K Number
K070146
Device Name
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
Manufacturer
Date Cleared
2007-10-12

(269 days)

Product Code
Regulation Number
862.1770
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The ABX PENTRA Urine Control L/H 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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. 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 control level is provided in one vial of 10 ml.
More Information

No
The summary describes a clinical chemistry analyzer and associated reagents and controls, which perform enzymatic UV tests. There is no mention of AI or ML in the device description, intended use, or performance studies.

No
The device is an in vitro diagnostic reagent used to measure urea/urea nitrogen, which aids in the diagnosis and monitoring of renal and metabolic diseases, but it does not directly treat or provide therapy.

Yes
The intended use states that "Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." This indicates its role in a diagnostic context.

No

The device description clearly states that the device consists of reagents, controls, and calibrators, which are physical chemical solutions and materials, not software. It also mentions use on a physical analyzer (ABX PENTRA 400).

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states the device is for "quantitative in vitro diagnostic determination of urea / urea nitrogen... in human serum, plasma and urine". It also mentions that the measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases." This clearly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
  • Device Description: The description details reagents, calibrators, and controls used to analyze human samples (serum, plasma, and urine) on a clinical chemistry analyzer. These components are typical of IVD devices used in laboratory settings.
  • Quality Control: The inclusion of the ABX PENTRA Urine Control L/H for "quality control by monitoring accuracy and precision" is a standard practice for ensuring the reliability of IVD tests.
  • Performance Studies: The document discusses performance testing on human samples (correlation with a predicate device on urine samples), which is a requirement for demonstrating the safety and effectiveness of IVD devices.
  • Predicate Devices: The mention of predicate devices (K971477 and K070249) which are also IVDs further supports the classification of this device as an IVD.

The entire context of the document describes a product designed and intended for use in a clinical laboratory setting to perform diagnostic testing on human biological samples.

N/A

Intended Use / Indications for Use

ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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

Product codes (comma separated list FDA assigned to the subject device)

CDQ, JJY

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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. 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 control level is provided in one vial of 10 ml.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ABX Pentra Urea CP (K060205 has already been cleared by the FDA for use on serum and plasma samples. No modification has been made to this device. The performances on serum and plasma samples have not been modified.

Therefore, for this device, only added performances, on urine samples, are discussed in the following pages.

Key results for ABX PENTRA Urea CP (Urine Sample Type):
Detection limit: Urea: 12.6 mmol/l, BUN: 35 mg/dl
Accuracy and Precision: CV Total

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.

0

K070146

Premarket Notification [510(k)] Summary

UCT I 2 2007

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 : K070146

Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 15 03 Fax: + (33) 4 67 14 15 17

Contact Persons: Olivier Ducamp (oducamp@fr.abx.fr) Caroline Ferrer (cferrer(a)fr.abx.fr)

Date Prepared: 24th September 2007

Device Names:

The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.

REAGENT :

Trade/Proprietary Name:ABX PENTRA Urea CP
Common or Usual Name:Urea / Urea Nitrogen
Device ClassClass II
Classification Name:§862.1770 : Urea nitrogen Test System
Product Code:CDQ ; urease and glutamic dehydrogenase, urea nitrogen

CONTROL :

ABX PENTRA Urine Control L/H

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

Urine control Class I §862.1660 : Quality control material (assaved) JJY ; Multi-Analyte Controls, All Kinds (Assayed)

1

Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices:

| Submission device | Substantially equivalent
Predicate device |
|------------------------------|----------------------------------------------|
| ABX PENTRA Urea CP | K971477 |
| ABX PENTRA Urine Control L/H | K070249 |

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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. 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 control level is provided in one vial of 10 ml.

Intended Use:

The reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of the respective analyte (Urea / Blood Urea Nitrogen) using human serum, plasma and urine.

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

Discussion of Performance Data:

ABX Pentra Urea CP (K060205 has already been cleared by the FDA for use on serum and plasma samples. No modification has been made to this device. The performances on serum and plasma samples have not been modified.

Therefore, for this device, only added performances, on urine samples, are discussed in the following pages.

2

REAGENT

ABX PENTRA Urea CP :
Sample typeUrine
Detection limitUrea: 12.6 mmol/l
BUN: 35 mg/dl
Accuracy and PrecisionCV Total