(158 days)
No
The summary describes a clinical chemistry analyzer and associated reagents, calibrators, and controls for measuring C-reactive protein using an immunoturbidimetric assay. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is standard for clinical chemistry analysis.
No
This device is an in vitro diagnostic assay used for the quantitative determination of C-reactive protein, which aids in evaluation but does not directly treat or prevent a disease.
No.
The device described is a C-reactive protein (CRP) reagent, along with associated calibrators and controls, intended for use on a clinical chemistry analyzer to measure CRP. While the measurement of CRP aids in the evaluation of injury to body tissue, the document states these are "quantitative in vitro diagnostic determination" products, meaning they are used to determine the level of a substance, not to directly diagnose a specific condition or disease by themselves. They are tools that provide data for a diagnostic process, but are not diagnostic devices on their own.
No
The device description clearly states that the submission includes reagents, controls, and calibrators, which are physical components used in an in vitro diagnostic assay on a clinical chemistry analyzer. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the CRP reagent, calibrators, and controls are "for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma". It also mentions that the measurement "aids in evaluation of the amount of injury to body tissue," which is a diagnostic purpose.
- Device Description: The description details reagents, calibrators, and controls designed to be used with a clinical chemistry analyzer (ABX PENTRA 400) to measure an analyte (C-reactive protein) in human samples (serum and plasma). This is the core function of an in vitro diagnostic device.
- Performance Studies: The document includes performance data like detection limit, accuracy, precision, measuring range, linearity, and correlation, which are typical metrics evaluated for IVD devices to demonstrate their analytical performance.
- Predicate Device(s): The mention of predicate devices (K023828 and K022486) indicates that this device is being compared to other legally marketed IVD devices for regulatory purposes.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CRP reagent, with associated calibrators and controls, are intended for use on ABX PENIRA 400 ClinicaLChemistry Analyzer to measure C-reactive Protein analyte.
The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.
ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.
The ABX PENTRA Immuno I Control L/H is for use in quality control by monitoring accuracy and precision for CRP.
Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIS, JJS, 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 CRP CP is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma based on an immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 25 ml and 23.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA CRP Cal is a liquid human serum calibrator with chemical additives. It has 5 levels to be used for the calibration of the crp assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA Immuno I Control L/H is a lyophilized two-level quality control product consisting of human serum. 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 level of control is provided in one vials of 3 ml.
The ABX PENTRA Low CRP Control is a liquid assayed control prepared by diluting crp at low concentration in human serum. It has to be used for the quality control of low levels measured with the crp assay. The assigned value is given in the enclosed annex. This control is provided in four vials of 1 ml.
The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and plasma
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)
REAGENTS
Sample type: Serum & plasma
Detection limit: 0.09 mg/l
Accuracy and Precision: Conventional range : CV Total
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
Premarket Notification [510(k)] Summary
SEP 2 9 2006
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
00 The assigned 510(k) number is : Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4
FRANCE Telephone: + (33) 4 67 14 73 20 Fax: + (33) 4 67 14 15 17
Contact Person: Tim Lawton (tlawton(afr.abx.fr)
Date Prepared: 1st September 2006
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
REAGENTS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
CALIBRATORS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA CRP CP
C-Reactive Protein Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control
ABX PENTRA CRP Cal
CRP Calibrator Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control
ABX PENTRA Immuno I Control L/H
Multi-analyte Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
1
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Low CRP Control
CRP Control Class II §866.5270 : C-reactive Protein Immunological Test System DCK ; C-Reactive Protein, Antigen, Antiserum and Control
CLEANING SOLUTIONS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Clean-Chem CP (K052007)
Cleaning solution : Clean-Chem Class I : Exempt from Premarket Not available Not available
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Clean-Chem 99 CP (K052007)
Cleaning solution : Clean-Chem 99 Class I : Exempt from Premarket Not available Not available
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 CRP CP | K023828 |
| ABX PENTRA CRP Cal | K023828 |
| ABX PENTRA Immuno I Control L/H | K022486 |
| ABX PENTRA Low CRP Control | K022486 |
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 CRP CP is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma based on an immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 25 ml and 23.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA CRP Cal is a liquid human serum calibrator with chemical additives. It has 5 levels to be used for the calibration of the crp assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA Immuno I Control L/H is a lyophilized two-level quality control product consisting of human serum. 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 level of control is provided in one vials of 3 ml.
The ABX PENTRA Low CRP Control is a liquid assayed control prepared by diluting crp at low concentration in human serum. It has to be used for the quality control of low levels measured with the crp assay. The assigned value is given in the enclosed annex. This control is provided in four vials of 1 ml.
The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.
Intended Use :
The reagent in this submission is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of conventional range crp using human serum and plasma.
The controls, calibrators and additional reagents are intended for use in association with the above reagent.
3
Discussion of Performance Data:
REAGENTS
| Sample type | Serum & plasma |
|---|---|
| Detection limit | 0.09 mg/l |
| Accuracy and Precision | Conventional range : CV Total |