ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

K062180 · Horiba Abx · JFJ · Oct 2, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062180
• Device Name: ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
• Applicant: Horiba Abx
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Oct 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The reagent in this submission is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of alpha-amylase using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagent.

Device Story

Device is an enzymatic photometric assay for quantitative determination of amylase activity in human serum and plasma. Input: patient serum or plasma sample. Principle: substrate 4,6-ethylidene-(G7)-p-nitrophenyl-(G1)-α-D-maltoheptaoside (EPS-G7) is cleaved by amylase; fragments are hydrolyzed by α-glucosidase to produce glucose and p-nitrophenol; increase in absorbance measured photometrically. Used on ABX PENTRA 400 Clinical Chemistry Analyzer in clinical laboratory settings by trained personnel. Output: amylase activity concentration (U/L). Results assist clinicians in diagnosing and monitoring pancreatitis. Benefits include rapid, automated quantitative assessment of amylase levels.

Clinical Evidence

No clinical data. Performance established via bench testing, including precision (Total CV < 2.74%), linearity (reportable range 4-2000 U/L), and method comparison against predicate (n=131, r=0.9985). Interference testing confirmed no significant interference from hemoglobin, bilirubin, or triglycerides.

Technological Characteristics

Enzymatic photometric assay. Reagents: Good's buffer, NaCl, MgCl2, α-glucosidase, EPS-G7, sodium azide. Form factor: liquid bi-reagent cassette. Analyzers: ABX PENTRA 400. Calibration: traceable to IRMM/IFCC 456. Sterilization: not applicable (reagent).

Indications for Use

Indicated for quantitative in vitro diagnostic determination of amylase activity in human serum and plasma for the diagnosis and treatment of pancreatitis. For use on the ABX PENTRA 400 Clinical Chemistry Analyzer. Prescription use only.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Predicate Devices

• K801295
• ABX PENTRA Multical (K052007)
• ABX PENTRA N Control (K052007)
• ABX PENTRA P Control (K052007)

Submission Summary (Full Text)

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## Premarket Notification [510(k)] Summary

OCT - 2 2006

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 : K062180

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

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

Date Prepared: 27th July 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: Common or Usual Name: Device Class Classification Name: Product Code:

#### CALIBRATORS:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

### CONTROLS :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

#### ABX PENTRA Amylase CP

Amvlase Class II §862.1070 : Amylase Test System JFJ ; Catalytic methods, Amylase

### ABX PENTRA Multical (K052007)

Multical Class II §862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

### ABX PENTRA N Control (K052007)

N Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

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| Trade/Proprietary Name: | ABX PENTRA P Control (K052007) |
|-------------------------|---------------------------------------------------|
| Common or Usual Name: | P Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (assayed) |

CLEANING SOLUTIONS:

| Trade/Proprietary Name: | ABX PENTRA Clean-Chem CP (K052007) |
|-------------------------|------------------------------------|
| Common or Usual Name: | Cleaning solution : Clean-Chem |
| Device Class | Class I : Exempt from Premarket |
| Classification Name: | Not available |
| Product Code: | Not available |

| Trade/Proprietary Name: | ABX PENTRA Clean-Chem 99 CP (K052007) |
|-------------------------|---------------------------------------|
| Common or Usual Name: | Cleaning solution : Clean-Chem 99 |
| Device Class | Class I : Exempt from Premarket |
| Classification Name: | Not available |
| Product Code: | Not available |

### 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 Amylase CP | K801295 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |

## 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 Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum and plasma based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6,5 ml compartments. Reagents are chemical solutions with additives.

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The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.

### Intended Use :

The reagent in this submission is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of alpha-amylase using human serum and plasma.

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

| ABX PENTRA Amylase CP : | |
|-------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 4 U/l |
| Accuracy and Precision | CV Total < 2.74% |
| Measuring range | 4.5 U/l – 2042 U/l |
| Upper linearity limit | 2000 U/l, and with automatic post-dilution : 6000 U/l |
| Correlation (n=131) | Y = 1.17 x - 6.23 with a correlation coefficient r² = 0.9971. |
| Calibration stability | 8 days |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability (refrigerated area): 42 days |

## Discussion of Performance Data:

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## CALIBRATORS

| ABX PENTRA Multical: | | |
|-----------------------------|---------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007) | Included in this submission |
| Alkaline phosphatase* | ✓ | |
| Alanine aminotransferase | ✓ | ✓ |
| Amylase | | |
| Aspartate aminotransferase* | | |
| Creatine kinase* | | |
| GGT | ✓ | |
| Lactate Dehydrogenase* | | |
| Lipase | ✓ | |
| Albumin* | | |
| Direct Bilirubin* | | |
| Total Bilirubin* | | |
| Calcium* | | |
| Cholesterol* | | |
| Creatinine* | | |
| Glucose HK | ✓ | |
| Glucose PAP | ✓ | |
| Iron* | | |
| Lactic acid | ✓ | |
| Magnesium* | | |
| Phosphorus* | | |
| Total Protein* | | |
| Triglycerides* | | |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | |
| Stability | Closed stability: 24 months at 2-8°C | |
| | Open stability: | |
| | Once opened, the calibrator components** are stable for : | |
| | 8 hours at 15°C to 25°C | |
| | 2 days at 2°C to 8°C | |
| | 2 weeks at -25°C to -15°C | |
| | | |
| | ** Exceptions | |
| | Direct Bilirubin<br>3 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 | |
| | 6 hours at 15°C to 25°C | |
| | 1 day at 2°C to 8°C | |
| | 2 weeks at -25°C to -15°C | |
| | | |
| Analytes | Already cleared (K052007) | Included in this submission |
| Alkaline phosphatase* | | |
| Alanine aminotransferase | ✓ | |
| Amylase | | ✓ |
| Aspartate aminotransferase* | | |
| Creatine kinase* | | |
| GGT | ✓ | |
| Lactate Dehydrogenase* | | |
| Lipase | ✓ | |
| Albumin* | | |
| Direct Bilirubin* | | |
| Total Bilirubin* | | |
| Calcium* | | |
| Chloride | ✓ | |
| Cholesterol* | | |
| HDL* | | |
| LDL* | | |
| Creatinine* | | |
| Glucose HK | ✓ | |
| Glucose PAP | ✓ | |
| Iron* | | |
| Lactic acid | ✓ | |
| Magnesium* | | |
| Phosphorus* | | |
| Potassium | ✓ | |
| Sodium | ✓ | |
| Total Protein* | | |
| Triglycerides* | | |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |

* Not cleared as of date of submission

# CONTROLS

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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| Format | Lyophilized human serum with chemical additives and materials of biological origin |
|--------|------------------------------------------------------------------------------------|
|--------|------------------------------------------------------------------------------------|

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| 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 |
| | **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 |

* Not cleared as of date of submission

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| ABX PENTRA P Control: | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007) | Included in this submission |
| Alkaline phosphatase* | | |
| Alanine aminotransferase | ✓ | ✓ |
| Amylase | | ✓ |
| Aspartate aminotransferase* | | |
| Creatine kinase* | | |
| GGT | ✓ | |
| Lactate Dehydrogenase* | | |
| Lipase | ✓ | |
| Albumin* | | |
| Direct Bilirubin* | | |
| Total Bilirubin* | | |
| Calcium* | | |
| Chloride | ✓ | |
| Cholesterol* | | |
| HDL* | | |
| LDL* | | |
| Creatinine* | | |
| Glucose HK | ✓ | |
| Glucose PAP | ✓ | |
| Iron* | | |
| Lactic acid | ✓ | |
| Magnesium* | | |
| Phosphorus* | | |
| Potassium | ✓ | |
| Sodium | ✓ | |
| Total Protein* | | |
| Triglycerides* | | |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | |
| 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><br>**Exceptions<br>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<br><br>Total Bilirubin | |

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| 8 hours at 15°C to 25°C | |
|---------------------------|--|
| 1 day at 2°C to 8°C | |
| 2 weeks at -25°C to -15°C | |

* Not cleared as of date of submission

## CLEANING SOLUTIONS

| | ABX PENTRA Clean-Chem CP (Already cleared K052007): |
|-----------|----------------------------------------------------------------------------------------|
| Format | Chemical liquid solution |
| Stability | Closed stability: 8 months at 2-8°C<br>On-board stability (refrigerated area): 15 days |

| ABX PENTRA Clean-Chem 99 CP (Already cleared K052007): | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------|
| Format | Chemical liquid solution |
| Stability | Closed stability: 8 months at 2-8°C<br>On-board stability (refrigerated area): 45 days |

## 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, desmonstrating that the devices are substantially equivalent to their respective predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an emblem of an eagle with outstretched wings. The text "U.S. Department of Health and Human Services" is written around the emblem in a circular fashion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tim Lawton, Regulatory Affairs Manager Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 France

0CT - 2 2006

Re: k062180

Trade/Device Name: Amylase on ABX PENTRA 400 Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ, JIX, JJY Dated: July 27, 2006 Received: July 31, 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 vours.

Alberto Gutierrez

Alberto Guticarez, 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):

Device Name: _Amylase on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte.

ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Prescription Use X (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)

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Cheerica Views Diagnostic Device Evaluation and Safe

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510(k) Number (if known): K062180

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 X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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

office of It Via a Designostic Device - aldation and Shippy

Page 1 of 4

Koiziro

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510(k) Number (if known): __ K062180

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 X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Diagnostic Device

ass safety

K062180

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510(k) Number (if known):__K062180

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 ___X ________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(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)

Diagnostic Device
Safety
1/06/20

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