ABX PENTRA 400: LIPOPROTEINS
Device Facts
| Record ID | K060854 |
|---|---|
| Device Name | ABX PENTRA 400: LIPOPROTEINS |
| Applicant | Horiba Abx |
| Product Code | JIT · Clinical Chemistry |
| Decision Date | Aug 24, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
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 : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
Device Story
System comprises reagents, calibrators, and controls for use on ABX PENTRA 400 clinical chemistry analyzer; performs quantitative in vitro diagnostic assays for cholesterol, HDL-C, LDL-C, and triglycerides. Input: human serum or plasma samples. Operation: enzymatic photometric/colorimetric assays (Trinder's reaction, accelerator selective detergent methodology, lipase hydrolysis/glycerol kinase). Output: quantitative analyte concentration values. Used in clinical laboratory settings by trained personnel. Healthcare providers use results to diagnose/monitor lipid metabolism disorders, diabetes, and endocrine conditions; aids in clinical decision-making regarding patient lipid management.
Clinical Evidence
Bench testing only. Performance evaluated via precision (CLSI EP05-A2), linearity (CLSI EP06-A), and method comparison (CLSI EP09-A2) against predicate reagents. Precision studies (N=80) showed CVs ranging from 0.53% to 6.39%. Method comparison (N=121-135 samples per analyte) yielded correlation coefficients (r²) between 0.9768 and 0.9994. Accuracy for cholesterol was validated via CRMLN certification.
Technological Characteristics
In vitro diagnostic reagents, lyophilized human serum calibrators/controls, and chemical cleaning solutions. Sensing principle: enzymatic photometric/colorimetric assays. Form factor: reagent cassettes for ABX PENTRA 400 benchtop analyzer. Connectivity: standalone analyzer integration. Sterilization: N/A (chemical reagents).
Indications for Use
Indicated for quantitative in vitro diagnostic determination of cholesterol, HDL-C, LDL-C, and triglycerides in human serum and plasma. Used in the diagnosis and treatment of lipid metabolism disorders, diabetes mellitus, nephrosis, liver obstruction, and endocrine disorders.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*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.
Predicate Devices
- Roche Cholesterol Reagent (k941573)
- Ultra N-Geneous HDL Cholesterol Reagent (k021316)
- N-Geneous LDL Cholesterol Reagent (k971573)
- Roche Reagent for Triglycerides (k893973)
- Roche Apolipoprotein Standard (k021316)
- Ultra N-Geneous HDL Cholesterol Reagent Calibrator (k971573)
- N-Geneous LDL Cholesterol Reagent Calibrator (k971573)
- Liquichek Lipids Control (k971573)
Related Devices
- K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT · Alfa Wassermann Diagnostic Technologies, Inc. · Oct 5, 2012
Submission Summary (Full Text)
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# Premarket Notification [510(k)] Summary
AUG 2 4 2006
This summary of 510(k) safety and effectiveness information is being submitted in This sammary of be requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : _______K060854________________________________________________________________________________________________________________________________
Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 10 July 2006
#### Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
#### REAGENTS :
Device Class
Product Code:
Classification Name:
| Trade/Proprietary Name: | ABX PENTRA Cholesterol CP |
|-------------------------|-----------------------------------------------|
| Common or Usual Name: | Cholesterol |
| Device Class | Class I |
| Classification Name: | 8862.1175 : Cholesterol (Total) Test System |
| Product Code: | CHH ; Enzymatic Esterase-Oxidase, Cholesterol |
| Trade/Proprietary Name: | ABX PENTRA HDL Direct CP |
| Common or Usual Name: | HDL Cholesterol |
Class I §862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### ABX PENTRA LDL Direct CP
LDL Cholesterol Class I \$862.1475 : Lipoprotein Test System LBS ; LDL/VLDL Precipitation, Cholesterol via Esterase-Oxidase, HDL
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Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
# ABX PENTRA Triglycerides CP
Triglycerides Class I §862.1705 : Triglycerides Test System SBT ; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
#### CALIBRATORS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### ABX PENTRA HDL Cal
HDL Calibrator Class II \$862.1150 : Calibrator JIT ; Calibrator, Secondary
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA LDL Cal LDL Calibrator Class II \$862.1150 : Calibrator JIT ; Calibrator, Secondary
## ABX PENTRA Multical (K052007)
Multical Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
#### CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name:
Product Code:
#### CLEANING SOLUTIONS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### ABX PENTRA N Control (K052007)
N Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
#### ABX PENTRA P Control (K052007)
P Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
## ABX PENTRA Clean-Chem CP (K052007)
Cleaning solution : Clean-Chem Class I : Exempt from Premarket Not available Not available
HORIBA ABX, FRANCE
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Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
## ABX PENTRA Clean-Chem 99 CP (K052007)
Cleaning solution : Clean-Chem 99 Class I : Exempt from Premarket Not available Not available
## Substantial Equivalence:
The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :
| Submission device | Substantially equivalent<br>Predicate device |
|-----------------------------|----------------------------------------------|
| ABX PENTRA Cholesterol CP | K941573 |
| ABX PENTRA HDL Direct CP | K021316 |
| ABX PENTRA LDL Direct CP | K971573 |
| ABX PENTRA Triglycerides CP | K893973 |
| ABX PENTRA HDL Cal | K021316 |
| ABX PENTRA LDL Cal | K971573 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
## 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 Cholesterol CP is an in vitro diagnostic assay for the quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of High Density Lipoprotein Cholesterol (HDL-C) in human squantaan plasma based on an enzymatic test, with accelerator selective detergent methodology. The assay is composed of a bi-reagent cassette, with 62 ml and 21 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA HDL Direct CP is an in vitro diagnostic assay for the quantitative determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and
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plasma based on an enzymatic colorimetric test. It is composed of a bi-reagent cassette, with 28 ml and 10 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Triglycerides CP is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
The ABX PENTRA HDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the HDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 ml.
The ABX PENTRA LDL Cal is a lyophilized calibrator prepared from human serum. It is used for the calibration of the LDL-C assay. The assigned value is given in the enclosed annex. This calibrator is provided in two vials of 1 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.
The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.
## 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 : Cholesterol, HDL-C. LDL-C and Triglycerides using human serum and plasma.
The controls, calibrators and additional reagents are intended for use in association with the above reagents.
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# Discussion of Performance Data:
| ABX PENTRA Cholesterol CP : | |
|-----------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 4 mg/dl |
| Accuracy and Precision | CV Total < 3.01% |
| Measuring range | 2.55 mg/dl - 583.26 mg/dl |
| Upper linearity limit | 580 mg/dl |
| Correlation (n=135) | Y = 0.95 x + 1.90 with a correlation coefficient r² = 0.9943. |
| Calibration stability | 8 days |
| Reagent stability | closed stability: 24 months at 2-8°C<br>on-board stability (refrigerated area): 48 days |
| ABX PENTRA HDL Direct CP : | |
|----------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 1.16 mg/dl |
| Accuracy and Precision | CV Total < 3.52% |
| Measuring range | 5.4 mg/dl - 151.9 mg/dl |
| Upper linearity limit | 154.8 mg/dl |
| Correlation (n=121) | Y = 0.91 x + 1.98 with a correlation coefficient r2 = 0.9768. |
| Calibration stability | 14 days |
| Reagent stability | closed stability: 22 months at 2-8°C<br>on-board stability (refrigerated area): 31 days |
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| ABX PENTRA LDL Direct CP : | |
|----------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 1.55 mg/dl |
| Accuracy and Precision | CV Total < 6.39% |
| Measuring range | 1.35 mg/dl - 369.39 mg/dl |
| Upper linearity limit | 387 mg/dl |
| Correlation (n=122) | Y = 0.96 x - 0.21 with a correlation coefficient r2 = 0.9963. |
| Calibration stability | 12 days |
| Reagent stability | closed stability: 18 months at 2-8°C<br>on-board stability (refrigerated area): 97 days |
| ABX PENTRA Triglycerides CP : | |
|-------------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 7 mg/dl |
| Accuracy and Precision | CV Total < 2.83% |
| Measuring range | 3.1 mg/dl - 1434 mg/dl |
| Upper linearity limit | 1470 mg/dl, with an automatique post-dilution : 5580 mg/dl |
| Correlation (n=135) | Y = 0.99 x + 0.20 with a correlation coefficient r² = 0.9994. |
| Calibration stability | 14 days |
| Reagent stability | closed stability: 16 months at 2-8°C<br>on-board stability (refrigerated area): 48 days |
:
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# CALIBRATORS
:
| ABX PENTRA HDL Cal: | |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Analytes | High Density Lipoprotein Cholesterol (HDL-C) |
| Format | Lyophilized preparation of human serum |
| Stability | Closed stability: 24 months at 2°C to 8°C<br>Open stability:<br>14 days at 2°C to 8°C<br>4 weeks at -70°C |
| ABX PENTRA LDL Cal: | |
|---------------------|---------------------------------------------------------------------------------------|
| Analytes | Low Density Lipoprotein Cholesterol (LDL-C) |
| Format | Lyophilized preparation of human serum |
| Stability | Closed stability: 24 months at 2°C to 8°C<br>Open stability:<br>2 weeks at 2°C to 8°C |
# THIS PART IS LEFT INTENTIONALLY BLANK
:
.
:
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| ABX PENTRA Multical: | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|
| Analytes | Already cleared (K052007) | Included in this submission | |
| Alkaline phosphatase* | | | |
| Alanine aminotransferase* | | | |
| Amylase* | | | |
| Aspartate aminotransferase* | | | |
| Creatine kinase* | | | |
| GGT* | | | |
| Lactate Dehydrogenase* | | | |
| Lipase* | | | |
| Albumin* | | | |
| Direct Bilirubin* | | | |
| Total Bilirubin* | | | |
| Calcium* | | | |
| Cholesterol | | 4 | |
| Creatinine* | | | |
| Glucose HK | 2 | | |
| Glucose PAP | 4 | r | |
| Iron* | | | |
| Lactic acid* | | | |
| Magnesium* | | | |
| Phosphorus* | | | |
| Total Protein* | | | |
| Triglycerides | | | |
| Urea / Blood Urea Nitrogen* | | 4 | |
| Uric acid* | | | |
| | | | |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | | |
| Stability | Closed stability: 24 months at 2-8°C<br>Open stability:<br>Once opened, the calibrator components** are stable for :<br>8 hours at 15°C to 25°C<br>2 days at 2°C to 8°C<br>2 weeks at -25°C to -15°C | | |
| | **Exceptions<br>Direct Bilirubin<br>3 hours at 15°C to 25°C<br>8 hours at 2℃ to 8℃<br>2 weeks at -25°C to -15°C<br>Total Bilirubin<br>6 hours at 15°C to 25°C<br>1 day at 2℃ to 8℃ | | |
| | 2 weeks at -25°C to -15°C | | |
| * Not cleared as of date of submission | | | |
:
HORIBA ABX, FRANCE
.
:
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# CONTROLS
·
| ABX PENTRA N Control: | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007) | Included in this submission |
| Alkaline phosphatase* | | |
| Alanine aminotransferase* | | |
| Amylase* | | |
| Aspartate aminotransferase* | | |
| Creatine kinase* | | |
| GGT* | | |
| Lactate Dehydrogenase* | | |
| Lipase* | | |
| Albumin* | | |
| Direct Bilirubin* | | |
| Total Bilirubin* | | |
| Calcium* | | |
| Chloride | √ | |
| Cholesterol | | √ |
| HDL | | √ |
| LDL | | √ |
| Creatinine* | | |
| Glucose HK | √ | √ |
| Glucose PAP | √ | |
| Iron* | | |
| Lactic acid* | | |
| Magnesium* | | |
| Phosphorus* | | |
| Potassium | √ | |
| Sodium | √ | √ |
| Total Protein* | | |
| Triglycerides | | √ |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | |
| Stability | Closed stability: 30 months at 2-8°C<br>Open stability:<br>Once opened, the control components** are stable for :<br>12 hours at 15°C to 25°C<br>5 days at 2°C to 8°C<br>1 month at -25°C to -15°C | |
| | **Exceptions | |
| ABX PENTRA N Control: | | |
| | Direct Bilirubin<br>4 hours at 15°C to 25°C<br>8 hours at 2°C to 8°C<br>2 weeks at -25°C to -15°C | |
| | Total Bilirubin<br>8 hours at 15°C to 25°C<br>1 day at 2°C to 8°C<br>2 weeks at -25°C to -15°C | |
HORIBA ABX, FRANCE
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* Not cleared as of date of submission
THIS PART IS LEFT INTENTIONALLY BLANK
HORIBA ABX, FRANCE
{10}------------------------------------------------
| ABX PENTRA P Control: | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K052007) | Included in this submission |
| Alkaline phosphatase* | | |
| Alanine aminotransferase* | | |
| Amylase* | | |
| Aspartate aminotransferase* | | |
| Creatine kinase* | | |
| GGT* | | |
| Lactate Dehydrogenase* | | |
| Lipase* | | |
| Albumin* | | |
| Direct Bilirubin* | | |
| Total Bilirubin* | | |
| Calcium* | | |
| Chloride | √ | |
| Cholesterol | | √ |
| HDL | | √ |
| LDL | | √ |
| Creatinine* | | |
| Glucose HK | √ | |
| Glucose PAP | √ | |
| Iron* | | |
| Lactic acid* | | |
| Magnesium* | | |
| Phosphorus* | | |
| Potassium | √ | |
| Sodium | √ | |
| Total Protein* | | |
| Triglycerides | | √ |
| Urea / Blood Urea Nitrogen* | | |
| Uric acid* | | |
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin | |
| Stability | Closed stability: 30 months at 2-8°C<br>Open stability:<br>Once opened, the control components** are stable for :<br>12 hours at 15°C to 25°C<br>5 days at 2°C to 8°C<br>1 month at -25°C to -15°C<br><br>**Exceptions<br>Direct Bilirubin<br>4 hours at 15°C to 25°C<br>8 hours at 2°C to 8°C<br>2 weeks at -25°C to -15°C<br><br>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 | |
HORIBA ABX, FRANCE
-
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* Not cleared as of date of submission
# CLEANING SOLUTIONS
| ABX PENTRA Clean-Chem CP: | |
|---------------------------|----------------------------------------------------------------------------------------|
| Format | Chemical liquid solution |
| Stability | Closed stability: 8 months at 2-8°C<br>On-board stability (refrigerated area): 15 days |
| ABX PENTRA Clean-Chem 99 CP: | |
|------------------------------|----------------------------------------------------------------------------------------|
| Format | Chemical liquid solution |
| Stability | Closed stability: 8 months at 2-8°C<br>On-board stability (refrigerated area): 45 days |
# 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/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
#### Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromèdecine Rue du Caducèe – BP 7290 34184 Montpellier cedex 4 - France
AUG 2 4 2006
k060854 Re:
Trade/Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer Regulation Number: 21CFR§-862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, CHH, JJY, CDT, LBR, MRR Dated: July 10, 2006
Received: July 14, 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 G
Alberto Guticarez, 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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# Indications for Use
510(k) Number (if known): k060854
Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction).
ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology.
ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
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 1 of
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety Evaluation of in Vitro Dia
Evaluation and Safety
K060854
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# Indications for Use
#### 510(k) Number (if known): k060854
#### Device Name: Lipoproteins and associated calibrators and controls on ABX PENTRA 400 Clinical Chemistry Analyzer
#### Indications For Use:
ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic colorimetric assay.
Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct 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)
Curl Benson
Page 2 of 2
ivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K060854
