PENTRA 80

K024002 · Abx Diagnostics · GKZ · Jan 3, 2003 · Hematology

Device Facts

• Record ID: K024002
• Device Name: PENTRA 80
• Applicant: Abx Diagnostics
• Product Code: GKZ · Hematology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

Device Story

Benchtop hematology analyzer; processes whole blood samples; utilizes cytochemistry, focused flow impedance, and halogen light transmission; microprocessor-controlled; internal PC performs data processing and hosts user interface. Used in clinical laboratories by trained personnel. Provides complete blood count (CBC) and 5-part leukocyte differential count. Output assists clinicians in hematological assessment and patient diagnosis. Benefits include automated, high-throughput blood analysis with established precision and linearity.

Clinical Evidence

Bench testing performed per NCCLS EP5-A guidelines. Demonstrated precision and linearity for WBC, RBC, HGB, HCT, and PLT. Accuracy validated via inter-procedural correlation against Abbott CD 4000 (R2>0.95). Leukocyte differentiation showed effective separation of true/false positives and negatives. Carry-over <2%. Sample stability confirmed for 48 hours at 4°C.

Technological Characteristics

Benchtop form factor; sensing via focused flow impedance and cytochemistry; halogen light source; microprocessor-controlled with internal PC; electrical safety per IEC 1010-1; electromagnetic compatibility per EN 61326.

Indications for Use

Indicated for in vitro diagnostic testing of whole blood specimens in clinical laboratory environments to provide complete blood counts and 5-part differential leukocyte counts.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• ABX PENTRA 60C+ (K003677)

Reference Devices

• ABBOTT CD 4000 (K961439)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for ABX Horiba Diagnostics. The logo is a stylized "ABX" with the "X" being formed by two intersecting lines that extend beyond the "A" and "B". Below the "ABX" is the word "HORIBA" in a smaller font. Underneath "HORIBA" is the word "DIAGNOSTICS" in a smaller font.

# 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 : K024002

- Company: ABX Diagnostics Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE Telephone: + (33) 4 67 14 73 20 Fax: + (33) 4 67 14 15 17
Contact Person: Tim Lawton ([e-mail])

Date Prepared: November 27th, 2002

#### Device Name:

| Trade/Proprietary Name: | ABX PENTRA 80 Hematology Analyzer |
|-------------------------|-------------------------------------------------------------------------------------------|
| Common or Usual Name: | Automated cell counter and<br>Automated differential cell counter |
| Device Class | Class II : Special Controls Guidance Document |
| Classification Name: | Automated cell counter (§864.5200) and<br>Automated differential cell counter (§864.5220) |
| Product Code: | GKZ |

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#### Substantial Equivalence:

The ABX PENTRA 80 based on the same fundamental technology as the predicate device ABX PENTRA 60C+ cleared to market under K003677.

The use of a second predicate device to show its clinical capability compatibility was used ABBOTT CD 4000 (K961439).

### Description:

The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.

### Intended Use :

The PENTRA 80 is fully automated (microprocessor controlled) multi-parameter hematology analyzer intended for in in-vitro diagnostic use in the clinical laboratory environment.

# Determination of substantial equivalence :

The PENTRA 80 is substantially equivalent to the already cleared device PENTRA 60C+ with respect to the indications for use, the hematological parameters for complete blood count and differential leukocyte count, and the principles of operation (fundamental scientific technology).

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# Discussion of Performance Data:

The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines.

The data presented in this 510K Pre-market Notification demonstrate good precision in accordance with EP5-A (NCCLS guidelines) and is entirely acceptable for all available parameters.

The linearity claim for the parameters WBC (0-120 x 103/μL), RBC (0 -- 8.0 x 10 /uL), HGB(0 -- 24g/dl), HCT (0 -- 67%), PLT with Hgb>2g/1(0 - 1,900 x 103/μL) and PLT with Hgb<2g/1 (0 - 2800 x 10 /uL) are entirely supported by the clinical data provided in this submission.

Accuracy (Inter-procedural Correlation) showed no evidence of significant bias between the PENTRA 80 and the Abbott CD 4000 provided good correlation of R2>0.95 for WBC, PLT, RBC, HGB, HCT parameters.

Leukocyte Differentiation provided good results on the differentiation between true & false positives and true & false negatives.

This study data assures a relative sample stability over a 48 hour period at 4°C.

No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry Over claim of <2% for WBC, RBC, HGB, PLT.

# Conclusions for non clinical and clinical tests :

The clinical studies tests conclude that the safety and effectiveness of the device is not compromised. Clinical testing met all acceptance criteria.

The device meets with the IEC 1010-1 standard of the International Electro-technical Commission on electrical equipment for measurement, control, and laboratory use. As well as the EN 61326 standard for Electromagnetic Compatibility.

All clinical and non clinical tests show appropriate levels of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three flowing lines representing the head, body, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Regulatory Affairs Manager ABX Parc Euromedecine Rue du Caducee BP 7290 34184 Montpellier Cedex 4 FRANCE

JAN 0 3 2003

Re: k024002

> Trade/Device Name: ABX PENTRA 80 Hematology Analyzers Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: November 29, 2002 Received: December 4, 2002

Dear Mr. Lawton:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a logo for ABX Horiba Diagnostics. The logo is a black square with the letters "ABX" stacked on top of each other in white. Below the letters, the word "HORIBA" is written in a smaller font. Below the black square, the word "DIAGNOSTICS" is written in a sans-serif font.

# PENTRA 80

Special 510(k): Device Modification

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

ABX PENTRA 80 Hematology Analyzers Device Name:

Indications For Use:

The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CRFR 801.109) | OR | Over-The-Counter Use __________ |
|-------------------------------------------|----|---------------------------------|
|-------------------------------------------|----|---------------------------------|

J. Reeves for S. Bautista

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number: K024002

ABX Diagnostics (Horiba Group)