
PERKINELMER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Device Description
PerkinElmer 226 Sample Collection Device is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. The PerkinElmer 226 Sample Collection contains Ahlstrom 226 filter paper that is made from 100% pure cotton linters with no wet-strength additives added and conforms to the Recognized Standard CLSI LA4-A4. The Ahlstrom 226 filter paper has four performance characteristics that can be assessed with lysed or intact red blood cells; blood absorption time, blood spot diameter, serum absorption volume and homogeneity. Physical properties of the Ahlstrom 226 filter paper monitored during manufacturing are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.
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K Number
K122495Device Name
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
Manufacturer
PERKINELMER, INC.
Date Cleared
2012-11-28
(104 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
PERKINELMER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XRD 1622 AP3 MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
Device Description
The XRD 1622 AP3 MED is a flat panel x-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRD 1622 AP3 MED detector has an active area of 41cm x 41cm at a pixel pitch of 200μm. Data and control communication is accomplished via a Gigabit Ethernet interface. The detector can be integrated into a fixed room x-ray system to enable digital radiography.
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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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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?
Applicant Name (Manufacturer) :
PERKINELMER, INC.
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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