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510(k) Data Aggregation
K Number
K041130Device Name
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Date Cleared
2004-06-10
(41 days)
Product Code
KRZ, KRY, KSA
Regulation Number
864.8165Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter: S-Plus IV-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, MD, Counto, OnyX, T series and A . T and A . T diff series analyzers; the Abbott Cell-Dyn 1100, Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 and Coulter Ac T diff analyzers used to count red cells, white cells and platelets. It is a stable suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.
Device Description
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K Number
K024173Device Name
CDS 3-PD HEMATOLOGY CONTROLS
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Date Cleared
2003-01-14
(27 days)
Product Code
JPK
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CDS 3-PD Hematology Controls are intended to serve as a means of verifying the results obtained from a hematology analyzer system. This material applies to hematology analyzer systems equipped to measure RBC count and size, WBC count and size, PLT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and number for lymphocyte, mononuclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.
Device Description
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K Number
K993375Device Name
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Date Cleared
1999-12-20
(74 days)
Product Code
KRX, KRY, KRZ, KSA
Regulation Number
864.8150Why did this record match?
Applicant Name (Manufacturer) :
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CDS LTX-Control Latex Particle Suspension is intended to serve as a calibration standard for the d.c. impedance, r.f. impedance and optical light scatter parameters of the VCS module of Coulter® Models STKS, MAXM and Gen.S Hematology Analyzer systems. Models STKS and MAXM analyzers equipped with 5-part differential capability only require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F5S. STKS and Gen. S analyzers equipped with 5-part differential and reticulocyte capability require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F57.
Device Description
The CDS LTX-Control for red cell, white cell, and platelet counting is a device that resembles red cells, white cells, and platelets, and is used to validate the electronic calibration of the volume, conductivity and light scatter parameters on Coulter® MAXM®, STKS® and GEN.S® instruments intended to count red cells, whire cells, and platelets. It is a suspension of uniform particles whose shape, size, and concentration and other characteristics have been precisely and accurately determined.
CDS LTX-Control is supplied as ready-to-use latex particles in a buffered suspension fluid. The particles pass through the flow cell producing characteristic electrical signals that are measured as volume, conductivity and light scatter for quality monitoring of the previously mentioned COULTER instruments.
Matrix base - aqueous, buffered, bacteriostatic and fungistatic medium containing a surfactant.
Constituents - alkali metal salts, detergents, antimicrobial materials and polymer beads of known size.
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