(90 days)
No
The device description details a chemical assay based on enzymatic reactions and colorimetric measurement, with no mention of AI or ML technologies.
No.
It is an in vitro diagnostic assay used for the quantitative determination of high density lipoprotein cholesterol in serum, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Wako Direct HDL-C test is an in vitro diagnostic assay for the quantitative determination of high density lipoprotein cholesterol in serum."
No
The device description clearly outlines a chemical assay involving reagents and enzymatic reactions, which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Wako Direct HDL-C test is an in vitro diagnostic assay for the quantitative determination of high density lipoprotein cholesterol in serum."
This statement directly identifies the device as an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
The Wako Direct HDL-C test is an in vitro diagnostic assay for the quantitative determination of high density lipoprotein cholesterol in serum.
Product codes
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Device Description
The Wako Direct HDL-C test eliminates the precipitation procedure by employing a specific antibody, and thus, can be applied on automated analyzers.
Anti human β-lipoprotein antibody Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by enzyme reactions with HDL-C yields a blue color complex upon condensation with FDAOS [N-ethyl-N- (2-hydroxy-3oxidase sulfopropyl)-3,5-dimethoxy-4-fluoroaniline, sodium salt] and 4aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 mm, the HDL-C concentration in the sample can be calculated when compared with the absorbance of the HDL-C Calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The safety and effectiveness of the Wako Direct HDL-C assay is demonstrated by its substantial equivalency to our previous HDL-Cholesterol assay (510 (k) # K801834) . Both test systems are used to measure high density lipoprotein cholesterol in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.972 and a regression equation Y=1.08x - 2.91 was obtained with serum samples. Precision studies indicate acceptable values cam be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1 mg/dL. The Wako Direct HDL-C assay has been determined to be linear to 120 mg/dL.
Key Metrics
correlation coefficient of 0.972
regression equation Y=1.08x - 2.91
minimum detectable level of 1 mg/dL
linear to 120 mg/dL
Predicate Device(s) There is no primary predicate.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEC 24 1996
510 (k) Summary of Safety and Effectiveness
The Wako Direct HDL-C test is an in vitro diagnostic assay for the quantitative determination of high density lipoprotein cholesterol in serum.
Blood total cholesterol levels have long been known to be related to coronary heart disease (CHD). In recent years, in addition to total cholesterol, high density lipoprotein cholesterol (HDL-C) has become an important tool used to assess an individual risk of developing CHD since a strong negative relationship between HDL-C concentration and the incidence of CHD was reported. Thus, there has been substantial interest in HDL-C measurements, and most clinical laboratories routinely perform HDL-C analysis. Selective chemical precipitation techniques are widely used for the HDL-C such as heparin-manganese, dextrandetermination of and phosphotungstate-magnesium.2 However, these magnesium, techniques require physical separation via centrifugation, which is not suited to large scale lab use. The Wako Direct HDL-C test eliminates the precipitation procedure by employing a specific antibody, and thus, can be applied on automated analyzers.
Anti human β-lipoprotein antibody Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by enzyme reactions with HDL-C yields a blue color complex upon condensation with FDAOS [N-ethyl-N- (2-hydroxy-3oxidase sulfopropyl)-3,5-dimethoxy-4-fluoroaniline, sodium salt] and 4aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 mm, the HDL-C concentration in the sample can be calculated when compared with the absorbance of the HDL-C Calibrator.
The safety and effectiveness of the Wako Direct HDL-C assay is demonstrated by its substantial equivalency to our previous HDL-Cholesterol assay (510 (k) # K801834) . Both test systems are used to measure high density lipoprotein cholesterol in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.972 and a regression equation Y=1.08x - 2.91 was obtained with serum samples. Precision studies indicate acceptable values cam be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1 mg/dL. The Wako Direct HDL-C assay has been determined to be linear to 120 mg/dL.
1
References
- Rifai, N. and Warnick, G.R., Ed. Laboratory Measurement of 1. Lipoproteins and Apolipoproteins. AACC Press, Lipids, Washington, DC, USA, 1994.
- Burtis, C.A. and Ashwood, E.R. Ed. Tietz Textbook of Clinical 2. Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.
- The Expert Panel. Summary of the second report of the National 3. Education Program (NCEP) expert panel on Cholesterol detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel II). JAMA 1993;269: 3015-23.
Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237