ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

K060434 · Horiba Abx · CIX · Jun 5, 2007 · Clinical Chemistry

Device Facts

• Record ID: K060434
• Device Name: ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
• Applicant: Horiba Abx
• Product Code: CIX · Clinical Chemistry
• Decision Date: Jun 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA Albumin CP reagent with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. ABX PENTRA Total Protein CP reagent with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Total Proteins in serum and plasma by colorimetry. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. ABX PENTRA Micro-albumin CP reagent with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (μALB) at low concentrations by immunoturbidimetric assay. Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases. The ABX PENTRA μ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA μ-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

Device Story

System comprises reagents, calibrators, and controls for ABX PENTRA 400 clinical chemistry analyzer. Albumin and Total Protein assays utilize colorimetric methods (Bromocresol Green and Biuret, respectively) on serum/plasma. Micro-albumin assay utilizes immunoturbidimetric method on urine. Calibrators and controls (lyophilized human serum or buffer-based) ensure assay accuracy and precision. Used in clinical laboratory settings by trained personnel. Output provides quantitative analyte concentrations to assist clinicians in diagnosing and monitoring liver, kidney, and metabolic diseases.

Clinical Evidence

Bench testing only. Performance validated via precision (within-run and between-run CVs), linearity (CLSI EP6-A), limit of detection/quantitation, and analytical specificity (interference testing). Method comparison studies performed against commercially available methods using 136 serum (Albumin), 126 urine (Micro-albumin), 115 serum (Total Protein), and 262 plasma (Total Protein) samples, showing high correlation (r > 0.98).

Technological Characteristics

Reagents: Albumin (Bromcresol Green), Total Protein (Biuret), Micro-albumin (Immunoturbidimetric). Materials: Liquid mono-reagent or bi-reagent cassettes. Energy: Photometric/turbidimetric measurement at specific wavelengths. Connectivity: Designed for ABX PENTRA 400 analyzer. Calibration: Multi-point or specific calibrators. Stability: Real-time stability data provided for reagents, calibrators, and controls.

Indications for Use

Indicated for quantitative in-vitro determination of albumin (serum/plasma), total protein (serum/plasma), and micro-albumin (urine) on the ABX PENTRA 400 analyzer. Used for diagnosis/treatment of liver, kidney, bone marrow, and metabolic/nutritional disorders. Prescription use only.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• PSI Albumin Reagent Set (k822471)
• Raichem Spia Microalbumin Reagent (k903123)
• Raichem Spia Microalbumin Control Set (k891475)
• Cobas Ready Total Protein Reagent (k896230)

Reference Devices

• ABX Pentra Multical (k052007)
• ABX Pentra N and P Controls (k052007)

Submission Summary (Full Text)

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# JUN - 5 2007

## 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 : K060434

Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 15 03 Fax: + (33) 4 67 14 15 17

Contact Person: Pascal Macziola (pmacziola(a)fr.abx.fr)

Date Prepared: 11th April 2007

### Device Names:

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

#### REAGENTS :

Device Class

Product Code:

Classification Name:

#### ABX PENTRA Albumin CP

Albumin Class II §862.1035 : Albumin Test System CIX ; Bromcresol Green Dye-Binding, Albumin

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

Trade/Proprietary Name: Common or Usual Name:

### ABX PENTRA Micro-albumin CP

Micro-albumin Class I §866.5040 : Albumin immunological Test System DCF ; Albumin, Antigen, Antiserum, Control

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

### ABX PENTRA Total Protein CP

Total Protein Class II §862.1635 : Total Protein Test System CEK ; Biuret (colorimetric), Total Protein

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## CALIBRATORS:

### ABX PENTRA p-Alb Cal

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

u-Alb Cal Class II \$862.1150 : Calibrator JIT ; Calibrator, Secondary

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

Trade/Proprietary Name: Common or Usual Name:

#### ABX PENTRA Multical (K052007) Multical

Class II \$862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

### CONTROLS :

Device Class

Product Code:

Classification Name:

#### ABX PENTRA u-Alb Control L/H u-Alb Control L/H Class I §862.1660 : Quality control material (assayed) JJX ; Single (Specified) Analyte Controls, assayed

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

#### ABX PENTRA N Control (K052007) N Control

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

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

## ABX PENTRA P Control (K052007)

P 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 Albumin CP | K896235 |
| ABX PENTRA Micro-albumin CP | K903123 |
| ABX PENTRA Total Protein CP | K896230 |

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### 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 Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.

The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.

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 Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.

The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.

HORIBA ABX, FRANCE

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### 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 :

- Albumin using human serum and plasma,

- Micro-albumin using urine,
- Total Protein using human serum and plasma.

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

## Discussion of Performance Data:

| ABX PENTRA Albumin CP : | |
|-------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 0.02 g/dl |
| Accuracy and Precision | CV Total < 1.86% |
| Measuring range | 0.46 g/dl – 5.60 g/dl |
| Upper linearity limit | 5.60 g/dl, and with automatic post-dilution : 11.20 g/dl |
| Correlation (n=272) | $Y = 0.94 x + 0.01$ with a correlation coefficient $r^2 = 0.9864$ . |
| Calibration stability | 14 days |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability (refrigerated area): 83 days |

| ABX PENTRA Micro-albumin CP : | |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Urine |
| Detection limit | 4 mg/l |
| Accuracy and Precision | CV Total < 7.99% |
| Measuring range | 9.0 mg/l – 200 mg/l |
| Upper linearity limit | 200 mg/l, and with automatic post-dilution : 2000 mg/l |
| Correlation (n=252) | Y = 0.91 x + 3.95 with a correlation coefficient r² = 0.9919. |
| Calibration stability | 7 days |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability (refrigerated area): 23 days |

HORIBA ABX, FRANCE

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| ABX PENTRA Total Protein CP : | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit<br>Quantitation limit | 0.14 g/dl<br>0.60 g/dl |
| Accuracy and Precision | CV Total < 2.82% |
| Measuring range | 0.60 g/dl - 10 g/dl |
| Upper linearity limit | 10 g/dl, and with automatic post-dilution : 20 g/dl |
| Correlation | Serum samples (n=230) :<br>Y = 1.03 x + 0.02 with a correlation coefficient r² = 0.9841.<br>Plasma samples (n=262) :<br>Y = 0.98 x - 0.02 with a correlation coefficient r² = 0.9815. |
| Calibration stability | 1 day |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability (refrigerated area): 6 days |

# CALIBRATORS

| ABX PENTRA µ-Alb Cal: | |
|-----------------------|--------------------------------------------------------------------------------------------------------------|
| Analyte | Albumin |
| Format | Purified human albumin added to a chemical buffer solution |
| Stability | Closed stability: 12 months at 2°C to 10°C<br>Open stability:<br>4 weeks at 2°C to 10°C<br>3 months at -20°C |

and the country of the county of

HORIBA ABX, FRANCE

:

:

·

Section 5-5

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| ABX PENTRA Multical: | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007,<br>K060205, K060318, K060325,<br>K060854, K062180) | Included in this submission |
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase* | | |
| GGT | √ | √ |
| 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<br>Open stability:<br>Once opened, the calibrator components** are stable for : | |
| | 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<br>**Exceptions | |
| | Direct Bilirubin | |
| | 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 | |

HORIBA ABX, FRANCE

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# CONTROLS

| ABX PENTRA µ-Alb Control: | |
|---------------------------|-----------------------------------------------------------------------------------------|
| Analyte | Albumin |
| Format | Purified human albumin added to a chemical buffer solution |
| Stability | Closed stability: 12 months at 2°C to 10°C<br>Open stability:<br>4 weeks at 2°C to 10°C |

.

| ABX PENTRA N Control: | | |
|----------------------------|------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007, K060205, K060318, K060325, K060854, K062180) | Included in this submission |
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase* | | |
| GGT | √ | √ |
| 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 | √ | √ |

HORIBA ABX, FRANCE

:

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| ABX PENTRA N Control: | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| | ** Exceptions<br>Direct Bilirubin<br>4 hours at 15°C to 25°C<br>8 hours at 2ºC to 8ºC<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 |

* Not cleared as of date of submission

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

:

:

.

HORIBA ABX, FRANCE

:

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| Analytes | Already cleared (K052007,<br>K060205, K060318, K060325,<br>K060854, K062180) | Included in this submission |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase* | √ | √ |
| GGT | √ | √ |
| 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 material<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 | |

.

HORIBA ABX, FRANCE :

{9}------------------------------------------------

| **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

.

## 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.

HORIBA ABX, FRANCE

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Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Horiba ABX c/o Pascal Macziola Pare Euromedecine Rue Du Caducee Montpellier, Herault, 34184 France

JUN - 5

Re: k060434

Trade/Device Name: ABX Pentra Albumin CP, ABX Pentra Total Protein CP, ABX Pentra Micro-albumin CP, ABX Pentra - Alb Control L/H, ABX Pentra u - Alb Cal, ABX Pentra N Control, ABX Pentra P Control, ABX Pentra Multical. Regulation Number: 21 CFR § 862.1035 Regulation Name: Albumin test system. Regulatory Class: Class II Product Code: CIX, CEK, JIQ, JIX, JIT, JJY Dated: April 13, 2007 Received: April 16, 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 yours.

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

Sean 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): _ K060434

Device Name: Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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 1 of 6

Carol C. Benson

Sign-On

Office of In Vitro Diagnostic Device -valuation and Safety

K060434

001 0 శ

{13}------------------------------------------------

510(k) Number (if known): _ K060434

Device Name: _Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.

Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

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 2 of _6

Carol C. Benson

Sign-Off

Cice of In Vitro Diagnostic Device Juation and Safety

K060434

002 " 0 4

{14}------------------------------------------------

K060434 510(k) Number (if known):

Device Name: Proteins on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (µALB) at low concentration by immunoturbidimetric assay.

Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.

The ABX PENTRA µ-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.

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 3 of 6

Carl C. Benson

on Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060434

{15}------------------------------------------------

510(k) Number (if known): K060434

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)

Carol Bener
Sign-Off

Page 4 of 6

ି Tice of In Vitro Diagnostic Device Caluation and Safety

K060434

0 4 0 0 4

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510(k) Number (if known): _ K060434

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)

Carol Benson

Sign-Off

୍ୱିତ of In Vitro Diagnostic Device The Juation and Safety

K060434

Page 5 of 6

0 4 0 0 5

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510(k) Number (if known): K060434

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 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Page

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Team Sign-Off

ීce of In Vitro Diagnostic Device Ination and Safety

K060434

006 0 4