The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in serum.

In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.

AI/ML Overview

This document describes the performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These reagents are intended for the quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (γ-GT) activity in serum, used in the diagnosis and treatment of certain liver and heart diseases.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as distinct from the reported performance. Instead, it presents the results of precision and accuracy studies. The implication is that these results demonstrate acceptable performance for the device. For the purpose of this table, the reported performance values are presented with the understanding that they met the internal requirements of the manufacturer for regulatory submission.

Metric	Acceptance Criteria (Implied)	ACE ALT Reagent	ACE AST Reagent	ACE γ-GT Reagent
Precision	Low CV% for within-run and total CV	Lab Setting (4 levels, 22 days): Within-run CV: 0.8% - 6.9%; Total CV: 1.1% - 6.9%. POL Sites (3 sites, 5 days): Within-run CV: 0.8% - 8.7%; Total CV: 1.3% - 8.7%.	Lab Setting (4 levels, 22 days): Within-run CV: 0.9% - 7.1%; Total CV: 1.4% - 8.5%. POL Sites (3 sites, 5 days): Within-run CV: 1.1% - 11.3%; Total CV: 1.2% - 11.3%.	Lab Setting (4 levels, 22 days): Within-run CV: 1.0% - 3.0%; Total CV: 1.1% - 6.1%. POL Sites (3 sites, 5 days): Within-run CV: 0.7% - 12.4%; Total CV: 1.3% - 13.0%.
Accuracy (Correlation to Predicate)	High correlation coefficient (near 1), low standard error, slope near 1, intercept near 0	Correlation Study (102 samples, 4-472 U/L): Correlation coefficient: 0.9996; Standard error: 2.4; CI slope: 1.035 to 1.047; CI intercept: -0.3 to 0.9. POL Sites: Correlation coefficients: 0.9997 to 0.9999; Standard error: 2.4 to 3.1; CI slopes: 1.009 to 1.035; CI intercepts: -1.1 to 2.4.	Correlation Study (117 samples, 8-440 U/L): Correlation coefficient: 0.9996; Standard error: 2.2; CI slope: 1.002 to 1.012; CI intercept: 1.9 to 2.8. POL Sites: Correlation coefficients: 0.9996 to 0.9998; Standard error: 2.5 to 2.9; CI slopes: 1.005 to 1.038; CI intercepts: -1.4 to 2.1.	Correlation Study (128 samples, 7-902 U/L): Correlation coefficient: 0.9998; Standard error: 3.4; CI slope: 0.981 to 0.988; CI intercept: -0.6 to 0.8. POL Sites: Correlation coefficients: 0.9992 to 0.9999; Standard error: 3.6 to 8.8; CI slopes: 0.967 to 1.053; CI intercepts: -1.7 to 4.8.
Detection Limit	Low U/L value	3.1 U/L	1.5 U/L	2.7 U/L

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

ACE ALT Reagent:
- Precision: Not explicitly stated as a "test set" sample size for patient samples. Precision was assessed at four ALT levels over 22 days in a lab setting and at three Physician Office Laboratory (POL) sites over 5 days. These studies would typically involve repeated measurements of control materials or pooled patient samples.
- Accuracy: 102 samples for the main correlation study (ALT values from 4 to 472 U/L) and patient correlation studies conducted at three separate POL sites.
- Data Provenance: Not explicitly stated, but the mention of Physician Office Laboratory (POL) sites suggests data from clinical settings. It is implied to be prospective data collected for the study, rather than retrospective.
ACE AST Reagent:
- Precision: Similar to ALT, assessed at four AST levels over 22 days in a lab and at three POL sites over 5 days.
- Accuracy: 117 samples for the main correlation study (AST values from 8 to 440 U/L) and patient correlation studies conducted at three separate POL sites.
- Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.
ACE γ-GT Reagent:
- Precision: Similar to ALT and AST, assessed at four γ-GT levels over 22 days in a lab and at three POL sites over 5 days.
- Accuracy: 128 samples for the main correlation study (γ-GT values from 7 to 902 U/L) and patient correlation studies conducted at three separate POL sites.
- Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.

The country of origin for the data is not specified, but the manufacturer is based in the US.

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

This information is not applicable as the device is an in vitro diagnostic (IVD) chemistry system that provides quantitative measurements of enzyme activity. The "ground truth" for IVD devices like this is typically established by comparing performance against a reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical assessments.

For accuracy, the device's performance was compared to the Alfa Wassermann ACE Clinical Chemistry System (predicate device K931786).

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human experts interpret results or clinical cases, and a consensus needs to be reached. For quantitative IVD tests, the "ground truth" is the result obtained from a reference method or predicate device.

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:

This information is not applicable. MRMC studies are relevant for medical imaging AI devices where human readers interpret images. This device is an in vitro diagnostic system for chemical analysis and does not involve human readers interpreting cases in the same way.

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

Yes, the performance studies described (precision, accuracy, and detection limit) represent the standalone performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These are objective, quantitative measurements generated directly by the analytical system, without human interpretation in the "loop" of the measurement process itself.

7. The Type of Ground Truth Used:

The ground truth used for the accuracy studies was the measurements obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System (K931786). The new reagents on the ACE Axcel system (y) were compared against the existing reagents on the ACE system (x) using patient samples. This is a common method for demonstrating substantial equivalence for new IVD devices by showing good correlation with an already legally marketed device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an in vitro diagnostic reagent and system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The reagents and system are developed and optimized through traditional chemical and engineering processes, followed by validation studies as described.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8. There is no training set in the machine learning context for this type of device.

Summary

{0}------------------------------------------------

K113.382

510(k) SUMMARY

JUL 1 9 2012

ACE ALT, AST, y-GT Reagents on the ACE Axcel Clinical Chemistry System

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:	July 13, 2012
Device:	Trade Name:	ACE ALT Reagent
	Classification:	Class 1
	Common/Classification Name:	NADH Oxidation/NAD Reduction, ALT/SGPT(21 C.F.R. § 862.1030)Product Code CKA
	Trade Name:	ACE AST Reagent
	Classification:	Class 2
	Common/Classification Name:	NADH Oxidation/NAD Reduction, AST/SGOT(21 C.F.R. § 862.1100)Product Code CIT
	Trade Name:	ACE γ-GT Reagent
	Classification:	Class 1
	Common/Classification Name:	Colorimetric Method, Gamma-Glutamyl Transpeptidase(21 C.F.R. § 862.1360)Product Code JPZ
Predicate Devices:	Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Reagents (K931786)

{1}------------------------------------------------

DeviceDescriptions:	In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate.Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to thecofactor. The rate of conversion of the reduced cofactor to the cofactor can bedetermined by monitoring the decrease in absorbance bichromatically at 340nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is afunction of the activity of ALT in the sample.In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. Theoxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ inthe malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH toNAD+ can be determined by monitoring the decrease in absorbance bichromaticallyat 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function ofthe activity of AST in the sample. Lactate dehydrogenase is added to preventinterference from endogenous pyruvate, which is normally present in serum.In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in thereagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rateof increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directlyproportional to the γ-GT activity in the sample.
Intended Use:	Indications for Use:
	The ACE ALT Reagent is intended for the quantitative determination of alanineaminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.Alanine aminotransferase measurements are used in the diagnosis and treatment ofcertain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This testis intended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only.
	The ACE AST Reagent is intended for the quantitative determination of aspartateaminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.Measurements of aspartate aminotransferase are used in the diagnosis and treatmentof certain types of liver and heart disease. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic use only.
	The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical ChemistrySystem. Gamma-glutamyltransferase measurements are used in the diagnosis andtreatment of liver diseases such as alcoholic cirrhosis and primary and secondaryliver tumors. This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only.

TechnologicalCharacteristics:	The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme).The reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide,reduced (NADH), lactate dehydrogenase and Tris buffer.
	The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme).The reagents contain L-aspartate, α-ketoglutarate, nicotinamide adeninedinucleotide, reduced (NADH), malate dehydrogenase, lactate dehydrogenase andTris buffer.
	The ACE Y-GT Reagent consists of two reagent bottles (Buffer and Substrate). TheBuffer Reagent (R1) contains: glycylglycine. The Substrate Reagent (R2) contains:L-y-glutamyl-3-carboxy-4-nitroanilide and buffer.
PerformanceData:	Performance data for the Alfa Wassermann ACE Reagents run on the AlfaWassermann ACE Axcel Clinical Chemistry System included precision, accuracy,and detection limit data.
	ACE ALT Reagent
	Precision: In testing conducted at four ALT levels for 22 days, the within-run CVranged from 0.8 to 6.9%, and total CV ranged from 1.1 to 6.9% In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 8.7% and total CV ranged from 1.3 to 8.7%.
	Accuracy: In the correlation study, 102 samples with ALT values ranging from 4 to472 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9996, a standarderror estimate of 2.4, a confidence interval slope of 1.035 to 1.047, and a confidenceinterval intercept of -0.3 to 0.9. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9997 to 0.9999, standard errorestimates of 2.4 to 3.1, confidence interval slopes of 1.009 to 1.035, and aconfidence interval intercepts of -1.1 to 2.4.
	Detection limit: The detection limit was 3.1 U/L.
	ACE AST Reagent
	Precision: In testing conducted at four AST levels for 22 days, the within-run CVranged from 0.9 to 7.1%, and total CV ranged from 1.4 to 8.5%. In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.1 to 11.3% and total CV ranged from 1.2 to 11.3%.
	Accuracy: In the correlation study, 117 samples with AST values ranging from 8 to440 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9996, a standarderror estimate of 2.2, a confidence interval slope of 1.002 to 1.012, and a confidence
	interval intercept of 1.9 to 2.8. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9996 to 0.9998, standard errorestimates of 2.5 to 2.9, confidence interval slopes of 1.005 to 1.038, and aconfidence interval intercepts of -1.4 to 2.1.
	Detection limit: The detection limit was 1.5 U/L.
	ACE y-GT Reagent.
	Precision: In testing conducted at four y-GT levels for 22 days, the within-run CVranged from 1.0 to 3.0%, and total CV ranged from 1.1 to 6.1%. In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 12.4% and total CV ranged from 1.3 to 13.0%.
	Accuracy: In the correlation study, 128 samples with y-GT values ranging from 7 to902 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9998, a standarderror estimate of 3.4, a confidence interval slope of 0.981 to 0.988, and a confidenceinterval intercept of -0.6 to 0.8. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9992 to 0.9999, standard errorestimates of 3.6to 8.8, confidence interval slopes of 0.967 to 1.053, and aconfidence interval intercepts of -1.7 to 4.8.
	Detection limit: The detection limit was 2.7 U/L.
Conclusions:	Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate device.

. .

{2}------------------------------------------------

{3}------------------------------------------------

September 19.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

K113382 Re: Trade Name: ACE AST Reagent JUL 1 9 2012 ACE ALT Reagent ACE y-GT Reagent Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Codes: CIT, CKA, JPZ Dated: June 19, 2012 Received: June 20, 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 Eederal 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).

Image /page/4/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

JUL 19 2012

{5}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire speently ad rive this Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, comation the orifical of in 1 around to "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrig's (OSB's) Division of Postmarket Surveillance at (301) 01160 of Sar remestions 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 Tou may 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/Resourcesfor You/Industry/default.htm

Sincerely vours.

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

{6}------------------------------------------------

Indications for Use

K113382 510(k) Number:

Device Name:

ACE ALT 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)

Xandria Wms

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

510(k) K 113382

Page 1 of 3

{7}------------------------------------------------

Indications for Use

K113382 510(k) Number:

Device Name:

ACE AST Reagent

Indications for Use:

Indications for Use: . The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. 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)

Tuandria Wms.

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

510(k) k 1133 82

Page 2 of 9

{8}------------------------------------------------

Indications for Use

510(k) Number:

K113382

Device Name:

ACE y-GT Reagent

Indications for Use:

The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. 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)

Juandia Wms
Division Sign-Off

Office of In vitro Diagnostic Device Evaluation and Safety

510(k) K113382.

Page 3 of 3

{0}------------------------------------------------

K113.382

510(k) SUMMARY

JUL 1 9 2012

ACE ALT, AST, y-GT Reagents on the ACE Axcel Clinical Chemistry System

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:	July 13, 2012
Device:	Trade Name:	ACE ALT Reagent
	Classification:	Class 1
	Common/Classification Name:	NADH Oxidation/NAD Reduction, ALT/SGPT(21 C.F.R. § 862.1030)Product Code CKA
	Trade Name:	ACE AST Reagent
	Classification:	Class 2
	Common/Classification Name:	NADH Oxidation/NAD Reduction, AST/SGOT(21 C.F.R. § 862.1100)Product Code CIT
	Trade Name:	ACE γ-GT Reagent
	Classification:	Class 1
	Common/Classification Name:	Colorimetric Method, Gamma-Glutamyl Transpeptidase(21 C.F.R. § 862.1360)Product Code JPZ
Predicate Devices:	Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Reagents (K931786)

{1}------------------------------------------------

DeviceDescriptions:	In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate.Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to thecofactor. The rate of conversion of the reduced cofactor to the cofactor can bedetermined by monitoring the decrease in absorbance bichromatically at 340nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is afunction of the activity of ALT in the sample.In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. Theoxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ inthe malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH toNAD+ can be determined by monitoring the decrease in absorbance bichromaticallyat 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function ofthe activity of AST in the sample. Lactate dehydrogenase is added to preventinterference from endogenous pyruvate, which is normally present in serum.In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in thereagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rateof increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directlyproportional to the γ-GT activity in the sample.
Intended Use:	Indications for Use:
	The ACE ALT Reagent is intended for the quantitative determination of alanineaminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.Alanine aminotransferase measurements are used in the diagnosis and treatment ofcertain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This testis intended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only.
	The ACE AST Reagent is intended for the quantitative determination of aspartateaminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.Measurements of aspartate aminotransferase are used in the diagnosis and treatmentof certain types of liver and heart disease. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic use only.
	The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical ChemistrySystem. Gamma-glutamyltransferase measurements are used in the diagnosis andtreatment of liver diseases such as alcoholic cirrhosis and primary and secondaryliver tumors. This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only.

TechnologicalCharacteristics:	The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme).The reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide,reduced (NADH), lactate dehydrogenase and Tris buffer.
	The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme).The reagents contain L-aspartate, α-ketoglutarate, nicotinamide adeninedinucleotide, reduced (NADH), malate dehydrogenase, lactate dehydrogenase andTris buffer.
	The ACE Y-GT Reagent consists of two reagent bottles (Buffer and Substrate). TheBuffer Reagent (R1) contains: glycylglycine. The Substrate Reagent (R2) contains:L-y-glutamyl-3-carboxy-4-nitroanilide and buffer.
PerformanceData:	Performance data for the Alfa Wassermann ACE Reagents run on the AlfaWassermann ACE Axcel Clinical Chemistry System included precision, accuracy,and detection limit data.
	ACE ALT Reagent
	Precision: In testing conducted at four ALT levels for 22 days, the within-run CVranged from 0.8 to 6.9%, and total CV ranged from 1.1 to 6.9% In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 8.7% and total CV ranged from 1.3 to 8.7%.
	Accuracy: In the correlation study, 102 samples with ALT values ranging from 4 to472 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9996, a standarderror estimate of 2.4, a confidence interval slope of 1.035 to 1.047, and a confidenceinterval intercept of -0.3 to 0.9. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9997 to 0.9999, standard errorestimates of 2.4 to 3.1, confidence interval slopes of 1.009 to 1.035, and aconfidence interval intercepts of -1.1 to 2.4.
	Detection limit: The detection limit was 3.1 U/L.
	ACE AST Reagent
	Precision: In testing conducted at four AST levels for 22 days, the within-run CVranged from 0.9 to 7.1%, and total CV ranged from 1.4 to 8.5%. In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.1 to 11.3% and total CV ranged from 1.2 to 11.3%.
	Accuracy: In the correlation study, 117 samples with AST values ranging from 8 to440 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9996, a standarderror estimate of 2.2, a confidence interval slope of 1.002 to 1.012, and a confidence
	interval intercept of 1.9 to 2.8. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9996 to 0.9998, standard errorestimates of 2.5 to 2.9, confidence interval slopes of 1.005 to 1.038, and aconfidence interval intercepts of -1.4 to 2.1.
	Detection limit: The detection limit was 1.5 U/L.
	ACE y-GT Reagent.
	Precision: In testing conducted at four y-GT levels for 22 days, the within-run CVranged from 1.0 to 3.0%, and total CV ranged from 1.1 to 6.1%. In precision studiesat three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 12.4% and total CV ranged from 1.3 to 13.0%.
	Accuracy: In the correlation study, 128 samples with y-GT values ranging from 7 to902 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical ChemistrySystem (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Leastsquares regression analysis yielded a correlation coefficient of 0.9998, a standarderror estimate of 3.4, a confidence interval slope of 0.981 to 0.988, and a confidenceinterval intercept of -0.6 to 0.8. In patient correlation studies at three separate POLsites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and theAlfa Wassermann ACE Clinical Chemistry System (x), least-squares regressionanalysis yielded correlation coefficients of 0.9992 to 0.9999, standard errorestimates of 3.6to 8.8, confidence interval slopes of 0.967 to 1.053, and aconfidence interval intercepts of -1.7 to 4.8.
	Detection limit: The detection limit was 2.7 U/L.
Conclusions:	Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate device.

. .

{2}------------------------------------------------

{3}------------------------------------------------

September 19.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

K113382 Re: Trade Name: ACE AST Reagent JUL 1 9 2012 ACE ALT Reagent ACE y-GT Reagent Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Codes: CIT, CKA, JPZ Dated: June 19, 2012 Received: June 20, 2012
Dear Dr Katz:

JUL 19 2012

{5}------------------------------------------------

Page 2

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

Sincerely vours.

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

{6}------------------------------------------------

Indications for Use

K113382 510(k) Number:

Device Name:

ACE ALT 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)

Xandria Wms

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

510(k) K 113382

Page 1 of 3

{7}------------------------------------------------

Indications for Use

K113382 510(k) Number:

Device Name:

ACE AST 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)

Tuandria Wms.

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

510(k) k 1133 82

Page 2 of 9

{8}------------------------------------------------

Indications for Use

510(k) Number:

K113382

Device Name:

ACE y-GT 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)

Juandia Wms
Division Sign-Off

Office of In vitro Diagnostic Device Evaluation and Safety

510(k) K113382.

Page 3 of 3

Regulation Number and Section

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.

(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(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.