CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Device Facts
| Record ID | K062737 |
|---|---|
| Device Name | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
| Applicant | Horiba Abx |
| Product Code | CGS · Clinical Chemistry |
| Decision Date | Jun 12, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
Intended Use
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes. ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-NAC method. ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoglobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay. Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease. The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision. 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 Story
System consists of reagents, calibrators, and controls for use on ABX PENTRA 400, a discrete photometric benchtop clinical chemistry analyzer. CK-NAC CP assay uses optimized UV test; Myoglobin CP assay uses latex-enhanced immunoturbidimetric test. Input: human serum or plasma samples. Analyzer performs photometric measurements; processes data to provide quantitative analyte concentrations. Used in clinical laboratory settings by trained personnel. Output: numerical concentration values for CK and myoglobin. Healthcare providers use results to assist in diagnosis/management of myocardial infarction, muscle diseases, and heart/renal conditions. Benefits include rapid, automated diagnostic testing.
Clinical Evidence
Bench testing only. Performance data includes: CK-NAC CP (n=350, r^2=0.9930, CV < 4.65%, range 8-1500 U/l) and Myoglobin CP (n=180, r^2=0.9756, CV < 5.24%, range 20.7-500 µg/l). Testing confirmed accuracy, precision, linearity, and stability against predicate methods.
Technological Characteristics
Reagents: bi-reagent cassettes. CK-NAC: optimized UV test. Myoglobin: latex-enhanced immunoturbidimetric assay. Controls/Calibrators: lyophilized or liquid human/bovine serum-based materials. Instrument: ABX PENTRA 400 (discrete photometric benchtop analyzer). Connectivity: standalone analyzer. Sterilization: not applicable (reagents/controls).
Indications for Use
Indicated for quantitative in vitro diagnostic determination of total creatine kinase and myoglobin in human serum and plasma. Used for diagnosis and treatment of myocardial infarction, muscle diseases (e.g., Duchenne-type muscular dystrophy), and heart or renal disease. For prescription use only on the ABX PENTRA 400 analyzer.
Regulatory Classification
Identification
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Predicate Devices
- Roche CK NAC Reagent Set (k834502)
- Beckman Coulter ACCESS Myoglobin Reagent (k021229)
- Pointe Scientific CK-MB Control Set Level I/Level II (k954074)
- Bio-Rad Liquicheck Cardiac Markers Control Level 2 (k961828)
- Beckman Coulter ACCESS Myoglobin Calibrators (k021229)
- ABX Pentra Multical (k060854)
- ABX Pentra N Control (k060854)
Related Devices
- K082226 — S40 CREATINE KINASE (CK) · Alfa Wassermann Diagnostic Technologies, Inc. · Sep 18, 2008
- K182702 — SEKURE Creatine Kinase Assay · Sekisui Diagnostics P.E.I., Inc. · Apr 17, 2019
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT · Alfa Wassermann Diagnostics Technologies, LLC · May 21, 2013
Submission Summary (Full Text)
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# JUN 1 2 2007
## 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 : k062737
Horiba ABX Company: Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 15 03 + (33) 4 67 14 15 17 Fax:
Contact Person: Pascal Macziola (pmacziola(a)fr.abx.fr)
Date Prepared: 24th April 2007
#### Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX . PENTRA 400, cleared to market under K052007.
#### REAGENTS :
Product Code:
| Trade/Proprietary Name: | ABX PENTRA CK NAC CP |
|-------------------------|---------------------------------------------------------------------------------|
| Common or Usual Name: | Total Creatine kinase |
| Device Class | Class II |
| Classification Name: | §862.1215 : Creatine Phosphokinase/Creatine kinase or isoenzymes<br>Test System |
| Product Code: | CGS ; Nad reduction/Nadh oxidation, Cpk or isoenzymes |
| Trade/Proprietary Name: | ABX PENTRA Myoglobin CP |
| Common or Usual Name: | Myoglobin |
| Device Class | Class II |
| Classification Name: | §866.5680 : Myoglobin immunological Test System |
DDR ; Myoglobin, antigen, antiserum, control
{1}------------------------------------------------
CALIBRATORS: Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
### ABX PENTRA Myoglobin Cal
Myoglobin Calibrator Class II §862.1150 : Calibrator JIT ; Calibrator, Secondary
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
### ABX PENTRA Multical (K060854)
Multical Class II \$862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture
#### CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
### ABX PENTRA CK Control
CK Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
### ABX PENTRA Immuno II Control L/H
Control Low/High Class I \$862.1660 : Ouality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name:
Common or Usual Name:
Classification Name:
Device Class
Product Code:
### ABX PENTRA N Control (K060854)
N Control Class I \$862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
### ABX PENTRA P Control (K060854)
P Control Class I §862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (assayed)
{2}------------------------------------------------
### 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 CK NAC CP | K834502 |
| ABX PENTRA Myoglobin CP | K021229 |
| ABX PENTRA Myoglobin Cal | K021229 |
| ABX PENTRA Multical | K060854 |
| ABX PENTRA CK Control | K954074 |
| ABX PENTRA Immuno II Control<br>L/H | K961828 |
| ABX PENTRA N Control | K060854 |
| ABX PENTRA P Control | K060854 |
#### 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 CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.
The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.
The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.
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The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.
The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 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.
### 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 : Total Creatine Kinase and Myoglobin using human serum and plasma.
The controls and calibrators are intended for use in association with the above reagents.
HORIBA ABX, FRANCE
Section 5-4
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## Discussion of Performance Data:
:
:
| ABX PENTRA CK NAC CP : | | |
|------------------------|-----------------------------------------------------------------------------------------|--|
| Sample type | Serum & plasma | |
| Detection limit | 8 U/l | |
| Accuracy and Precision | CV Total < 4.65% | |
| Measuring range | 8 U/l - 1500 U/l | |
| Upper linearity limit | 1500 U/l, and with automatic post-dilution : 4500 U/l | |
| Correlation (n=350) | $Y = 1.05 x - 1.75$ with a correlation coefficient $r^2 = 0.9930$ . | |
| Calibration stability | 8 days | |
| Reagent stability | closed stability: 18 months at 2-8°C<br>on-board stability (refrigerated area): 64 days | |
| ABX PENTRA Myoglobin CP : | |
|---------------------------|-----------------------------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 6.7 $\mu$ g/l |
| Accuracy and Precision | CV Total < 5.24% |
| Measuring range | 20.7 $\mu$ g/l – 500 $\mu$ g/l |
| Upper linearity limit | 500 $\mu$ g/l |
| Correlation (n=180) | Y = 0.94 x + 19.44 with a correlation coefficient r2 = 0.9756. |
| Calibration stability | 21 days |
| Reagent stability | closed stability: 12 months at 2-8°C<br>on-board stability (refrigerated area): 35 days |
{5}------------------------------------------------
## CALIBRATORS
| ABX PENTRA Myoglobin Cal: | |
|---------------------------|-----------------------------------------------------------------------------------------|
| Analytes | Myoglobin |
| Format | Liquid preparation of diluted purified myoglobin positive human<br>sera : 5 levels |
| Stability | Closed stability: 12 months at 2°C to 10°C<br>Open stability:<br>7 weeks at 2°C to 10°C |
| ABX PENTRA Multical: | | |
|----------------------------|-----------------|-----------------------------|
| Analytes | Already cleared | Included in this submission |
| Alkaline phosphatase | (K060205) | |
| Alanine aminotransferase | (CLIA) | |
| Amylase | (K062180) | |
| Aspartate aminotransferase | (K060318) | |
| Creatine kinase | | |
| GGT | (CLIA) | |
| Lipase | (CLIA) | |
| Albumin* | | |
| Direct Bilirubin | (K060325) | |
| Total Bilirubin | (K060325) | |
| Calcium | (K060205) | |
| Cholesterol | (K060854) | |
| Creatinine | (K060205) | |
| Glucose HK | (K052007) | |
| Glucose PAP | (K052007) | |
| Iron | (K060205) | |
| Lactic acid | (CLIA) | |
| Magnesium | (K060205) | |
| Phosphorus | (K060205) | |
| Total Protein* | | |
| Triglycerides | (K060854) | |
| Urea / Blood Urea Nitrogen | (K060205) | |
| Uric acid | (K060205) | |
HORIBA ABX, FRANCE
:
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| Format | Lyophilized human serum with chemical additives and materials 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<br><br>**Exceptions<br>Direct Bilirubin<br>3 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<br>6 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 |
* Not cleared as of date of submission
## CONTROLS
| ABX PENTRA CK Control: | | |
|------------------------|------------------------------------------------------------------------------------------------------------------|--|
| Analytes | Total Creatine Kinase | |
| Format | Lyophilized preparation of bovine serum albumin with chemical<br>additives and material of animal origin | |
| Stability | Closed stability: 18 months at 2°C to 8°C<br>Open stability:<br>24 hours at 15°C to 25°C<br>3 days at 2°C to 8°C | |
| ABX PENTRA Immuno II Control L/H: | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------|
| Analytes | Myoglobin |
| Format | Lyophilized preparation of bovine serum albumin with chemical<br>additives and material of animal origin |
| Stability | Closed stability: 18 months at 2°C to 10°C<br>Open stability:<br>2 weeks at 2°C to 10°C<br>3 months at -20°C |
{7}------------------------------------------------
| Analytes | Already cleared | Included in this submission |
|----------------------------|-----------------|-----------------------------|
| Alkaline phosphatase | (K060205) | |
| Alanine aminotransferase | (CLIA) | |
| Amylase | (K062180) | |
| Aspartate aminotransferase | (K060318) | |
| Creatine kinase | | |
| GGT | (CLIA) | |
| Lipase | (CLIA) | |
| Albumin* | | |
| Direct Bilirubin | (K060325) | |
| Total Bilirubin | (K060325) | |
| Calcium | (K060205) | |
| Chloride | (K052007) | |
| Cholesterol | (K060854) | |
| HDL | (K060854) | |
| LDL | (K060854) | |
| Creatinine | (K060205) | |
| Glucose HK | (K052007) | |
| Glucose PAP | (K052007) | |
| Iron | (K060205) | |
| Lactic acid | (CLIA) | |
| Magnesium | (K060205) | |
| Phosphorus | (K060205) | |
| Potassium | (K052007) | |
| Sodium | (K052007) | |
| Total Protein* | | |
| Triglycerides | (K060854) | |
| Urea / Blood Urea Nitrogen | (K060205) | |
| Uric acid | (K060205) | |
{8}------------------------------------------------
| Format | Lyophilized human serum with chemical additives and materials<br>of biological origin |
|-----------|---------------------------------------------------------------------------------------|
| 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 |
:
* Not cleared as of date of submission
.
:
11:00 PM IST 11:00 PM
HORIBA ABX, FRANCE
Section 5-9
:
:
{9}------------------------------------------------
| ABX PENTRA P Control:<br>Analytes | Already cleared | Included in this submission |
|-----------------------------------|-----------------|-----------------------------|
| Alkaline phosphatase | (K060205) | |
| Alanine aminotransferase | (CLIA) | |
| Amylase | (K062180) | |
| Aspartate aminotransferase | (K060318) | |
| Creatine kinase | | |
| GGT | (CLIA) | |
| Lipase | (CLIA) | |
| Albumin* | | |
| Direct Bilirubin | (K060325) | |
| Total Bilirubin | (K060325) | |
| Calcium | (K060205) | |
| Chloride | (K052007) | |
| Cholesterol | (K060854) | |
| HDL | (K060854) | |
| LDL | (K060854) | |
| Creatinine | (K060205) | |
| Glucose HK | (K052007) | |
| Glucose PAP | (K052007) | |
| Iron | (K060205) | |
| Lactic acid | (CLIA) | |
| Magnesium | (K060205) | |
| Phosphorus | (K060205) | |
| Potassium | (K052007) | |
| Sodium | (K052007) | |
| Total Protein* | | |
| Triglycerides | (K060854) | |
| Urea / Blood Urea Nitrogen | (K060205) | |
| Uric acid | (K060205) | |
{10}------------------------------------------------
| Format | Lyophilized human serum with chemical additives and materials 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>**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>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 |
* Not cleared as of date of submission
### 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.
{11}------------------------------------------------
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Horiba ABX c/o Pascal Macziola Regulatory Affairs Manager Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 France
JUN 1 2 2007
Re: k062737
> Trade/Device Name: ABX Pentra CK NAC CP, ABX Pentra Myoglobin CP, ABX Pentra CK Control, ABX Pentra Immuno II Control L/H, ABX Pentra Myoglobin Cal, ABX Pentra N Control, ABX Pentra P Control, ABX Pentra Multical Regulation Number: 21 CFR & 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: CGS, DDR, JIY, JIX, JIT Dated: April 25, 2007 Received: April 30, 2007
Dear Pascal Macziola:
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 10(x) marketed predicate device results in a classification for your device and thus, berroits 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) 276-0490. 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 tollefree number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. 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):
Device Name: Cardíac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer .
Indications For Use:
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.
ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.
Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.
The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.
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 1 of *2 6*
Carol Benson
Sign-Off
ాం of In Vitro Diagnostic Device uation and Safety
K062737
{14}------------------------------------------------
510(k) Number (if known):
Device Name: Cardiac Markers on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.
Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin 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)
Page 2 of _q lo
Carol Benson
Sign-Off
ാ of In Vitro Diagnostic Device tion and Safety
{15}------------------------------------------------
510(k) Number (if known):
Device Name: ABX PENTRA Immuno II Control L/H
Indications For Use:
The ABX PENTRA Immuno II Control L/H 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)
Page 3 of 6
Carol C. Benson
Sign-Off
ice of In Vitro Diagnostic Device * aluation and Safety
K06 2737
{16}------------------------------------------------
510(k) Number (if known):
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)
Carol Benson
Sign-Off
ා of In Vitro Diagnostic Device ation and Safety
Page 4 of 6
{17}------------------------------------------------
510(k) Number (if known):
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)
Carol C. Benson
Sign-Off
Sign-Up
୍ତ of In Vitro Diagnostic Device stion and Safety
Page 5 of 6
K062737
{18}------------------------------------------------
510(k) Number (if known):
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)
Carol Benson
Sign-Off
Page bof b
be of In Vitro Diagnostic Device Tuation and Safety
