(188 days)
No
The summary describes a photometric clinical chemistry analyzer and associated reagents, calibrators, and controls. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on standard photometric methods.
No
This device is an in vitro diagnostic (IVD) reagent used for quantitative determination of bilirubin levels, which aids in the diagnosis and treatment of certain disorders. It does not directly provide therapy.
Yes
The device is described as "for quantitative in vitro diagnostic determination" and the measurements are "used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders".
No
The device description explicitly states that the reagents, controls, and calibrators are for use on a "discrete photometric benchtop clinical chemistry analyzer" (ABX PENTRA 400), which is a hardware device. The submission is for the reagents, controls, and calibrators used with this analyzer, not the software that might run on it.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents, calibrators, and controls are "for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma" and "for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma." 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.
- Device Description: The document describes the reagents, controls, and calibrators as being used on a "discrete photometric benchtop clinical chemistry analyzer" for "quantitative in-vitro determination of their respective parameters." This further confirms their use in an in vitro setting.
- Performance Studies: The performance studies detail the testing of these reagents and controls using serum and plasma samples, which are specimens taken from the human body.
The entire submission revolves around the use of these components to perform diagnostic tests on human biological samples outside of the body, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
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
CIG, JJY, JIX
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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters.
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
ABX PENTRA Bilirubin, Direct CP: Sample type: Serum & plasma; Detection limit: 0.04 mg/dl; Accuracy and Precision: CV Total
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
Premarket Notification [510(k)] Summary
AUG 1 6 2006
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 : K060325
| Company: | Horiba ABX
Parc Euromédecine
Rue du Caducée – BP 7290
34184 Montpellier cedex 4
FRANCE |
|------------|----------------------------------------------------------------------------------------------------|
| Telephone: | + (33) 4 67 14 73 20 |
- (33) 4 67 14 73 20
- (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 06th February 2006
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 Bilirubin, Direct CP |
| Common or Usual Name: | Direct Bilirubin |
| Device Class | Class II |
| Classification Name: | §862.1110 : Bilirubin (Total or Direct) Test System |
| Product Code: | CIG ; Diazo Colorimetry, Bilirubin |
| Trade/Proprietary Name: | ABX PENTRA Bilirubin, Total CP |
| Common or Usual Name: | Total Bilirubin |
| Device Class | Class II |
| Classification Name: | §862.1110 : Bilirubin (Total or Direct) Test System |
| Product Code: | CIG ; Diazo Colorimetry, Bilirubin |
| 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 and unassayed) |
| Product Code: | JJY : Multi-Analyte Controls All Kinds (Assayed and Unassayed) |
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 and unassayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
CALIBRATORS:
| Trade/Proprietary Name: | ABX PENTRA Multical (K052007) |
|---|---|
| Common or Usual Name: | Multical |
| Device Class | Class II |
| Classification Name: | §862.1150 : Calibrator |
JIX ; Calibrator, Multi-Analyte Mixture
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 Bilirubin, Direct CP | K910593 |
| ABX PENTRA Bilirubin, Total CP | K910591 |
Description:
Product Code:
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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).
All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters.
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 (Direct Bilirubin, Total Bilirubin) using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
2
Discussion of Performance Data:
| ABX PENTRA Bilirubin, Direct CP : | |
|---|---|
| Sample type | Serum & plasma |
| Detection limit | 0.04 mg/dl |
| Accuracy and Precision | CV Total Trade/Device Name: Bilirubin on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA Multical ABX PENTRA N Control ABX PENTRA P Control Regulation Number: 21 CFR§862.1110 Regulation Name: Bilirubin (total and direct) test system Regulatory Class: Class II Product Code: CIG, JJY, JIX, Dated: July 5, 2006 Received: July 7, 2006 |
Dear Mr. Lawton:
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 idencions 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 In Intersality devices that have been reclassified in accordance with the provisions of the Fedral Food, Dr to 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, isting 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 anteenig southerns from the vice 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).
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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) 276-0484. Also, please not 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 the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known):
Device Name: Bilirubin on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
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)
| Division Sign Off | Page 1 of 4 |
|---|---|
| Office of In Vitro Diagnostic Device | |
| Funtion and Safety | K060325 |
8
510(k) Number (if known):__K060325
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)
C.J. L.
Office of In Vitre Diagnostic Device Evaluation and Safety
060325
Page 2 of 4
9
510(k) Number (if known): ___K060325
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)
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
KC60325
Page 1 of 4
10
510(k) Number (if known): ___K060325
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 _ 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)
AFCth
Division Sign-Off
Office of In Vit - Diagnostic Device Evaluation and Safe
KC60325
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