(316 days)
Not Found
No
The summary describes a standard benchtop clinical chemistry analyzer performing automated photometric and potentiometric measurements. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on standard analytical metrics like accuracy, precision, linearity, and correlation.
No
The device is a diagnostic chemistry analyzer used for quantitative measurements of analytes in clinical laboratories, not for treating patients.
Yes
The device is described as a "discrete photometric benchtop chemistry analyzer for use in clinical laboratories" and is intended for "quantitative measurements of a variety of analytes" such as Glucose, Sodium, Potassium, and Chloride. It also states that these measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia" and "in diagnosis and treatment of diseases involving electrolyte imbalance," which are all diagnostic purposes.
No
The device description clearly states it is a "benchtop clinical chemistry analyzer" that performs physical actions like pipetting, mixing, heating, and measuring color intensity, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the PENTRA C200 is for "quantitative in vitro diagnostic determination of glucose in serum and plasma" and "quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine". The term "in vitro diagnostic" is used directly.
- Purpose: The device is used to measure analytes (Glucose, Sodium, Potassium, Chloride) in biological samples (serum, plasma, urine) to aid in the diagnosis and treatment of various conditions (carbohydrate metabolism disorders, electrolyte imbalance). This is the core function of an IVD.
- Reagents and Calibrators: The description mentions the use of "ABX Pentra Glucose HK CP reagent with associated calibrators and controls" and "associated reference solution, calibrators and controls" for the ISE module. These are essential components of an IVD system.
- Clinical Laboratories: The intended user/care setting is "clinical laboratories," which is a typical environment for IVD testing.
The information provided clearly indicates that the PENTRA C200 is designed and intended for use in performing diagnostic tests on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings.
It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride.
ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiometry using ion selective electrode with associated reference solution, calibrators and controls.
Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.
Product codes (comma separated list FDA assigned to the subject device)
CFR, JGS, CEM, CGZ, JJE
Device Description
The PENTRA C200 is a benchtop clinical chemistry analyzer using two measuring principles: absorbance and ion selective electrodes.
The instrument may be summarized as follows :
- Multi-parametric (up to 15 simultaneous tests + 3 ISE tests) .
- On routine or Stat
- 90 (without ISE) to 360 (with ISE) tests / hour (in single or bi-reaction mode) -(analytical cycle of 40 seconds)
- random access working on primary tubes or sample cups
- ABX PENTRA reagent cassettes are compact and ready-to-use. .
- on board bar-code reader is used to identify newly loaded reagent cassettes and samples for patient identification
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ABX PENTRA Glucose HK CP:
Sample type: Serum & plasma
Limit of Quantitation: 5 mg/dL
Accuracy and Precision: CV Total ≤ 1.99%
Measuring range: 5 mg/dL - 900 mg/dL; Automatic post-dilution : 2700 mg/dL
Correlation (n=103): Y = 0.98 x + 4.46 (mg/dL) with r2 = 0.998.
Calibration stability: 20 days
Reagent stability: On-board stability (refrigerated area): 39 days
Calibrator: ABX Pentra Multical
Controls: ABX Pentra N Control, ABX Pentra P Control
ABX PENTRA Sodium - E:
Sample type: Serum & plasma; Urine
Accuracy and Precision: Serum & plasma: CV Total ≤ 1.1 %; Urine: CV Total ≤ 4.91 %
Linearity & Measuring range: Serum & plasma: 90 - 190 mmol/L; Urine: 60 – 280 mmol/L
Correlation:
Serum (n=129): Y = 0.96 x + 6.42 with r2 = 0.982.
Plasma (n=132): Y = 1.05 x - 5.32 with r2 = 0.998.
Urine (n=101): Y = 1.01 x - 2.20 with r2 = 0.989.
Calibrators: ABX Pentra Standard 1, ABX Pentra Standard 2, ABX Pentra Reference
Controls: ABX Pentra N Control, ABX Pentra P Control
ABX PENTRA Potassium - E:
Sample type: Serum & plasma; Urine
Accuracy and Precision: Serum & plasma: CV Total ≤ 1.07 %; Urine: CV Total ≤ 2.87 %
Linearity & Measuring range: Serum & plasma: 2 - 9.5 mmol/L; Urine: 25 - 250 mmol/L
Correlation:
Serum (n=122): Y = 1.01 x - 0.06 with r2 = 0.998.
Plasma (n=125): Y = 1.01 x - 0.09 with r2 = 0.998.
Urine (n=159): Y = 1.02 x - 0.27 with r2 = 0.997.
Calibrators: ABX Pentra Standard 1, ABX Pentra Standard 2, ABX Pentra Reference
Controls: ABX Pentra N Control, ABX Pentra P Control
ABX PENTRA Chloride – E:
Sample type: Serum & plasma; Urine
Accuracy and Precision: Serum & plasma: CV Total ≤ 1.55 %; Urine: CV Total ≤ 4.59 %
Linearity & Measuring range: Serum & plasma: 70 – 170 mmol/L; Urine: 70 – 280 mmol/L
Correlation:
Serum (n=170): Y = 0.96 x + 3.74 with r2 = 0.996.
Plasma (n=131): Y = 1.04 x - 4.17 with r2 = 0.997.
Urine (n=112): Y = 1.04 x - 5.63 with r2 = 0.987.
Calibrators: ABX Pentra Standard 1, ABX Pentra Standard 2, ABX Pentra Reference
Controls: ABX Pentra N Control, ABX Pentra P Control
Conclusions for non clinical and clinical tests:
The non clinical studies tests conclude that the safety and effectiveness of the devices are not compromised. Clinical testing met all acceptance criteria, and data demonstrates that the devices are substantially equivalent to their predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
NOV = 8 2011
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 : K103788
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: 07th September 2011
Device Name:
ﻴﺔ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
| Trade/Proprietary Name: | PENTRA C200 |
|---|---|
| Common or Usual Name: | Clinical Chemistry analyzer |
| Device Class | Class I : General Controls : Exempt from premarket. |
| Classification Name: | §862.2160 : Discrete photometric chemistry analyzer for clinical use |
| Product Code: | JJE |
| Trade/Proprietary Name: | I.S.E. Module |
| Common or Usual Name: | Ion Selective Electrode |
| Device Class | Class I : General Controls : Exempt from premarket. |
| Classification Name: | §862.2160 : Discrete photometric chemistry analyzer for clinical use |
| Product Code: | JJE |
| Trade/Proprietary Name: | ABX PENTRA Glucose HK CP |
| Common or Usual Name: | Glucose HK |
| Device Class | Class II |
| Classification Name: | §862.1345 : Glucose Test System |
| Product Code: | CFR ; Hexokinase, Glucose |
The PENTRA C200 is a new device developed in a joint-venture by HORIBA Medical, and commercialized under HORIBA ABX SAS manufacturer responsibility. HORIBA ABX SAS is the registered company name. Our company is part of the Medical segment of HORIBA group. Trade name of our activity is HORIBA Medical.
1
Predicate Devices:
The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices:
| Candidate device | Predicate device | |
|---|---|---|
| 510(k) number | Device name | |
| PENTRA C200 | K052007 | ABX PENTRA 400 |
| PENTRA C200 I.S.E. Module | K052007 | ABX PENTRA 400 I.S.E. Module |
| ABX PENTRA Glucose HK CP | K052007 | ABX Pentra Glucose HK CP |
Similarities and Differences between the predicate devices and candidate devices:
| Predicate device | Candidate device | |
|---|---|---|
| Device Name | ABX PENTRA 400 | PENTRA C200 |
| Instrument Type | Benchtop | Same |
| Separate workstation | No | No |
| Touch Screen Interface | Yes | Yes |
| Intended Use | Discrete photometric | |
| benchtop chemistry | ||
| analyzer for clinical use | Same | |
| Maximum throughput | 420 Tests/Hour | 360 Tests/Hour |
| Methodologies | Spectrophotometry | |
| Mono and Bi-chromatic | ||
| measurement of light | ||
| absorbance | ||
| Potentiometry (for I.S.E. | ||
| Module) | Same | |
| STAT Capability | Yes | Yes |
| Sample ID Input | Barcoded ID | |
| Manual | Same | |
| Reagent Barcode | ||
| Reader | Integrated | Same |
| Reagent Positions | Up to 52 positions |
- 3 I.S.E. | Up to 15 positions
- 3 I.S.E. |
| Sample Positions | Up to 60 samples | Up to 15 positions |
Table1: Comparison between PENTRA C200 and ABX PENTRA 400 (K052007)
2
| Table 2: Comparison between PENTRA C200 I.S.E. Module and ABX PENTRA | |||
|---|---|---|---|
| 400 I.S.E. Module (K052007) | |||
| Predicate device | Candidate device | ||
| Device Name | I.S.E. Module | I.S.E. Module | |
| Instrument | ABX PENTRA 400 | PENTRA C200 | |
| Optional | Yes | Yes | |
| Parameters | Na, K, Cl | Same | |
| Potentiometry | Direct and Indirect | Same | |
| Material | |||
| Sodium Electrode | Glass membrane | ||
| selective to Na+ ions | Same | ||
| Potassium Electrode | Plastic membrane | ||
| selective to K+ ions | Same | ||
| Chloride Electrode | Plastic membrane | ||
| selective to Cl- ions | Same | ||
| Specimen Types | Serum | ||
| Plasma | |||
| Urine | Same |
Table 3: Comparison between Glucose HK assay on PENTRA C200 and on ABX PENTRA 400 (K052007)
| Predicate device | Candidate device | |
|---|---|---|
| Device Name | ABX PENTRA Glucose | |
| HK CP | ABX PENTRA Glucose | |
| HK CP | ||
| Instrument | ABX PENTRA 400 | PENTRA C200 |
| Parameter | Glucose | Glucose |
| Method | Enzymatic method using | |
| hexokinase couple with | ||
| glucose-6-phosphate | ||
| dehydrogenase | Same | |
| Material | Bi-reagent cassette, | |
| ready-to-use | ||
| Reagent 1: NAD, ATP, | ||
| Buffer Sodium azide | ||
| Reagent 2: Hexokinase, | ||
| G-6-PDH, Magnesium | ||
| sulphate, Sodium azide | Same | |
| Specimen Types | Serum | |
| Plasma | ||
| Urine | Serum | |
| Plasma |
·
3
Substantial Equivalence:
It has been demonstrated that the PENTRA C200 can be considered substantially equivalent to the predicate device ABX PENTRA 400 (K052007).
The I.S.E. module has been similarly demonstrated as being substantially equivalent to the predicate device K052007.
The ABX PENTRA Glucose HK CP used on the PENTRA C200 has been demonstrated substantially equivalent to the same reagent used on the ABX PENTRA 400 as described in K052007.
Description:
The PENTRA C200 is a benchtop clinical chemistry analyzer using two measuring principles: absorbance and ion selective electrodes.
The instrument may be summarized as follows :
- Multi-parametric (up to 15 simultaneous tests + 3 ISE tests) .
- On routine or Stat
- 90 (without ISE) to 360 (with ISE) tests / hour (in single or bi-reaction mode) -(analytical cycle of 40 seconds)
- random access working on primary tubes or sample cups
- ABX PENTRA reagent cassettes are compact and ready-to-use. .
- on board bar-code reader is used to identify newly loaded reagent cassettes and samples for patient identification
4
Intended Use / Indications for use :
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings.
It duplicates manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride.
ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. *
The I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiometry using ion selective electrode with associated reference solution, calibrators and controls.
Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.
5
Discussion of Performance Data:
| ABX PENTRA Glucose HK CP: | |
|---|---|
| Sample type | Serum & plasma |
| Limit of Quantitation | 5 mg/dL |
| Accuracy and Precision | CV Total ≤ 1.99% |
| Measuring range | 5 mg/dL - 900 mg/dL |
| Automatic post-dilution : 2700 mg/dL | |
| Correlation (n=103) | Y = 0.98 x + 4.46 (mg/dL) with r2 = 0.998. |
| Calibration stability | 20 days |
| Reagent stability | On-board stability (refrigerated area): 39 days |
| Calibrator | ABX Pentra Multical |
| Controls | ABX Pentra N Control |
| ABX Pentra P Control |
| ABX PENTRA Sodium - E : | ||
|---|---|---|
| Sample type | Serum & plasma | Urine |
| Accuracy and Precision | CV Total ≤ 1.1 % | CV Total ≤ 4.91 % |
| Linearity & Measuring range | 90 - 190 mmol/L | 60 – 280 mmol/L |
| Correlation | Serum (n=129) | |
| Y = $0.96 x + 6.42$ with $r^2$ = | ||
| $0.982$ . | Urine (n=101) | |
| Y = $1.01 x - 2.20$ with $r^2$ = | ||
| $0.989$ . | ||
| Plasma (n=132) | ||
| Y = $1.05 x - 5.32$ with $r^2$ = | ||
| $0.998$ . | ||
| Calibrators | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ||
| Controls | ABX Pentra N Control | |
| ABX Pentra P Control | ABX Pentra N Control | |
| ABX Pentra P Control |
6
| ABX PENTRA Potassium - E : | ||
|---|---|---|
| Sample type | Serum & plasma | Urine |
| Accuracy and Precision | CV Total ≤ 1.07 % | CV Total ≤ 2.87 % |
| Linearity & Measuring range | 2 - 9.5 mmol/L | 25 - 250 mmol/L |
| Correlation | Serum (n=122) | |
| Y = $1.01 x - 0.06$ with $r^2$ = | ||
| 0.998. | Urine (n=159) | |
| Y = $1.02 x - 0.27$ with $r^2$ = | ||
| 0.997. | ||
| Plasma (n=125) | ||
| Y = $1.01 x - 0.09$ with $r^2$ = | ||
| 0.998. | ||
| Calibrators | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ||
| Controls | ABX Pentra N Control | |
| ABX Pentra P Control | ABX Pentra N Control | |
| ABX Pentra P Control |
| ABX PENTRA Chloride – E : | ||
|---|---|---|
| Sample type | Serum & plasma | Urine |
| Accuracy and Precision | CV Total ≤ 1.55 % | CV Total ≤ 4.59 % |
| Linearity & Measuring range | 70 – 170 mmol/L | 70 – 280 mmol/L |
| Correlation | Serum (n=170) | |
| $Y = 0.96 x + 3.74 with r2 = 0.996.$ | ||
| Plasma (n=131) | ||
| $Y = 1.04 x - 4.17 with r2 = 0.997.$ | Urine (n=112) | |
| $Y = 1.04 x - 5.63 with r2 = 0.987.$ | ||
| Calibrators | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ABX Pentra Standard 1 | |
| ABX Pentra Standard 2 | ||
| ABX Pentra Reference | ||
| Controls | ABX Pentra N Control | |
| ABX Pentra P Control | ABX Pentra N Control | |
| ABX Pentra P Control |
Conclusions for non clinical and clinical tests :
The non clinical studies tests conclude that the safety and effectiveness of the devices are not compromised.
7
The PENTRA C200 (with ISE module) meets :
IEC 61010-1 / IEC 61010-2-081 / IEC 61010-2-101 :
Safety requirements for electrical equipment for measurement, control, and laboratory use
Part 1: General requirements
Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
EN 61326-2-6 : i
Standard for Electrical equipment for measurement, control and laboratory use -EMC requirements
Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical device
UL631010 - 1 / CSA - C22.2 No. 61010-1 :
Safety requirements for electrical equipement for measurement, control, and laboratory use,
Part 1 : General Requirements
Clinical testing met all acceptance criteria, and data demonstrates that the devices are substantially equivalent to their predicate devices.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Horiba ABX SAS c/o Ms. Caroline Ferrer Regulatory Affairs Specialist Parc Euromedecine Rue du Caducee - BP 7290 34184 Montpellier cedex 4 France
Food & Drug Administration 10903 New Hampshire Avenue Buildina 66 Silver Spring, MD 20993
NOV - 8 2011
Re: K103788 Trade Name: PENTRA C200, I.S.E. Module, and ABX PENTRA Glucose HK CP Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: CFR, JGS, CEM, CGZ, JJE Dated: November 4 , 2011 Received: November 7 . 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 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 80 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).
9
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro 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/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 for (1 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use Form
510(k) Number (if known): K103788
Device Name: PENTRA C200, I.S.E. Module, and ABX Pentra Glucose HK CP
Indications for Use:
The PENTRA C200 is a discrete photometric benchtop chemistry analyzer for use in clinical laboratories. It is not intended for use in Point of Care settings.
It duplicates manual analytical procedures by performing various steps such as pipetting. mixing, heating and measuring color intensity. The PENTRA C200 is intended for quantitative measurements of a variety of analytes: Glucose, Sodium, Potassium and Chloride.
ABX Pentra Glucose HK CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and odiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The I.S.E. (Ion Selective Electrode) Module is intended for the quantitative determination of Sodium, Potassium and Chloride in serum, plasma and urine by potentiometry using ion selective electrode with associated reference solution, calibrators and controls. Measurement of Sodium, Potassium and Chloride are used in diagnosis and treatment of diseases involving electrolyte imbalance.
Prescription Use x r rescription Ose ------------------------------------------------------------------------------------------------------------------------------------------------------------ Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Dus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103788
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