(469 days)
No
The summary describes reagents, calibrators, and controls for use on a clinical chemistry analyzer, focusing on standard colorimetric and immunoturbidimetric assays. There is no mention of AI, ML, or any computational analysis beyond basic quantitative determination.
No
The device is described as a diagnostic reagent and clinical chemistry analyzer used for quantitative in-vitro determination of various analytes, which aids in the diagnosis and treatment of diseases. It does not directly provide therapy.
Yes
The document explicitly states that the various reagents "are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes" and are described as "diagnostic reagents." It also mentions that the measurements obtained by the device "are used in the diagnosis and treatment of a variety of diseases."
No
The device description clearly states that the submission includes reagents, controls, and calibrators, which are physical components used with a clinical chemistry analyzer. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document repeatedly states that the reagents are "diagnostic reagents" and "in vitro diagnostic assay".
- Intended Use: The intended use clearly describes the measurement of analytes (Albumin, Total Protein, Micro-albumin) in human biological samples (serum, plasma, urine) for the purpose of diagnosis and treatment of various diseases. This is a core characteristic of IVDs.
- Device Description: The device description details reagents, calibrators, and controls designed to be used with a clinical chemistry analyzer to perform these diagnostic tests.
- Performance Studies: The inclusion of performance data like accuracy, precision, measuring range, and correlation further supports its use in a clinical diagnostic setting.
N/A
Intended Use / Indications for Use
Proteins reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
ABX PENTRA Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry.
Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (microALB) at low concentration by immunoturbidimetric assay.
Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases.
The ABX PENTRA micro-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA u-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
Product codes (comma separated list FDA assigned to the subject device)
CIX, DCF, CEK, JIT, JIX, JJX, 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 Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.
The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.
The ABX PENTRA Multical is a lyophilized human serum calibrator 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 ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum 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 annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.
The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 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
Not Found
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 Albumin CP:
Sample type: Serum & plasma
Detection limit: 0.02 g/dl
Accuracy and Precision: CV Total
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
JUN - 5 2007
Premarket Notification [510(k)] Summary
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 : K060434
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 Person: Pascal Macziola (pmacziola(a)fr.abx.fr)
Date Prepared: 11th April 2007
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
REAGENTS :
Device Class
Product Code:
Classification Name:
ABX PENTRA Albumin CP
Albumin Class II §862.1035 : Albumin Test System CIX ; Bromcresol Green Dye-Binding, Albumin
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name:
ABX PENTRA Micro-albumin CP
Micro-albumin Class I §866.5040 : Albumin immunological Test System DCF ; Albumin, Antigen, Antiserum, Control
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Total Protein CP
Total Protein Class II §862.1635 : Total Protein Test System CEK ; Biuret (colorimetric), Total Protein
1
CALIBRATORS:
ABX PENTRA p-Alb Cal
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
u-Alb Cal Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name:
ABX PENTRA Multical (K052007) Multical
Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
CONTROLS :
Device Class
Product Code:
Classification Name:
ABX PENTRA u-Alb Control L/H u-Alb Control L/H Class I §862.1660 : Quality control material (assayed) JJX ; Single (Specified) Analyte Controls, assayed
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA N Control (K052007) N Control
Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA P Control (K052007)
P Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
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 Albumin CP | K896235 |
| ABX PENTRA Micro-albumin CP | K903123 |
| ABX PENTRA Total Protein CP | K896230 |
2
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 Albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum and plasma based on a colorimetric test using Bromocresol Green (BCG). It is composed of a 99 ml mono-reagent cassette.
The ABX PENTRA Total Protein CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 61 ml mono-reagent cassette.
The ABX PENTRA Multical is a lyophilized human serum calibrator 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 ten vials of 3 ml.
The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum 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 annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Micro-albumin CP is an in vitro diagnostic assay for the quantitative determination of albumin in human urine based on an immunoturbidimetric test. It is composed of a bi-reagent cassette, with 19 ml and 4.5 ml compartments.
The ABX PENTRA u-Alb Cal is a liquid calibrator prepared by adding purified human albumin to a chemical buffer solution. It has 5 levels to be used for the calibration of the urinary albumin assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA u-Alb Control L/H is a liguid assayed control prepared by adding purified human albumin to a chemical buffer solution. It has 2 levels (Low and High) to be used for the quality control of the urinary albumin assay. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 1 ml.
HORIBA ABX, FRANCE
3
Intended Use :
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes :
-
Albumin using human serum and plasma,
-
Micro-albumin using urine,
-
Total Protein using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
Discussion of Performance Data:
| ABX PENTRA Albumin CP : | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 0.02 g/dl |
| Accuracy and Precision | CV Total |