(130 days)
No
The summary describes standard in vitro diagnostic reagents and controls for use on a clinical chemistry analyzer, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic reagent used for quantitative determination of glucose and uric acid in human samples, which aids in the diagnosis and treatment of various disorders. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagents (ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP) are for "quantitative in vitro diagnostic determination" and that their measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders" and "numerous renal and metabolic disorders," respectively. This clearly indicates a 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. These are intended for use on a separate hardware analyzer (ABX PENTRA 400).
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states the intended use of the ABX PENTRA Glucose HK CP and ABX PENTRA Uric Acid CP reagents as being for "quantitative in vitro diagnostic determination" of glucose and uric acid in human samples.
Furthermore, the ABX PENTRA Urine Control L/H is described as being for "quality control by monitoring accuracy and precision," which is a standard component of in vitro diagnostic testing.
The Device Description section also refers to the reagents as "in vitro diagnostic assay[s]".
Finally, the Summary of Performance Studies discusses the performance of these devices in the context of "safety and effectiveness" and "substantial equivalence to their respective predicate devices," which are terms used in the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. .
ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Product codes
CFR, KNK, 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 bench top clinical chemistry analyzer.
The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 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 annex, 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
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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
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 Glucose HK CP:
- Sample type: Urine
- Limit of Blank: 1.95 mg/dl
- Limit of Detection: 2.9 mg/dl
- Limit of Quantitation: 3.3 mg/dl
- Accuracy and Precision: CV Total
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image contains a handwritten number, which appears to be "1081276". The numbers are written in a connected manner, with some variations in stroke thickness. The handwriting is somewhat stylized, but the numbers are still legible.
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 : K081276
| Company: | Horiba ABX SAS
Parc Euromédecine
Rue du Caducée – BP 7290
34184 Montpellier cedex 4
FRANCE |
|------------|--------------------------------------------------------------------------------------------------------|
| Telephone: | + (33) 4 67 14 73 92 |
| Fax: | + (33) 4 67 14 15 17 |
Contact Persons: Olivier Ducamp (oducamp@fr.abx.fr) Caroline Ferrer (cferrer@fr.abx.fr)
Date Prepared: 03rd September 2008
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: | ABX PENTRA Glucose HK CP |
|---|---|
| Common or Usual Name: | Glucose HK |
| Device Class | Class II |
| Classification Name: | §862.1345 : Glucose Test System |
| Product Code: | CFR; Hexokinase, Glucose |
| Trade/Proprietary Name: | ABX PENTRA Uric Acid CP |
| Common or Usual Name: | Uric Acid |
| Device Class | Class I |
| Classification Name: | §862.1775 : Uric acid Test System |
| Product Code: | KNK ; acid, uric, uricase (colorimetric) |
1
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-Analytc 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 Glucose HK CP | K944406 |
| ABX PENTRA Uric Acid CP | K971485 |
| ABX PENTRA Urine Control L/H | K070146 |
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 bench top clinical chemistry analyzer.
The ABX PENTRA Glucose HK CP is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma and urine based on an enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase. It is composed of a bi-reagent cassette, with 56 ml and 14 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Uric Acid CP is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). It is composed of a bi-reagent cassette, with 60 ml and 15 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 annex, 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 (Glucose, Uric Acid) using human serum, plasma and/or urine.
The controls and calibrators are intended for use in association with the above reagents.
3
Discussion of Performance Data:
ABX Pentra Glucose HK CP (K052007) and ABX Pentra Uric Acid CP (K060205) 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 2 devices, only added performances, on urine samples, are discussed below.
| ABX PENTRA Glucose HK CP : | |
|---|---|
| Sample type | Urine |
| Limit of Blank | 1.95 mg/dl |
| Limit of Detection | 2.9 mg/dl |
| Limit of Quantitation | 3.3 mg/dl |
| Accuracy and Precision | CV Total |