K Number
K060318
Device Name
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Manufacturer
Date Cleared
2006-08-08

(181 days)

Product Code
Regulation Number
862.1100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes. ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. 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.
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
More Information

No
The document describes reagents, calibrators, and controls for a standard clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.

No
The device, ABX PENTRA 400, is an in vitro diagnostic (IVD) clinical chemistry analyzer that measures analytes in human samples for diagnosis and monitoring, not for direct therapeutic intervention.

Yes

The device components (reagents, calibrators, and controls) are intended for "quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma" and "Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases." This clearly indicates a diagnostic purpose.

No

The device description explicitly states that the reagents, controls, and calibrators are for use on a "discrete photometric benchtop clinical chemistry analyzer," which is a hardware device. The submission is for the reagents and associated components, not a standalone software product.

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 "intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes" and specifically mentions the "quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma". The calibrators and controls are also described as being for "calibration of quantitative Horiba ABX methods" and "quality control by monitoring accuracy and precision", all of which are functions of IVD devices.
  • Device Description: The document states that the reagents, controls, and calibrators are "for use on the ABX PENTRA 400... which is a discrete photometric benchtop clinical chemistry analyzer." Clinical chemistry analyzers are a common type of IVD device used to perform tests on biological samples. It also explicitly states that "All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters".
  • Performance Studies: The performance studies described (Sample type, Detection limit, Accuracy and Precision, Measuring range, Correlation, Calibration stability, Reagent stability) are typical performance characteristics evaluated for IVD devices.
  • Predicate Device(s): The mention of a predicate device (K801118) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.

The core function of these components is to perform tests on human biological samples (serum and plasma) outside of the body ("in vitro") to provide information for diagnosis and treatment. This aligns perfectly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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

CIT, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy and Precision: CV Total

§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

0

AUG - 8 2006

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 :K060318
------------------------------------------

Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 20 + (33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton (tlawton@fr.abx.fr)

Date Prepared: 03rd 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 AST CP
Common or Usual Name:AST -- Aspartate amino transferase
Device ClassClass II
Classification Name:§862.1100 : Aspartate amino transferase (AST/SGOT) Test System
Product Code:CIT ; NADH oxidation/ NAD reduction, Ast/Sgot

CONTROLS :

Device Class

Product Code:

Classification Name:

ABX PENTRA N Control (K052007)

Trade/Proprietary Name: Common or Usual Name: N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

Trade/Proprietary Name:
Common or Usual Name:
Device Class
Classification Name:

ABX PENTRA P Control (K052007)

P Control Class I §862.1660 : Quality control material (assayed and unassayed)

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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 ClassClass II
Classification Name:§862.1150: Calibrator
Product Code: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 AST CP | K801118 |

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

Intended Use :

All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of AST - Aspartate amino transferase using human serum and plasma.

The controls and calibrators are intended for use in association with the above reagent.

Discussion of Performance Data:

ABX PENTRA AST CP :
Sample typeSerum & plasma
Detection limit4 U/l

2

| Accuracy and Precision | CV Total Trade/Device Name: Hepatic Enzymes on ABX PENTRA 400 Clinical Chemistry Analyzer ABX PENTRA Multical ABX PENTRA N Control ABX PENTRA P Control Regulation Number: 21 CFR§ 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system

Regulatory Class: Class II Product Code: CIT, JJY, JIX Dated: June 29, 2006 Received: July 03, 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 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).

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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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

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

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510(k) Number (if known): K060318

Device Name: Hepatic Enzymes on ABX PENTRA 400 Clinical Chemistry Analyzer

Indications For Use:

Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

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
Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

ﻜﺎﻥ ﺍﻟﻘﺮﺁﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ

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510(k) Number (if known): ____K060318

.

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)

sion Sign-Off

Page 2 of 1

Office of In Vit o Diagnostic Device Evaluation and Safety

KDb0310

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510(k) Number (if known):__K060318

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)

G.C.

Custom Sign Off

Office of In Van Diagnostic Device Evaluation and Safety

060318

Page 3 of 4

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510(k) Number (if known):__K060318

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)

Page 4 of 4

Office of in Vi. - Diagnostic Device Evaluation and Sa

060318