HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K060318 · Horiba Abx · CIT · Aug 8, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060318
• Device Name: HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
• Applicant: Horiba Abx
• Product Code: CIT · Clinical Chemistry
• Decision Date: Aug 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of AST - Aspartate amino transferase using human serum and plasma. The controls and calibrators are intended for use in association with the above reagent.

Device Story

ABX PENTRA AST CP is a reagent for quantitative in-vitro determination of aspartate aminotransferase (AST) in human serum and plasma. Used on the ABX PENTRA 400, a discrete photometric benchtop clinical chemistry analyzer. Operates via UV test using L-aspartate and 2-oxoglutarate. System includes associated calibrators (ABX PENTRA Multical) and controls (ABX PENTRA N and P Controls) to ensure accuracy and precision. Operated by laboratory personnel in clinical settings. Output is a quantitative AST concentration value (U/l). Results assist clinicians in diagnosing and monitoring liver and heart diseases.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical bench testing: precision (within-run CV 1.08-2.71%; total CV 2.5-4.97%), linearity (4-600 U/L), and method comparison against the predicate (n=103, y=0.9654x + 4.0431, r²=0.9963). Interference testing confirmed no significant impact from hemoglobin, bilirubin, or triglycerides.

Technological Characteristics

Liquid bi-reagent cassette (Reagent 1: TRIS, L-Aspartate, MDH, LDH, Sodium azide; Reagent 2: 2-Oxoglutarate, NADH, Sodium azide). Measurement principle: Optimized UV test (NADH-NAD). Measuring range: 4-600 U/L (up to 1800 U/L with dilution). Analyzers: ABX PENTRA 400. Calibrators/Controls: Serum-based, traceable to master lots.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma for the diagnosis and treatment of liver and heart diseases. Intended for prescription use on the ABX PENTRA 400 clinical chemistry analyzer.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Roche Reagent for AST (k801118)
• ABX PENTRA N MultiCal and ABX PENTRA N & P Controls (k052007)

Submission Summary (Full Text)

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## AUG - 8 2006

## Premarket Notification [510(k)} Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

| The assigned 510(k) number is : | K060318 |
|---------------------------------|---------|
|---------------------------------|---------|

Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 20 + (33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton ([e-mail])

Date Prepared: 03rd February 2006

#### Device Names:

The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.

#### REAGENTS :

| Trade/Proprietary Name: | ABX PENTRA AST CP |
|-------------------------|----------------------------------------------------------------|
| Common or Usual Name: | AST -- Aspartate amino transferase |
| Device Class | Class II |
| Classification Name: | §862.1100 : Aspartate amino transferase (AST/SGOT) Test System |
| Product Code: | CIT ; NADH oxidation/ NAD reduction, Ast/Sgot |

#### CONTROLS :

Device Class

Product Code:

Classification Name:

#### ABX PENTRA N Control (K052007)

Trade/Proprietary Name: Common or Usual Name: N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

| Trade/Proprietary Name: |
|-------------------------|
| Common or Usual Name: |
| Device Class |
| Classification Name: |

#### ABX PENTRA P Control (K052007)

P Control Class I §862.1660 : Quality control material (assayed and unassayed)

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| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
|---------------|-----------------------------------------------------------------|
|---------------|-----------------------------------------------------------------|

CALIBRATORS:

| Trade/Proprietary Name: | ABX PENTRA Multical (K052007) |
|-------------------------|-----------------------------------------|
| Common or Usual Name: | Multical |
| Device Class | Class II |
| Classification Name: | §862.1150: Calibrator |
| Product Code: | JIX ; Calibrator, Multi-Analyte Mixture |

### Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :

| Submission device | Substantially equivalent<br>predicate device |
|-------------------|----------------------------------------------|
| ABX PENTRA AST CP | K801118 |

### Description:

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

### Intended Use :

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of AST - Aspartate amino transferase using human serum and plasma.

The controls and calibrators are intended for use in association with the above reagent.

## Discussion of Performance Data:

| ABX PENTRA AST CP : | |
|---------------------|----------------|
| Sample type | Serum & plasma |
| Detection limit | 4 U/l |

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| Accuracy and Precision | CV Total < 4.97% |
|------------------------|-----------------------------------------------------------------------------------------|
| Measuring range | 4 U/l – 600 U/l<br>Automatic post-dilution : 1800 U/l |
| Correlation (n=103) | Y = 0.99 x + 1.25 with a correlation coefficient r² = 0.9963. |
| Calibration stability | 8 days |
| Reagent stability | closed stability: 15 months at 2-8°C<br>on-board stability (refrigerated area): 55 days |

# CALIBRATORS

| ABX PENTRA Multical: | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Closed stability: 24 months at 2-8°C<br>Open stability:<br>Once opened, the calibrator components* are stable for :<br>8 hours at 15°C to 25°C<br>2 days at 2°C to 8°C<br>2 weeks at -25°C to -15°C |
| | *Exceptions<br>Direct Bilirubin<br>3 hours at 15°C to 25°C<br>8 hours at 2°C to 8°C<br>2 weeks at -25°C to -15°C |
| | Total Bilirubin<br>6 hours at 15°C to 25°C<br>1 day at 2°C to 8°C<br>2 weeks at -25°C to -15°C |

# CONTROLS

| ABX PENTRA N Control: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Closed stability: 30 months at 2-8°C<br>Open stability:<br>Once opened, the control components* are stable for:<br>12 hours at 15°C to 25°C<br>5 days at 2°C to 8°C<br>1 month at -25°C to -15°C<br>*Exceptions |

.

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| ABX PENTRA N Control: | |
|---------------------------------------------------------------------------------------------------|--|
| Direct Bilirubin<br>4 hours at 15°C to 25°C<br>8 hours at 2°C to 8°C<br>2 weeks at -25°C to -15°C | |
| Total Bilirubin<br>8 hours at 15°C to 25°C<br>1 day at 2°C to 8°C<br>2 weeks at -25°C to -15°C | |

| ABX PENTRA P Control: | |
|-----------------------|-------------------------------------------------------|
| Stability | Closed stability: 30 months at 2-8°C |
| | Open stability: |
| | Once opened, the control components* are stable for : |
| | 12 hours at 15°C to 25°C |
| | 5 days at 2°C to 8°C |
| | 1 month at -25°C to -15°C |
| | *Exceptions |
| | Direct Bilirubin |
| | 4 hours at 15°C to 25°C |
| | 8 hours at 2°C to 8°C |
| | 2 weeks at -25°C to -15°C |
| | Total Bilirubin |
| | 8 hours at 15°C to 25°C |
| | 1 day at 2°C to 8°C |
| | 2 weeks at -25°C to -15°C |

### Conclusions for Performance Testing :

The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 8 2006

Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromedecine Rue Du Caducee- BP 7290 34184 Montpellier cedex 4 France

Re: k060318

> Trade/Device Name: Hepatic Enzymes on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA Multical ABX PENTRA N Control ABX PENTRA P Control Regulation Number: 21 CFR§ 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system

Regulatory Class: Class II Product Code: CIT, JJY, JIX Dated: June 29, 2006 Received: July 03, 2006

Dear Mr. Lawton:

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 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

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

Enclosure

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510(k) Number (if known): K060318

Device Name: Hepatic Enzymes on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 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)

C
Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) Number (if known): ____K060318

.

Device Name:_ABX PENTRA Multical

Indications For Use:

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 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)

sion Sign-Off

Page 2 of 1

Office of In Vit o Diagnostic Device Evaluation and Safety

KDb0310

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510(k) Number (if known):__K060318

Device Name: ABX PENTRA N Control

Indications For Use:

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 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)

G.C.

Custom Sign Off

Office of In Van Diagnostic Device Evaluation and Safety

060318

Page 3 of 4

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510(k) Number (if known):__K060318

Device Name:_ABX PENTRA P Control

Indications For Use:

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 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)

Page 4 of 4

Office of in Vi. - Diagnostic Device Evaluation and Sa

060318