(431 days)
No
The summary describes a chemical reagent kit and associated calibrators and controls for use on a specific clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is a standard kinetic chemical assay (Jaffé method).
No
The device is described as an in vitro diagnostic reagent for quantitative determination of Creatinine, used for diagnosis and monitoring of renal diseases, not for therapeutic purposes.
Yes
The device, "ABX PENTRA Creatinine 120 CP reagent," is described as a "diagnostic reagent for quantitative in vitro determination of Creatinine," and its measurements "are used in the diagnosis and treatment of renal diseases." This explicitly states its diagnostic purpose.
No
The device description clearly states that the submission includes reagents, controls, and calibrators, which are physical chemical solutions and materials, not software. It also mentions their use on a physical clinical chemistry analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the ABX PENTRA Creatinine 120 CP reagent is a "diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine". It also mentions that "Creatinine measurements are used in the diagnosis and treatment of renal diseases". This clearly indicates the intended use is for diagnostic purposes on samples taken from the human body (in vitro).
- Device Description: The description details reagents, calibrators, and controls used to perform a test on human samples (serum, plasma, and urine) to measure a specific analyte (Creatinine). These components are designed to be used with a clinical chemistry analyzer, which is a common piece of equipment in a clinical laboratory setting for performing in vitro diagnostic tests.
- Performance Studies: The document describes performance testing data related to the accuracy, precision, detection limit, and measuring range of the assay when used with human samples. This type of testing is standard for IVD devices to demonstrate their reliability for diagnostic purposes.
- Predicate Devices: The listed predicate devices (K934361, K052007, K070249) are likely also IVD devices, as they are being used as a basis for demonstrating substantial equivalence for this submission.
The entire context of the document points to the use of these reagents, calibrators, and controls for performing diagnostic tests on human samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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.
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)
CGX, JIX, JJY
Device Description
All the reagent, controls and calibrator 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.
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 SAS 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 SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
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 SAS 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
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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 Creatinine 120 CP :
Sample type: Serum, Plasma and Urine
Detection limit: Serum/Plasma : 0.074 mg/dl; Urine : 1.40 mg/dl
Limit of Quantitation: Serum/Plasma : 0.22 mg/dl; Urine : 2.90 mg/dl
Accuracy and Precision: Serum/Plasma CV. Total
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
APR 3 0 2012
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 : K110530
Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 18 43 Fax: + (33) 4 67 14 15 17
Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com)
Date Prepared: 12th April, 2012
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400 instrument, 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 Creatinine 120 CP
Creatinine Class II $862.1225 : Creatinine Test System CGX: alkaline picrate, colorimetry, creatinine
ABX PENTRA Multical (K052007)
Multical Class II $862.1150 : Calibrator JIX : Calibrator, Multi-Analyte Mixture
ABX PENTRA N Control (K052007)
N Control Class I $862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
HORIBA ABX SAS, FRANCE
1
| Trade/Proprietary Name: | ABX PENTRA P Control (K052007) |
|---|---|
| Common or Usual Name: | P Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (assayed) |
| Trade/Proprietary Name: | ABX PENTRA Urine Control L/H (K070249) |
| Common or Usual Name: | Urine control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | 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 Creatinine 120 CP | K934361 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
| ABX PENTRA Urine Control L/H | K070249 |
Description:
All the reagent, controls and calibrator 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.
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 SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
2
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 SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
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 SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
Intended Use:
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of Creatinine using human serum, plasma and/or urine.
The controls and calibrator are intended for use in association with the above reagent.
HORIBA ABX SAS, FRANCE
3
Discussion of Performance Data:
| ABX PENTRA Creatinine 120 CP : | |
|---|---|
| Sample type | Serum, Plasma and Urine |
| Detection limit | Serum/Plasma : 0.074 mg/dl |
| Urine : 1.40 mg/dl | |
| Limit of Quantitation | Serum/Plasma : 0.22 mg/dl |
| Urine : 2.90 mg/dl | |
| Accuracy and Precision | Serum/Plasma CV. Total |