(90 days)
No
The summary describes chemical reagents and controls for use on a clinical chemistry analyzer, focusing on photometric and kinetic methods. 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 assay used for quantitative determination of various substances in human serum, plasma, and urine on a clinical chemistry analyzer. It is used for diagnosis and treatment monitoring, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents are for "quantitative in vitro diagnostic determination" of various substances, and that these measurements are "used in the diagnosis and treatment of" specific diseases and conditions.
No
The device description clearly states that the submission includes reagents, controls, and calibrators for use on a clinical chemistry analyzer. These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the reagents and associated components are intended for "quantitative in vitro diagnostic determination" of various analytes in human serum, plasma, and urine. This directly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
Furthermore, the "Device Description" section also refers to the reagents as "in vitro diagnostic assay[s]".
N/A
Intended Use / Indications for Use
ABX PENTRA Calcium CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ABX PENTRA Creatinine CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic 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.
ABX PENTRA Phosphorus CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ABX PENTRA Amylase CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of the activity of the enzyme amylase in human serum, plasma and urine 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 Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Product codes
CIC, CGX, CEO, JFJ, 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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Creatinine CP is an in vitro diagnostic assay for the quantitative 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, with two 28 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine 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 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 annexe, ensuring control of the appropriate HORIBA ABX 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
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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)
ABX Pentra Calcium CP:
Sample type: Urine
Detection limit: 0.12 mg/dl
Accuracy and Precision: CV Total
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
0
APR 26 2007
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 : K070249
- Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 15 03 Telephone: Fax: + (33) 4 67 14 15 17
Contact Person: Pascal Macziola (pmacziola(@fr.abx.fr)
Date Prepared: 24th January 2007
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:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Calcium CP
Calcium Class II §862.1145 : Calcium Test System CIC ; cresolphthalein complexone, calcium
ABX PENTRA Creatinine CP
Creatinine Class II §862.1225 : Creatinine Test System CGX ; alkaline picrate, colorimetry, creatinine
Trade/Proprietary Name: Common or Usual Name:
Device Class Classification Name: Product Code:
ABX PENTRA Phosphorus CP
Phosphorus Class I §862.1580 : Phosphorus (inorganic) Test System CEO ; phosphomolybdate (colorimetric), inorganic phosphorus
Section 5-1
1
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Amylase CP
Amylase Class II §862.1070 : Amylase Test System JFJ ; Catalytic methods, Amylase
CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Urine Control L/H
Urine 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 Calcium CP | K896224 |
| ABX PENTRA Creatinine CP | K941837 |
| ABX PENTRA Phosphorus CP | K883962 |
| ABX PENTRA Amylase CP | K972297 |
| ABX PENTRA Urine Control L/H | K020817 |
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 Calcium CP is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma and urine based on a photometric test using orthocresolphtalein complexone. It is composed of a bi-reagent cassette, with 66 ml and 16.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Creatinine CP is an in vitro diagnostic assay for the quantitative 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, with two 28 ml compartments. Reagents are chemical solutions with additives.
2
The ABX PENTRA Phosphorus CP is an in vitro diagnostic assay for the quantitative determination of phosphorus in human serum, plasma and urine based on a UV method using phosphomolybdate. It is composed of a mono-reagent cassette, with 29.5 ml compartment. The reagent is a chemical solution with additives.
The ABX PENTRA Amylase CP is an in vitro diagnostic assay for the quantitative determination of alpha-amylase in human serum, plasma and urine 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 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 annexe, ensuring control of the appropriate HORIBA ABX 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 their respective analytes (Calcium, Creatinine, Phosphorus, Amylase) using human serum, plasma and urine.
The controls, calibrators and additional reagents are intended for use in association with the above reagents.
3
Discussion of Performance Data:
ABX Pentra Calcium CP (K060205), ABX Pentra Creatinine CP (K060205), ABX Pentra Phosphorus CP (K060205) and ABX Amylase CP (K062180) have already been cleared by the FDA for use on serum and plasma samples. No modification has been made to these devices. The performances on serum and plasma samples have not been modified. Therefore, for these 4 devices, only added performances, on urine samples, are discussed below.
| ABX PENTRA Calcium CP : | |
|---|---|
| Sample type | Urine |
| Detection limit | 0.12 mg/dl |
| Accuracy and Precision | CV Total |