ACE ALT REAGENT

K113382 · Alfa Wassermann · CKA · Jul 19, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113382
• Device Name: ACE ALT REAGENT
• Applicant: Alfa Wassermann
• Product Code: CKA · Clinical Chemistry
• Decision Date: Jul 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Intended Use

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 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 Story

Reagents for ACE Axcel Clinical Chemistry System; measure enzyme activity in serum samples. ALT assay: converts L-alanine/α-ketoglutarate to L-glutamate/pyruvate; LDH-catalyzed oxidation of reduced cofactor monitored via absorbance decrease at 340/647 nm. AST assay: converts L-aspartate/α-ketoglutarate to oxalacetate/L-glutamate; MDH-catalyzed reduction of oxalacetate with NADH oxidation monitored at 340/647 nm. γ-GT assay: transfers γ-glutamyl group from substrate to glycylglycine; product absorbance increase monitored at 408/486 nm. Used in clinical/physician office labs by trained personnel. Output is enzyme activity level (U/L) displayed on system interface; assists clinicians in diagnosing/monitoring liver and heart conditions.

Clinical Evidence

Bench testing only. Precision studies (22 days, 4 levels) and POL site studies (5 days) performed. Accuracy evaluated via correlation studies (n=102 for ALT, n=117 for AST, n=128 for γ-GT) comparing ACE Axcel to ACE system; correlation coefficients >0.999. Detection limits: 3.1 U/L (ALT), 1.5 U/L (AST), 2.7 U/L (γ-GT).

Technological Characteristics

Reagents consist of substrate and coenzyme/buffer bottles. ALT: L-alanine, α-ketoglutarate, NADH, LDH, Tris buffer. AST: L-aspartate, α-ketoglutarate, NADH, MDH, LDH, Tris buffer. γ-GT: glycylglycine, L-γ-glutamyl-3-carboxy-4-nitroanilide. Sensing principle: bichromatic spectrophotometry (absorbance monitoring). System: ACE Axcel Clinical Chemistry System.

Indications for Use

Indicated for quantitative determination of ALT, AST, and γ-GT activity in serum for diagnosis/treatment of liver and heart diseases. Intended for use in clinical laboratories or physician office laboratories (point-of-care).

Regulatory Classification

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.

Predicate Devices

• Alfa Wassermann ACE plus ISE/Clinical Chemistry System; ACE Reagents (K931786)

Submission Summary (Full Text)

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K113.382

# 510(k) SUMMARY

JUL 1 9 2012

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

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] | |
| Date Summary Prepared: | July 13, 2012 | |
| Device: | Trade Name: | ACE ALT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, ALT/SGPT<br>(21 C.F.R. § 862.1030)<br>Product Code CKA |
| | Trade Name: | ACE AST Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, AST/SGOT<br>(21 C.F.R. § 862.1100)<br>Product Code CIT |
| | Trade Name: | ACE γ-GT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Colorimetric Method, Gamma-Glutamyl Transpeptidase<br>(21 C.F.R. § 862.1360)<br>Product Code JPZ |
| Predicate Devices: | Manufacturer for analyzer/reagent system predicate:<br>Alfa Wassermann ACE plus ISE/Clinical Chemistry System<br>ACE Reagents (K931786) | |

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| Device<br>Descriptions: | In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-<br>alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate.<br>Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the<br>cofactor. The rate of conversion of the reduced cofactor to the cofactor can be<br>determined by monitoring the decrease in absorbance bichromatically at 340<br>nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a<br>function of the activity of ALT in the sample.<br><br>In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-<br>aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The<br>oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in<br>the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at<br>340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to<br>NAD+ can be determined by monitoring the decrease in absorbance bichromatically<br>at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of<br>the activity of AST in the sample. Lactate dehydrogenase is added to prevent<br>interference from endogenous pyruvate, which is normally present in serum.<br><br>In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-<br>glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the<br>reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate<br>of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly<br>proportional to the γ-GT activity in the sample. |
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| Intended Use: | Indications for Use: |
| | The ACE ALT Reagent is intended for the quantitative determination of alanine<br>aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.<br>Alanine aminotransferase measurements are used in the diagnosis and treatment of<br>certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test<br>is intended for use in clinical laboratories or physician office laboratories. For <i>in<br/>vitro</i> diagnostic use only. |
| | The ACE AST Reagent is intended for the quantitative determination of aspartate<br>aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.<br>Measurements of aspartate aminotransferase are used in the diagnosis and treatment<br>of certain types of liver and heart disease. This test is intended for use in clinical<br>laboratories or physician office laboratories. For <i>in vitro</i> diagnostic use only. |
| | The ACE γ-GT Reagent is intended for the quantitative determination of gamma-<br>glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry<br>System. Gamma-glutamyltransferase measurements are used in the diagnosis and<br>treatment of liver diseases such as alcoholic cirrhosis and primary and secondary<br>liver tumors. This test is intended for use in clinical laboratories or physician office<br>laboratories. For <i>in vitro</i> diagnostic use only. |
| | |
| Technological<br>Characteristics: | The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme).<br>The reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide,<br>reduced (NADH), lactate dehydrogenase and Tris buffer. |
| | The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme).<br>The reagents contain L-aspartate, α-ketoglutarate, nicotinamide adenine<br>dinucleotide, reduced (NADH), malate dehydrogenase, lactate dehydrogenase and<br>Tris buffer. |
| | The ACE Y-GT Reagent consists of two reagent bottles (Buffer and Substrate). The<br>Buffer Reagent (R1) contains: glycylglycine. The Substrate Reagent (R2) contains:<br>L-y-glutamyl-3-carboxy-4-nitroanilide and buffer. |
| Performance<br>Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa<br>Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy,<br>and detection limit data. |
| | ACE ALT Reagent |
| | Precision: In testing conducted at four ALT levels for 22 days, the within-run CV<br>ranged from 0.8 to 6.9%, and total CV ranged from 1.1 to 6.9% In precision studies<br>at three separate Physician Office Laboratory (POL) sites over 5 days, the within-<br>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 to<br>472 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry<br>System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least<br>squares regression analysis yielded a correlation coefficient of 0.9996, a standard<br>error estimate of 2.4, a confidence interval slope of 1.035 to 1.047, and a confidence<br>interval intercept of -0.3 to 0.9. In patient correlation studies at three separate POL<br>sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the<br>Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression<br>analysis yielded correlation coefficients of 0.9997 to 0.9999, standard error<br>estimates of 2.4 to 3.1, confidence interval slopes of 1.009 to 1.035, and a<br>confidence 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 CV<br>ranged from 0.9 to 7.1%, and total CV ranged from 1.4 to 8.5%. In precision studies<br>at three separate Physician Office Laboratory (POL) sites over 5 days, the within-<br>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 to<br>440 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry<br>System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least<br>squares regression analysis yielded a correlation coefficient of 0.9996, a standard<br>error 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 POL<br>sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the<br>Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression<br>analysis yielded correlation coefficients of 0.9996 to 0.9998, standard error<br>estimates of 2.5 to 2.9, confidence interval slopes of 1.005 to 1.038, and a<br>confidence 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 CV<br>ranged from 1.0 to 3.0%, and total CV ranged from 1.1 to 6.1%. In precision studies<br>at three separate Physician Office Laboratory (POL) sites over 5 days, the within-<br>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 to<br>902 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry<br>System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least<br>squares regression analysis yielded a correlation coefficient of 0.9998, a standard<br>error estimate of 3.4, a confidence interval slope of 0.981 to 0.988, and a confidence<br>interval intercept of -0.6 to 0.8. In patient correlation studies at three separate POL<br>sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the<br>Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression<br>analysis yielded correlation coefficients of 0.9992 to 0.9999, standard error<br>estimates of 3.6to 8.8, confidence interval slopes of 0.967 to 1.053, and a<br>confidence 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 also<br>indicate substantial equivalence to the predicate device. |

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1. September 19.

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#### 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

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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 [phone]. 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 [phone] or [phone] 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

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### Indications for Use

k113382 510(k) Number:

Device Name:

ACE ALT Reagent

Indications for Use:

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.

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

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## 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

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#### 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.

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