Search Results
Found 52 results
510(k) Data Aggregation
K Number
K061775Device Name
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2007-02-23
(245 days)
Product Code
JFY, JIT
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The L-Type Creatinine-M is an in-vitro assay for the quantitative determination of creatinine in serum, plasma, and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Device Description
L-Type Creatinine M is a reagent kit for creatinine assay based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase and N-(3-sulfopropyl)-3-methoxy-5-methylaniline (HMMPS) as a new color agent.
Ask a Question
K Number
K062368Device Name
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2007-01-31
(170 days)
Product Code
OAU, JIT, JJX
Regulation Number
866.6030Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.
Device Description
The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys". This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement.
Ask a Question
K Number
K053131Device Name
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2005-12-30
(52 days)
Product Code
JFM
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Device Description
Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidating agent, shows good correlation with conventional methods, practically no interference by coexistent serum and plasma substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, total bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the total bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.
Ask a Question
K Number
K053132Device Name
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2005-12-30
(52 days)
Product Code
JFM, LFM
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.
Device Description
When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.
Ask a Question
K Number
DEN050002Device Name
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2005-05-19
(42 days)
Product Code
NSF, TES
Regulation Number
866.6030Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wako AFP-L3% assay is intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD). Elevated AFPL3% values (≥ 10%) have been shown to be associated with a seven-fold increase in the risk of developing HCC within the next 21 months. Patients with elevated serum AFPL3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
Device Description
The Wako AFP-L3% device consists of reagent 1 (LCA and anion 1-conjugated anti-AFP mouse monoclonal antibody), reagent 2 (horseradish peroxidase (POD)labeled anti-AFP mouse monoclonal antibody and anion 2 conjugated anti-AFP mouse monoclonal antibody, substrate 1 (4 acetamidophenol in 2-propanol) and substrate 2 (hydrogen peroxide) and a column. Reagent 1, reagent 2 and the column are ready-to-use. Elution buffers A to C, sample cups, inside and outside cuvettes are sold separately from kit.
The Wako AFP-L3 Calibrator set and Control set are sold separately. The calibrator set consisted of Calibrator 1 and 2. Calibrator 1 contains human AFP -L1 fraction and Calibrator 2 has human AFP-L3 fraction. The control set consisted of Control 1 and 2, each containing different concentrations of human AFP-L1 and L-3.
Ask a Question
K Number
K042551Device Name
MULTI-CHEM CALIBRATOR A
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-11-16
(57 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Chem Calibrator A is designed to be used with Wako's assays to betermine The Multi-Offern Oulibratel free used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.
Device Description
Not Found
Ask a Question
K Number
K042549Device Name
MULTI CHEM CAL B
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-11-08
(49 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Chem Calibrator B is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Glucose, Uric Acid and Urea N in human serum.
Device Description
Not Found
Ask a Question
K Number
K042550Device Name
MULTI-LIPID CALIBRATOR
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-11-08
(49 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.
Device Description
Not Found
Ask a Question
K Number
K040918Device Name
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-05-17
(39 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wako Quality Control is intended for use as an assay quality maroations in of ooo. The transecision of laboratory testing procedures for the Wako Control scrain to monitor the processor of L-Cholesterol, LDL-Cholesterol, lipid assuy cash as Thigyonins, NEFA C, Free Cholesterol and beta Lipoprotein assays.
Device Description
Not Found
Ask a Question
K Number
K033860Device Name
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
2004-04-23
(133 days)
Product Code
JIT
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
WAKO CHEMICALS, USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wako Total Ketone Body Calibrators are intended to be used with the Wako Autokit Total Ketone Body products and instruments to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-hydroxybutyrate in human serum or plasma.
Device Description
Not Found
Ask a Question
Page 1 of 6