Who can help prepare an FDA 510(k) submission like ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

Alfa Wassermann Diagnostic Technologies, Inc. filed the 510(k) submission for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757).

Q: What is the FDA product code for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

CHH. It is classified under 21 CFR 862.1175 as a Class 1 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

510(k) clearance (submission type: Traditional).

K122757 · Alfa Wassermann Diagnostic Technologies, Inc. · CHH · Oct 5, 2012 · Clinical Chemistry

Device Facts

Record ID	K122757
Device Name	ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Applicant	Alfa Wassermann Diagnostic Technologies, Inc.
Product Code	CHH · Clinical Chemistry
Decision Date	Oct 5, 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 and lithium heparin plasma 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 and lithium heparin plasma 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 and lithium heparin plasma 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 and lithium heparin plasma 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

ACE Axcel Clinical Chemistry System reagents (Cholesterol, HDL-C, LDL-C, Triglycerides) perform quantitative in vitro diagnostic analysis of lipid profiles. System accepts serum or lithium heparin plasma samples; utilizes enzymatic colorimetric assays. Cholesterol/Triglycerides reagents use single-bottle enzymatic reactions; HDL-C/LDL-C reagents use two-bottle detergent-based selective solubilization. Reactions produce colored quinoneimine complexes measured via bichromatic spectrophotometry (absorbance increase proportional to analyte concentration). Operated by laboratory personnel in clinical or physician office settings. Output provides quantitative lipid concentrations to assist clinicians in diagnosing/treating metabolic, cardiovascular, and endocrine disorders.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per EP10-A3 (20 replicates per level). Matrix comparison studies per EP9-A2-IR compared serum vs. lithium heparin plasma across dynamic ranges; results showed high correlation (r > 0.99) and slopes near 1.0, confirming equivalence.

Technological Characteristics

Enzymatic colorimetric assays. Reagents contain enzymes (cholesterol oxidase, cholesterol esterase, peroxidase, lipase, glycerol kinase, glycerol phosphate oxidase), chromogens (4-aminoantipyrine, p-hydroxybenzoic acid, p-chlorophenol, DSBmT), and detergents. Bichromatic spectrophotometric detection. System is a clinical chemistry analyzer. No specific material standards or connectivity details provided.

Indications for Use

Indicated for quantitative determination of cholesterol, HDL-C, LDL-C, and triglycerides in serum and lithium heparin plasma. Used for diagnosis/treatment of lipid metabolism disorders, diabetes mellitus, atherosclerosis, nephrosis, liver/renal diseases, and endocrine disorders. Intended for clinical or physician office laboratory use.

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.

Related Devices

K112538 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · Mar 29, 2012
K060854 — ABX PENTRA 400: LIPOPROTEINS · Horiba Abx · Aug 24, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ 122 757 Alfa Wassermann Diagnostic Technologies, LLC 510(k) Submission ACE Axcel Clinical Chemistry System ACE Reagents OCT 5 2012 . #### 510(k) SUMMARY 510(k) Owner: Alfa Wassermann Diagnostic Technologies, LLC 4 Henderson Drive West Caldwell, NJ 07006 Contact: Hyman Katz, Ph.D. Phone: 973-852-0158 Fax: 973-852-0237 Date Summary September 6, 2012 Prepared: Device: Trade Name: ACE Cholesterol Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: Enzymatic Esterase-Oxidase, Cholesterol (21 CFR § 862.1175) Product Code CHH Trade Name: ACE HDL-C Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase, HDL (21 CFR § 862.1475) Product Code LBS Trade Name: ACE LDL-C Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: System, Test, Low Density, Lipoprotein (21 CFR § 862.1475) Product Code MRR Trade Name: ACE Triglycerides Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (21 CFR § 862.1705) Product Code CDT Predicate Predicates: Devices: . September 6, 2012 {1}------------------------------------------------ . | | | ACE Cholesterol Reagent (k113262) ACE HDL-C Reagent (k113262) ACE LDL-C Reagent (k113262) ACE Triglycerides Reagent (k113262) | | |--|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Similarities | Candidate Device | Predicate Device | | | 510(k) # | k122757 | K113262 | | | Company | Alfa Wassermann Diagnostic Technologies, LLC | Alfa Wassermann Diagnostic Technologies, LLC | | | Name | ACE Axcel Clinical Chemistry System, ACE Cholesterol Reagent | ACE Axcel Clinical Chemistry System, ACE Cholesterol Reagent | | | Intended Use/ Indications for Use | Same | The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration 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. | | | Instrument Platform | Same | ACE Axcel Clinical Chemistry System | | | Basic Principle | Same | Enzymatic method for cholesterol | | | Reagent Composition Reactive Ingredients | Same | 4-Aminoantipyrene p-Hydroxybenzoic acid Cholesterol oxidase (Nocardia) Cholesterol esterase (porcine pancreas and Pseudomonas) Peroxidase (Horseradish) | | | Differences | | | | | Sample Type | Serum and lithium heparin | Serum | {2}------------------------------------------------ | Similarities | Candidate Device | Predicate Device | |---------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) # | k122757 | K113262 | | Company | Alfa Wassermann | Alfa Wassermann · | | | Diagnostic Technologies, LLC | DiagnosticTechnologies, LLC | | Name | ACE Axcel Clinical | ACE Axcel Clinical Chemistry | | | Chemistry System, ACE HDL-C Reagent | System, ACE HDL-C Reagent | | Intended Use/ Indications for Use | Same | The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration 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 | | Instrument | Same | office laboratories. For in vitro diagnostic use only. ACE Axcel Clinical Chemistry | | Platform | | System | | Basic Principle | Same | Detergent solubilization of HDL to selectively measure HDL cholesterol using an enzymatic method. | | Reagent Composition Reactive Ingredients | Same | Cholesterol oxidase (E. coli) Peroxidase (Horseradish) N, N-bis(4-sulphobutyl)-m- toluidine-disodium salt Accelerator Ascorbic oxidase (Curcurbita sp.) 4-Aminoantipyrene Cholesterol esterase (Pseudomonas) | | Differences | | | | Sample Type | Serum and lithium heparin plasma | Serum | ・・ September 6, 2012 {3}------------------------------------------------ | Similarities | Candidate Device | Predicate Device | |---------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) # | k122757 | K113262 | | Company | Alfa Wassermann Diagnostic Technologies, LLC | Alfa Wassermann Diagnostic Technologies, LLC | | Name | ACE Axcel Clinical Chemistry System, ACE LDL-C Reagent | ACE Axcel Clinical Chemistry System, ACE LDL-C Reagent | | Intended Use/ Indications for Use | Same | The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration 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. | | Instrument Platform | Same | ACE Axcel Clinical Chemistry System | | Basic Principle | Same | Detergent solubilization of LDL to selectively measure LDL cholesterol using an enzymatic method | | Reagent Composition Reactive Ingredients | Same | Cholesterol esterase Cholesterol oxidase Peroxidase 4-Aminoantipyrine Ascorbic acid oxidase Buffer N,N-bis (4-sulfobutyl)-m- toluidine, disodium salt | | Differences | | | | Sample Type | Serum and lithium heparin | Serum | {4}------------------------------------------------ | | Similarities | Candidate Device | Predicate Device | | | |---------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|--| | | 510(k) # | k122757 | K113262 | | | | | Company | Alfa Wassermann | Alfa Wassermann Diagnostic | | | | | | Diagnostic Technologies, | Technologies, LLC | | | | | | rro | | | | | | Name | ACE Axcel Clinical | ACE Axcel Clinical Chemistry | | | | | | Chemistry System, ACE | System, ACE Triglycerides | | | | | | Triglycerides Reagent | Reagent | | | | | Intended Use/ | Same | The ACE Triglycerides Reagent | | | | | Indications | | is intended for the quantitative | | | | | for Use | | determination of triglyceride | | | | | | | concentration 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. | | | | | Instrument Platform | Same | ACE Axcel Clinical Chemistry | | | | | Basic | | System | | | | | Principle | Same | Coupled enzymatic reaction | | | | | Reagent | Same | 4-Aminoantipyrine | | | | | Composition | | adenosine 5'-triphosphate | | | | | Reactive | | p-Chlorophenol | | | | | Ingredients | | Glycerol phosphate oxidase | | | | | | | (Microorganism) | | | | | | | Lipase (Pseudomonas) | | | | | | | Peroxidase (Horseradish) | | | | | | | Glycerol kinase (Cellulomonas) | | | | | Differences | | | | | | | Sample Type | Serum and lithium heparin | Serum | | | | | | plasma | | | | | Device | | | In the ACE Cholesterol Reagent assay, cholesterol esters in serum are completely | | | | Descriptions: | hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The | | | | | | | cholesterol liberated by the esterase, plus any endogenous free cholesterol, are | | | | | | | both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen | | | | | | | | | peroxide then acts to oxidatively couple p-hydroxybenzoic acid and 4-amin- | | | | | | oantipyrine in a reaction catalyzed by peroxidase, producing a red colored | | | | {5}------------------------------------------------ | | quinoneimine complex which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance, bichromatically at 505 nm/647 nm, is directly proportional to the cholesterol concentration in the sample. | |---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The HDL-C Reagent assay utilizes two reagent bottles, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to produce color. The detergent also inhibits the reaction of the cholesterol 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 substrates, 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 Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma 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. | | | | · {6}------------------------------------------------ | | The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum and lithium heparin plasma 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 and lithium heparin plasma 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 and lithium heparin plasma 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. | | Technological Characteristics: | The ACE Cholesterol Reagent is composed of a single reagent bottle. The reagent contains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase, cholesterol esterase and peroxidase. | | | The ACE HDL-C Reagent is composed of two reagent bottles (Buffer and Color Reagent). The reagents contain Good's buffer, cholesterol oxidase, peroxidase, N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt, ascorbic oxidase, cholesterol esterase 4-aminoantipyrine and a detergent. | | | The ACE LDL-C Reagent is composed of two reagent bottles (Buffer and Color Reagent). The reagents contain MES Buffer (pH 6.3), detergent 1, cholesterol esterase, cholesterol oxidase, peroxidase, 4-aminoantipyrine, ascorbic acid oxidase, detergent 2 and N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt. | | | The ACE Triglycerides Reagent is composed of a single reagent bottle. The reagent contains aminoantipyrine, adenosine 5'-triphosphate, p-chlorophenol, glycerol phosphate oxidase, lipase, peroxidase and glycerol kinase. | | Performance Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included matrix comparison data and precision/reproducibility data. | | | Precision/Reproducibility | ، ﺮ {7}------------------------------------------------ Precision was evaluated following the guideline EP10-A3. Two replicates each of 3 levels of samples at clinically relevant decision levels were tested twice a day on 5 separate days, yielding 20 replicates total. The results are presented in the tables below: . | Analyte | Precision (SD, %CV) | | | | | |----------------------|---------------------|----------------|----------------|----------------|-----------| | Cholesterol mg/dL | Mean | Within- Run | Between Run | Between Day | Total | | Serum Low | 150.9 | 2.3, 1.5% | 0.0, 0.0% | 0.8, 0.6% | 2.4, 1.6% | | Serum Mid | 252.5 | 2.5, 1.0% | 2.5, 1.0% | 0.0, 0.0% | 3.6, 1.4% | | Serum High | 522.4 | 5.8, 1.1% | 3.5, 0.7% | 0.0, 0.0% | 6.8, 1.3% | | Plasma Low | 130.2 | 2.4, 1.8% | 0.5, 0.4% | 1.1, 0.8% | 2.7, 2.1% | | Plasma Mid | 338.0 | 4.1, 1.2% | 0.0, 0.0% | 0.0, 0.0% | 4.1, 1.2% | | Plasma High | 550.8 | 6.6, 1.2% | 0.0, 0.0% | 4.4, 0.8% | 7.9, 1.4% | | Analyte HDL-C mg/dL | Precision (SD, %CV) | Mean | Within-Run | Between Run | Between Day | Total | |---------------------------|---------------------|-----------|------------|-------------|-------------|-------| | Serum Low | 47.6 | 1.8, 3.8% | 0.9, 1.9% | 0.3, 0.7% | 2.0, 4.3% | | | Serum Mid | 76.4 | 1.9, 2.5% | 0.0, 0.0% | 0.5, 0.7% | 2.0, 2.6% | | | Serum High | 105.7 | 1.8, 1.7% | 0.0, 0.0% | 1.5, 1.4% | 2.4, 2.2% | | | Plasma Low | 41.3 | 1.1, 2.6% | 0.0, 0.0% | 0.7, 1.6% | 1.3, 3.1% | | | Plasma Mid | 71.2 | 0.7, 1.0% | 0.3, 0.4% | 1.0, 1.3% | 1.2, 1.7% | | | Plasma High | 102.9 | 2.2, 2.1% | 1.5, 1.5% | 0.0, 0.0% | 2.7, 2.6% | | | Analyte | Precision (SD, %CV) | | | | | | |----------------|---------------------|----------------|----------------|----------------|-----------|--| | LDL-C mg/dL | Mean | Within- Run | Between Run | Between Dav | Total | | | Serum Low | 92.4 | 2.1, 2.3% | 0.7, 0.8% | 1.0, 1.1% | 2.4, 2.6% | | | Serum Mid | ા રેતે રે | 3.0, 1.9% | 2.0, 1.2% | 0.7.0.4% | 3.7, 2.3% | | | Serum High | 345.6 | 5.9. 1.7% | 3.9.1.1% | 0.0. 0.0% | 7.1,2.1% | | | Plasma Low | 78.7 | 1.2, 1.6% | 0.6, 0.8% | 1.1.1.4% | 1.8.2.3% | | | Plasma Mid | 214.8 | 5.5. 2.6% | 0.7, 0.3% | 0.3. 0.2% | 5.6, 2.6% | | | Plasma High | 364.8 | 5.9, 1.6% | 2.5, 0.7% | 7.2, 2.0% | 9.6, 2.6% | | | Analyte | Precision (SD, %CV) | | | | | |------------------------|---------------------|----------------|----------------|----------------|------------| | Triglycerides mg/dL | Mean | Within- Run | Between Run | Between Day | Total | | Serum Low | 67.5 | 0.9, 1.4% | 0.5, 0.7% | 0.9, 1.4% | 1.4, 2.1% | | Serum Mid | 330.2 | 2.5, 0.8% | 1.6. 0.5% | 1.6. 0.5% | 3.4. 1.0% | | Serum High | 596.6 | 3.6, 0.6% | 0.0, 0.0% | 2.3, 0.4% | 4.3.0.7% | | Plasma Low | 69.5 | 0.8, 1.2% | 1.1.1.5% | 1.8. 2.5% | 2.2, 3.2% | | Plasma Mid | 341.5 | 2.5. 0.7% | 2.4, 0.7% | 0.0. 0.0% | 3.5, 1.0% | | Plasma High | 601.0 | 6.0, 1.0% | 7.3, 1.2% | 9.6, 1.6% | 13.5, 2.3% | {8}------------------------------------------------ | Linearity/assay reportable range: | Refer to previously cleared submission k113262 | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Traceability, Stability, Expected values (controls, calibrators, or methods): | Refer to previously cleared submission k113262 | | Expected values/Reference range: | Refer to previously cleared submission k113262 | | Detection Limit: | Refer to previously cleared submission k113262 | | Analytical specificity: | Refer to previously cleared submission k113262 | | Method Comparison/Bias Determination: | Refer to previously cleared submission k113262 | | Matrix Comparison: | Matrix comparison studies were carried out following guideline EP9-A2-IR. The studies consisted of running a series of paired serum (x) and lithium heparin plasma (y) specimens in singlicate with varying levels of analyte that cover the assay's dynamic range on the ACE Axcel Clinical Chemistry System. Results were analyzed using Deming regression. | ﺮ ﺗﻢ {9}------------------------------------------------ ﻦ | Reagent | Range | Results ACE Axcel Serum vs. Plasma | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cholesterol 54 pairs | 24-574 mg/dL | Slope: 0.987 Intercept: -1.9 Correlation: 0.9987 Std. Error Est: 4.7 Confidence Interval Slope: 0.974 to 1.001 Confidence Interval Intercept: -4.6 to 0.8 | | HDL 53 pairs | 6-112 mg/dL | Slope: 1.011 Intercept: -1.1 Correlation: 0.9981 Std. Error Est: 1.5 Confidence Interval Slope: 0.993 to 1.028 Confidence Interval Intercept: -2.0 to -0.2 | | LDL 54 pairs | 10-428 mg/dL | Slope: 1.006 Intercept: -1.6 Correlation: 0.9981 Std. Error Est: 4.7 Confidence Interval Slope: 0.989 to 1.023 Confidence Interval Intercept: -3.7 to 0.5 | | Triglycerides 55 pairs | 34-994 mg/dL | Slope: 0.992 Intercept: -3.6 Correlation: 0.9993 Std. Error Est: 7.2 Confidence Interval Slope: 0.981 to 1.002 Confidence Interval Intercept: -6.2 to -0.9 | | Conclusions: | Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate device. | | : : . {10}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle. 10903 New Hampshire Avenue Silver Spring, MD 20993 OCT 5 2012 Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph. D. Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006 Re: k122757 Trade/Device Name: ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, ACE Triglycerides Reagent Regulation Number: 21 CFR§ 862.1175 Regulation Name: Cholesterol (Total) Test System Regulatory Class: Class I, meets limitations per 21 CFR§ 862.9(c)(4) (9) Product Code: CHH, LBS, MRR, CDT Dated: September 6, 2012 Received: September 7, 2012 Dear Dr. Katz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {11}------------------------------------------------ #### Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH'S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ... You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm Sincerely yours, 2 Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {12}------------------------------------------------ # Indications for Use 510(k) Number (if known): k122757 Device Name: ACE Cholesterol Reagent Indications for Use: The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration 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. Device Name: ACE HDL-C Reagent Indications for Use: The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration 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. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use. (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Yung Chan Divis Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k/22757 {13}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __k122757_ Device Name: ACE LDL-C Reagent The ACE LDL-C Reagent is intended for the quantitative determination of Indications for Use: low density lipoprotein cholesterol (LDL-C) concentration 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. Device Name: ACE Triglycerides Reagent Indications for Use: The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration 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. Prescription Use X (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use. (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Yung Chan Divisidn Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k122757 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Page 2 of 2