(63 days)
No
The summary describes a clinical chemistry analyzer and associated reagents, calibrators, and controls for measuring amylase. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is standard enzymatic photometric assay and chemical analysis.
No
This device is an in vitro diagnostic (IVD) reagent system used to measure amylase levels in human samples, primarily for the diagnosis and treatment of pancreatitis. It does not directly provide therapy or treatment.
No
The provided text describes reagents, controls, and calibrators used on a clinical chemistry analyzer, and the analyzer itself (ABX PENTRA 400). It does not describe a diagnostic device that directly performs the diagnosis, but rather components used by a diagnostic device or the diagnostic device itself (the analyzer). The question asks about "this device" which implies the subject of the submission, and the submission is primarily for the reagents, calibrators, and controls used in a diagnostic test, not the analyzer performing the test. If "this device" refers to the entire submission package as a diagnostic "solution", then an argument could be made for "Yes". However, typically "device" refers to the physical instrument. The text clearly states the ABX PENTRA 400 is the analyzer and the submission refers to the reagents/controls/calibrators for use on it.
No
The device description explicitly states that the submission includes reagents, controls, and calibrators, which are physical chemical solutions and materials, not software. The device is intended for 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 Amylase reagent, calibrators, and controls are for "quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma". It also mentions their use for the "diagnosis and treatment of pancreatitis". This clearly indicates the intended use is for testing biological samples in vitro (outside the body) to provide information for diagnosis and treatment.
- Device Description: The description refers to the ABX PENTRA Amylase CP as an "in vitro diagnostic assay". It also describes the calibrators and controls as being used in conjunction with a "clinical chemistry analyzer". These are all hallmarks of IVD devices.
- Performance Studies: The document includes a summary of performance studies, which are required for IVD devices to demonstrate their safety and effectiveness for their intended use.
- Predicate Device(s): The mention of predicate devices (K801295 and K052007) is typical for regulatory submissions of IVD devices, where substantial equivalence to previously cleared devices is demonstrated.
The entire context of the document points to the device being an IVD used in a clinical laboratory setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
Amylase reagent, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure amylase analyte.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum and plasma based on an enzymatic photometric assay. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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
JFJ, 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 Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum and plasma based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6,5 ml compartments. 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 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
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)
The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, desmonstrating that the devices are substantially equivalent to their respective predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ABX PENTRA Amylase CP :
Sample type: Serum & plasma
Detection limit: 4 U/l
Accuracy and Precision: CV Total
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
0
Premarket Notification [510(k)] Summary
OCT - 2 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
The assigned 510(k) number is : K062180
Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: Fax: + (33) 4 67 14 15 17
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 27th 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 :
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 Amylase CP
Amvlase Class II §862.1070 : Amylase Test System JFJ ; Catalytic methods, Amylase
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)
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) |
CLEANING SOLUTIONS:
| Trade/Proprietary Name: | ABX PENTRA Clean-Chem CP (K052007) |
|---|---|
| Common or Usual Name: | Cleaning solution : Clean-Chem |
| Device Class | Class I : Exempt from Premarket |
| Classification Name: | Not available |
| Product Code: | Not available |
| Trade/Proprietary Name: | ABX PENTRA Clean-Chem 99 CP (K052007) |
|---|---|
| Common or Usual Name: | Cleaning solution : Clean-Chem 99 |
| Device Class | Class I : Exempt from Premarket |
| Classification Name: | Not available |
| Product Code: | 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 Amylase CP | K801295 |
| 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 Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum and plasma based on an enzymatic photometric test. The assay is composed of a bi-reagent cassette, with 26 ml and 6,5 ml compartments. Reagents are chemical solutions with additives.
2
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 :
The reagent in this submission is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of alpha-amylase using human serum and plasma.
The controls, calibrators and additional reagents are intended for use in association with the above reagent.
| ABX PENTRA Amylase CP : | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 4 U/l |
| Accuracy and Precision | CV Total |