(204 days)
No
The description focuses on a chemical reagent and associated calibrators/controls for a clinical chemistry analyzer, using an enzymatic and photometric method. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is for in vitro diagnostic (IVD) use, specifically for quantitative determination of Creatinine in human serum, plasma and urine, which aids in the diagnosis and monitoring of renal diseases. It is not designed to treat or alleviate diseases.
Yes
The ABX PENTRA Enzymatic Creatinine CP reagent is intended for "quantitative in vitro determination of Creatinine in human serum, plasma and urine," and "Creatinine measurements are used in the diagnosis and treatment of renal diseases." This clearly states its role in diagnosis.
No
The device description explicitly states that the submission includes reagents, controls, and calibrators, which are physical components used with a clinical chemistry analyzer. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ABX PENTRA Enzymatic Creatinine CP reagent is a "diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine". It also mentions that these measurements are used in the "diagnosis and treatment of renal diseases". This clearly indicates an in vitro diagnostic purpose.
- Device Description: The description of the ABX PENTRA Enzymatic Creatinine CP explicitly calls it an "in vitro diagnostic assay".
- Components: The submission includes reagents, calibrators, and controls, which are typical components of an in vitro diagnostic system used for laboratory testing.
- Performance Studies: The inclusion of performance studies (detection limit, limit of quantitation, accuracy, precision, measuring range, linearity, correlation, stability) is standard for demonstrating the analytical performance of an IVD.
- Predicate Devices: The listing of predicate devices with K numbers (which are FDA clearance numbers) further confirms that this device is being submitted for regulatory review as an IVD.
All of these factors strongly indicate that the described device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ABX PENTRA Enzymatic Creatinine 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 an enzymatic method using a multi-step approach ending with a photometric end-point reaction. 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.
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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)
JFY, JIX, JJY
Device Description
All the reagent, controls and calibrator 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 Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). 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 SAS 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 SAS 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 SAS 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)
The ABX PENTRA Enzymatic Creatinine CP showed:
Sample type: Serum, Plasma and Urine
Detection limit: Serum/Plasma : 0.026 mg/dl, Urine : 0.66 mg/dl
Limit of Quantitation: Serum/Plasma : 0.11 mg/dl, Urine : 1.71 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 : _ K 110137____
Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 18 43 Telephone: Fax: + (33) 4 67 14 15 17
Caroline Ferrer (caroline.ferrer@horiba.com) Contact Person:
Date Prepared: 26th July 2011
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:
Trade/Proprietary Name: Common or Usual Name:
ABX PENTRA Enzymatic Creatinine CP
Creatinine Class II §862.1225 : Creatinine Test System JFY ; Enzymatic Method Creatinine
CALIBRATORS:
Device Class Classification Name:
Product Code: CONTROLS :
Device Class
Product Code:
Classification Name:
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) |
| 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 Enzymatic Creatinine
CP | K070383 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
| ABX PENTRA Urine Control L/H | K070249 |
Description:
All the reagent, controls and calibrator 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 Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). 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 SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
2
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 SAS 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 SAS 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 Creatinine using human serum, plasma and/or urine.
The controls and calibrator are intended for use in association with the above reagent.
3
Discussion of Performance Data:
| ABX PENTRA Enzymatic Creatinine CP : | ||||
|---|---|---|---|---|
| Sample type | Serum, Plasma and Urine | |||
| Detection limit | Serum/Plasma : 0.026 mg/dl | |||
| Urine : 0.66 mg/dl | ||||
| Limit of Quantitation | Serum/Plasma : 0.11 mg/dl | |||
| Urine : 1.71 mg/dl | ||||
| Accuracy and Precision | Serum/Plasma CV Total Trade Name: ABX PENTRA Enzymatic Creatinine CP, 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: JFY, JIX, JJY Dated: June 28, 2011 Received: June 30, 2011 |
Dear Ms. Ferrer:
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 Aci 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
10
Page 2 --
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courtney Harper. Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 上一
Enclosure
11
510(k) Number (if known):
Device Name: New Enzymatic Creatinine on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Enzymatic Creatinine 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 an enzymatic method using a multi-step approach ending with a photometric end-point reaction. 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.
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)
Ruth Cheb
510(k) K110137
12
K110137 510(k) Number (if known):
Device Name: ABX PENTRA Multical
Indication For Use:
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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)
Ruta Chube
510(k) K110137
13
510(k) Number (if known):
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)
Ruth Chusler
510(k) K110137
14
KII0137
510(k) Number (if known):
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)
Rutt Chealer
510(k) K110637
15
KII0137 510(k) Number (if known):
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)
Rutt Chelen
510(k) K110137