ABX PENTRA URINE CAL

K071779 · Horiba Abx · JIX · Mar 5, 2008 · Clinical Chemistry

Device Facts

• Record ID: K071779
• Device Name: ABX PENTRA URINE CAL
• Applicant: Horiba Abx
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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.

Device Story

ABX PENTRA Urine Cal is a single-level, aqueous, buffered calibrator solution derived from human and sheep sources; contains protein, albumin, a1-microglobulin, and Immunoglobulin G. Used in clinical chemistry laboratories to calibrate the ABX PENTRA Urinary Proteins CP assay on the Horiba ABX PENTRA 400 analyzer. Value assignment involves assaying new lots across multiple analyzers over 5 days; target values determined by median results if inter-analyzer deviation is <10%. Ensures accuracy of quantitative protein measurements in patient urine samples, aiding clinicians in diagnosing or monitoring renal function and protein-related pathologies.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (shelf life 12 months, open vial 4 weeks) and value assignment protocols (multi-analyzer testing over 5 days) met acceptance criteria. Traceability established to NIST SRM 927c.

Technological Characteristics

Liquid calibrator; buffered aqueous solution with chemical additives and biological materials. Designed for use on the ABX PENTRA 400 discrete photometric benchtop clinical chemistry analyzer. Stability: 12 months closed at 2-8°C; 4 weeks open at 2-8°C. Provided in 1 ml vials.

Indications for Use

Indicated for use as a calibrator for the quantitative measurement of urinary proteins on the Horiba ABX PENTRA 400 clinical chemistry analyzer.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Roche C.F.A.S.Proteins in Urine (k062319)

Submission Summary (Full Text)

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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 [e-mail])

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 equivalent<br>Predicate 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°C<br>Open 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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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 [phone]. 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 [phone] or [phone] 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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