ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT

K113262 · Alfa Wassermann Diagnostic Technologies, Inc. · CHH · Jul 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113262
• Device Name: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

Reagents for quantitative colorimetric assay of serum cholesterol, HDL-C, LDL-C, and triglycerides; used on ACE Axcel Clinical Chemistry System. Input: serum samples. Operation: enzymatic reactions (esterase, oxidase, peroxidase) produce colored quinoneimine complex; absorbance measured at 505/647 nm. Output: concentration values (mg/dL). Used in clinical labs/physician offices by trained personnel. Results assist clinicians in diagnosing/managing lipid disorders, atherosclerosis, and metabolic conditions. Benefits: standardized, rapid lipid panel assessment for patient monitoring.

Clinical Evidence

Bench testing only. Precision and accuracy evaluated over 22 days and at three Physician Office Laboratory (POL) sites. Correlation studies (n=108-111) compared ACE Axcel to predicate system, yielding correlation coefficients >0.989. Detection limits reported for all assays (3.6-11.6 mg/dL).

Technological Characteristics

Quantitative colorimetric enzymatic assays. Reagents contain cholesterol esterase, cholesterol oxidase, peroxidase, lipase, glycerol kinase, and glycerol phosphate oxidase. Uses p-hydroxybenzoic acid or p-chlorophenol and 4-aminoantipyrine as chromogens. Form factor: liquid reagents in bottles. Platform: ACE Axcel Clinical Chemistry System. Calibration: GEMCAL or specific LDL-C calibrators. Traceable to NIST SRM 1951 or CDC reference methods.

Indications for Use

Indicated for quantitative determination of cholesterol, HDL-C, LDL-C, and triglycerides in serum. Used in clinical or physician office laboratories for diagnosis and treatment of lipid metabolism disorders, diabetes mellitus, atherosclerosis, liver, renal, and endocrine diseases.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• Alfa Wassermann ACE plus ISE/Clinical Chemistry System (K931786)
• ACE Cholesterol Reagent (K931786)
• ACE HDL-C Reagent (K971526)
• ACE LDL-C Reagent (K991733)
• ACE Triglycerides Reagent (K931786)

Submission Summary (Full Text)

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K113262

# JUL

## `510(k) SUMMARY

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] | |
| Date Summary<br>Prepared: | November 3, 2011 | |
| Device: | Trade Name:<br>System | ACE Axcel Clinical Chemistry |
| | Classification: | Class 1 |
| | Common/Classification Name: | Analyzer, Chemistry (Photometric,<br>Discrete), For Clinical Use<br>(21 C. F.R. § 862.2610)<br>Product Code JJE |
| | Trade Name: | ACE Cholesterol Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Enzymatic Esterase-Oxidase,<br>Cholesterol (21 C. F.R. §<br>862.1175)<br>Product Code CHH |
| | Trade Name: | ACE HDL-C Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | LDL & VLDL Precipitation,<br>Cholesterol Via Esterase-Oxidase,<br>HDL<br>(21 C. F.R. § 862.1475)<br>Product Code LBS |
| | Trade Name: | ACE LDL-C Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | System, Test, Low Density,<br>Lipoprotein |
| | | Product Code MRR |
| | Trade Name: | ACE Triglycerides Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Lipase Hydrolysis/Glycerol Kinase<br>Enzyme, Triglycerides<br>(21 C. F.R. § 862.1705)<br>Product Code CDT |
| Predicate<br>Devices: | Manufacturer for analyzer/reagent system predicates: | Alfa Wassermann ACE plus ISE/Clinical Chemistry System (K931786)<br>ACE Cholesterol Reagent (K931786)<br>ACE HDL-C Reagent (K971526)<br>ACE LDL-C Reagent (K991733)<br>ACE Triglycerides Reagent (K931786) |
| Device<br>Descriptions: | | The ACE Axcel Clinical Chemistry System consists of two major<br>components, the chemistry instrument and an integrated Panel PC. The<br>instrument accepts the physical patient samples, performs the<br>appropriate optical or potentiometric measurements on those samples<br>and communicates that data to an integral Panel PC. The Panel PC uses<br>keyboard or touch screen input to manually enter a variety of data,<br>control and accept data from the instrument, manage and maintain<br>system information and generate reports relative to patient status and<br>instrument performance. The Panel PC also allows remote download of<br>patient requisitions and upload of patient results via a standard<br>interface. |
| | | In the ACE Cholesterol Reagent assay, cholesterol esters in serum are<br>completely hydrolyzed by cholesterol esterase to free cholesterol and<br>free fatty acids. The cholesterol liberated by the esterase, plus any<br>endogenous free cholesterol, are both oxidized by cholesterol oxidase<br>to yield hydrogen peroxide. The hydrogen peroxide then acts to<br>oxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in a<br>reaction catalyzed by peroxidase, producing a red colored<br>quinoneimine complex which absorbs strongly at 505 nm. The amount<br>of chromogen formed, determined by measuring the increase in<br>absorbance, bichromatically at 505 nm/647 nm, is directly proportional<br>to the cholesterol concentration in the sample. |
| | | The HDL-C Assay utilizes two reagents, the second containing a<br>unique detergent. This detergent solubilizes only the HDL lipoprotein<br>particles, thus releasing HDL cholesterol to react with the cholesterol<br>esterase and cholesterol oxidase, in the presence of a chromogen to |
| | enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample. | |
| | In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase sub- strates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample. | |
| | In the ACE Triglycerides Reagent Assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/692 nm, is directly proportional to the triglycerides concentration in the sample. | |
| Intended Use: | Indications for Use: | |
| | The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for <i>in vitro</i> diagnostic use in the quantitative determination of constituents in blood and other fluids. | |
| | The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is | |
| The ACE HDL-C Reagent is intended for the quantitative<br>determination of high density lipoprotein cholesterol (HDL-C)<br>concentration in serum using the ACE Axcel Clinical Chemistry<br>System. Lipoprotein measurements are used in the diagnosis and<br>treatment of lipid disorders (such as diabetes mellitus), atherosclerosis,<br>and various liver and renal diseases. This test is intended for use in<br>clinical laboratories or physician office laboratories. For in vitro<br>diagnostic use only. | | |
| The ACE LDL-C Reagent is intended for the quantitative determination<br>of low density lipoprotein cholesterol (LDL-C) concentration in serum<br>using the ACE Axcel Clinical Chemistry System. Lipoprotein<br>measurements are used in the diagnosis and treatment of lipid disorders<br>(such as diabetes mellitus), atherosclerosis, and various liver and renal<br>diseases. This test is intended for use in clinical laboratories or<br>physician office laboratories. For in vitro diagnostic use only. | |…