(181 days)
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.
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
Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA AST CP reagent, ABX PENTRA Multical, ABX PENTRA N Control, and ABX PENTRA P Control, as derived from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| ABX PENTRA AST CP (Reagent) | ||
| Sample Type | Compatibility with human serum and plasma | Serum & plasma |
| Detection Limit | Implied to be clinically acceptable for AST measurement, and at least as good as predicate device | 4 U/l |
| Accuracy and Precision | Implied to be clinically acceptable and comparable to predicate device. Specifically, for precision, a total CV below a certain threshold would be desired. | CV Total < 4.97% |
| Measuring Range | Implied to cover a clinically relevant range for AST, and at least as good as predicate device. | 4 U/l – 600 U/l (Automatic post-dilution: 1800 U/l) |
| Correlation | High correlation (r²) close to 1, and a slope close to 1 with a small intercept, when compared to a reference method or predicate device. | Y = 0.99 x + 1.25 with a correlation coefficient r² = 0.9963 (n=103) |
| Calibration Stability | Implied to provide stable calibration for a reasonable period, comparable to predicate devices. | 8 days |
| Reagent Stability (Closed) | Implied to provide a reasonable shelf-life. | 15 months at 2-8°C |
| Reagent Stability (On-board) | Implied to provide a reasonable on-board stability for practical use. | 55 days (refrigerated area) |
| ABX PENTRA Multical (Calibrator) | ||
| Stability (Closed) | Implied to provide a reasonable shelf-life. | 24 months at 2-8°C |
| Stability (Open) | Implied to maintain stability for practical use after opening for various timeframes and storage conditions. Specific limits for standard and exception analytes. | Once opened, calibrate components (general): 8 hours at 15-25°C, 2 days at 2-8°C, 2 weeks at -25 to -15°C. Exceptions for Direct Bilirubin and Total Bilirubin with shorter stabilities as listed in the document. |
| ABX PENTRA N Control (Control) | ||
| Stability (Closed) | Implied to provide a reasonable shelf-life. | 30 months at 2-8°C |
| Stability (Open) | Implied to maintain stability for practical use after opening for various timeframes and storage conditions. Specific limits for standard and exception analytes. | Once opened, control components (general): 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25 to -15°C. Exceptions for Direct Bilirubin and Total Bilirubin with shorter stabilities as listed in the document. |
| ABX PENTRA P Control (Control) | ||
| Stability (Closed) | Implied to provide a reasonable shelf-life. | 30 months at 2-8°C |
| Stability (Open) | Implied to maintain stability for practical use after opening for various timeframes and storage conditions. Specific limits for standard and exception analytes. | Once opened, control components (general): 12 hours at 15-25°C, 5 days at 2-8°C, 1 month at -25 to -15°C. Exceptions for Direct Bilirubin and Total Bilirubin with shorter stabilities as listed in the document. |
Study Details:
The provided document describes a premarket notification (510(k)) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical effectiveness study as might be seen for novel devices. The performance data presented are used to support this substantial equivalence claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study: n=103 (for the ABX PENTRA AST CP reagent).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer (Horiba ABX Company) is based in France, it is likely that at least some, if not all, of the data originated from studies conducted in France or related European sites. For in vitro diagnostic devices, method validation studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For in vitro diagnostic assays like this, "ground truth" for method comparisons is typically established by comparing the candidate device's results against a well-established, often FDA-cleared or gold standard, reference method or predicate device, rather than expert consensus on individual cases. The correlation data (Y = 0.99 x + 1.25 with r² = 0.9963) refers to this type of comparison.
4. Adjudication Method for the Test Set
- This concept of "adjudication method" (like 2+1 or 3+1) is not applicable to this type of in vitro diagnostic device study. Adjudication usually refers to a process in diagnostic imaging or clinical trials where multiple human readers or clinicians evaluate cases and resolve discrepancies. For this blood test device, performance is evaluated through analytical methods (precision, accuracy, correlation to a reference method).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging AI devices that assist human interpretation, not for an in vitro diagnostic chemistry analyzer and its associated reagents and controls. The device described here is for quantitative measurement of a biochemical marker, not for interpreting complex human data like radiology images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is essentially a standalone device in terms of its ability to perform the measurement. The ABX PENTRA 400 analyzer (the platform) and the ABX PENTRA AST CP reagent system measure AST levels, and this measurement is done by the automated system without direct human interpretation of the "result generation" process for each test. The human "in the loop" is the lab technician who loads samples, ensures quality control, and reviews the reported numerical results. The performance metrics provided (detection limit, accuracy, precision, measuring range, correlation, stability) all reflect the standalone analytical performance of the system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for the ABX PENTRA AST CP reagent and the associated controls/calibrators is implicitly established by comparison to a predicate device (K801118) and likely other well-established or reference analytical methods for AST measurement. The correlation study directly relates the device's measurements (Y) to those of a comparator (x), which serves as the "truth" or reference for the study's purpose of demonstrating substantial equivalence. For calibrators and controls, ground truth relates to their assigned values and their stability characteristics under various conditions.
8. The Sample Size for the Training Set
- This information is not applicable in the context of this 510(k) submission for an in vitro diagnostic reagent system. "Training set" refers to data used to train machine learning models. This device is a chemical reagent and an automated analyzer, not an AI/ML-based diagnostic tool. The development process would involve extensive analytical validation experiments, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the concept of a "training set" and associated "ground truth establishment" for it does not apply to this type of device. The ground truth for analytical performance, as discussed in point 7, is established through comparison with established reference methods or predicate devices.
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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 Class | Class 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 Class | Class 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 equivalentpredicate 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 type | Serum & plasma |
| Detection limit | 4 U/l |
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| Accuracy and Precision | CV Total < 4.97% |
|---|---|
| Measuring range | 4 U/l – 600 U/lAutomatic post-dilution : 1800 U/l |
| Correlation (n=103) | Y = 0.99 x + 1.25 with a correlation coefficient r² = 0.9963. |
| Calibration stability | 8 days |
| Reagent stability | closed stability: 15 months at 2-8°Con-board stability (refrigerated area): 55 days |
CALIBRATORS
| ABX PENTRA Multical: | |
|---|---|
| Stability | Closed stability: 24 months at 2-8°COpen stability:Once opened, the calibrator components* are stable for :8 hours at 15°C to 25°C2 days at 2°C to 8°C2 weeks at -25°C to -15°C |
| *ExceptionsDirect Bilirubin3 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C | |
| Total Bilirubin6 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C |
CONTROLS
| ABX PENTRA N Control: | |
|---|---|
| Stability | Closed stability: 30 months at 2-8°COpen stability:Once opened, the control components* are stable for:12 hours at 15°C to 25°C5 days at 2°C to 8°C1 month at -25°C to -15°C*Exceptions |
.
{3}------------------------------------------------
| ABX PENTRA N Control: | |
|---|---|
| Direct Bilirubin4 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C | |
| Total Bilirubin8 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C |
| ABX PENTRA P Control: | |
|---|---|
| Stability | Closed stability: 30 months at 2-8°C |
| Open stability: | |
| Once opened, the control components* are stable for : | |
| 12 hours at 15°C to 25°C | |
| 5 days at 2°C to 8°C | |
| 1 month at -25°C to -15°C | |
| *Exceptions | |
| Direct Bilirubin | |
| 4 hours at 15°C to 25°C | |
| 8 hours at 2°C to 8°C | |
| 2 weeks at -25°C to -15°C | |
| Total Bilirubin | |
| 8 hours at 15°C to 25°C | |
| 1 day at 2°C to 8°C | |
| 2 weeks at -25°C to -15°C |
Conclusions for Performance Testing :
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 2006
Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromedecine Rue Du Caducee- BP 7290 34184 Montpellier cedex 4 France
Re: K060318
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
§ 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.