(272 days)
No
The summary describes standard clinical chemistry assays and reagents for use on a benchtop analyzer. 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 (IVD) assay designed to measure cardiac markers in human serum and plasma, which aids in diagnosis and monitoring, but does not directly treat or cure any medical condition.
Yes
The 'Intended Use / Indications for Use' section states that the reagents are for "quantitative in vitro diagnostic determination" of creatine kinase and myoglobin, and that "Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases" and "Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease." This indicates the device is used to provide information for diagnosis.
No
The device description explicitly states that the submission includes reagents, controls, and calibrators for use on a clinical chemistry analyzer, which are physical components and not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document repeatedly states that the reagents, calibrators, and controls are for "in vitro diagnostic determination."
- Intended Use: The intended use clearly describes the measurement of analytes (cardiac markers, creatine kinase, myoglobin) in human specimens (serum and plasma) to aid in the diagnosis and treatment of diseases (myocardial infarction, muscle diseases, heart or renal disease). This aligns directly with the definition of an IVD.
- Device Description: The device description further reinforces this by describing the components as "in vitro diagnostic assays."
- Performance Studies: The performance studies detail the evaluation of the assays using human serum and plasma samples, which is typical for IVD devices.
The entire submission focuses on products designed to be used outside of the human body to examine specimens for diagnostic purposes, which is the core function of an IVD.
N/A
Intended Use / Indications for 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 : Total Creatine Kinase and Myoglobin using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
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 (comma separated list FDA assigned to the subject device)
CGS, DDR, JIY, JIX, JIT
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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV 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 Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 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.
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 CK NAC CP:
- Sample type: Serum & plasma
- Detection limit: 8 U/l
- Accuracy and Precision: CV Total
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
JUN 1 2 2007
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 : K062737
Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 15 03 + (33) 4 67 14 15 17 Fax:
Contact Person: Pascal Macziola (pmacziola(a)fr.abx.fr)
Date Prepared: 24th April 2007
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX . PENTRA 400, cleared to market under K052007.
REAGENTS :
Product Code:
| Trade/Proprietary Name: | ABX PENTRA CK NAC CP |
|---|---|
| Common or Usual Name: | Total Creatine kinase |
| Device Class | Class II |
| Classification Name: | §862.1215 : Creatine Phosphokinase/Creatine kinase or isoenzymes |
| Test System | |
| Product Code: | CGS ; Nad reduction/Nadh oxidation, Cpk or isoenzymes |
| Trade/Proprietary Name: | ABX PENTRA Myoglobin CP |
| Common or Usual Name: | Myoglobin |
| Device Class | Class II |
| Classification Name: | §866.5680 : Myoglobin immunological Test System |
DDR ; Myoglobin, antigen, antiserum, control
1
CALIBRATORS: Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Myoglobin Cal
Myoglobin Calibrator Class II §862.1150 : Calibrator JIT ; Calibrator, Secondary
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Multical (K060854)
Multical Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA CK Control
CK Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA Immuno II Control L/H
Control Low/High Class I $862.1660 : Ouality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name:
Common or Usual Name:
Classification Name:
Device Class
Product Code:
ABX PENTRA N Control (K060854)
N Control Class I $862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
ABX PENTRA P Control (K060854)
P Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
2
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 CK NAC CP | K834502 |
| ABX PENTRA Myoglobin CP | K021229 |
| ABX PENTRA Myoglobin Cal | K021229 |
| ABX PENTRA Multical | K060854 |
| ABX PENTRA CK Control | K954074 |
| ABX PENTRA Immuno II Control
L/H | K961828 |
| ABX PENTRA N Control | K060854 |
| ABX PENTRA P Control | K060854 |
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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV 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 Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
3
The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 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.
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 : Total Creatine Kinase and Myoglobin using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
HORIBA ABX, FRANCE
Section 5-4
4
Discussion of Performance Data:
:
:
| ABX PENTRA CK NAC CP : | ||
|---|---|---|
| Sample type | Serum & plasma | |
| Detection limit | 8 U/l | |
| Accuracy and Precision | CV Total Trade/Device Name: ABX Pentra CK NAC CP, ABX Pentra Myoglobin CP, ABX Pentra CK Control, ABX Pentra Immuno II Control L/H, ABX Pentra Myoglobin Cal, ABX Pentra N Control, ABX Pentra P Control, ABX Pentra Multical Regulation Number: 21 CFR & 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: CGS, DDR, JIY, JIX, JIT Dated: April 25, 2007 Received: April 30, 2007 |
Dear Pascal Macziola:
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).
12
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 10(x) marketed predicate device results in a classification for your device and thus, berroits 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 tollefree 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.
Yean 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
13
510(k) Number (if known):
Device Name: Cardíac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer .
Indications For Use:
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 2 6
Carol Benson
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ాం of In Vitro Diagnostic Device uation and Safety
14
510(k) Number (if known):
Device Name: Cardiac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 2 of _q lo
Carol Benson
Sign-Off
ാ of In Vitro Diagnostic Device tion and Safety
15
510(k) Number (if known):
Device Name: ABX PENTRA Immuno II Control L/H
Indications For Use:
The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 3 of 6
Carol C. Benson
Sign-Off
ice of In Vitro Diagnostic Device * aluation and Safety
K06 2737
16
510(k) Number (if known):
Device Name: ABX PENTRA Multical
Indications 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Sign-Off
ා of In Vitro Diagnostic Device ation and Safety
Page 4 of 6
17
510(k) Number (if known):
Device Name: ABX PENTRA N Control
Indications For Use:
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Sign-Off
Sign-Up
୍ତ of In Vitro Diagnostic Device stion and Safety
Page 5 of 6
18
510(k) Number (if known):
Device Name: ABX PENTRA P Control
Indications For Use:
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Sign-Off
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be of In Vitro Diagnostic Device Tuation and Safety