The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 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 BUN/Urea Reagent assay, urea in serum is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxdatively couple dichlorohydroxybenzene sulfonic 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/610 nm, is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains alpha-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and reduced (NADH).

The ACE Creatinine Reagent consists of two reagent bottles (Sodium Hydroxide Reagent and Picric Acid Reagent). The Sodium Hydroxide Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric Acid.

The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase.

The ACE CK Reagent consists of two reagent bottles (Buffer and Substrate). The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA, NADP and hexokinase. The Substrate Reagent (R2) contains: creatine phosphate, ADP, AMP, diadenosine pentaphosphate, EDTA and glucose-6-phosphate dehydrogenase.

AI/ML Overview

This 510(k) summary describes the analytical performance of the Alfa Wassermann ACE BUN, Creatinine, Uric Acid, and CK Reagents when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to a predicate device by evaluating precision, accuracy, and detection limits.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria for this type of device are generally understood to be that the performance of the new device (ACE Axcel System with new reagents) should be comparable to or better than a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System). While explicit numerical acceptance criteria are not strictly stated as "acceptance criteria" but rather as "reported performance," the goal is to show the device performs within acceptable analytical limits for clinical chemistry assays and is strongly correlated with the predicate.

Reagent (Analyte)	Performance Metric	Implied Acceptance Criteria (Comparison to Predicate)	Reported Device Performance (ACE Axcel vs. ACE Clinical Chemistry System)
ACE BUN/Urea	Precision (Within-run CV)	< 5% (typical clinical chemistry expectation)	1.1% to 3.3% (lab), 0.0% to 2.6% (POL)
	Precision (Total CV)	< 10% (typical clinical chemistry expectation)	3.5% to 4.6% (lab), 3.0% to 5.2% (POL)
	Accuracy (Correlation Coeff.)	R > 0.975 (strong correlation)	0.9963 (lab), 0.9982 to 0.9988 (POL)
	Accuracy (Slope CI)	Close to 1 (e.g., 0.95-1.05)	0.995 to 1.028 (lab), 0.983 to 1.039 (POL)
	Accuracy (Intercept CI)	Close to 0 (e.g., -5 to 5)	-0.3 to 0.6 (lab), -0.7 to 1.6 (POL)
	Detection Limit	Clinically relevant low level	1.1 mg/dL
ACE Creatinine	Precision (Within-run CV)	< 10% (typical clinical chemistry expectation)	1.3% to 9.6% (lab), 0.9% to 5.1% (POL)
	Precision (Total CV)	< 15% (typical clinical chemistry expectation, higher for very low values)	2.7% to 9.8% (lab), 2.1% to 6.1% (POL)
	Accuracy (Correlation Coeff.)	R > 0.975 (strong correlation)	0.9998 (lab), 0.9994 to 0.9998 (POL)
	Accuracy (Slope CI)	Close to 1 (e.g., 0.95-1.05)	0.975 to 0.983 (lab), 0.961 to 1.027 (POL)
	Accuracy (Intercept CI)	Close to 0 (e.g., -0.1 to 0.1)	-0.022 to 0.010 (lab), -0.136 to 0.001 (POL)
	Detection Limit	Clinically relevant low level	0.19 mg/dL
ACE Uric Acid	Precision (Within-run CV)	< 5% (typical clinical chemistry expectation)	1.8% to 4.9% (lab), 1.5% to 4.4% (POL)
	Precision (Total CV)	< 10% (typical clinical chemistry expectation)	2.0% to 5.4% (lab), 1.8% to 5.2% (POL)
	Accuracy (Correlation Coeff.)	R > 0.975 (strong correlation)	0.9958 (lab), 0.9858 to 0.9961 (POL)
	Accuracy (Slope CI)	Close to 1 (e.g., 0.95-1.05)	1.023 to 1.060 (lab), 0.972 to 1.054 (POL)
	Accuracy (Intercept CI)	Close to 0 (e.g., -0.5 to 0.5)	-0.18 to 0.07 (lab), -0.31 to 0.28 (POL)
	Detection Limit	Clinically relevant low level	1.13 mg/dL

Note: Acceptance criteria are implied based on typical expectations for clinical chemistry assays and the intent to demonstrate substantial equivalence to a predicate device. Specific numerical targets for acceptance were not explicitly stated in the provided text, but the strong correlation and low CVs indicate meeting such criteria.

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

ACE BUN/Urea Reagent:
- Accuracy (Correlation Study): 113 samples (clinical laboratory), and patient correlation studies at three Physician Office Laboratory (POL) sites (number of samples not explicitly stated for POL, but implied to be sufficient for regression analysis).
- Precision: Four BUN levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
- Data Provenance: Not explicitly stated, but clinical laboratory and Physician Office Laboratory (POL) settings are mentioned, suggesting human serum samples. Whether these were retrospective or prospective is not specified, but typically, method comparison studies use prospective or collected retrospective clinical samples.
ACE Creatinine Reagent:
- Accuracy (Correlation Study): 136 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
- Precision: Four creatinine levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
- Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.
ACE Uric Acid Reagent:
- Accuracy (Correlation Study): 106 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
- Precision: Four uric acid levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
- Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of chemical analytes (BUN, Creatinine, Uric Acid, CK) in serum. The 'ground truth' for such devices is established by a reference method or a legally marketed predicate device, not by expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD device for quantitative chemical analysis. Adjudication methods are typically used for qualitative or interpretive diagnostic devices where human expert disagreement might occur (e.g., radiology, pathology). Here, the comparison is directly numerical between the candidate device and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an IVD device for laboratory chemical analysis, not an imaging or interpretive diagnostic device that involves human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The described studies evaluate the performance of the algorithm/system only (the ACE Axcel Clinical Chemistry System with the new reagents) in quantifying the analytes in serum. The performance data (precision, accuracy, detection limit) are intrinsic to the device's analytical capability, independent of human interpretation of the results for the purpose of generating the values themselves. While trained personnel operate the system, the analytical performance is measured as a standalone function of the device.

7. The Type of Ground Truth Used

The "ground truth" for the accuracy studies was established by comparing the results from the Alfa Wassermann ACE Axcel Clinical Chemistry System (the new device, 'y') to a legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System ('x'). This is a common method for IVD substantial equivalence, where the predicate is considered the accepted reference for performance. For detection limits, it would typically involve analyzing samples with known, very low concentrations of the analytes or diluting higher concentration samples to determine the lowest measurable level.

8. The Sample Size for the Training Set

The provided text describes performance validation studies, not the development or training of an algorithm in the machine learning sense. Therefore, there is no "training set" for an algorithm to learn from in this context. The study focuses on verifying the performance of the already-developed reagent and instrument system.

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

Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device submission.

Summary

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AUG 1 0 2012

Alfa Wassermann Diagnostic Technologies, LLC

K113389

510(k) Submission ACE BUN, Creatinine, Uric Acid and CK Reagents ACE Axcel Clinical Chemistry System

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 1, 2011
Device:	Trade Name:	System	ACE Axcel Clinical Chemistry
	Classification:		Class 1
	Common/Classification Name:		Analyzer, Chemistry(Photometric, Discrete), ForClinical Use(21 C.F.R. § 862.2610)Product Code JJE
	Trade Name:		ACE BUN/Urea Reagent
	Classification:		Class 2
	Common/Classification Name:	Nitrogen	Urease, Photometric, Urea(21 C.F.R. § 862.1770)Product Code CDN
	Trade Name:		ACE Creatinine Reagent
	Classification:		Class 2
	Common/Classification Name:		Alkaline Picrate, Colorimetry,Creatinine (21 C.F.R. § 862.1225)Product Code CGX
	Trade Name:		ACE Uric Acid Reagent
	Classification:		Class 1
	Common/Classification Name:		Acid, Uric, Uricase (Colorimetric)(21 C.F.R. § 862.1775)Product Code KNK
	Trade Name:	ACE CK Reagent
	Classification:	Class 2
	Common/Classification Name:	NAD Reduction/NADHOxidation, CPK Or Isoenzymes(21 C.F.R. § 862.1215)Product Code CGS
PredicateDevices:	Manufacturer for analyzer/reagent system predicate:
	Alfa Wassermann ACE Clinical Chemistry System, Calibrators,Chemistry Controls, plus 12 ACE Reagents (K930104)
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 PCuses keyboard or touch screen input to manually enter a variety ofdata, control and accept data from the instrument, manage andmaintain system information and generate reports relative to patientstatus and instrument performance. The Panel PC also allows remotedownload of patient requisitions and upload of patient results via astandard interface.
	In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed toyield ammonia and carbon dioxide in the presence of urease. Theammonia formed then reacts with 2-oxoglutarate and NADH in thepresence of glutamate dehydrogenase to yield glutamate and NAD.Two moles of NADH are oxidized for each mole of urea present.NADH absorbs strongly at 340 nm, whereas NAD+ does not. Theinitial rate of decrease in absorbance, monitored bichromatically at 340nm/647 nm, is proportional to the urea concentration in the sample.
	In the ACE Creatinine Reagent assay, creatinine reacts with picric acidin an alkaline medium to form a red-orange colored complex, whichabsorbs strongly at 505 nm. The rate of complex formation,determined by measuring the increase in absorbance bichromatically at505 nm/573 nm during a fixed time interval, is directly proportional tothe creatinine concentration in the sample.
	In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized byuricase to allantoin and hydrogen peroxide. The hydrogen peroxidethen acts to oxdatively couple dichlorohydroxybenzene sulfonic acidand 4-aminoantipyrine in a reaction catalyzed by peroxidase,producing a red colored quinoneimine complex, which absorbsstrongly at 505 nm. The amount of chromogen formed, determined by

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	measuring the increase in absorbance bichromatically at 505 nm/610 nm, is directly proportional to the uric acid concentration in the sample.
	In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.
Intended Use:	Indications for Use:
	The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
	The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
	The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
ACE Axcel Clinical Chemistry System
The ACE CK Reagent is intended for the quantitative determination ofcreatine kinase activity in serum using the ACE Axcel ClinicalChemistry System. Measurement of creatine kinase is used in thediagnosis and treatment of myocardial infarction and muscle diseasessuch as progressive, Duchenne-type muscular dystrophy. This test isintended for use in clinical laboratories or physician office laboratories.For in vitro diagnostic use only.
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 forroutine, single reagent chemistries. System throughput will behigher 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 duringinstrument operation. Reagent containers are identified by computer coded labels tosimplify system operation. All reagents in the system mustinclude an identification label on the container. Sample and reagent sensing notify the operator of a depletedcondition 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 thesystem for closed tube sampling. Positive tube identification canbe achieved with an optional barcode scanner. An aliquot volumesufficient for all tests ordered is transferred and stored and theclosed tube is returned to the user. Sample cups are introduced to the system one at a time or bysample ring segment. Disposable cuvettes are loaded in bulk and then automaticallyinjected as needed by a cuvette hopper system. The ACE Axcelclinical chemistry optical system is capable of monitoring amaximum of 48 cuvettes at one time. The absorbance optical system is capable of absorbancemeasurements in a linear range of 0.0 to 2.0 absorbance units (at0.67 cm pathlength). Sixteen wavelengths are measuredsimultaneously using a photodiode array.
The ACE BUN/Urea Reagent consists of a single reagent bottle. Thereagent contains α-ketoglutarate, urease, glutamate dehydrogenase,adenosine diphosphate (ADP), nicotinamide adenine dinucleotide andreduced (NADH).
ACE Axcel Clinical Chemistry System
	The ACE Creatinine Reagent consists of two reagent bottles (SodiumHydroxide Reagent and Picric Acid Reagent). The Sodium HydroxideReagent (R1) contains sodium hydroxide. The Picric Acid Reagent(R2) contains picric Acid.
	The ACE Uric Acid Reagent consists of a single reagent bottle. Thereagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonicacid, peroxidase and uricase.
	The ACE CK Reagent consists of two reagent bottles (Buffer andSubstrate).The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA, NADP and hexokinase. TheSubstrate Reagent (R2) contains: creatine phosphate, ADP, AMP,diadenosine pentaphosphate, EDTA and glucose-6-phosphatedehydrogenase.
PerformanceData:	Performance data for the Alfa Wassermann ACE Reagents run on theAlfa Wassermann ACE Axcel Clinical Chemistry System includedprecision, accuracy, and detection limit data.
	ACE BUN/Urea Reagent
	Precision: In testing conducted at four BUN levels for 22 days, thewithin-run CV ranged from 1.1 to 3.3%, and total CV ranged from 3.5to 4.6%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 0.0to 2.6% and total CV ranged from 3.0 to 5.2%.
	Accuracy: In the correlation study, 113 samples with BUN valuesranging from 4 to 96 mg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9963, a standard error estimate of1.5, a confidence interval slope of 0.995 to 1.028, and a confidenceinterval intercept of -0.3 to 0.6. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9982 to 0.9988, standard error estimates of1.0 to 1.6, confidence interval slopes of 0.983 to 1.039, and aconfidence interval intercepts of -0.7 to 1.6.
	Detection limit: The detection limit was 1.1 mg/dL.
	ACE Axcel Clinical Chemistry System
ACE Creatinine Reagent	Precision: In testing conducted at four creatinine levels for 22 days, thewithin-run CV ranged from 1.3 to 9.6%, and total CV ranged from 2.7to 9.8%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 0.9to 5.1% and total CV ranged from 2.1 to 6.1%.Accuracy: In the correlation study, 136 samples with creatinine valuesranging from 0.28 to 22.95 mg/dL were assayed on the AlfaWassermann ACE Axcel Clinical Chemistry System (y) and the AlfaWassermann ACE Clinical Chemistry System (x). Least squaresregression analysis yielded a correlation coefficient of 0.9998, astandard error estimate of 0.082, a confidence interval slope of 0.975 to0.983, and a confidence interval intercept of -0.022 to 0.010. In patientcorrelation studies at three separate POL sites, using the AlfaWassermann ACE Axcel Clinical Chemistry System (y) and the AlfaWassermann ACE Clinical Chemistry System (x), least-squaresregression analysis yielded correlation coefficients of 0.9994 to 0.9998,standard error estimates of 0.123 to 0.192, confidence interval slopes of0.961 to 1.027, and a confidence interval intercepts of -0.136 to 0.001.Detection limit: The detection limit was 0.19 mg/dL.
ACE Uric Acid Reagent	Precision: In testing conducted at four uric acid levels for 22 days, thewithin-run CV ranged from 1.8 to 4.9%, and total CV ranged from 2.0to 5.4%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 1.5to 4.4% and total CV ranged from 1.8 to 5.2%.Accuracy: In the correlation study, 106 samples with uric acid valuesranging from 1.7 to 15.9 mg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9958, a standard error estimate of0.23, a confidence interval slope of 1.023 to 1.060, and a confidenceinterval intercept of -0.18 to 0.07. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9858 to 0.9961, standard error estimates of0.22 to 0.44, confidence interval slopes of 0.972 to 1.054, and aconfidence interval intercepts of -0.31 to 0.28.Detection limit: The detection limit was 1.13 mg/dL.

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ないというという

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November 1, 2011

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Image /page/6/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 an abstract symbol that resembles an eagle or a stylized human profile, rendered in black.

10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 1 0 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: K113389

Trade/Device Name: ACE BUN Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, ACE CK Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDN, CGX, KNK, CGS Dated: July 31, 2012 Received: August 1, 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).

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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 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 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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,

C. K. Linn, Ph.D.

Counney 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

5100k) Number (if known):

Device Name: ACE BUN/Urea Reagent

The ACE BUN/Urea Reagent is intended for the quantitative Indications for Use: determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Creatinine Reagent

The ACE Creatinine Reagent is intended for the quantitative Indications for Use: determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. 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)

Q. Chul

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

510(k) 113389

Page 1 of 2

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Indications for Use

510(k) Number (if known): K113389

Device Name: ACE Uric Acid Reagent

The ACE Uric Acid Reagent is intended for the quantitative Indications for Use: determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE CK Reagent

The ACE CK Reagent is intended for the quantitative determination of Indications for Use: creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 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)

R chin

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

510(k) 11389

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Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.