(121 days)
No
The summary describes chemical reagents, calibrators, and controls for use on a clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as a diagnostic reagent and calibrators/controls for quantitative in vitro determination of analytes, not for direct therapy.
Yes
The device (ABX PENTRA 400 Clinical Chemistry Analyzer) measures analytes like Creatinine and Total Protein, and the measured values are explicitly stated to be "used in the diagnosis and treatment of renal diseases" and "used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders," which directly 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 clinical chemistry analyzer, which is also a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents are "diagnostic reagents for quantitative in vitro determination" of Creatinine and Total Proteins in human samples (serum, plasma, and urine). It also mentions that the measurements are "used in the diagnosis and treatment" of various diseases.
- Device Description: The description of the reagents clearly labels them as "in vitro diagnostic assay".
- Overall Purpose: The entire system (reagents, calibrators, controls, and the analyzer) is designed to perform tests on biological samples outside of the body to provide information for diagnosis and treatment.
The document consistently uses language and descriptions that align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
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.
ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
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.
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, CEK, 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 Creatinine 120 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 27 ml monoreagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution 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 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
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)
ABX PENTRA Creatinine 120 CP:
Sample type: Serum, Plasma and Urine
Detection limit: Serum/Plasma : 0.18 mg/dl; Urine : 1.39 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
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: | K072115 |
---|---|
-------------------------------- | --------- |
Company: | Horiba ABX |
---|---|
Parc Euromédecine | |
Rue du Caducée - BP 7290 | |
34184 Montpellier cedex 4 | |
FRANCE | |
Telephone: | + (33) 4 67 14 73 92 |
Fax: | + (33) 4 67 14 18 75 |
Contact Persons: | Olivier Ducamp (oducamp@fr.abx.fr) |
Caroline Ferrer (cferrer@fr.abx.fr) |
NOV 3 0 2007Date Prepared: 26th July 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: | ABX PENTRA Creatinine 120 CP |
---|---|
Common or Usual Name: | Creatinine |
Device Class | Class II |
Classification Name: | §862.1225 : Creatinine Test System |
Product Code: | CGX ; alkaline picrate, colorimetry, creatinine |
Trade/Proprietary Name: | ABX PENTRA Total Protein 100 CP |
Common or Usual Name: | Total Protein |
Device Class | Class II |
Classification Name: | §862.1635 : Total Protein Test System |
Product Code: | CEK ; Biuret (colorimetric) total protein |
CALIBRATORS: | |
Trade/Proprietary Name: | |
Common or Usual Name: | |
Device Class | |
Classification Name: | |
Product Code: | ABX PENTRA Multical (K052007) |
Multical | |
Class II | |
§862.1150 : Calibrator | |
JIX ; Calibrator, Multi-Analyte Mixture |
HORIBA ABX, FRANCE
1
CONTROLS : | |
---|---|
Trade/Proprietary Name: | ABX PENTRA N Control (K052007) |
Common or Usual Name: | N 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 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 | K973869 (serum/plasma samples)
K941837 (urine samples) |
| ABX PENTRA Total Protein 100 CP | K973869 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
| ABX PENTRA Urine Control L/H | K070249 |
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 Creatinine 120 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 27 ml monoreagent cassette. Reagent is a chemical solution with additives.
2
The ABX PENTRA Total Protein 100 CP is an in vitro diagnostic assay for the quantitative determination of total proteins in human serum and plasma based on a colorimetric test (Biuret reaction). It is composed of a 28 ml mono-reagent cassette. Reagent is a chemical solution 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 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 (Creatinine, Total Protein) using human serum, plasma and/or urine.
The controls and calibrator are intended for use in association with the above reagents.
3
Discussion of Performance Data:
ABX PENTRA Creatinine 120 CP : | |
---|---|
Sample type | Serum, Plasma and Urine |
Detection limit | Serum/Plasma : 0.18 mg/dl |
Urine : 1.39 mg/dl | |
Accuracy and Precision | Serum/Plasma CV Total Trade Name: ABX PENTRA Creatinine 120 CP Reagent, ABX PENTRA Total Protein 100 CP Reagent, ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Codes: CGX, CEK, JIX, JJY Dated: November 07, 2007 Received: November 13, 2007 |
Dear Olivier DUCAMP:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
11
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
12
510(k) Number (if known): K072115
Device Name: New Creatinine and Total Protein on ABX PENTRA 400 Clinical Chemistry Analyzer
Indication For Use:
Creatinine and Total Protein reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes.
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.
ABX PENTRA Total Protein 100 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry.
Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072115
13
510(k) Number (if known): K072115
Device Name: ABX PENTRA Multical
Indication For Use:
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Bennm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072115
14
510(k) Number (if known): K072115
Device Name: ABX PENTRA N Control
Indication For Use:
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072115
15
510(k) Number (if known): K072115
Device Name: ABX PENTRA P Control
Indication For Use:
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carl Benan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072115
Page 4 of 5
16
510(k) Number (if known): K072115
Device Name: ABX PENTRA Urine Control L/H
Indication For Use:
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benam
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072115