ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
Device Facts
| Record ID | K110137 |
|---|---|
| Device Name | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN |
| Applicant | HORIBA ABX SAS |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | Aug 10, 2011 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Intended Use
ABX PENTRA Enzymatic Creatinine 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 an enzymatic method using a multi-step approach ending with a photometric end-point reaction. 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
Assay uses enzymatic colorimetric method to measure creatinine in human serum, plasma, and urine; requires ABX PENTRA 400 Clinical Chemistry Analyzer. Process: creatinine converted to creatine via creatinine amidohydrolase; creatine broken down to sarcosine and urea; subsequent enzyme-linked steps with sarcosine oxidase and peroxidase produce colored chromogen measured at 545nm. System includes bi-reagent cassette, lyophilized human serum calibrator, and quality controls. Used in clinical laboratories by trained personnel. Output: quantitative creatinine concentration (mg/dL). Results assist clinicians in diagnosing/treating renal disease and monitoring dialysis. Benefits: provides standardized, automated measurement of renal function markers.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP5-A2 (N=20/run, 80 total); serum CV% 0.29-4.12%, urine CV% 0.83-2.21%. Linearity per CLSI EP6-A; reportable range 0.11-16.95 mg/dL (serum), 3.56-175 mg/dL (urine). LoD/LoQ per CLSI EP17-A. Method comparison (N=153 serum, N=106 urine) against predicate showed high correlation (Slope 1.00/0.96, R2 0.999/0.997). Matrix comparison (N=40) confirmed no significant effect between serum, Li-Heparin, and EDTA plasma.
Technological Characteristics
Enzymatic photometric assay. Reagents: bi-reagent cassette. Calibrators/Controls: lyophilized human serum or liquid urine with chemical additives. Connectivity: designed for ABX PENTRA 400 analyzer. Stability: Reagent 18 months closed/30 days on-board; Calibrator/Control stability varies by analyte and storage condition.
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, monitoring renal dialysis, and as a calculation basis for other urine analytes. Intended for prescription use.
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
- Diagnostic Chemicals Limited Enzymatic Creatinine Assay (k070383)
- ABX PENTRA Multical; ABX PENTRA Control N and P; ABX PENTRA Urine Control L/H (k072115)
Related Devices
- K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL · HORIBA ABX SAS · Apr 30, 2012
- K103376 — ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL · Seppim S.A.S. · Nov 18, 2011
- K193649 — Yumizen C1200 Creatinine PAP · HORIBA ABX SAS · May 10, 2021
- K061412 — THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 · Thermo Electron Corp. · Mar 23, 2007
Submission Summary (Full Text)
{0}------------------------------------------------
## 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 : _ K 110137____
Company: Horiba ABX SAS Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 18 43 Telephone: Fax: + (33) 4 67 14 15 17
> Caroline Ferrer (caroline.ferrer@horiba.com) Contact Person:
Date Prepared: 26th July 2011
### 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: Common or Usual Name: Device Class Classification Name: Product Code:
Trade/Proprietary Name: Common or Usual Name:
Trade/Proprietary Name: Common or Usual Name:
### ABX PENTRA Enzymatic Creatinine CP
Creatinine Class II §862.1225 : Creatinine Test System JFY ; Enzymatic Method Creatinine
#### CALIBRATORS:
Device Class Classification Name:
Product Code: CONTROLS :
Device Class
Product Code:
Classification Name:
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)
{1}------------------------------------------------
| 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 Enzymatic Creatinine<br>CP | K070383 |
| 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 Enzymatic Creatinine CP is an in vitro diagnostic assay for the quantitative in vitro determination of creatinine in human serum, plasma and urine based on an enzymatic method using a multi-step approach ending with a photometric end-point reaction. It is composed of a bi-reagent cassette (R1= 22 mL ; R2= 8 mL). Reagent is a chemical solution 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.
{2}------------------------------------------------
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 annexe, 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.
{3}------------------------------------------------
## Discussion of Performance Data:
| ABX PENTRA Enzymatic Creatinine CP : | | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Sample type | Serum, Plasma and Urine | | | |
| Detection limit | Serum/Plasma : 0.026 mg/dl<br>Urine : 0.66 mg/dl | | | |
| Limit of Quantitation | Serum/Plasma : 0.11 mg/dl<br>Urine : 1.71 mg/dl | | | |
| Accuracy and Precision | Serum/Plasma CV Total < 4.12%<br>Urine CV Total < 4.84% | | | |
| Measuring range | Serum/Plasma : 0.11 mg/dl - 16.95 mg/dl<br>Urine : 3.56 mg/dl - 175 mg/dl | | | |
| Upper linearity limit | Serum/Plasma : 16.95 mg/dl, and with automatic post-dilution :<br>50.85 mg/dl<br>Urine : 175 mg/dl, and with automatic post-dilution : 525 mg/dl | | | |
| Correlation | Serum/Plasma (n=153) : Y = 1.00 x + 0.00 (mg/dl) with r2 =<br>0.999.<br>Urine (n=105) : Y = 0.97 x - 0.33 (mg/dl) with r2 = 0.9982. | | | |
| Calibration stability | Serum/Plasma : 14 days<br>Urine : 14 days | | | |
| Reagent stability | closed stability: 18 months at 2-8°C<br>on-board stability : 30 days | | | |
.
{4}------------------------------------------------
# CALIBRATOR
| ABX PENTRA Multical: | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115) | Included in this submission |
| Alkaline phosphatase | √ | √ |
| Alanine aminotransferase | √ | √ |
| Amylase | √ | √ |
| Aspartate aminotransferase | √ | √ |
| Creatine kinase | √ | √ |
| GGT | √ | √ |
| LDH | √ | √ |
| Lipase | √ | √ |
| Albumin | √ | √ |
| Direct Bilirubin | √ | √ |
| Total Bilirubin | √ | √ |
| Calcium | √ | √ |
| Cholesterol | √ | √ |
| 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<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<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 | |
| | Total Bilirubin | |
| ABX PENTRA Multical: | 6 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 SAS, FRANCE
: :
{5}------------------------------------------------
# CONTROLS
| ABX PENTRA N Control: | | | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115) | Included in this submission | |
| Alkaline phosphatase | ﮨﮯ | イ | |
| Alanine aminotransferase | V | イ | |
| Amylase | ﮨﮯ | イ | |
| Aspartate aminotransferase | 1 | l | |
| Creatine kinase | 4 | -4- | |
| GGT | N | ﮩﮯ | |
| LDH | ﮨﮯ | イ | |
| Lipase | ﮨﮯ | ゾ | |
| Albumin | V | - ﻳﻌ | |
| Direct Bilirubin | 1 | ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ | |
| Total Bilirubin | 4 | ﮨﮯ | |
| Calcium | ﭩﮯ | ્રી | |
| Chloride | V | ﮨﮯ | |
| Cholesterol | 4 | イ | |
| HDL | N | イ | |
| LDL | 4 | ﯿﮯ | |
| Creatinine 120 | 4 | ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ | |
| Enzymatic Creatinine | | ﮨﮯ۔ | |
| Glucose HK | ﮨﮯ | ﮨﯿﮟ ﮨﮯ ﮨﯿﮟ ﮨﯿﮟ ﮨﯿﮟ ﮨﯿﮟ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ ﻣﯿﮟ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﮐﮯ ﺳﺎﺗﮫ | |
| Glucose PAP | ﮯ | ﺮ | |
| Iron | ﮯ | イ | |
| Lactic acid | ﮯ | イ | |
| Magnesium | V | ﺮﯾﻤ | |
| Phosphorus | ﮯ | ﮯ۔ | |
| Potassium | 2 | イ | |
| Sodium | V | ಗ | |
| Total Protein | 1 | ど | |
| Total Protein 100 | 4 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Triglycerides | ﮨﮯ | ど | |
| Urea / Blood Urea Nitrogen | 1 | -4 | |
| Uric acid | t | イ | |
| / .<br>Lyophilized human serum with chemical additives and materials<br>Format | | | |
| of biological origin | | | |
HORIBA ABX SAS, FRANCE
{6}------------------------------------------------
| ABX PENTRA N Control: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<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 |
(
{7}------------------------------------------------
| ABX PENTRA P Control: | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared<br>(K052007, K060205, K060318,<br>K060325, K060854, K062180,<br>K062737, K060434, K072115) | 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 | √ | √ |
| Enzymatic Creatinine | | √ |
| 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<br>5 days at 2°C to 8°C<br>1 month at -25°C to -15°C | |
| ABX PENTRA P 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 | |
{8}------------------------------------------------
| ABX PENTRA Urine Control L/H: | | |
|-------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------|
| Analytes | Already cleared (K07249,<br>K072115) | Included in this submission |
| Amylase | √ | √ |
| Calcium | √ | √ |
| Creatinine 120 | √ | √ |
| Enzymatic Creatinine | | √ |
| Phosphorus | √ | |
| Glucose | √ | √ |
| Urea / Blood Urea Nitrogen | √ | √ |
| Uric acid | √ | |
| Urinary proteins | √ | √ |
| Format | Liquid solution prepared from human urine with chemical<br>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.
{9}------------------------------------------------
#### i i DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a human figure.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Horiba ABX SAS c/o Ms. Caroline Ferrer Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE
AUG 1 0 2011
Re: k110137
> Trade Name: ABX PENTRA Enzymatic Creatinine CP, 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: JFY, JIX, JJY Dated: June 28, 2011 Received: June 30, 2011
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 Aci 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).
{10}------------------------------------------------
Page 2 --
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courtney Harper. Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 上一
Enclosure
{11}------------------------------------------------
510(k) Number (if known):
Device Name: New Enzymatic Creatinine on ABX PENTRA 400 Clinical Chemistry Analyzer
Indications For Use:
ABX PENTRA Enzymatic Creatinine 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 an enzymatic method using a multi-step approach ending with a photometric end-point reaction. 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)
Ruth Cheb
510(k) k110137
{12}------------------------------------------------
k110137 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)
Ruta Chube
510(k) K110137
{13}------------------------------------------------
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 (OIVD)
Ruth Chusler
510(k) K110137
{14}------------------------------------------------
KII0137
510(k) Number (if known):
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)
Rutt Chealer
510(k) K110637
{15}------------------------------------------------
KII0137 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 (OIVD)
Rutt Chelen
510(k) K110137
