← Product Code [JIS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS) · K963847 # WAKO DIRECT HDL-C (K963847) _Wako Chemicals USA, Inc. · JIS · Dec 24, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K963847 ## Device Facts - **Applicant:** Wako Chemicals USA, Inc. - **Product Code:** [JIS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS.md) - **Decision Date:** Dec 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## 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. ## Device Story In vitro diagnostic assay for quantitative HDL-C measurement in serum; replaces traditional precipitation/centrifugation methods. Reagent 1 contains anti-human β-lipoprotein antibody to bind non-HDL lipoproteins (LDL, VLDL, chylomicrons), blocking their reaction. Reagent 2 contains cholesterol esterase, cholesterol oxidase, peroxidase, and chromogenic substrates (FDAOS, 4AA). Enzyme reactions with HDL-C produce hydrogen peroxide, yielding a blue color complex measured at ~600 nm via automated analyzer. Concentration calculated by comparing sample absorbance to HDL-C Calibrator. Used in clinical laboratories to assess coronary heart disease risk. ## Clinical Evidence Bench testing only. Comparison study against predicate assay (n=serum samples) yielded correlation coefficient 0.972, regression Y=1.08x - 2.91. Precision studies performed on day-to-day basis. Minimum detectable level 1 mg/dL; linearity up to 120 mg/dL. ## Technological Characteristics In vitro diagnostic chemical assay. Reagents: anti-human β-lipoprotein antibody, cholesterol esterase, cholesterol oxidase, peroxidase, FDAOS, 4AA. Sensing principle: colorimetric absorbance measurement at ~600 nm. Form factor: liquid reagents for automated analyzer use. ## Regulatory 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.) ## Special Controls *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. ## Predicate Devices - HDL-Cholesterol assay ([K801834](/device/K801834.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A. Telephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791 K963847 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.¹ 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 determination of HDL-C such as heparin-manganese, dextran-magnesium, and phosphotungstate-magnesium.² However, these 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 oxidase condensation with FDAOS [N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy-4-fluoroaniline, sodium salt] and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 nm, 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 can 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 1. Rifai, N. and Warnick, G.R., Ed. Laboratory Measurement of Lipids, Lipoproteins and Apolipoproteins. AACC Press, Washington, DC, USA, 1994. 2. Burtis, C.A. and Ashwood, E.R. Ed. Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994. 3. The Expert Panel. Summary of the second report of the National Cholesterol Education Program (NCEP) expert panel on 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K963847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIS/K963847) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com