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510(k) Data Aggregation
K Number
K053031Device Name
EXTENDSURE HBFASC CONTROL
Manufacturer
CANTEBURY SCIENTIFIC LTD.
Date Cleared
2005-12-07
(41 days)
Product Code
JCM
Regulation Number
864.7415Why did this record match?
Product Code :
JCM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization.
The control is for in vitro diagnostic use only and should not be used past the expiry date.
Device Description
The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. It contains stabilizers and preservatives to maintain the stability of the hemoglobin variants. The product is provided in a lyophilized form and is reconstituted with 1.0 ml of reconstitution fluid (0.09% sodium azide) prior to use.
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K Number
K011389Device Name
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
Manufacturer
CANTERBURY HEALTH LABORATORIES
Date Cleared
2001-06-21
(45 days)
Product Code
JCM
Regulation Number
864.7415Why did this record match?
Product Code :
JCM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983704Device Name
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
Manufacturer
ROCHE DIAGNOSTIC SYSTEMS, INC.
Date Cleared
1999-02-10
(112 days)
Product Code
JCM
Regulation Number
864.7415Why did this record match?
Product Code :
JCM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.
Device Description
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse.
The proposed Abuscreen ONLINE Phencyclidine test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Phencyclidine test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.
The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and testprocessing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.
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