(247 days)
The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.
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 Urine Cal is a liquid calibrator based on a buffered aqueous solution, with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 1 ml.
This document describes the premarket notification for the ABX PENTRA Urine Calibrator, a device intended for use on the ABX PENTRA 400 clinical chemistry analyzer to quantify total proteins in urine.
1. Acceptance Criteria and Reported Device Performance:
The document states that the performance testing data demonstrated that the device met all acceptance criteria, and its safety and effectiveness are not compromised. The specific, quantitative acceptance criteria are not explicitly detailed in the provided text, nor are specific performance metrics like accuracy, precision, or linearity values for the calibrator directly reported beyond the general statement of meeting criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device.
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample size used for the test set (performance testing) of the ABX PENTRA Urine Calibrator. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth:
The document does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method:
The document does not mention any adjudication method for the test set. This is not typically relevant for a calibrator study.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed or reported. This type of study is not applicable for a device like a calibrator, which is evaluated for its analytical performance rather than impact on human reader interpretation.
6. Standalone Performance (Algorithm Only):
The device is a calibrator, not an algorithm, so a standalone performance study in the context of an "algorithm only" is not applicable. The performance testing described relates to the analytical performance of the calibrator itself and its interaction with the analyzer and reagent.
7. Type of Ground Truth Used:
The document does not explicitly state the type of "ground truth" used for performance testing. For a calibrator, the ground truth would typically be established by reference methods or gravimetric/volumetric analysis to assign precise values to the calibrator components. The document mentions "assigned values of the calibrator components are given in the enclosed annex," implying that these assigned values serve as the reference for performance evaluation.
8. Sample Size for Training Set:
The concept of a "training set" is typically associated with machine learning algorithms. Since the ABX PENTRA Urine Cal is a calibrator and not an AI/ML device, a training set in that context is not applicable and therefore not reported.
9. How Ground Truth for Training Set Was Established:
As there is no training set mentioned or applicable for this device, the method for establishing its ground truth is not applicable.
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Premarket Notification [510(k)] Summary
MAR - 5 2008
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 : K071779
Company : Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 92 Fax: + (33) 4 67 14 18 75
Contact Persons: Olivier Ducamp (oducamp(@fr.abx.fr) Caroline Ferrer (c ferrer@fr.abx.fr)
Date Prepared: 21st December 2007
Device Name:
The following calibrator is for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
CALIBRATOR:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Urine 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 Urine Cal | K050026 |
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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 Urine Cal is a liquid calibrator based on a buffered aqueous solution, with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 1 ml.
Intended Use:
This calibrator is intended for use on the ABX PENTRA 400 in association with the ABX Pentra Urinary Proteins CP reagent for the quantitative determination of total proteins in urine.
CALIBRATOR
| ABX PENTRA Urine Cal: | |
|---|---|
| Analytes | Total Proteins in urine |
| Format | Liquid with chemical additives and materials of biological origin |
| Stability | Closed stability: 12 months at 2-8°COpen stability: 4 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Horiba ABX c/o Olivier Ducamp Regulatory Affairs Manager Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 France
MAR - 5 2008
K071779 Re:
Trade/Device Name: ABX Pentra Urine Calibrator Regulation Number: 21 CFR8862.1150 Regulation Name: Calibrator, Multi-analyte mixture Regulatory Class: Class II Product Code: JIX Dated: February 05, 2008 Received: February 08, 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 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.
Jean 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
510(k) Number (if known): K071779
Device Name: ABX PENTRA Urine Cal
Indication For Use:
The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.
Prescription Use __X (21 CFR Part 801 Subpart D)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
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) K071779
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§ 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.