ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer.

ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer.

Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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 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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters.

AI/ML Overview

The provided text describes the performance data for the ABX PENTRA Bilirubin Reagents (Direct CP and Total CP), Calibrators, and Controls, but it does not specify explicit acceptance criteria. Instead, it presents observed performance metrics and concludes that these metrics "met all acceptance criteria." The study is a submission for a 510(k) premarket notification, indicating it is a validation study demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not provided in the document, I will infer them from the reported performance data where applicable. The document states that "performance testing data conclude that... they met all acceptance criteria," implying that the reported values are within acceptable limits.

ABX PENTRA Bilirubin, Direct CP:

Performance Metric	Reported Device Performance	Inferred Acceptance Criteria (based on reported performance)
Sample type	Serum & plasma	Use with Serum & plasma
Detection limit	0.04 mg/dl	≤ 0.04 mg/dl
Accuracy and Precision	CV Total < 4.26%	CV Total < 4.26% (or acceptable clinical precision)
Measuring range	0.04 mg/dl - 6.79 mg/dl; Auto post-dilution: 33.90 mg/dl	0.04 mg/dl - 6.79 mg/dl (with auto post-dilution up to 33.90 mg/dl)
Correlation (n=110)	Y = 1.09 x + 0.03; $r^2$ = 0.9974	$r^2$ close to 1 (e.g., ≥ 0.99)
Calibration stability	10 days	≥ 10 days
Reagent stability (closed)	18 months at 2-8°C	≥ 18 months at 2-8°C
Reagent stability (on-board)	25 days (refrigerated area)	≥ 25 days (refrigerated area)

ABX PENTRA Bilirubin, Total CP:

Performance Metric	Reported Device Performance	Inferred Acceptance Criteria (based on reported performance)
Sample type	Serum & plasma	Use with Serum & plasma
Detection limit	0.20 mg/dl	≤ 0.20 mg/dl
Accuracy and Precision	CV Total < 3.35%	CV Total < 3.35% (or acceptable clinical precision)
Measuring range	0.20 mg/dl - 69.38 mg/dl; Auto post-dilution: 346.90 mg/dl	0.20 mg/dl - 69.38 mg/dl (with auto post-dilution up to 346.90 mg/dl)
Correlation (n=106)	Y = 1.00 x - 0.13; $r^2$ = 0.9961	$r^2$ close to 1 (e.g., ≥ 0.99)
Calibration stability	10 days	≥ 10 days
Reagent stability (closed)	18 months at 2-8°C	≥ 18 months at 2-8°C
Reagent stability (on-board)	25 days (refrigerated area)	≥ 25 days (refrigerated area)

ABX PENTRA Multical (Calibrator) - Stability:

Performance Metric	Reported Device Performance	Inferred Acceptance Criteria
Closed stability	24 months at 2-8°C	≥ 24 months at 2-8°C
Open stability (General)	8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25 to -15°C	Meeting stated durations
Open stability (Direct Bilirubin)	3 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25 to -15°C	Meeting stated durations
Open stability (Total Bilirubin)	6 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25 to -15°C	Meeting stated durations

ABX PENTRA N Control & P Control - Stability:

Performance Metric	Reported Device Performance	Inferred Acceptance Criteria
Closed stability	30 months at 2-8°C	≥ 30 months at 2-8°C
Open stability (General)	12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25 to -15°C	Meeting stated durations
Open stability (Direct Bilirubin)	4 hours at 15-25°C, 8 hours at 2-8°C, 2 weeks at -25 to -15°C	Meeting stated durations
Open stability (Total Bilirubin)	8 hours at 15-25°C, 1 day at 2-8°C, 2 weeks at -25 to -15°C	Meeting stated durations

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

Correlation for ABX PENTRA Bilirubin, Direct CP: n=110
Correlation for ABX PENTRA Bilirubin, Total CP: n=106
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). The submitting company is based in France, suggesting the data may originate from there or other European locations, but this is not confirmed. The study appears to be a prospective validation study for a new device intended for market clearance, as is typical for 510(k) submissions.

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

This information is not provided in the document. For in-vitro diagnostic devices like this, "ground truth" for correlation studies usually comes from an existing, legally marketed predicate device or a reference method. The document states correlation was done against predicate devices (K910593 for Direct Bilirubin, K910591 for Total Bilirubin), implying these predicate devices provide the reference for truth. The qualifications of personnel performing these reference measurements are not mentioned.

4. Adjudication Method for the Test Set:

This information is not applicable as this is an in-vitro diagnostic device measuring analytes, not typically involving human adjudication of interpretive results like in imaging studies. The assessment is based on quantitative measurements and statistical correlation with a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images. This submission concerns a clinical chemistry analyzer and its reagents, controls, and calibrators, where the output is a quantitative measure of bilirubin, not a subjective interpretation requiring human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the performance data presented is for the standalone device (analyzer and reagents). The core of the 510(k) submission for this type of IVD is to demonstrate the analytical performance of the device itself (accuracy, precision, linearity, stability, etc.) without human intervention in the measurement process, aside from standard operational procedures. The reported performance metrics such as detection limit, accuracy, precision, measuring range, correlation, and stability are all indicative of standalone device performance.

7. The Type of Ground Truth Used:

The ground truth for the correlation studies was established by comparison to predicate devices. The document explicitly states:

"ABX PENTRA Bilirubin, Direct CP" is substantially equivalent to "K910593".
"ABX PENTRA Bilirubin, Total CP" is substantially equivalent to "K910591".
This implies that measurements obtained from these previously cleared predicate devices served as the reference standard for the correlation analysis.

8. The Sample Size for the Training Set:

This information is not provided in the document. For IVD devices, a "training set" is typically not discussed in the same way as machine learning models. Instead, analytical methods are developed and optimized, followed by validation studies (which is what the provided "Performance Data" represents).

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

This information is not provided and is generally not applicable in the context of this type of IVD device development. "Ground truth" for an IVD kit's development would involve using reference materials, spiked samples, and comparison to established reference methods or predicate devices during the R&D phase to optimize reagent formulations and analyzer parameters. The document focuses on the validation and performance data of the final product.

Summary

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Premarket Notification [510(k)] Summary

AUG 1 6 2006

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 : K060325

Company:	Horiba ABXParc EuromédecineRue du Caducée – BP 729034184 Montpellier cedex 4FRANCE
Telephone:	+ (33) 4 67 14 73 20

(33) 4 67 14 73 20
(33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton (tlawton@fr.abx.fr)

Date Prepared: 06th February 2006

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 Bilirubin, Direct CP
Common or Usual Name:	Direct Bilirubin
Device Class	Class II
Classification Name:	§862.1110 : Bilirubin (Total or Direct) Test System
Product Code:	CIG ; Diazo Colorimetry, Bilirubin
Trade/Proprietary Name:	ABX PENTRA Bilirubin, Total CP
Common or Usual Name:	Total Bilirubin
Device Class	Class II
Classification Name:	§862.1110 : Bilirubin (Total or Direct) Test System
Product Code:	CIG ; Diazo Colorimetry, Bilirubin
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 and unassayed)
Product Code:	JJY : Multi-Analyte Controls All Kinds (Assayed and Unassayed)

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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 and unassayed)
Product Code:	JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

CALIBRATORS:

Trade/Proprietary Name:	ABX PENTRA Multical (K052007)
Common or Usual Name:	Multical
Device Class	Class II
Classification Name:	§862.1150 : Calibrator

JIX ; Calibrator, Multi-Analyte Mixture

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 Bilirubin, Direct CP	K910593
ABX PENTRA Bilirubin, Total CP	K910591

Description:

Product Code:

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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters.

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 (Direct Bilirubin, Total Bilirubin) using human serum and plasma.

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

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Discussion of Performance Data:

ABX PENTRA Bilirubin, Direct CP :
Sample type	Serum & plasma
Detection limit	0.04 mg/dl
Accuracy and Precision	CV Total < 4.26%
Measuring range	0.04 mg/dl - 6.79 mg/dlAutomatic post-dilution : 33.90 mg/dl
Correlation (n=110)	$Y = 1.09 x + 0.03$ with a correlation coefficient $r^2 = 0.9974$ .
Calibration stability	10 days
Reagent stability	closed stability: 18 months at 2-8°Con-board stability (refrigerated area): 25 days

		ABX PENTRA Bilirubin, Total CP :
Sample type	Serum & plasma
Detection limit	0.20 mg/dl
Accuracy and Precision	CV Total < 3.35%
Measuring range	0.20 mg/dl - 69.38 mg/dlAutomatic post-dilution : 346.90 mg/dl
Correlation (n=106)	Y = 1.00 x - 0.13 with a correlation coefficient r² = 0.9961.
Calibration stability	10 days
Reagent stability	closed stability: 18 months at 2-8°Con-board stability (refrigerated area): 25 days

CALIBRATORS

ABX PENTRA Multical:
Stability	Closed stability: 24 months at 2-8°COpen stability:Once opened, the calibrator components* are stable for:
	8 hours at 15°C to 25°C
	2 days at 2°C to 8°C
	2 weeks at -25°C to -15°C

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	*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

CONTROLS

ABX PENTRA N Control:
Stability	Closed stability: 30 months at 2-8°COpen stability:Once opened, the control components* are stable for:12 hours at 15°C to 25°C5 days at 2°C to 8°C1 month at -25°C to -15°C
	*ExceptionsDirect Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C
	Total Bilirubin8 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C

ABX PENTRA P Control:
Stability	Closed stability: 30 months at 2-8°C
	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

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	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

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Regulatory Affairs Manger Horiba ABX Parc Euromèdecine Rue du Caducèe-BP 7290 34184 Montpellier cedex 4-France

AUG 1 6 2006

Re: K060325

Trade/Device Name: Bilirubin on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA Multical ABX PENTRA N Control ABX PENTRA P Control Regulation Number: 21 CFR§862.1110 Regulation Name: Bilirubin (total and direct) test system Regulatory Class: Class II Product Code: CIG, JJY, JIX, Dated: July 5, 2006 Received: July 7, 2006

Dear Mr. Lawton:

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 idencions 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 In Intersality devices that have been reclassified in accordance with the provisions of the Fedral Food, Dr to 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, isting 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 anteenig southerns from the vice 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) 276-0484. Also, please not 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 the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G. A.

Alberto Gutierrez, Ph.D. 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):

Device Name: Bilirubin on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

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)

Division Sign Off	Page 1 of 4
Office of In Vitro Diagnostic DeviceFuntion and Safety	K060325

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510(k) Number (if known):__K060325

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)

C.J. L.

Office of In Vitre Diagnostic Device Evaluation and Safety

060325

Page 2 of 4

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510(k) Number (if known): ___K060325

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)

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

KC60325

Page 1 of 4

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510(k) Number (if known): ___K060325

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)

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

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

AFCth
Division Sign-Off

Office of In Vit - Diagnostic Device Evaluation and Safe

KC60325

4 Page 4 of

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.