ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

K070249 · Horiba Abx · CIC · Apr 26, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070249
• Device Name: ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
• Applicant: Horiba Abx
• Product Code: CIC · Clinical Chemistry
• Decision Date: Apr 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Device Story

Reagents for ABX PENTRA 400 Clinical Chemistry Analyzer; perform quantitative in vitro diagnostic determination of amylase, calcium, creatinine, and phosphorus in human serum, plasma, and urine. Amylase uses enzymatic photometric assay; Calcium uses photometric test with orthocresolphtalein complexone; Creatinine uses kinetic alkaline picrate (Jaffe) method; Phosphorus uses UV phosphomolybdate method. Device includes liquid urine controls (low/high) for accuracy/precision monitoring. Operated by laboratory personnel in clinical settings. Output provides analyte concentration/activity levels to assist clinicians in diagnosing/monitoring pancreatitis, renal disease, parathyroid disorders, and bone conditions.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2; linearity per CLSI EP6-A; method comparison per CLSI EP9-A2 using 110-124 human urine specimens per analyte. Results showed high correlation (r > 0.99) and acceptable bias (range -1.1% to 9.1%) against predicate methods. No clinical studies performed.

Technological Characteristics

Photometric clinical chemistry reagents; bi-reagent or mono-reagent cassettes. Methods: orthocresolphtalein complexone (Calcium), alkaline picrate/Jaffé (Creatinine), phosphomolybdate UV (Phosphorus), enzymatic photometric (Amylase). Liquid-based urine controls. Designed for use on ABX PENTRA 400 discrete photometric benchtop analyzer.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of calcium, creatinine, phosphorus, and amylase in human serum, plasma, and urine to aid in the diagnosis and treatment of parathyroid, bone, renal, and pancreatic diseases. Intended for prescription use on the ABX PENTRA 400 analyzer.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• K896224
• K941837
• K883962
• K972297
• K020817

Submission Summary (Full Text)

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APR 26 2007

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 : K070249

- Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 15 03 Telephone: Fax: + (33) 4 67 14 15 17
Contact Person: Pascal Macziola (pmacziola(@fr.abx.fr)

Date Prepared: 24th January 2007

#### 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:

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

## ABX PENTRA Calcium CP

Calcium Class II §862.1145 : Calcium Test System CIC ; cresolphthalein complexone, calcium

#### ABX PENTRA Creatinine CP

Creatinine Class II §862.1225 : Creatinine Test System CGX ; alkaline picrate, colorimetry, creatinine

## Trade/Proprietary Name: Common or Usual Name:

Device Class Classification Name: Product Code:

## ABX PENTRA Phosphorus CP

Phosphorus Class I §862.1580 : Phosphorus (inorganic) Test System CEO ; phosphomolybdate (colorimetric), inorganic phosphorus

Section 5-1

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

### ABX PENTRA Amylase CP

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

#### CONTROLS :

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

### ABX PENTRA Urine Control L/H

Urine control Class I \$862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

### 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 Calcium CP | K896224 |
| ABX PENTRA Creatinine CP | K941837 |
| ABX PENTRA Phosphorus CP | K883962 |
| ABX PENTRA Amylase CP | K972297 |
| ABX PENTRA Urine Control L/H | K020817 |

#### 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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Creatinine CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette, with two 28 ml compartments. Reagents are chemical solutions with additives.

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The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.

The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine 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.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine 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 annexe, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

### Intended Use :

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes (Calcium, Creatinine, Phosphorus, Amylase) using human serum, plasma and urine.

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

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## Discussion of Performance Data:

ABX Pentra Calcium CP (K060205), ABX Pentra Creatinine CP (K060205), ABX Pentra Phosphorus CP (K060205) and ABX Amylase CP (K062180) have already been cleared by the FDA for use on serum and plasma samples. No modification has been made to these devices. The performances on serum and plasma samples have not been modified. Therefore, for these 4 devices, only added performances, on urine samples, are discussed below.

| ABX PENTRA Calcium CP : | |
|-------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Urine |
| Detection limit | 0.12 mg/dl |
| Accuracy and Precision | CV Total < 3.61% |
| Measuring range | 0.12 mg/dl – 24.06 mg/dl |
| Upper linearity limit | 24.06 mg/dl, and with automatic post-dilution : 48.12 mg/dl |
| Correlation (n=124) | Y = 1.13 x - 0.50 with a correlation coefficient r² = 0.9904. |
| Calibration stability | 6 hours |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability (refrigerated area): 14 days |

| ABX PENTRA Creatinine CP : | |
|----------------------------|---------------------------------------------------------------------|
| Sample type | Urine |
| Detection limit | 1.3 mg/dl |
| Accuracy and Precision | CV Total < 4.60% |
| Measuring range | 1.3 mg/dl - 316.4 mg/dl |
| Upper linearity limit | 316.4 mg/dl, and with automatic post-dilution : 949.2 mg/dl |
| Correlation (n=110) | Y = 0.99 x - 0.98 with a correlation coefficient r2 = 0.9953. |
| Calibration stability | 1 day |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability : 7 days |

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| ABX PENTRA Phosphorus CP : | |
|----------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Urine |
| Detection limit | 1.28 mg/dl |
| Accuracy and Precision | CV Total < 5.95% |
| Measuring range | 1.28 mg/dl - 198.4 mg/dl |
| Upper linearity limit | 198.4 mg/dl, and with automatic post-dilution : 396.8 mg/dl |
| Correlation (n=119) | Y = 1.07 x - 1.10 with a correlation coefficient r² = 0.9892. |
| Calibration stability | 34 days |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability (refrigerated area): 34 days |

| ABX PENTRA Amylase CP : | |
|-------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Urine |
| Detection limit | 4.92 U/l |
| Accuracy and Precision | CV Total < 6.03% |
| Measuring range | 4.92 U/l – 2000 U/l |
| Upper linearity limit | 2000 U/l, and with automatic post-dilution : 6000 U/l |
| Correlation (n=121) | Y = 1.17 x + 21.90 with a correlation coefficient r² = 0.9891. |
| Calibration stability | 8 days |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability (refrigerated area): 42 days |

.

HORIBA ABX, FRANCE

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Image /page/5/Picture/13 description: The image shows a logo for the Department of Health. The logo features a stylized abstract symbol, possibly representing a human figure or a stylized design, with three curved lines forming the upper part and two curved lines forming the lower part. To the left of the symbol, the words "DEPARTMENT OF HEALTH" are written vertically, with the letters arranged one below the other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Horiba ABX c/o Pascal Macziola Regulatory Affairs Manager Parc Euromédecine, Rue Du Caducée - BP7290 34184 Montpellier cedex 4, France

APR 2 6 2007

Re: k070249

Trade/Device Name: ABX Pentra Calcium CP, ABX Pentra Creatinine CP, ABX Pentra Phosphorus CP, ABX Pentra Amylase CP & ABX Pentra Urine Control L/H Regulation Number: 21 CFR8862.1145

Regulation Name: Calcium test system. Regulatory Class: Class II Product Code: CIC, CGX, CEO, JFJ, JJY Dated: January 24, 2007 Received: January 26, 2007

Dear Pascal Macziola:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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):__K070249

Device Name:_ABX PENTRA Calcium CP

Indications For Use:

ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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)

Caul C. Benson
Sign-On

Page 1 of 5

co of In Vitro Diagnostic Device Lation and Safety

K070249

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510(k) Number (if known):_K070249

Device Name: ABX PENTRA Creatinine CP

Indications For Use:

ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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)

Carol C. Benam

Page 2 of 5

( duation and Safety

K070249

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510(k) Number (if known): K070249

Device Name: ABX PENTRA Phosphorus CP

Indications For Use:

ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

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)

Carol C. Benson
Sign-off

Page 3 of 5

Care of In Vitro Diagnostic Device aluation and Safety ﺎ ……

K070249

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510(k) Number (if known): K070249

Device Name: ABX PENTRA Amylase CP

Indications For Use:

ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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)

Carol C. Benam

Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 4 of 5

K070249

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510(k) Number (if known): K070249

Device Name: _ABX PENTRA Urine Control L/H

Indications For Use:

The ABX PENTRA Urine Control L/H 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)

Carol C. Benson
Division Sign-Off

Page 5 of 5

Office of In Vitro Diagnostic Device I valuation and Safety

K070249