The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on ABX PENTRA 400 clinical chemistry analyzer as specified on the vials.

Device Description

The calibrator included in this submission is for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA TPU Cal is a liquid calibrator based on a buffered aqueous solution, containing human serum. The assigned values of the calibrator components are given on the calibrator vials, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 3 ml.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a calibrator device (ABX PENTRA TPU Cal) used with a clinical chemistry analyzer. It is not a diagnostic imaging or AI-powered device, and therefore the requested information fields related to AI performance, such as sample size for test sets (including data provenance), number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.

The document primarily focuses on demonstrating that the new calibrator (ABX PENTRA TPU Cal) is substantially equivalent to a predicate calibrator (ABX PENTRA Urine Cal) for the purpose of calibrating total proteins in urine measurements on the ABX PENTRA 400 analyzer.

Here's an analysis of the provided information, addressing the applicable points:

Acceptance Criteria and Reported Device Performance

The document states that "The performance testing data conclude that the safety and effectiveness of the device are not compromised, and that they met all acceptance criteria, demonstrating that the device is substantially equivalent to the predicate device." However, no specific quantitative acceptance criteria or detailed device performance metrics (e.g., accuracy, precision values) are explicitly listed in the provided text.

The acceptance criteria for a calibrator would typically relate to its stability, assigned values, and its ability to enable accurate and precise measurements when used with the associated assay and analyzer. The document implies these were met, but does not provide the specifics.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Demonstrate substantial equivalence to the predicate device (ABX PENTRA Urine Cal).	Performance testing data met all acceptance criteria, demonstrating substantial equivalence. (No specific quantitative metrics for comparison are provided in the document).
Stability (Closed)	Not explicitly stated, but implied to be sufficient for 24 months at 2-8°C.	24 months at 2-8°C
Stability (Open)	Not explicitly stated, but implied to be sufficient for 9 weeks at 2-8°C.	9 weeks at 2-8°C
Intended Use	Calibrate total proteins in urine measurement with reagent ABX Pentra Urinary Proteins CP on ABX PENTRA 400 analyzer.	Device is for this intended use.

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a calibrator, not an AI or diagnostic device that analyzes patient data. The "performance testing" mentioned would have involved laboratory studies on the calibrator's characteristics and its performance on the analyzer, not a test set of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Ground truth for patient cases is not relevant for a calibrator.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods for diagnostic test results are not relevant for a calibrator.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a calibrator, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical calibrator solution, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For a calibrator, "ground truth" would refer to the accurately assigned values of the analytes within the calibrator itself, established through reference methods and internal validation according to good manufacturing practices. The document states: "The assigned values of the calibrator components are given on the calibrator vials."
The sample size for the training set:
- N/A. This is a calibrator, not an AI model that requires a training set.
How the ground truth for the training set was established:
- N/A. Not applicable as there is no training set for a calibrator.

Summary

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Premarket Notification [510(k)] Summary

OCT 1 6 2009

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 : 1092570

Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 18 43 Telephone: Fax: + (33) 4 67 14 18 75

Contact Person: Caroline Ferrer (caroline.ferrer(@horiba.com)

Date Prepared: 11th August 2009

Device Name:

The following calibrator is for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.

CALIBRATOR:

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

ABX PENTRA TPU Cal Urine calibrator Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary

Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to the predicate device:

Submission device	Substantially equivalentPredicate device
ABX PENTRA TPU Cal	ABX PENTRA Urine Cal
Horiba ABX SAS	Horiba ABX SASK071779

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Description:

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The calibrator included in this submission is for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA TPU Cal is a liquid calibrator based on a buffered aqueous solution, containing human serum. The assigned values of the calibrator components are given on the calibrator vials, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 3 ml.

Intended Use:

ABX Pentra TPU Cal is used to calibrate total proteins in urine measurement with reagent ABX Pentra Urinary Proteins CP on ABX PENTRA 400 analyzer.

CALIBRATOR

ABX PENTRA TPU Cal:
Analytes	Total Proteins in urine
Format	Liquid with chemical additives and materials of biologicalorigin
Stability	Closed stability: 24 months at 2-8°COpen stability: 9 weeks at 2-8°C

Conclusions for Performance Testing :

The performance testing data conclude that the safety and effectiveness of the device are not compromised, and that they met all acceptance criteria, demonstrating that the device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Horiba ABX SAS, Inc. c/o Ms. Caroline Ferrer Regulatory Affairs Specialist Parc Euromedecine Rue Du Caducee, BP 7290 34184 Montpellier Cedex 4. France

OCT 1 6 2009

Re: K092570

Trade Name: ABX PENTRA TPU Cal Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: August 18, 2009 Received: August 21, 2009

Dear Ms. Ferrer:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harner, 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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Indication for Use

510(k) Number (if known): K0935 70

Device Name: ABX PENTRA TPU Cal

Indication For Use:

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 Bens

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

510(k) K 092570

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Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.