ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
Device Facts
| Record ID | K110530 |
|---|---|
| Device Name | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL |
| Applicant | HORIBA ABX SAS |
| Product Code | CGX · Clinical Chemistry |
| Decision Date | Apr 30, 2012 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Intended Use
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical 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. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Device Story
Diagnostic reagent kit for quantitative creatinine measurement in human serum, plasma, and urine; utilizes kinetic Jaffé method (alkaline picrate). Input: patient samples (serum, plasma, urine) processed on ABX PENTRA 400 Clinical Chemistry Analyzer. Operation: creatinine reacts with alkaline picrate to form Janousky complex; rate of absorbance increase at 510 nm measured; rate proportional to creatinine concentration. Output: quantitative creatinine concentration (mg/dL). Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing/treating renal disease and monitoring dialysis. Includes lyophilized human serum calibrators and controls (N, P, and Urine L/H) for accuracy/precision monitoring.
Clinical Evidence
Bench testing only. Performance data for ABX PENTRA Creatinine 120 CP: Serum/plasma detection limit 0.074 mg/dL, urine 1.40 mg/dL. Measuring range 0.22-18.08 mg/dL (serum/plasma) and 2.90-282.50 mg/dL (urine). Accuracy/precision: CV < 4.72% (serum/plasma), < 2.06% (urine). Correlation studies (n=165 serum/plasma, n=117 urine) showed r2=0.9984. Stability data provided for reagents, calibrators, and controls.
Technological Characteristics
Photometric clinical chemistry analyzer reagents; kinetic Jaffé method (alkaline picrate). Reagents: bi-reagent cassette. Calibrators/Controls: lyophilized human serum or liquid urine with chemical additives. Connectivity: designed for ABX PENTRA 400 benchtop analyzer. Storage: 2-8°C.
Indications for Use
Indicated for quantitative in vitro determination of creatinine in human serum, plasma, and urine to aid in diagnosis and treatment of renal diseases and monitoring of renal dialysis. For prescription use only.
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Predicate Devices
Related Devices
- K110137 — ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN · HORIBA ABX SAS · Aug 10, 2011
- K033058 — CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS · Diamond Diagnostics, Inc. · Jan 30, 2004
Submission Summary (Full Text)
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# APR 3 0 2012
## 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 : K110530
Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 18 43 Fax: + (33) 4 67 14 15 17
> Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com)
Date Prepared: 12th April, 2012
#### Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400 instrument, cleared to market under K052007.
#### REAGENTS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### CALIBRATORS:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
### CONTROLS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
#### ABX PENTRA Creatinine 120 CP
Creatinine Class II \$862.1225 : Creatinine Test System CGX: alkaline picrate, colorimetry, creatinine
### ABX PENTRA Multical (K052007)
Multical Class II \$862.1150 : Calibrator JIX : Calibrator, Multi-Analyte Mixture
### ABX PENTRA N Control (K052007)
N Control Class I \$862.1660 : Quality control material (assayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed)
HORIBA ABX SAS, FRANCE
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| Trade/Proprietary Name: | ABX PENTRA P Control (K052007) |
|-------------------------|---------------------------------------------------|
| Common or Usual Name: | P Control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (assayed) |
| Trade/Proprietary Name: | ABX PENTRA Urine Control L/H (K070249) |
| Common or Usual Name: | Urine control |
| Device Class | Class I |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-Analyte Controls, All Kinds (Assayed) |
### 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 Creatinine 120 CP | K934361 |
| ABX PENTRA Multical | K052007 |
| ABX PENTRA N Control | K052007 |
| ABX PENTRA P Control | K052007 |
| ABX PENTRA Urine Control L/H | K070249 |
#### Description:
All the reagent, controls and calibrator 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 Creatinine 120 CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). It is composed of a bi-reagent cassette (R1= 27.5 mL ; R2= 8 mL). Reagents are chemical solutions with additives.
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 SAS methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.
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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 SAS methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.
The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine 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 annex, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.
### Intended Use:
All reagents in this submission are intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of Creatinine using human serum, plasma and/or urine.
The controls and calibrator are intended for use in association with the above reagent.
### HORIBA ABX SAS, FRANCE
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## Discussion of Performance Data:
| ABX PENTRA Creatinine 120 CP : | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum, Plasma and Urine |
| Detection limit | Serum/Plasma : 0.074 mg/dl<br>Urine : 1.40 mg/dl |
| Limit of Quantitation | Serum/Plasma : 0.22 mg/dl<br>Urine : 2.90 mg/dl |
| Accuracy and Precision | Serum/Plasma CV. Total < 4.72%<br>Urine CV Total < 2.06% |
| Measuring range | Serum/Plasma : 0.22 mg/dl - 18.08 mg/dl<br>Urine : 2.90 mg/dl - 282.50 mg/dl |
| Upper linearity limit | Serum/Plasma : 18.08 mg/dl, and with automatic post-dilution :<br>54.24 mg/dl<br>Urine : 282.5 mg/dl, and with automatic post-dilution : 847.50<br>mg/dl |
| Correlation | Serum/Plasma (n=165): Y = 0.99 x + 0.03 (mg/dl) with r2 =<br>0.9984<br>Urine (n=117) : Y = 1.00 x - 0.60 (mg/dl) with r2 = 0.9984 |
| Calibration stability | Serum/Plasma : 3 days<br>Urine : 3 days |
| Reagent stability | closed stability: 36 months at 2-8°C<br>on-board stability : 19 days |
# CALIBRATOR
and the comments
:
| ABX PENTRA Multical: | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115,<br>K110137) | Included in this submission |
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
HORIBA ABX SAS, FRANCE
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| ABX PENTRA Multical: | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| Cholesterol | √ | √ |
| Creatinine 120 | √ | √ |
| New Creatinine 120 | | √ |
| Enzymatic Creatinine CP | √ | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| Triglycerides | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| 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>**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>Total Bilirubin<br>6 hours at 15°C to 25°C<br>1 day at 2°C to 8°C | |
# CONTROLS
and the comments of the comments of the comments of
:
| ABX PENTRA N Control: | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115,<br>K110137) | Included in this submission |
HORIBA ABX SAS, FRANCE
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Carolina Career States
:
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| ABX PENTRA N Control: | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| Chloride | √ | √ |
| Cholesterol | √ | √ |
| HDL | √ | √ |
| LDL | √ | √ |
| Creatinine 120 | √ | √ |
| New Creatinine 120 | | √ |
| Enzymatic Creatinine CP | √ | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| 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: | |
| | 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 | |
| | Direct Bilirubin | |
| | 4 hours at 15°C to 25°C | |
| ABX PENTRA N Control: | 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 | |
. . . . .
HORIBA ABX SAS, FRANCE
:
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. . . . . .
100 - 100 - 100
. . . . . . . .
. .
.
:
. . .
and the comments of the comments of
.
HORIBA ABX SAS, FRANCE ---------
:
and the comments of the comments of
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| ABX PENTRA P Control:<br>Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115,<br>K110137) | Included in this submission |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| Chloride | √ | √ |
| Cholesterol | √ | √ |
| HDL | √ | √ |
| LDL | √ | √ |
| Creatinine 120 | √ | √ |
| New Creatinine 120 | | √ |
| Enzymatic Creatinine CP | √ | √ |
| Glucose HK | √ | √ |
| Glucose PAP | √ | √ |
| Iron | √ | √ |
| Lactic acid | √ | √ |
| Magnesium | √ | √ |
| Phosphorus | √ | √ |
| Potassium | √ | √ |
| Sodium | √ | √ |
| Total Protein | √ | √ |
| Total Protein 100 | √ | √ |
| 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 | |
| ABX PENTRA P Control: | | |
| | 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 | |
.
:
1.00
HORIBA ABX SAS, FRANCE
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------8
:
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| ABX PENTRA Urine Control L/H: | | |
|-------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K07249, K072115, K110137) | Included in this submission |
| Amylase | √ | √ |
| Calcium | √ | √ |
| Creatinine 120 | √ | √ |
| New Creatinine 120 | | √ |
| Enzymatic Creatinine CP | √ | √ |
| Phosphorus | √ | √ |
| Glucose | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | √ |
| Urinary proteins | | √ |
| Format | Liquid solution prepared from human urine with chemical additives and materials of biological origin | |
| Stability | Closed stability: 2 years at 2-8°C<br>Open stability: 30 days at 2-8°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/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The emblem itself is a stylized design, possibly representing human figures or abstract shapes.
### Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Horiba ABX SAS c/o Ms. Caroline Ferrer Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE
APR 3 9 2012
Re: k110530
Trade Name: ABX PENTRA Creatinine 120 CP on ABX PENTRA 400 Clinical . Chemistry Analyzer; ABX PENTRA Multical, ABX PENTRA N Control, ABX PENTRA P Control, ABX PENTRA Urine Control L/H
Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: CGX, JIX, JJY Dated: April 23, 2012 Received: April 25, 2012
Dear Ms. Ferrer:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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### Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
R
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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#### K110530 510(k) Number (if known):
Device Name: ABX Pentra Creatinine 120 CP on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Prescription Use_X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) (
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110530
Page 1 of 5
{12}------------------------------------------------
110530
.510(k) Number (if known):
.
Device Name: ABX PENTRA Multical
Indication For Use:
The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba Medical methods on Horiba Medical chemistry analyzers.
Prescription Use _ X (21 CFR Part 801 Subpart D)
### And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110530
Page 2 of 5
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110530
510(k) Number (if known):
Device Name: ABX PENTRA N Control
Indication For Use:
The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
.
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k110530
Page 3 of 5
{14}------------------------------------------------
510(k) Number (if known):
KII0530
Device Name: ABX PENTRA P Control
Indication For Use:
The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.
Prescription Use X (21 CFR Part 801 Subpart D) `And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k110530
Page 4 of 5
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KU0530 510(k) Number (if known):
Device Name: ABX PENTRA Urine Control L/H
Indication For Use:
The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Prescription Use _X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110530
Page 5 of 5
