CRP reagent, with associated calibrators and controls, are intended for use on ABX PENIRA 400 ClinicaLChemistry Analyzer to measure C-reactive Protein analyte.

The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.

ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.

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

Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

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 CRP CP is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma based on an immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 25 ml and 23.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA CRP Cal is a liquid human serum calibrator with chemical additives. It has 5 levels to be used for the calibration of the crp assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA Immuno I Control L/H is a lyophilized two-level quality control product consisting of human serum. 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 level of control is provided in one vials of 3 ml.

The ABX PENTRA Low CRP Control is a liquid assayed control prepared by diluting crp at low concentration in human serum. It has to be used for the quality control of low levels measured with the crp assay. The assigned value is given in the enclosed annex. This control is provided in four vials of 1 ml.

The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.

AI/ML Overview

The provided document describes the Horiba ABX PENTRA CRP CP reagent and associated calibrators, controls, and cleaning solutions for use on the ABX PENTRA 400 clinical chemistry analyzer. The study detailed is aimed at demonstrating substantial equivalence to predicate devices for these in vitro diagnostic products.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a distinct set of pre-defined thresholds. Instead, it presents "Performance Data" for the reagents, which are implicitly considered in evaluating substantial equivalence. For the purpose of this response, I will interpret the 'Performance Data' section for the ABX PENTRA CRP CP reagent as the established performance and thus the implicit criteria met by the device.

Performance Characteristic	Acceptance Criteria (Implicit from Reported Performance)	Reported Device Performance (ABX PENTRA CRP CP)
Sample Type	Serum & plasma compatibility	Serum & plasma
Detection Limit	Ability to detect CRP at low concentrations	0.09 mg/l
Accuracy and Precision	CV Total within acceptable clinical limits	Conventional range: CV Total < 7.04%
Measuring Range	Broad enough to cover clinically relevant CRP levels	0.13 mg/l - 158.30 mg/l
Upper Linearity Limit	Accurate measurement up to a certain high concentration	160 mg/l, with automatic post-dilution: 800 mg/l
Correlation	Strong correlation with a reference method/predicate	Y = 1.03 x - 0.18 with r² = 0.997 (n=190)
Calibration Stability	Sufficient duration for practical use	18 days
Reagent Stability (Closed)	Long shelf-life for storage	24 months at 2-10°C
Reagent Stability (On-board)	Sufficient duration for use on the analyzer	64 days (refrigerated area)

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

Sample Size for the Test Set: For the "Correlation" study, a sample size of n=190 was used.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the submitter (Horiba ABX) is located in France, it's plausible the studies were conducted in France or Europe, but this is not confirmed. The nature of the studies (e.g., "Performance Data" for accuracy, precision, stability) suggests these are likely prospective studies conducted during the device development and validation.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the CRP assay described. The "ground truth" for chemical assays like CRP is typically established by comparing the device's results to a predicate device or a well-established reference method, not by expert consensus in the same way it would be for imaging diagnostics. The document doesn't mention any experts for establishing ground truth, as it relies on analytical performance metrics.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, often involving human readers interpreting data where there might be subjective differences. For analytical performance of an IVD like a CRP assay, measurements are quantitative, and the "ground truth" is derived from the reference method, not through consensus or adjudication amongst human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. The device described is an in vitro diagnostic reagent and system for measuring C-reactive protein. It is not an AI-assisted diagnostic tool or an imaging device that involves human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a chemical reagent and an automated analyzer, not an algorithm. Its performance is inherent to the chemical reaction and the analytical instrument, which operates without "human-in-the-loop" interpretation for the actual CRP measurement (though a human operator initiates tests and reviews results). The "standalone" performance here refers to the analytical performance of the system itself.

7. The Type of Ground Truth Used

The ground truth for the ABX PENTRA CRP CP assay is established through correlation with a predicate device or a well-established reference method. The correlation data (Y = 1.03 x - 0.18 with r² = 0.997) suggests a comparison against another method (likely the predicate device K023828). This is a form of analytical ground truth, where the accuracy of the new device is verified against a method known to provide accurate measurements.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For in vitro diagnostic assays, the development process involves extensive internal testing and optimization of reagent formulations, calibration curves, and instrument parameters, which could be considered analogous to "training" data. However, the exact sample sizes for such internal optimization are not provided, nor is this typically reported in a 510(k) summary for this type of device. The reported sample size of 190 (for correlation) is for the performance validation/test set.

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

As "training set" is not explicitly defined or discussed in the context of this IVD, the method for establishing its ground truth is not provided. Assuming "ground truth" for an IVD refers to accurate concentration values, these would typically be established using traceable reference materials or highly accurate reference methods during the development and optimization phases.

Summary

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Premarket Notification [510(k)] Summary

SEP 2 9 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

00 The assigned 510(k) number is : Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4

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

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

Date Prepared: 1st September 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: Common or Usual Name: Device Class Classification Name: Product Code:

CALIBRATORS:

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

CONTROLS :

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

ABX PENTRA CRP CP

C-Reactive Protein Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control

ABX PENTRA CRP Cal

CRP Calibrator Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control

ABX PENTRA Immuno I Control L/H

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

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

ABX PENTRA Low CRP Control

CRP Control Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control

CLEANING SOLUTIONS:

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

ABX PENTRA Clean-Chem CP (K052007)

Cleaning solution : Clean-Chem Class I : Exempt from Premarket Not available Not available

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

ABX PENTRA Clean-Chem 99 CP (K052007)

Cleaning solution : Clean-Chem 99 Class I : Exempt from Premarket Not available Not available

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 CRP CP	K023828
ABX PENTRA CRP Cal	K023828
ABX PENTRA Immuno I Control L/H	K022486
ABX PENTRA Low CRP Control	K022486

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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.

Intended Use :

The reagent in this submission is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of conventional range crp using human serum and plasma.

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

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Discussion of Performance Data:

REAGENTS

Sample type	Serum & plasma
Detection limit	0.09 mg/l
Accuracy and Precision	Conventional range : CV Total < 7.04%
Measuring range	0.13 mg/l - 158.30 mg/l
Upper linearity limit	160 mg/l, and with automatic post-dilution : 800 mg/l
Correlation (n=190)	Y = 1.03 x - 0.18 with a correlation coefficient r2 = 0.997.
Calibration stability	18 days
Reagent stability	Closed stability: 24 months at 2-10°COn-board stability (refrigerated area): 64 days

CALIBRATORS

ABX PENTRA CRP Cal:
Analytes	C-Reactive Protein (CRP)
Format	Liquid human serum with chemical additives (preservatives) andmaterials of biological origin
Stability	Closed stability: 12 months at 2-10°COpen stability: 3 months at 2-10°C

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CONTROLS

ABX PENTRA Immuno I Control L/H:
Analyte	Multi-Analyte Control : ASO, CRP, RF
	2 levels: Low and High
Format	Lyophilized pool of human sera with chemical additives
	(preservatives)
Stability	Closed stability: 24 months at 2-10°C
	Open stability:
	2 weeks at 2-10°C
	3 months at -20°C

ABX PENTRA Low CRP Control:
Analyte	Single-Analyte Control : CRP
Format	Liquid human serum with chemical additives (preservatives) andmaterials of biological origin
Stability	Closed stability: 12 months at 2-10°COpen stability: 4 weeks at 2-10°C

CLEANING SOLUTIONS

ABX PENTRA Clean-Chem CP:
Format	Chemical liquid solution
Stability	Closed stability: 8 months at 2-8°COn-board stability (refrigerated area): 15 days

ABX PENTRA Clean-Chem 99 CP:
Format	Chemical liquid solution
Stability	Closed stability: 8 months at 2-8°COn-board stability (refrigerated area): 45 days

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 (HHS). The logo consists of the department's name arranged in a circular fashion around a stylized symbol. The symbol is a graphic representation of a human form, with flowing lines suggesting movement and vitality.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Horiba ABX Parc Euromedecine Rue du Caducee - BP 7290 34184 Montpellier cedex 4 FRANCE

SEP 2 9 2006

20 138

Trade/Device Name: C-Reactive Protein on ABX PENTRA 400 Clinical Chemistry

Analyzer Regulation Number: 21 CFR 866.5270

Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK, JIS, JJS, JJY Dated: September 15, 2006 Received: September 20, 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 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 fabeling 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 note the regulation cations "Misbranding by reference to premarket nothcation" (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 (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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Indications for Use

510(k) Number (if known):

Device Name: C-Reactive Protein on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

CRP reagent, with associated calibrators and controls, are intended for use on ABX PENIRA 400 ClinicaLChemistry Analyzer to measure C-reactive Protein analyte.

The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.

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

Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

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
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Office of In Vitro Diagnostic Device Evaluation and Safety

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K061138

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).