ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

K072115 · Horiba Abx · CGX · Nov 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072115
• Device Name: ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
• Applicant: Horiba Abx
• Product Code: CGX · Clinical Chemistry
• Decision Date: Nov 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

Creatinine and Total Protein 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 Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro 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 Total Protein 100 CP reagent, with associated calibrator 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. 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 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 colorimetric assays for Creatinine and Total Protein. Creatinine assay uses kinetic alkaline picrate (Jaffé) method; Total Protein assay uses copper II ions in alkaline solution (Biuret reaction). Input: human serum, plasma, or urine samples. Output: concentration values measured via spectrophotometry (500 nm for Creatinine; 520-560 nm for Total Protein). Used in clinical laboratories by trained personnel. Output assists clinicians in diagnosing/monitoring renal, liver, bone marrow, and metabolic disorders. Includes calibrators (Multical) and controls (N, P, Urine L/H) to ensure accuracy/precision.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2; linearity per CLSI EP6-A; LoD/LoB per CLSI EP17-A; method comparison per CLSI EP9-A2. Method comparison against predicates showed high correlation (r ≥ 0.99). Interference studies defined limits for hemoglobin, bilirubin, lipemia, glucose, and protein. No clinical studies performed.

Technological Characteristics

Liquid mono-reagents. Creatinine: Picric acid, NaOH, surfactants. Total Protein: Copper II Sulphate, Potassium Sodium Tartrate, Potassium Iodide, NaOH. Spectrophotometric detection. Calibrators traceable to SRM909b and SRM927C/Verichem 9460. Automated on ABX PENTRA 400 analyzer.

Indications for Use

Indicated for quantitative in vitro determination of creatinine (serum, plasma, urine) and total protein (serum, plasma) in patients requiring diagnostic assessment for renal, liver, bone marrow, metabolic, or nutritional disorders. Used for monitoring renal dialysis and as a calculation basis for other urine analytes.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. 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.

Predicate Devices

• K973869
• K941837
• K052007
• K070249

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: | K072115 |
|--------------------------------|---------|
|--------------------------------|---------|

| Company: | Horiba ABX |
|------------------|-------------------------------------|
| | Parc Euromédecine |
| | Rue du Caducée - BP 7290 |
| | 34184 Montpellier cedex 4 |
| | FRANCE |
| Telephone: | + (33) 4 67 14 73 92 |
| Fax: | + (33) 4 67 14 18 75 |
| Contact Persons: | Olivier Ducamp ([e-mail]) |
| | Caroline Ferrer ([e-mail]) |

NOV 3 0 2007Date Prepared: 26th July 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: | ABX PENTRA Creatinine 120 CP |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Creatinine |
| Device Class | Class II |
| Classification Name: | §862.1225 : Creatinine Test System |
| Product Code: | CGX ; alkaline picrate, colorimetry, creatinine |
| Trade/Proprietary Name: | ABX PENTRA Total Protein 100 CP |
| Common or Usual Name: | Total Protein |
| Device Class | Class II |
| Classification Name: | §862.1635 : Total Protein Test System |
| Product Code: | CEK ; Biuret (colorimetric) total protein |
| CALIBRATORS:<br>Trade/Proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification Name:<br>Product Code: | ABX PENTRA Multical (K052007)<br>Multical<br>Class II<br>§862.1150 : Calibrator<br>JIX ; Calibrator, Multi-Analyte Mixture |

HORIBA ABX, FRANCE

{1}------------------------------------------------

| CONTROLS : | |
|-------------------------|---------------------------------------------------|
| Trade/Proprietary Name: | ABX PENTRA N Control (K052007) |
| Common or Usual Name: | N Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (Assayed) |
| 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) |
| Trade/Proprietary Name: | ABX PENTRA Urine Control L/H (K070249) |
| Common or Usual Name: | Urine control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | 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 Creatinine 120 CP | K973869 (serum/plasma samples)<br>K941837 (urine samples) |
| ABX PENTRA Total Protein 100 CP | K973869 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
| ABX PENTRA Urine Control L/H | K070249 |

#### 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 Creatinine 120 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 27 ml monoreagent cassette. Reagent is a chemical solution with additives.

{2}------------------------------------------------

The ABX PENTRA Total Protein 100 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 28 ml mono-reagent cassette. Reagent is a chemical solution with additives.

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 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 (Creatinine, Total Protein) using human serum, plasma and/or urine.

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

{3}------------------------------------------------

### Discussion of Performance Data:

| ABX PENTRA Creatinine 120 CP : | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum, Plasma and Urine |
| Detection limit | Serum/Plasma : 0.18 mg/dl<br>Urine : 1.39 mg/dl |
| Accuracy and Precision | Serum/Plasma CV Total < 5.83%<br>Urine CV Total < 6.00% |
| Measuring range | Serum/Plasma : 0.18 mg/dl - 22.60 mg/dl<br>Urine : 1.39 mg/dl - 282.5 mg/dl |
| Upper linearity limit | Serum/Plasma : 22.60 mg/dl, and with automatic post-dilution :<br>67.8 mg/dl<br>Urine : 282.5 mg/dl, and with automatic post-dilution : 857.5<br>mg/dl |
| Correlation | Serum/Plasma (n=122) : Y = 0.98 x - 0.04 with r² = 0.9991<br>Urine (n=119) : Y = 0.96 x - 0.73 with r² = 0.9975 |
| Calibration stability | Serum/Plasma : 24 hours<br>Urine : 24 hours |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability : 10 days |

{4}------------------------------------------------

| ABX PENTRA Total Protein 100 CP : | |
|-----------------------------------|------------------------------------------------------------------------------------------|
| Sample type | Serum/Plasma |
| Detection limit | 0.01 g/dl |
| Accuracy and Precision | CV Total < 1.62% |
| Measuring range | 0.10 g/dl – 10.0 g/dl |
| Upper linearity limit | 10.0 g/dl, and with automatic post-dilution : 20.0 g/dl |
| Correlation (n=178) | $Y = 1.03 x - 0.20$ with a correlation coefficient r2 = 0.9921. |
| Calibration stability | 1 day |
| Reagent stability | closed stability: 26 months at 2-25°C<br>on-board stability (refrigerated area): 14 days |

{5}------------------------------------------------

# CALIBRATORS

| ABX PENTRA Multical: | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434) | Included in this submission |
| Alkaline phosphatase | √ | |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| Lipase | √ | √ |
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| Cholesterol | √ | √ |
| Creatinine | √ | √ |
| Creatinine 120 | | √ |
| Glucose HK | √ | |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | | √ |
| 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 :<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<br>**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<br>Total Bilirubin<br>6 hours at 15°C to 25°C | |

HORIBA ABX, FRANCE

.

{6}------------------------------------------------

## ABX PENTRA Multical:

1 day at 2°C to 8°C 2 weeks at –25°C to –15°C

### CONTROLS

| ABX PENTRA N Control: | | |
|----------------------------|---------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434) | 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 | √ | √ |
| Creatinine 120 | | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | | √ |
| Triglycerides | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | |

HORIBA ABX, FRANCE

{7}------------------------------------------------

| ABX PENTRA N Control: | |
|-----------------------|--------------------------------------------------------|
| | 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 |

:

:

.

{8}------------------------------------------------

| ABX PENTRA P Control: | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434) | 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 | √ | √ |
| Creatinine 120 | | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | | √ |
| 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 : | |
| | | |
| | 12 hours at 15°C to 25°C | |
| | 5 days at 2°C to 8°C | |
| | 1 month at -25°C to -15°C<br>**Exceptions | |
| | Direct Bilirubin | |
| | 4 hours at 15°C to 25°C | |
| | | |
| ABX PENTRA P Control: | | |
| | 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 | |

HORIBA ABX, FRANCE

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

| ABX PENTRA Urine Control L/H: | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K070249) | Included in this submission |
| Amylase | √ | √ |
| Calcium | √ | √ |
| Creatinine | √ | √ |
| Creatinine 120 | | √ |
| Phosphorus | √ | √ |
| Glucose* | | |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |
| Urinary proteins* | | |
| Format | Liquid solution prepared from human urine with chemical<br>additives and materials of biological origin | |
| Stability | Closed stability: 2 years at 2-8°C<br>Open stability: 30 days at 2-8°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.

{10}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 3 0 2007

Horiba ABX c/o Olivier DUCAMP Regulatory Affairs Manager Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4, France

Re: k072115

> Trade Name: ABX PENTRA Creatinine 120 CP Reagent, ABX PENTRA Total Protein 100 CP Reagent, ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Codes: CGX, CEK, JIX, JJY Dated: November 07, 2007 Received: November 13, 2007

Dear Olivier DUCAMP:

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).

{11}------------------------------------------------

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.

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

{12}------------------------------------------------

510(k) Number (if known): K072115

Device Name: New Creatinine and Total Protein on ABX PENTRA 400 Clinical Chemistry Analyzer

Indication For Use:

Creatinine and Total Protein 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 Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro 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 Total Protein 100 CP reagent, with associated calibrator 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 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 Device Evaluation and Safety (OVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072115

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

510(k) Number (if known): K072115

Device Name: ABX PENTRA Multical

Indication 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 (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 Device Evaluation and Safety (OVD)

Carol C. Bennm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072115

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

510(k) Number (if known): K072115

Device Name: ABX PENTRA N Control

Indication For Use:

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

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 Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072115

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

510(k) Number (if known): K072115

Device Name: ABX PENTRA P Control

Indication For Use:

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

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 Device Evaluation and Safety (OIVD)

Carl Benan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072115

Page 4 of 5

{16}------------------------------------------------

510(k) Number (if known): K072115

Device Name: ABX PENTRA Urine Control L/H

Indication For Use:

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

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 Device Evaluation and Safety (OIVD)

Carol Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072115