ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)

K052007 · Horiba Abx · CFR · Dec 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052007
• Device Name: ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
• Applicant: Horiba Abx
• Product Code: CFR · Clinical Chemistry
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ABX PENTRA Glucose HK CP is a ready-to-use reagent for use on the ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase method by colorimetry. The ABX PENTRA Glucose PAP CP is a ready-to-use reagent for use on the ABX Pentra 400 system for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose oxidase method by colorimetry. The ABX PENTRA Sodium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Sodium in human serum, plasma and urine. The ABX PENTRA Potassium – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Potassium in human serum, plasma and urine. The ABX PENTRA Chloride – E is an electrode for use on the I.S.E. module of the ABX Pentra 400 system for quantitative in vitro diagnostic determination of Chloride in human serum, plasma and urine. The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode. The ABX PENTRA Multical is a calibrator for use in the calibration of specified quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Standard 1, Standard 2 and Reference reagents are for use in the calibration of quantitative determination of sodium, potassium and chloride on ABX PENTRA 400 ISE module. The ABX PENTRA N Control and P Control are for use in quality control by monitoring accuracy and precision for specified quantitative methods.

Device Story

Benchtop clinical chemistry analyzer; performs automated pipetting, mixing, heating, and measurement. Inputs: primary tubes or sample cups containing serum, plasma, or urine. Principles: spectrophotometry (colorimetry/turbidimetry) for glucose; potentiometry (ion-selective electrodes) for electrolytes. Features: random access, bar-code sample/reagent identification, refrigerated reagent storage, and fibrin detection. Output: quantitative analyte concentrations displayed to healthcare providers for clinical decision-making. Operated by laboratory personnel in clinical environments. Benefits: replaces manual analytical procedures with high-throughput, automated, standardized testing.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per NCCLS EP5-A2; linearity per NCCLS EP6-A; method comparison against commercial reference reagents per NCCLS EP9-A2 (N=103-152 samples). Correlation coefficients (r²) ranged from 0.9651 to 0.9991. Analytical specificity tested against hemoglobin, triglycerides, and bilirubin; no significant interference observed within specified limits.

Technological Characteristics

Benchtop discrete photometric analyzer. Measuring principles: absorbance photometry and potentiometry (ISE). Throughput: 150-300 tests/hour. Connectivity: Barcode reader for reagent/sample identification. Safety standards: EN 61010-1, EN 61326 (EMC), UL 3101-1, CSA C22.2 No. 1010-1.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of glucose (serum/plasma) and sodium, potassium, and chloride (serum/plasma/urine) in clinical settings using the ABX Pentra 400 analyzer.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Roche Cobas Mira Plus/Option I.S.E module (K920402/K963627)
• Cobas Reagent for Glucose Rapid (K801297)
• Roche Calibrator for Automated Systems (C.f.a.s.) (K041227)
• Roche Precinorm Universal (K041227)

Submission Summary (Full Text)

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# DEC 16 2005

# Premarket Notification [510(k)] Summary

This summary of 510(k) safety and effectiveness information is being submitted in I m3 summary of 510(tr) sales) and 1990 and 21 CFR 807.92

The assigned 510(k) number is : K052007

Horiba ABX Company: Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton ([e-mail])

Date Prepared: 16th November 2005

#### Device Name:

Classification Name:

Product Code:

| Trade/Proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification Name: | ABX PENTRA 400 Clinical Chemistry Analyzer<br>Clinical Chemistry analyzer<br>Class I : General Controls : Exempt from premarket.<br>§862.2160 : Discrete photometric chemistry analyzer for<br>clinical use |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | JJE |
| Trade/Proprietary Name:<br>Common or Usual Name:<br>Device Class<br>Classification Name:<br>Product Code: | I.S.E Module (Optional)<br>Ion Selective Electrode Option<br>Class I : General Controls : Exempt from premarket.<br>§862.2160 : Discrete photometric chemistry analyzer for<br>clinical use<br>JJE |
| Electrodes :<br>Trade/Proprietary Name:<br>Common or Usual Name:<br>Device Class | ABX PENTRA Sodium-E<br>Sodium Electrode<br>Class II |

Class II §862.1665 : Sodium Test System JGS : electrode, ion specific, sodium

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Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

## Trade/Proprietary Name:

Common or Usual Name: Device Class Classification Name: Product Code:

## Trade/Proprietary Name:

Common or Usual Name: Device Class Classification Name: for a specific medical use Product Code:

## Reagents :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

## Calibrators :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

## ABX PENTRA Chloride -E

Chloride Electrode Class II \$862.1170 : Chloride Test System CGZ : electrode, ion-specific, chloride

## ABX PENTRA Potassium -E

Potassium Electrode Class II \$862.1600 : Potassium Test System CEM : electrode, ion specific, potassium

## ABX PENTRA Reference -E

Reference Electrode Class I : 510(k) exempt 5862.2050 : General purpose laboratory equipment labeled or promoted

JJP : electrode, ion specific (non-specified)

# ABX PENTRA Glucose HK CP

Glucose HK Class II \$862.1345 : Glucose Test System CFR ; Hexokinase, Glucose

## ABX PENTRA Glucose PAP CP

Glucose PAP Class II §862.1345 : Glucose Test System CGA ; Glucose Oxidase, Glucose

## ABX PENTRA Multical

Multical Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

## ABX PENTRA Standard 1

Standard 1 Class II 8862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

## ABX PENTRA Standard 2

Standard 2 Class II \$862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

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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:

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

### Cleaning solutions :

Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:

#### Trade/Proprietary Name:

Common or Usual Name: Device Class Classification Name: Product Code:

#### Trade/Proprietary Name:

Common or Usual Name: Device Class Classification Name: Product Code:

Trade/Proprietary Name: Common or Usual Name:

Device Class Classification Name: Product Code:

#### ABX PENTRA Reference

Reference Class II \$862.1150 : Calibrator JIX ; Calibrator, Multi-Analyte Mixture

## ABX PENTRA N Control

N Control Class I §862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

### ABX PENTRA P Control

P Control Class ! \$862.1660 : Quality control material (assayed and unassayed) JJY ; Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

## ABX PENTRA Clean-Chem CP

Clean-Chem Class I : Exempt from Premarket Notification Not available Not available

#### ABX PENTRA Clean-Chem 99 CP

Clean-Chem 99 Class I : exempt from Premarket Not available Not available

### ABX PENTRA Deproteinizer CP

Deproteinizer Class 1 : Exempt from Premarket Not available Not available

## ABX PENTRA Etching CP

Etching Class I : Exempt from Premarket Not available Not available

### Substantial Equivalence:

The ABX PENTRA 400 is a new device developed by HoribaABX. It has been demonstrated that the ABX PENTRA 400 can be considered substantially equivalent to the predicate device Roche Cobas Mira Plus (K920402).

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The optional ISE module has been similarly demonstrated as being substantially The optional ISE moductias been shimally done elective Electrode. Whilst the ABX PENTRA equivalent to R905027, the Rooms Ton Sector of Second PAP CP have been demonstrated Glucose HK CF, and ADX FENTRY Gracoss Preagent for Glucose Rapid (K801297).
substantially equivalent to K801297; the Cobas Reagent DV PENTERA P Courted how substaniany equivalent to K601297, the Coose - 110 Control and ABX PENTRA P Control have a ADA FENTRA Munical, ADA PER PER EF eing substantially equivalent to K033501, Roche been respectively demonstated as being blockers, Roche Precinorm U and Roche Precipath U.

## Description:

Description.
The ABX PENTRA 400 is a benchtop clinical chemistry analyzer using two measuring principals absorbance and ion selective electrodes.

The instrument may be summarized as follows :

- Multi-parametric (up to 52 simultaneous tests + 3 ISE tests) ।
- Patient per patient -
- On routine or Stat -
- On routine of Stat
150 to 300 tests / hour (in single or bi-reaction mode) (analytical cycle of 12seconds) -
- random access working on primary tubes or sample cups -
- ABX PENTRA reagent cassettes are compact and ready-to-use. -
- ADATEATIC Freaders are used to identify newly loaded reagent cassettes and samples for patient identification

The ABX PENTRA 400 offers both Closed and Open channels for a multitude of Phe ADA I ENTERS 400 Offers COLL, TDM, plasma protein, hemostasis, optional ISE module).

# Intended Use :

The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.

The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity.

The device is intended for use in conjunction with certain materials to measure, control and calibrate a variety of analytes.

The option of an ISE (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, Potassium by potentiometry using ion selective electrode.

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# Discussion of Performance Data:

| ABX PENTRA Glucose HK CP: | |
|---------------------------|----------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 1.98 mg/dl |
| Accuracy and Precision | CV Total < 2.03% |
| Measuring range | 1.98 mg/dl – 900 mg/dl<br>Automatic post-dilution : 2700 mg/dl |
| Correlation (n=103) | Y = 0.93 x + 2.70 with a correlation coefficient r² = 0.9958. |
| Calibration stability | 14 days |
| Reagent stability | on-board stability (refrigerated area): 55 days |
| Calibrator | ABX Pentra Multical |
| Controls | ABX Pentra N Control<br>ABX Pentra P Control |

| ABX PENTRA Glucose PAP CP: | |
|----------------------------|---------------------------------------------------------------------|
| Sample type | Serum & plasma |
| Detection limit | 1.80 mg/dl |
| Accuracy and Precision | CV Total < 1.44 % |
| Measuring range | 1.80 mg/dl - 432 mg/dl<br>With automatic post-dilution : 1296 mg/dl |
| Correlation (n=103) | Y = 0.98 x + 0.72 with a correlation coefficient r2 = 0.9974. |
| Calibration stability | 11 days |
| Reagent stability | on-board stability (refrigerated area): 83 days |
| Calibrator | ABX Pentra Multical |
| Controls | ABX Pentra N Control<br>ABX Pentra P Control |

. .

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| ABX PENTRA Chloride- E : | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 1.21 % |
| Linearity & Measuring range | Plasma / Serum : 85 - 200 mmol/l<br>Urine : 70 - 300 mmol/l |
| Correlation<br>Serum / Plasma (n=152)<br>Urine (n=103) | $Y = 1.09 x - 10.60 with a correlation coefficient r² = 0.9651.$<br>$Y = 0.99 x + 2.64 with a correlation coefficient r² = 0.9730.$ |
| Calibrators | ABX Pentra Standard 1<br>ABX Pentra Standard 2<br>ABX Pentra Reference |
| Controls | ABX Pentra N Control<br>ABX Pentra P Control |

| ABX PENTRA Potassium- E : | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 1.56 % |
| Linearity & Measuring range | Plasma / Serum : 1.4 - 10 mmol/l |
| | Urine : 2 - 150 mmol/l |
| Correlation<br>Serum (n=100)<br>Plasma (n=100)<br>Urine (n=103) | Y = 1.00 x + 0.00 with a correlation coefficient r2 = $0.9988$ .<br>Y = 1.00 x + 0.00 with a correlation coefficient r2 = $0.9977$ .<br>Y = 1.03 x - 0.72 with a correlation coefficient r2 = $0.9753$ . |
| Calibrators | ABX Pentra Standard 1 |
| | ABX Pentra Standard 2 |
| | ABX Pentra Reference |
| Controls | ABX Pentra N Control<br>ABX Pentra P Control |

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| ABX PENTRA Sodium – E : | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum, plasma & urine |
| Accuracy and Precision | CV Total < 0.92 % |
| Linearity & Measuring range | Plasma / Serum : 110 – 200 mmol/l<br>Urine : 80 – 300 mmol/l |
| Correlation<br>Serum (n=100)<br>Plasma (n=100)<br>Urine (n=103) | Y = 0.98 x + 2.64 with a correlation coefficient r² = 0.9991.<br>Y = 0.97 x + 4.77 with a correlation coefficient r² = 0.9960.<br>Y = 1.00 x + 1.00 with a correlation coefficient r² = 0.9851. |
| Calibrators | ABX Pentra Standard 1<br>ABX Pentra Standard 2<br>ABX Pentra Reference |
| Controls | ABX Pentra N Control<br>ABX Pentra P Control |

# Conclusions for non clinical and clinical tests :

Conclusions for 1882 studies that the safety and effectiveness of the devices are not compromised.

# The ABX PENTRA 400 (Option ISE) meets the :

- ADA TENTICA 400 (Option 102) incents for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- EN 61326 : standard for Electrical equipment for measurement, control and laboratory use EMC requirements
- UL 3101 -- 1 / CSA -- C22.2 No. 1010-1 : 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 16 2005

Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromèdecine Rue du Caducèe – BP 7290 34184 Montpellier cedex 4 France

k052007 Re:

R052007
Trade/Device Name: ABX PENTRA 400 Clinical Chemistry Analyzers ABX PENTRA 400 Calibrators and Controls Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, JGS, CEM, CGZ, JIX, JJY, JJE Dated: November 16, 2005 Received: November 21, 2005

Dear Mr. Lawton:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) (c regars) the enactment date of the Medical Device Amendments, or to conninered pror co rize) 2017-11-17, 11 accordance with the provisions of the Federal Food, Drug, de MCS mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Tree (1100) that the device, subject to the general controls provisions of the Act. The r ou may, attress provisions of the Act include requirements for annual registration, listing of general controls provincities, 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 n may 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 r lease of acressed that I Dr. mination that your device complies with other requirements of the Act that I Drival statutes and regulations administered by other Federal agencies. You must or any I odotar statuates and requirements, including, but not limited to: registration and listing (21 compty with7); 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) This letter will anow you to ough manieting of substantial equivalence of your device to a legally prematics notification: "The PDT Interlig stification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, II you destions on the promotion and advertising of your device, please contact the Office of In of questions on the prometical ation and Safety at [phone]. Also, please note the V Into Diagnosuo Dorto Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation chities, Triboranang of Streetion on your responsibilities under the Act from the I ou may other belief other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): X 5 5 2 0 0 7

Device Name: _ABX PENTRA 400 Clinical Chemistry Analyzer Option : I.S.E. module

Indications For Use:

The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use.

clinical use.
The device is intended to duplicate manual analytical procedures by performing various The device is intention to daptions the suring color intensity.

The device is intended for use in conjunction with certain materials to measure a variety of analytes.

ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators ABA PENTRA Glucose TH OF , Slaose FAN OF , Slaoses . An Selumination of glucose in serium and controls are for quantitative in vi... 8 alaghes methods by colorimetry.
and plasma using glucose hexokinase and glucose oxidase methods by coloriments and plasma using glucoso noxoninates and treatment of carbohydrate Glucose measuremonto are acceliabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantiative The option of Sodium, Chloride, and Potassium by potentiometry using ion selective delemmination of Obduin, Onliner, and For, valibrators and controls. Measurement of electrode with associated forement are used in diagnosis and treatment diseases involving electrolyte imbalance.

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)

Albert Schertz

**Division Sign-Off**

Office of In Vitro Dlagr Device Evaluation and

510(k) K052007

Page 1 of

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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 as specified in the enclosed annex.

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)

signature

Circ of In Viro Diagnostic Device . Frion End Salocy

KOSZOOD

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510(k) Number (if known): K052007

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 for the quantitative methods as specified in the enclosed annex.

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)

signature

- rf In Vitro Diagnostic Device
Page 1 of _

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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 for the quantitative methods as specified in the enclosed annex.

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)

signature

- s of In Vitro Diagnostic Device for, and Sufery
Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Kcs2007