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 Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum using the ACE Axcel Clinical Chemistry System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Axcel Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. 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 Alkaline Phosphatase Reagent assay, alkaline phosphatase in serum catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE AST Reagent assay, a-amylase hydrolyzes the 2-chloro-p- nitrophenyl-a-D-maltotrioside substrate to release 2-chloro-p- nitrophenol and form 2-chloro-p- nitrophenyl-a-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the a- amylase activity in the sample.

In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L- lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for ACE Alkaline Phosphatase, Amylase, and LDH-L Reagents on the ACE Axcel Clinical Chemistry System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents, K931786) by showing a high degree of correlation and acceptable precision. The reported device performance is compared to the predicate device.

ACE Alkaline Phosphatase Reagent

Metric	Acceptance Criteria (Implied/Compared To Predicate)	Reported Device Performance (ACE Axcel System)
Precision	Within-run CV and Total CV should be at acceptable levels for clinical use and comparable to the predicate device.	Central Lab (22 days): Within-run CV: 1.3 to 3.2%; Total CV: 2.8 to 4.7%.POL Sites (3 sites, 5 days): Within-run CV: 1.0 to 4.8%; Total CV: 2.0 to 5.7%.
Accuracy	Strong correlation (high correlation coefficient), small standard error, and confidence intervals for slope and intercept indicating agreement with the predicate device (y ≈ x).	Correlation Study (112 samples): Correlation coefficient: 0.9997; Standard error estimate: 5.1; Confidence interval slope: 0.978 to 0.987; Confidence interval intercept: -0.5 to 1.8.POL Patient Correlation (3 sites): Correlation coefficients: 0.9957 to 0.9998; Standard error estimates: 6.0 to 25.3; Confidence interval slopes: 0.966 to 1.063; Confidence interval intercepts: -4.0 to 14.5.
Detection Limit	The lowest concentration of analyte that can be reliably detected. (Implicitly, the limit should be clinically acceptable and comparable to existing methods, potentially including the predicate).	1.3 U/L

ACE Amylase Reagent

Metric	Acceptance Criteria (Implied/Compared To Predicate)	Reported Device Performance (ACE Axcel System)
Precision	Within-run CV and Total CV should be at acceptable levels for clinical use and comparable to the predicate device.	Central Lab (22 days): Within-run CV: 1.5 to 3.4%; Total CV: 1.7 to 3.6%.POL Sites (3 sites, 5 days): Within-run CV: 0.8 to 4.7%; Total CV: 0.9 to 5.7%.
Accuracy	Strong correlation (high correlation coefficient), small standard error, and confidence intervals for slope and intercept indicating agreement with the predicate device (y ≈ x).	Correlation Study (111 samples): Correlation coefficient: 0.9997; Standard error estimate: 6.5; Confidence interval slope: 0.953 to 0.962; Confidence interval intercept: -0.7 to 2.0.POL Patient Correlation (3 sites): Correlation coefficients: 0.9985 to 1.0000; Standard error estimates: 3.4 to 22.3; Confidence interval slopes: 0.968 to 1.022; Confidence interval intercepts: -7.7 to 6.7.
Detection Limit	The lowest concentration of analyte that can be reliably detected. (Implicitly, the limit should be clinically acceptable and comparable to existing methods, potentially including the predicate).	8.5 U/L

ACE LDH-L Reagent

Metric	Acceptance Criteria (Implied/Compared To Predicate)	Reported Device Performance (ACE Axcel System)
Precision	Within-run CV and Total CV should be at acceptable levels for clinical use and comparable to the predicate device.	Central Lab (22 days): Within-run CV: 1.6 to 3.1%; Total CV: 2.3 to 4.6%.POL Sites (3 sites, 5 days): Within-run CV: 1.1 to 3.0%; Total CV: 1.7 to 3.3%.
Accuracy	Strong correlation (high correlation coefficient), small standard error, and confidence intervals for slope and intercept indicating agreement with the predicate device (y ≈ x).	Correlation Study (121 samples): Correlation coefficient: 0.9986; Standard error estimate: 7.5; Confidence interval slope: 1.036 to 1.056; Confidence interval intercept: 2.8 to 7.0.POL Patient Correlation (3 sites): Correlation coefficients: 0.9983 to 0.9993; Standard error estimates: 6.3 to 13.1; Confidence interval slopes: 0.995 to 1.052; Confidence interval intercepts: -8.5 to 6.2.
Detection Limit	The lowest concentration of analyte that can be reliably detected. (Implicitly, the limit should be clinically acceptable and comparable to existing methods, potentially including the predicate).	8.3 U/L

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

ACE Alkaline Phosphatase Reagent:
- Accuracy (Correlation Study): 112 samples.
- Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
- Precision (Central Lab): Data collected over 22 days, with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified but is typical for precision studies (e.g., n=2 or n=3 replicates).
- Precision (POL Sites): Data collected over 5 days at 3 separate Physician Office Laboratories (POLs), with 4 alkaline phosphatase levels tested. The exact number of individual samples run per level/day is not specified.
- Data Provenance: Not explicitly stated, but the mention of "Central Lab" and "Physician Office Laboratory (POL) sites" suggests clinical laboratory settings. It does not specify country of origin or if retrospective/prospective, but stability studies and clinical accuracy studies usually involve prospective collection or use of banked clinical samples. Given it is a 510(k) submission, it is likely representing real-world clinical samples.
ACE Amylase Reagent:
- Accuracy (Correlation Study): 111 samples.
- Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
- Precision (Central Lab): Data collected over 22 days, with 4 amylase levels tested.
- Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 amylase levels tested.
- Data Provenance: Similar to Alkaline Phosphatase, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.
ACE LDH-L Reagent:
- Accuracy (Correlation Study): 121 samples.
- Accuracy (POL Patient Correlation): Not specified (implied to be numerous patient samples tested at 3 POL sites).
- Precision (Central Lab): Data collected over 22 days, with 4 LDH levels tested.
- Precision (POL Sites): Data collected over 5 days at 3 separate POL sites, with 4 LDH levels tested.
- Data Provenance: Similar to the previous reagents, suggesting clinical laboratory settings in the US, likely using prospective or banked clinical samples.

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

This device is a clinical chemistry analyzer, not an imaging or diagnostic AI device that requires expert adjudication for "ground truth." The "ground truth" for the accuracy studies is established by the performance of the predicate device (Alfa Wassermann ACE Clinical Chemistry System). The predicate device itself would have been validated against established reference methods or clinical outcomes when it was initially cleared/approved. Therefore, no human experts directly establish "ground truth" in the way it might for image interpretation.

4. Adjudication Method for the Test Set

Not applicable for this type of device (clinical chemistry analyzer). Adjudication methods like 2+1 or 3+1 are used for subjective interpretations or classifications (e.g., by radiologists or pathologists) to reach a consensus "ground truth." For quantitative measurements, the "truth" is typically a measurement from a reference method or a well-established, previously validated method (in this case, the predicate device).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is typically for evaluating the performance of AI algorithms in conjunction with human readers, often in image interpretation tasks. This submission is for a clinical chemistry analyzer and reagents.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the new ACE Axcel Clinical Chemistry System with the specific reagents. The system measures analyte concentrations automatically, and its performance (precision, accuracy, detection limit) is assessed without direct human intervention in the measurement process itself, although human operators load samples and maintain the system. The "comparison" is to the predicate device, which is also a standalone automated system.

7. The Type of Ground Truth Used

The "ground truth" used for accuracy (correlation) studies is the measurement result from the legally marketed predicate device: the Alfa Wassermann ACE Clinical Chemistry System and its corresponding ACE Reagents (K931786). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a recognized gold standard method might not be readily available for routine testing or if the goal is to show equivalence to an existing market performer.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The device is a traditional clinical chemistry analyzer based on established photometric and enzymatic reaction principles. The "training" for such a system would involve instrument calibration (which uses control materials, not a "training set" of patient data) and reagent manufacturing/quality control.

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

Not applicable, as there is no "training set" for an AI algorithm. For instrument calibration, the "ground truth" for calibrators would be established by the manufacturer using reference methods or certified reference materials, and then verified through quality control materials.

Summary

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K113436

Attachment 4

: :

JUL 1 2 2012

New 510(k) Summary

Alkaline Phosphatase, Amylase and LDH-L Reagents on the 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 Summary Prepared:	April 12, 2012
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:Reagent		ACE Alkaline Phosphatase
	Classification:		Class 2
	Common/Classification Name:		Nitrophenylphosphate, AlkalinePhosphatase Or Isoenzymes(21 C. F.R. § 862.1050)Product Code CJE
	Trade Name:		ACE Amylase Reagent
	Classification:		Class 2
	Common/Classification Name:		Saccharogenic, Amylase(21 C. F.R. § 862.1070)Product Code CIJ

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. .

Trade Name:	ACE LDH-L Reagent
Classification:	Class 2
Common/Classification Name:	NAD Reduction/NADH Oxidation,Lactate Dehydrogenase(21 C. F.R. § 862.1440)Product Code CFJ
PredicateDevices:	Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE Clinical Chemistry SystemACE Reagents (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 Alkaline Phosphatase Reagent assay, alkaline phosphatasein serum catalyzes the hydrolysis of colorless p-nitrophenyl phosphateto p-nitrophenol and inorganic phosphate. In an alkaline solution (pH10.5), p-nitrophenol is in the phenoxide form and has a strongabsorbance at 408 nm. The rate of increase in absorbance, monitoredbichromatically at 408 nm/486 nm, is directly proportional to thealkaline phosphatase activity in the sample.In the ACE AST Reagent assay, a-amylase hydrolyzes the 2-chloro-p-nitrophenyl-a-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p- nitrophenyl-a-D-maltoside,maltotriose and glucose. The rate of increase in absorbance, monitoredbichromatically at 408 nm/ 647 nm, is directly proportional to the a-amylase activity in the sample.In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes theconversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide(NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide(NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not.Therefore, the rate of conversion of NAD+ to NADH can be determined
Intended Use:	by monitoring the increase in absorbance bichromatically at 340nm/647 nm. This rate of conversion from NAD+ to NADH is directlyproportional to the lactate dehydrogenase activity in the sample.Indications for Use:
	The ACE Axcel Clinical Chemistry System is an automated, discrete,bench-top, random access analyzer that is intended for in vitrodiagnostic use in the quantitative determination of constituents in bloodand other fluids.
	The ACE Alkaline Phosphatase Reagent is intended for the quantitativedetermination of alkaline phosphatase activity in serum using the ACEAxcel Clinical Chemistry System. Measurements of alkalinephosphatase are used in the diagnosis and treatment of liver, bone,parathyroid, and intestinal diseases. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
	The ACE Amylase Reagent is intended for the quantitativedetermination of α-amylase activity in serum using the ACE AxcelClinical Chemistry System. Amylase measurements are used primarilyfor the diagnosis and treatment of pancreatitis (inflammation of thepancreas). This test is intended for use in clinical laboratories orphysician office laboratories. For in vitro diagnostic use only.
	The ACE LDH-L Reagent is intended for the quantitativedetermination of lactate dehydrogenase activity in serum using theACE Axcel Clinical Chemistry System. Lactate dehydrogenasemeasurements are used in the diagnosis and treatment of liver diseasessuch as acute viral hepatitis, cirrhosis, and metastatic carcinoma of theliver, cardiac diseases such as myocardial infarction and tumors of thelung or kidneys. This test is intended for use in physician officelaboratories or clinical 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 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 sufficient for all tests ordered is transferred and stored and the 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 Alkaline Phosphatase Reagent is composed of two reagent bottles (Buffer and Substrate Reagent). The reagents contain AMP Buffer (pH 10.45), magnesium acetate, p-nitrophenyl phosphate.The ACE Amylase Reagent is composed of a single reagent bottle. The reagents contain 2-chloro-p-nitrophenyl-α-D-maltotrioside, sodium chloride, calcium acetate, potassium thiocyanate and MES buffer (pH 6.0).The ACE LDH-L Reagent is composed of two reagent bottles (Substrate and Coenzyme Reagent). The reagents contain L-lactic acid and nicotinamide adenine dinucleotide.
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 Alkaline Phosphatase ReagentPrecision: In testing conducted at four alkaline phosphatase levels for 22 days, the within-run CV ranged from 1.3 to 3.2%, and total CV ranged from 2.8 to 4.7%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.0 to 4.8% and total CV ranged from 2.0 to 5.7%.

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Accuracy: In the correlation study, 112 samples with alkaline phosphatase values ranging from 12 to 1363 U/L 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 0.9997, a standard error estimate of 5.1, a confidence interval slope of 0.978 to 0.987, and a confidence interval intercept of -0.5 to 1.8. 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 0.9957 to 0.9998, standard error estimates of 6.0 to 25.3, confidence interval slopes of 0.966 to 1.063, and a confidence interval intercepts of -4.0 to 14.5.

Detection limit: The detection limit was 1.3 U/L.

ACE Amylase Reagent

Precision: In testing conducted at four amylase levels for 22 days, the within-run CV ranged from 1.5 to 3.4%, and total CV ranged from 1.7 to 3.6%. In precision studies at three separate Physician Office Laboratory (POL) sites 5 days, the within-run CV ranged from 0.8 to 4.7% and total CV ranged from 0.9 to 5.7%.

Accuracy: In the correlation study, 111 samples with amylase values ranging from 11 to 1650 U/L 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 yielded a correlation coefficient of 0.9997, a standard error estimate of 6.5. a confidence interval slope of 0.953 to 0.962. and a confidence interval intercept of -0.7 to 2.0. 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 0.9985 to 1.0000, standard error estimates of 3.4 to 22.3, confidence interval slopes of 0.968 to 1.022, and a confidence interval intercepts of -7.7 to 6.7.

Detection limit: The detection limit was 8.5 U/L.

ACE LDH-L Reagent

Precision: In testing conducted at four LDH levels for 22 days, the within-run CV ranged from 1.6 to 3.1%, and total CV ranged from 2.3 to 4.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.1 to 3.0% and total CV ranged from 1.7 to 3.3%.

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	Accuracy: In the correlation study, 121 samples with LDH valuesranging from 22 to 829 U/L 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 0.9986, a standard error estimate of7.5, a confidence interval slope of 1.036 to 1.056, and a confidenceinterval intercept of 2.8 to 7.0. 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 0.9983 to 0.9993, standard error estimates of6.3 to 13.1, confidence interval slopes of 0.995 to 1.052, and aconfidence interval intercepts of -8.5 to 6.2.Detection limit: The detection limit was 8.3 U/L.
Conclusions:	Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate device.

Accuracy: In the correlation study, 121 samples with LDH valuesranging from 22 to 829 U/L 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 0.9986, a standard error estimate of7.5, a confidence interval slope of 1.036 to 1.056, and a confidenceinterval intercept of 2.8 to 7.0. 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 0.9983 to 0.9993, standard error estimates of6.3 to 13.1, confidence interval slopes of 0.995 to 1.052, and aconfidence interval intercepts of -8.5 to 6.2.Detection limit: The detection limit was 8.3 U/L.

Conclusions:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the outer edge. Inside the circle is a stylized image of an eagle, which is a common symbol of the United States.

10903 New Hampshire Avenue Silver Spring, MD 20993

Alfa Wasserman Diagnostic Technologies, .LLC c/o Hyman Katz, Ph.D. 4 Henderson Drive West Caldwell, NJ 07006

Re: K113436

Trade Name: ACE Alkaline Phosphatase Reagent ACE Amylase Reagent ACE LDH-L Reagent Regulation Number: 21 CFR §862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Codes: CJE, CIJ, CFJ Dated: June 7, 2012 Received: June 8, 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

JUL 12 2012

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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 desire specific advice for your cic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21) prease note the regulation official crearding postmarket surveillance, please contact CDRH3 CITY at 607.97). For questions regarding postmarket Surveillance at (301) Office of but romance and 22cline the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

CITY art 005), product go to hear in 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 Tou may octuril one. Benefal memational 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/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courtney 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

Device Name: ACE Alkaline Phosphatase Reagent

The ACE Alkaline Phosphatase Reagent is intended for the quantitative Indications for Use: determination of alkaline phosphatase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Amylase Reagent

The ACE Amylase Reagent is intended for the quantitative determination Indications for Use: of a-amylase activity in serum using the ACE Axcel Clinical Chemistry System. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE LDH-L Reagent

Indications for Use:

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) K113436

Page 1 of 1

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.