ABX PENTRA Urea 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 urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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

Device 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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. 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.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria and performance study for the ABX PENTRA Urea CP reagent (for urine samples) and ABX PENTRA Urine Control L/H.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: ABX PENTRA Urea CP (for urine samples)

Acceptance Criteria	Reported Device Performance
Detection Limit	Urea: 12.6 mmol/l
	BUN: 35 mg/dl
Accuracy and Precision	CV Total < 7.50%
Measuring Range	Urea: 12.6 - 750.0 mmol/l
	BUN: 35 - 2106 mg/dl
Upper Linearity Limit	Urea: 750 mmol/l (3750 mmol/l with automatic post-dilution)
	BUN: 35 mg/dl (2106 mg/dl with automatic post-dilution)
Correlation	Urea: $Y = 1.13 x - 0.71$ with $r^2 = 0.9947$
	BUN: $Y = 1.13 x - 2.08$ with $r^2 = 0.9947$
Calibration Stability	8 days
Reagent Stability	Closed: 24 months at 2-8°C
	On-board: 70 days

Device: ABX PENTRA Urine Control L/H

Acceptance Criteria	Reported Device Performance
Analytes Covered	Amylase, Calcium, Creatinine, Phosphorus, Urea / Blood Urea Nitrogen, Urinary proteins (some were already cleared, Urea/BUN is included in this submission).
Format	Liquid solution prepared from human urine with chemical additives and materials of biological origin.
Stability	Closed: 2 years at 2-8°C
	Open: 30 days at 2-8°C

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For the Correlation study of ABX PENTRA Urea CP (urine samples), n=147 samples were used.
- No specific sample size is explicitly stated for other performance metrics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability) but these are typically tested with a sufficient number of replicates and samples to satisfy internal validation protocols.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The studies described are for an in vitro diagnostic (IVD) reagent and control, where "ground truth" often refers to reference methods or comparative assays, not expert consensus in the same way it would for imaging diagnostics.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple human readers, not for analytical performance testing of biochemical assays.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. MRMC studies are relevant for imaging devices or software that assist human interpretation. This submission is for an in vitro diagnostic reagent and control.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance data presented is for the reagent and control used on the ABX PENTRA 400 analyzer, which is an automated clinical chemistry analyzer. Therefore, the reported performance metrics (detection limit, accuracy, precision, measuring range, linearity, correlation, stability) represent the standalone performance of the device system (reagent + analyzer) without human interpretive input. The product is not an "algorithm" in the sense of AI/ML, but a chemical test system.

7. Type of Ground Truth Used

For the Correlation study of ABX PENTRA Urea CP, the reported correlation coefficients ($r^2$) and linear equations imply a comparison against a reference method or predicate device's results (denoted as 'x' in the equations). The document does not explicitly name the reference method, but states the device demonstrates "substantial equivalence to their respective predicate devices."

For the other analytical performance characteristics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability), the "ground truth" would be established through a combination of:

Use of reference materials or calibrators with known analyte concentrations.
Comparison with established laboratory methods or predicate devices.
Internal validation procedures demonstrating adherence to pre-defined specifications.

8. Sample Size for the Training Set

This information is not provided and not applicable in the context of this traditional IVD product. Training sets are typically associated with machine learning or AI-based devices. This submission describes a chemical reagent and control.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and not applicable as there is no "training set" in the context of this device.

Summary

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K070146

Premarket Notification [510(k)] Summary

UCT I 2 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 : K070146

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 Persons: Olivier Ducamp (oducamp@fr.abx.fr) Caroline Ferrer (cferrer(a)fr.abx.fr)

Date Prepared: 24th September 2007

Device Names:

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

REAGENT :

Trade/Proprietary Name:	ABX PENTRA Urea CP
Common or Usual Name:	Urea / Urea Nitrogen
Device Class	Class II
Classification Name:	§862.1770 : Urea nitrogen Test System
Product Code:	CDQ ; urease and glutamic dehydrogenase, urea nitrogen

CONTROL :

ABX PENTRA Urine Control L/H

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

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

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Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices:

Submission device	Substantially equivalentPredicate device
ABX PENTRA Urea CP	K971477
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.

Intended Use:

The reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of the respective analyte (Urea / Blood Urea Nitrogen) using human serum, plasma and urine.

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

Discussion of Performance Data:

ABX Pentra Urea CP (K060205 has already been cleared by the FDA for use on serum and plasma samples. No modification has been made to this device. The performances on serum and plasma samples have not been modified.

Therefore, for this device, only added performances, on urine samples, are discussed in the following pages.

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REAGENT

ABX PENTRA Urea CP :
Sample type	Urine
Detection limit	Urea: 12.6 mmol/lBUN: 35 mg/dl
Accuracy and Precision	CV Total < 7.50%
Measuring range	Urea : 12.6 mmol/l – 750.0 mmol/lBUN: 35 mg/dl - 2106 mg/dl
Upper linearity limit	Urea: 750 mmol/l and with automatic post-dilution: 3750 mmol/lBUN: 35 mg/dl and with automatic post-dilution : 2106 mg/dl
Correlation (n=147):	Urea: $Y = 1.13 x - 0.71$ with a correlation coefficient $r^2 = 0.9947$ .BUN: $Y = 1.13 x - 2.08$ with a correlation coefficient $r^2 = 0.9947$ .
Calibration stability	8 days
Reagent stability	closed stability: 24 months at 2-8°Con-board stability (refrigerated area): 70 days

CONTROL

ABX PENTRA Urine Control L/H:
Analytes	Already cleared	Included in this submission
Amylase	√ (K070249)
Calcium	√ (K070249)
Creatinine	√ (K070249)
Phosphorus	√ (K070249)
Glucose*
Urea / Blood Urea Nitrogen
Uric acid*
Urinary proteins	√ (510k exempt)
Chloride*
Potassium*
Sodium*
Format	Liquid solution prepared from human urine with chemicaladditives and materials of biological origin
Stability	Closed stability: 2 years at 2-8°COpen stability: 30 days at 2-8°C

Not cleared as of date of submission

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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 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 -

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 1 2 2007

Re: K070146 Trade/Device Name: ABX PENTRA Urea CP, Urine Control L/H Regulation Number: 21 CFR§862.1770 Regulation Name: Urea Nitrogen Test System Regulatory Class: Class II Product Code: CDQ, JJY Dated: September 24, 2007 Received: September 27, 2007

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 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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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Indications for Use

510(k) Number (if known):

Device Name: ABX PENTRA Urea CP

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

5100k

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 2

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Indications for Use

K070146 510(k) Number (if known):

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 X (Part 21 CFR 801 Subpart D) AND/OR

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

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

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Sa

510(k) K070146

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Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.