(148 days)
No
The summary describes in vitro diagnostic reagents and calibrators for use on a clinical chemistry analyzer, relying on enzymatic photometric and colorimetric tests. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic reagent used to quantify certain substances in human samples, not to treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the various reagents "are for quantitative in vitro diagnostic determination" of specific substances, and that the measurements are "used in the diagnosis and treatment of disorders" or "patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders." This indicates its role in disease diagnosis and management.
No
The device description clearly states that the submission includes reagents, controls, and calibrators, which are physical chemical solutions and materials, not software. These are intended for use on a clinical chemistry analyzer, which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the reagents are "for quantitative in vitro diagnostic determination" of various analytes in human serum and plasma.
- Purpose: The intended use describes the device's purpose as being used in the "diagnosis and treatment of disorders" involving lipid metabolism and related conditions. This is a key characteristic of IVD devices.
- Sample Type: The device is intended for use with human serum and plasma, which are biological specimens.
- Measurement: The device performs quantitative measurements of specific substances (cholesterol, HDL-C, LDL-C, triglycerides) within these biological specimens.
- Device Description: The "Device Description" section further reinforces that the reagents are "in vitro diagnostic assay[s]".
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction).
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay.
Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
Product codes
CHH, LBS, SBT, JIT, JIX, 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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human squantaan plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
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 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices.
ABX PENTRA Cholesterol CP:
Sample type: Serum & plasma
Detection limit: 4 mg/dl
Accuracy and Precision: CV Total
§ 862.1150 Calibrator.
(a)
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.)(b)
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.
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Premarket Notification [510(k)] Summary
AUG 2 4 2006
This summary of 510(k) safety and effectiveness information is being submitted in This sammary of be requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : K060854_________________________________________________________________________________________________________________________
Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 10 July 2006
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:
| Trade/Proprietary Name: | ABX PENTRA Cholesterol CP |
|---|---|
| Common or Usual Name: | Cholesterol |
| Device Class | Class I |
| Classification Name: | 8862.1175 : Cholesterol (Total) Test System |
| Product Code: | CHH ; Enzymatic Esterase-Oxidase, Cholesterol |
| Trade/Proprietary Name: | ABX PENTRA HDL Direct CP |
| Common or Usual Name: | HDL Cholesterol |
Class I §862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA LDL Direct CP
LDL Cholesterol Class I $862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL
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Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Triglycerides CP
Triglycerides Class I §862.1705 : Triglycerides Test System SBT ; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
CALIBRATORS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA HDL Cal
HDL Calibrator 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: Device Class Classification Name: Product Code:
ABX PENTRA LDL Cal LDL Calibrator Class II $862.1150 : Calibrator JIT ; Calibrator, Secondary
ABX PENTRA Multical (K052007)
Multical Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name:
Product Code:
CLEANING SOLUTIONS:
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)
ABX PENTRA P Control (K052007)
P Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
ABX PENTRA Clean-Chem CP (K052007)
Cleaning solution : Clean-Chem Class I : Exempt from Premarket Not available Not available
HORIBA ABX, FRANCE
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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 Cholesterol CP | K941573 |
| ABX PENTRA HDL Direct CP | K021316 |
| ABX PENTRA LDL Direct CP | K971573 |
| ABX PENTRA Triglycerides CP | K893973 |
| ABX PENTRA HDL Cal | K021316 |
| ABX PENTRA LDL Cal | K971573 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human squantaan plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and
3
plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
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 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 :
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of their respective analytes : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma.
The controls, calibrators and additional reagents are intended for use in association with the above reagents.
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Discussion of Performance Data:
| ABX PENTRA Cholesterol CP : | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 4 mg/dl |
| Accuracy and Precision | CV Total |