The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro 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 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 Description

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Cholesterol Reagent assay, cholesterol esters in serum are completely 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-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/647 nm, is directly proportional to the cholesterol concentration in the sample.

The HDL-C Assay utilizes two reagents, 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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Alfa Wassermann ACE Axcel Clinical Chemistry System and its associated reagents, based on the provided 510(k) summary:

Overview of Device and Study Purpose:

This submission describes the ACE Axcel Clinical Chemistry System and four associated reagents (ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, ACE Triglycerides Reagent). The study's primary purpose is to demonstrate the substantial equivalence of the new ACE Axcel System and its reagents to predicate devices (Alfa Wassermann ACE plus ISE/Clinical Chemistry System and its reagents) by showing comparable performance in terms of precision, accuracy, and detection limits.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the typical expectations for clinical chemistry analyzers. The document focuses on demonstrating that the new system's performance is equivalent or better than the predicate.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (ACE Axcel Clinical Chemistry System with specific reagents)
ACE Cholesterol Reagent
Precision (Within-run CV)	Acceptably low CV, comparable to predicate, demonstrating consistency.	Ranged from 1.3 to 2.0% (lab), 0.7 to 1.5% (POL sites).
Precision (Total CV)	Acceptably low CV, comparable to predicate, demonstrating consistency over time.	Ranged from 1.6 to 2.2% (lab), 1.0 to 1.7% (POL sites).
Accuracy (Correlation Coeff.)	High correlation (e.g., >0.98) with predicate device, indicating agreement.	0.9977 (lab), 0.9945 to 0.9995 (POL sites).
Accuracy (Slope CI)	Confidence interval for slope close to 1.0, indicating proportional agreement.	0.999 to 1.026 (lab), 0.964 to 1.034 (POL sites).
Accuracy (Intercept CI)	Confidence interval for intercept close to 0, indicating minimal constant bias.	-6.2 to -0.5 (lab), -7.3 to 6.7 (POL sites).
Detection Limit	Clinically acceptable lower limit of detection.	3.6 mg/dL.
ACE HDL-C Reagent
Precision (Within-run CV)	Acceptably low CV.	Ranged from 1.4 to 2.7% (lab), 0.7 to 2.6% (POL sites).
Precision (Total CV)	Acceptably low CV.	Ranged from 3.2 to 4.8% (lab), 1.1 to 3.5% (POL sites).
Accuracy (Correlation Coeff.)	High correlation with predicate.	0.9959 (lab), 0.9898 to 0.9970 (POL sites).
Accuracy (Slope CI)	Confidence interval for slope close to 1.0.	0.956 to 0.990 (lab), 0.936 to 1.061 (POL sites).
Accuracy (Intercept CI)	Confidence interval for intercept close to 0.	-0.5 to 1.4 (lab), -3.8 to 2.0 (POL sites).
Detection Limit	Clinically acceptable lower limit of detection.	1.5 mg/dL.
ACE LDL-C Reagent
Precision (Within-run CV)	Acceptably low CV.	Ranged from 2.5 to 4.6% (lab), 1.7 to 4.4% (POL sites).
Precision (Total CV)	Acceptably low CV.	Ranged from 3.2 to 4.9% (lab), 2.4 to 5.9% (POL sites).
Accuracy (Correlation Coeff.)	High correlation with predicate.	0.9973 (lab), 0.9940 to 0.9974 (POL sites).
Accuracy (Slope CI)	Confidence interval for slope close to 1.0.	0.968 to 0.996 (lab), 0.991 to 1.071 (POL sites).
Accuracy (Intercept CI)	Confidence interval for intercept close to 0.	-3.1 to 1.0 (lab), -8.4 to 4.0 (POL sites).
Detection Limit	Clinically acceptable lower limit of detection.	4.0 mg/dL.
ACE Triglycerides Reagent
Precision (Within-run CV)	Acceptably low CV.	Ranged from 1.2 to 2.9% (lab), 0.5 to 2.3% (POL sites).
Precision (Total CV)	Acceptably low CV.	Ranged from 1.8 to 3.2% (lab), 0.6 to 4.1% (POL sites).
Accuracy (Correlation Coeff.)	High correlation with predicate.	0.9995 (lab), 0.9992 to 0.9996 (POL sites).
Accuracy (Slope CI)	Confidence interval for slope close to 1.0.	1.025 to 1.037 (lab), 0.989 to 1.024 (POL sites).
Accuracy (Intercept CI)	Confidence interval for intercept close to 0.	-2.7 to 1.1 (lab), -6.3 to 0.7 (POL sites).
Detection Limit	Clinically acceptable lower limit of detection.	11.6 mg/dL.

2. Sample Size Used for the Test Set and Data Provenance

ACE Cholesterol Reagent (Accuracy): 110 samples.
ACE HDL-C Reagent (Accuracy): 109 samples.
ACE LDL-C Reagent (Accuracy): 108 samples.
ACE Triglycerides Reagent (Accuracy): 111 samples.

The samples for the accuracy ("correlation") studies were assayed on both the new ACE Axcel System (y) and the predicate Alfa Wassermann ACE Clinical Chemistry System (x).

Data Provenance: The document does not explicitly state the country of origin. The studies were conducted at a main lab and three separate Physician Office Laboratory (POL) sites, suggesting real-world clinical samples. There is no indication of whether the data was retrospective or prospective, but given the nature of a comparability study for a new device, it is typically prospective, involving fresh samples run on both systems simultaneously.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of device (clinical chemistry analyzer) does not typically involve human experts establishing ground truth in the way radiological or pathological devices do. The "ground truth" for the test set is established by the predicate device (Alfa Wassermann ACE Clinical Chemistry System) itself, which is assumed to be accurate and clinically acceptable. The study's goal is to show agreement with this established method. Therefore, no external human experts are used for ground truth establishment for individual samples.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is a quantitative comparison study against a predicate device, not an interpretation-based study requiring expert adjudication of results. The predicate device's readings serve as the comparator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a study for an automated clinical chemistry analyzer which provides quantitative measurements, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies presented are generally "standalone" in the sense that they evaluate the performance of the automated ACE Axcel Clinical Chemistry System (device and reagents) directly. The system provides quantitative results, and the performance metrics (precision, accuracy, detection limit) are intrinsic to the device's operation. There isn't a human-in-the-loop component being evaluated for diagnostic decision-making, rather the system is automated to provide a numerical result.

7. The Type of Ground Truth Used

The ground truth used for accuracy (correlation) studies is the measurement obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System. This is a common approach for demonstrating substantial equivalence for clinical chemistry analyzers, where the new device's performance is compared against another legally marketed device's performance.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a clinical chemistry system and its reagents, not an AI/ML algorithm that typically requires a separate training set. The "training" for such systems would involve chemical formulation and instrument calibration, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the instrument and formulation of reagents are based on established chemical and engineering principles rather than data-driven ground truth for machine learning.

Summary

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K113262

JUL

`510(k) SUMMARY

510(k) Owner:	Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006
Contact:	Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237
Date SummaryPrepared:	November 3, 2011
Device:	Trade Name:System	ACE Axcel Clinical Chemistry
	Classification:	Class 1
	Common/Classification Name:	Analyzer, Chemistry (Photometric,Discrete), For Clinical Use(21 C. F.R. § 862.2610)Product Code JJE
	Trade Name:	ACE Cholesterol Reagent
	Classification:	Class 1
	Common/Classification Name:	Enzymatic Esterase-Oxidase,Cholesterol (21 C. F.R. §862.1175)Product Code CHH
	Trade Name:	ACE HDL-C Reagent
	Classification:	Class 1
	Common/Classification Name:	LDL & VLDL Precipitation,Cholesterol Via Esterase-Oxidase,HDL(21 C. F.R. § 862.1475)Product Code LBS
	Trade Name:	ACE LDL-C Reagent
	Classification:	Class 1
	Common/Classification Name:	System, Test, Low Density,Lipoprotein
		Product Code MRR
	Trade Name:	ACE Triglycerides Reagent
	Classification:	Class 1
	Common/Classification Name:	Lipase Hydrolysis/Glycerol KinaseEnzyme, Triglycerides(21 C. F.R. § 862.1705)Product Code CDT
PredicateDevices:	Manufacturer for analyzer/reagent system predicates:	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)
DeviceDescriptions:		The ACE Axcel Clinical Chemistry System consists of two majorcomponents, the chemistry instrument and an integrated Panel PC. Theinstrument accepts the physical patient samples, performs theappropriate optical or potentiometric measurements on those samplesand communicates that data to an integral Panel PC. The Panel PC useskeyboard or touch screen input to manually enter a variety of data,control and accept data from the instrument, manage and maintainsystem information and generate reports relative to patient status andinstrument performance. The Panel PC also allows remote download ofpatient requisitions and upload of patient results via a standardinterface.
		In the ACE Cholesterol Reagent assay, cholesterol esters in serum arecompletely hydrolyzed by cholesterol esterase to free cholesterol andfree fatty acids. The cholesterol liberated by the esterase, plus anyendogenous free cholesterol, are both oxidized by cholesterol oxidaseto yield hydrogen peroxide. The hydrogen peroxide then acts tooxidatively couple p-hydroxybenzoic acid and 4-aminoantipyrine in areaction catalyzed by peroxidase, producing a red coloredquinoneimine complex which absorbs strongly at 505 nm. The amountof chromogen formed, determined by measuring the increase inabsorbance, bichromatically at 505 nm/647 nm, is directly proportionalto the cholesterol concentration in the sample.
		The HDL-C Assay utilizes two reagents, the second containing aunique detergent. This detergent solubilizes only the HDL lipoproteinparticles, thus releasing HDL cholesterol to react with the cholesterolesterase 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 in vitro 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 quantitativedetermination of high density lipoprotein cholesterol (HDL-C)concentration in serum using the ACE Axcel Clinical ChemistrySystem. Lipoprotein measurements are used in the diagnosis andtreatment of lipid disorders (such as diabetes mellitus), atherosclerosis,and various liver and renal diseases. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
The ACE LDL-C Reagent is intended for the quantitative determinationof low density lipoprotein cholesterol (LDL-C) concentration in serumusing the ACE Axcel Clinical Chemistry System. Lipoproteinmeasurements are used in the diagnosis and treatment of lipid disorders(such as diabetes mellitus), atherosclerosis, and various liver and renaldiseases. This test is intended for use in clinical laboratories orphysician office laboratories. For in vitro diagnostic use only.
The ACE Triglycerides Reagent is intended for the quantitativedetermination of triglyceride concentration in serum using the ACEAxcel Clinical Chemistry System. Triglyceride measurements are usedin the diagnosis and treatment of patients with diabetes mellitus,nephrosis, liver obstruction, other diseases involving lipid metabolismor various endocrine disorders. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic useonly.
TechnologicalCharacteristics:	The following is a description of the major features of the ACE AxcelClinical Chemistry System:System throughput is approximately 160 test results per hour for routine, single reagent chemistries. System throughput will be higher when the test workload includes ISE's. The instrument has a capacity of 40 reagent containers on board. A reagent cooling system maintains the reagents at 12°C during instrument operation. Reagent containers are identified by computer coded labels to simplify system operation. All reagents in the system must include an identification label on the container. Sample and reagent sensing notify the operator of a depleted condition during operation. The system performs analysis at a reaction temperature of 37°C. An electrolyte subsystem capable of measuring sodium, potassium and chloride concentrations is included. Primary draw tubes may be introduced one at a time into the system for closed tube sampling. Positive tube identification can be achieved with an optional barcode scanner. An aliquot volume
	closed tube is returned to the user. Sample cups are introduced to the system one at a time or by sample ring segment. Disposable cuvettes are loaded in bulk and then automatically injected as needed by a cuvette hopper system. The ACE Axcel clinical chemistry optical system is capable of monitoring a maximum of 48 cuvettes at one time. The absorbance optical system is capable of absorbance measurements in a linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen wavelengths are measured simultaneously using a photodiode array.
	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 precision, accuracy, and detection limit data.
	ACE Cholesterol Reagent
	Precision: In testing conducted at four cholesterol levels for 22 days, the within-run CV ranged from 1.3 to 2.0%, and total CV ranged from 1.6 to 2.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.5% and total CV ranged from 1.0 to 1.7%.
	Accuracy: In the correlation study, 110 samples with cholesterol values ranging from 7 to 527 mg/dL were assayed on the Alfa Wassermann

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ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9977, a standard error estimate of 5.0. a confidence interval slope of 0.999 to 1.026, and a confidence interval intercept of -6.2 to -0.5. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9945 to 0.9995, standard error estimates of 3.0 to 8.4. confidence interval slopes of 0.964 to 1.034. and a confidence interval intercepts of -7.3 to 6.7.

Detection limit: The detection limit was 3.6 mg/dL.

ACE HDL-C Reagent

Precision: In testing conducted at four HDL-C levels for 22 days, the within-run CV ranged from 1.4 to 2.7%, and total CV ranged from 3.2 to 4.8%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 2.6% and total CV ranged from 1.1 to 3.5%.

Accuracy: In the correlation study, 109 samples with HDL-C values ranging from 4 to 122 mg/dL were assaved on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), Least squares regression analysis yielded a correlation coefficient of 0.9959, a standard error estimate of 1.7, a confidence interval slope of 0.956 to 0.990, and a confidence interval intercept of -0.5 to 1.4. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis vielded correlation coefficients of 0.9898 to 0.9970, standard error estimates of 1.7 to 2.4. confidence interval slopes of 0.936 to 1.061, and a confidence interval intercepts of -3.8 to 2.0.

Detection limit: The detection limit was 1.5 mg/dL.

ACE LDL-C Reagent

Precision: In testing conducted at four LDL-C levels for 22 days, the within-run CV ranged from 2.5 to 4.6%, and total CV ranged from 3.2 to 4.9%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.7

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to 4.4% and total CV ranged from 2.4 to 5.9%.

Accuracy: In the correlation study, 108 samples with LDL-C values ranging from 10 to 422 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis vielded a correlation coefficient of 0.9973, a standard error estimate of 4.7, a confidence interval slope of 0.968 to 0.996, and a confidence interval intercept of -3.1 to 1.0. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis vielded correlation coefficients of 0.9940 to 0. 9974, standard error estimates of 5.9 to 9.0, confidence interval slopes of 0.991 to 1.071, and a confidence interval intercepts of -8.4 to 4.0.

Detection limit: The detection limit was 4.0 mg/dL.

ACE Triglycerides Reagent

Precision: In testing conducted at four triglycerides levels for 22 days. the within-run CV ranged from 1.2 to 2.9%, and total CV ranged from 1.8 to 3.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.5 to 2.3% and total CV ranged from 0.6 to 4.1%.

Accuracy: In the correlation study, 111 samples with triglycerides values ranging from 18 to 996 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis vielded a correlation coefficient of 0.9995, a standard error estimate of 6.6, a confidence interval slope of 1.025 to 1.037, and a confidence interval intercept of -2.7 to 1.1. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis vielded correlation coefficients of 0.9992 to 0.9996. standard error estimates of 5.9 to 8.4. confidence interval slopes of 0.989 to 1.024, and a confidence interval intercepts of -6.3 to 0.7.

Detection limit: The detection limit was 11.6 mg/dL.

Conclusions: Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate device.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

10903 New Hampshire Avenue Silver Spring, MD 20993

Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph. D. C/O Hymeldent, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006

JUL 3 2012

Re: K113262

K113262
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 Regulation Name: "Choroscros (vimitations of exemption per 21 CFR 862.9(c)(4)

Product Code: CHH, LBS, MRR, CDT

Dated: May 31, 2012

Received: June 1, 2012

Dear Dr. Katz:

We have reviewed your Section 510(k) premarket notification of intent to market the device in the indication we nave revewed your Section 510(x) premarter neme in the indications for the indications for referenced above and nave determined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicated in interest to devices that use stated in the enclosure) to legally mankelou processarial device Amendments, or to devices that prior to May 26, 1976, the enactions and of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From Wall of the move Act (Act) that do not require approval of a premarket approval application (PMA). The mays Act (Act) that do not require approval or a provisions of the Act . The general
therefore, market the device, subject to the general controls provisions of devices of devices therefore, market the device, subject to the general some some so annual registration, list in the mice controls provisions of the Net merade requiritions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) the United on to regulations affecting your device can be
may may be subject to such adultional comrois: Entering and on 895. In addition, FDA may found in The 21, Code of Peacharters concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat FDA s Issualled of a substainler squire with other requirements of the Act or that FDA has made a determination that your covices Federal agencies. You must comply
any Federal statutes and regulations administered by other Federal section and lightng any Federal Statules and regulations animinate of our registration and listing (2) CFR Part
with all the Act's requirements, including, but not for registration progrise requ with all the Act's requirents, including, but not not not works on the more of the requirements as set
807); labeling (21 CFR Parts 801 and 809); and good man as 300 forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active of In Vitro Diagnostic Device Evaluation and Safety 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 CITY at 807.97). For questions regarding (OSB's) Division of Postmarket Surveillance at (301) 016-5760. 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,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ACE Cholesterol Reagent

Indications for Use:

Device Name: ACE HDL-C Reagent

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D) Over-The-Counter Use. (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113262

Page 1 of 2

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Indications for Use

510(k) Number (if known):

Device Name: ACE LDL-C Reagent

The ACE LDL-C Reagent is intended for the quantitative Indications for Use: 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.

Device Name: ACE Triglycerides Reagent

Indications for Use: 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.

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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113262

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Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.