ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

K081276 · Horiba Abx · CFR · Sep 12, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081276
• Device Name: ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
• Applicant: Horiba Abx
• Product Code: CFR · Clinical Chemistry
• Decision Date: Sep 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Device Story

Device consists of enzymatic reagents (Glucose HK CP and Uric Acid CP) and multi-analyte urine controls (L/H). Input: human urine, serum, or plasma samples. Operation: reagents mixed with samples in bi-reagent cassettes on ABX PENTRA 400 analyzer; colorimetric/enzymatic reaction occurs; analyzer measures absorbance. Output: quantitative concentration values for glucose and uric acid. Used in clinical laboratories by trained personnel. Output assists clinicians in diagnosing/monitoring metabolic and renal disorders. Benefits: provides automated, accurate, and precise diagnostic data for patient management.

Clinical Evidence

Bench testing only. Precision (n=80 per sample), linearity (CLSI EP6-A), limit of detection/quantitation (CLSI EP17-A), and analytical specificity (interference studies) were performed. Method comparison against predicates using 105-113 human urine samples showed high correlation (r² > 0.99). No clinical studies required.

Technological Characteristics

Reagents: Bi-reagent cassettes containing enzymatic chemical solutions. Glucose HK CP: Hexokinase/G6PDH method. Uric Acid CP: Uricase/Peroxidase (Trinder) method. Controls: Liquid human urine-based solutions with chemical additives. Connectivity: Designed for use on the ABX PENTRA 400 discrete photometric benchtop analyzer. Stability: Reagents 36 months closed; Controls 2 years closed.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of glucose and uric acid in human serum, plasma, and urine. Used for diagnosis and treatment of carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia) and renal/metabolic disorders (e.g., renal failure, gout, leukemia, wasting conditions). For prescription use on the ABX PENTRA 400 analyzer.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Olympus Glucose Reagent (k944406)
• Infinity Uric Acid Liquid Stable Reagent (k971485)
• ABX PENTRA Urine Control L/H (k070146)

Submission Summary (Full Text)

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# 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 : K081276

| Company: | Horiba ABX SAS<br>Parc Euromédecine<br>Rue du Caducée – BP 7290<br>34184 Montpellier cedex 4<br>FRANCE |
|------------|--------------------------------------------------------------------------------------------------------|
| Telephone: | + (33) 4 67 14 73 92 |
| Fax: | + (33) 4 67 14 15 17 |

Contact Persons: Olivier Ducamp ([e-mail]) Caroline Ferrer ([e-mail])

Date Prepared: 03rd September 2008

#### 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 Glucose HK CP |
|-------------------------|------------------------------------------|
| Common or Usual Name: | Glucose HK |
| Device Class | Class II |
| Classification Name: | §862.1345 : Glucose Test System |
| Product Code: | CFR; Hexokinase, Glucose |
| Trade/Proprietary Name: | ABX PENTRA Uric Acid CP |
| Common or Usual Name: | Uric Acid |
| Device Class | Class I |
| Classification Name: | §862.1775 : Uric acid Test System |
| Product Code: | KNK ; acid, uric, uricase (colorimetric) |

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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-Analytc 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 Glucose HK CP | K944406 |
| ABX PENTRA Uric Acid CP | K971485 |
| ABX PENTRA Urine Control L/H | K070146 |

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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 bench top clinical chemistry analyzer.

The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 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 annex, 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 (Glucose, Uric Acid) using human serum, plasma and/or urine.

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

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### Discussion of Performance Data:

ABX Pentra Glucose HK CP (K052007) and ABX Pentra Uric Acid CP (K060205) 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 2 devices, only added performances, on urine samples, are discussed below.

| ABX PENTRA Glucose HK CP : | |
|----------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Urine |
| Limit of Blank | 1.95 mg/dl |
| Limit of Detection | 2.9 mg/dl |
| Limit of Quantitation | 3.3 mg/dl |
| Accuracy and Precision | CV Total < 4.82% |
| Linearity | 3.9 mg/dl - 900 mg/dl |
| Measuring range | 3.9 mg/dl - 900 mg/dl, , and with automatic post-dilution : up to<br>2700 mg/dl |
| Correlation (n=208): | Y = 0.96 x + 0.84 mg/dl with a correlation coefficient r² = 0.997 |
| Calibration stability | 21 days |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability (refrigerated area): 55 days |

| ABX PENTRA Uric Acid CP : | |
|---------------------------|---------------------------------------------------------------------------------------|
| Sample type | Urine |
| Limit of Blank | 2.33 mg/dl |
| Limit of Detection | 3.49 mg/dl |
| Limit of Quantitation | 5.20 mg/dl |
| Accuracy and Precision | CV Total < 4.36% |
| Linearity | 5.20 mg/dl - 252 mg/dl |
| Measuring range | 5.20 mg/dl - 252.00 mg/dl, , and with automatic post-dilution :<br>up to 756.00 mg/dl |
| Correlation (n=226): | Y = 1.01 x + 0.99 mg/dl with a correlation coefficient r2 = 0.9949 |
| Calibration stability | 15 days |

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| ABX PENTRA Uric Acid CP : | |
|---------------------------|-----------------------------------------------------------------------------------------|
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability (refrigerated area): 41 days |

# CONTROLS

| ABX PENTRA Urine Control L/H: | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared | Included in this submission |
| Amylase | √ (K070249) | |
| Calcium | √ (K070249) | |
| Creatinine | √ (K070249) | |
| Phosphorus | √ (K070249) | |
| Glucosc | | √ |
| Urea / Blood Urea Nitrogen | √ (K070146) | |
| Uric acid | | √ |
| Urinary proteins | √ (510k exempt) | |
| 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.

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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle-like design with flowing lines, symbolizing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 2 2008

HORIBA ABX Diagnostics c/o Mr. Olivier Ducamp, Regulatory Affairs Manager Parc Euromedecine, Rue du Caducee -- BP 7290 34184 Montpellier cedex 4 France

Re: k081276

Trade/Device Name: ABX PENTRA Glucose HK CP, ABX PENTRA Uric Acid CP, ABX PENTRA Urine Control L/H

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code(s): CFR, KNK, JJY Dated: August 13, 2008 Received: August 15, 2008

Dear Mr. 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 commercc 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.

Yean 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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### Indication for Use

608/276 510(k) Number (if known):

Device Name: ABX PENTRA Glucose HK CP

Indication For Use:

ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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)

Signature

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

510(k) K081276

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### Indication for Use

108 276 510(k) Number (if known):

Device Name: ABX PENTRA Uric Acid CP

Indication For Use:

ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. .

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)

Division Sign Off

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

510(k) k081276

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### Indication for Use

510(k) Number (if known):

Device Name: ABX PENTRA Urine Control L/H

Indication For Use:

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)

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

510(k) K081276