PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120

K022200 · Abx Diagnostics · GKZ · Jul 29, 2002 · Hematology

Device Facts

• Record ID: K022200
• Device Name: PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
• Applicant: Abx Diagnostics
• Product Code: GKZ · Hematology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET) for the in vitro diagnostic use in clinical laboratories. The clinical use in the ABX PENTRA 120 RETIC Hematology Analyzer of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients. The option of the SPS (Slide Preparation System) smears and stains on a clean microscope slide.

Device Story

Bench-top hematology analyzer; processes whole blood samples; utilizes cytochemistry, focused flow impedance, light absorbance, and fluorescence. Microprocessor-controlled; provides CBC, differential leukocyte counts, and reticulocyte counts (including IRF). Optional Slide Preparation System (SPS) performs automated blood film smearing and staining on microscope slides. Used in clinical laboratories by trained personnel. Output data assists clinicians in monitoring erythropoietic activity and hematological status. SPS module enables automated slide identification and preparation, replacing manual methods.

Clinical Evidence

Bench testing only. Precision assessed per NCCLS EP5-A (Total Imprecision 1.1-3.9% CV for Leukocytes; 3.1-7.4% CV for Platelets). Accuracy/bias assessed per NCCLS EP9-A; correlation with Abbott CD 4000 for WBC (R2=0.995) and Baker 9110 Plus for platelets (R2=0.99). Linearity validated up to 150 x 10^3/uL for WBC and 2000 x 10^3/uL for platelets. SPS module accuracy validated by comparing automated vs. manual slide preparation; all pathologies correctly identified.

Technological Characteristics

Bench-top analyzer; cytochemistry, flow impedance, light absorbance, fluorescence sensing. Electrical safety per IEC 1010-1. Microprocessor-driven. Optional SPS module for automated smearing/staining. Connectivity: On-line sample aspiration from analyzer.

Indications for Use

Indicated for clinical laboratory use to perform complete blood counts (CBC), differential leukocyte counts (DIFF), and reticulocyte counts (RET), including immature reticulocyte fraction (IRF) to monitor erythropoietic activity in patients. Includes optional automated slide smearing and staining.

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 120 (K962633, K990311, K991839)
• Coulter GEN-S SMTM Integrated Slide Maker (K962988)
• ABBOTT CD 4000 (K961439)
• BAKER 9110 Plus (K953598)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a logo for ABX Horiba Diagnostics. The logo features the letters "ABX" in a stylized font, with the "X" extending vertically. Below the letters, the word "HORIBA" is written in a smaller font. The background of the logo is a dark, textured square.

# Premarket Notification [510(k)] Summary

#### ABX Diagnostics

Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 - France Tél. : [phone] Fax : [phone]

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 : h0 2 2 2 00

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

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

Date Prepared: June 28, 2002

#### Device Name:

| Trade/Proprietary Name: | ABX PENTRA 120/120 RETIC 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 | | |
| Optional device name :<br>Trade/Proprietary Name: | SPS (Slide Preparation System) | | |
| Common or Usual Name: | Slide Preparation System | | |
| Device Class | Class I : exempt | | |
| Classification Name: | Automated Slide Stainer : §864.3800<br>Automated Slide Spinner : §864.5850 | | |

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# Substantial Equivalence:

The ABX PENTRA 120 (version 4.50) is a modification to the predicate device ABX PENTRA 120 cleared to market under K962633, K990311 and K991839.

The optional device SPS (Slide Preparation System) has a substantially equivalent predicate device Coulter GEN-S SMTM Integrated Slide Maker cleared to market under K962988.

The modification to the extension of the linearity range for white blood cells on whole blood and for platelets on the ABX PENTRA 120 used two predicate devices:

ABBOTT CD 4000 (K961439) : for the leukocyte extension to linearity BAKER 9110 Plus (K953598) : for the platelet count extension to linearity

# Description:

The PENTA 120 / P120 RETIC Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.

Controlled by the PENTRA 120 the optional device SPS (Slide Preparation System) smears and stains the slides.

## Intended Use :

ABX PENTRA Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF). The PENTRA 120 RETIC provides in addition a reticulocyte count (RET): specifically the immature reticulocyte fraction (IRF) to monitor erythropoietic activity in patients. The option of the SPS (Slide Preparation System) is used to smear a blood film and to stain it on a clean microscope slide for microscope examination.

The instrument is for in vitro diagnostic use in clinical laboratories.

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# Determination of substantial equivalence :

The ABX PENTRA 120 in this submission is substantially equivalent to the predicate device.

The following modifications to parameters and additional features have been made :

- Increase of the upper linearity ranges for white blood cells (WBC) on whole blood . and for platelets (PLT)
- Optional module interfacing with the SPS (slide-preparation system) automated slide-. stainer
- Miscellaneous software corrections .

The optional device SPS (Slide Preparation System) is the same intended use as the predicate device to Coulter GEN-STM SM System (K962988). Both systems aspire on-line the blood sample from the analyzer enabling slide preparation : smearing, staining and slide identification.

# Discussion of Performance Data:

The data presented in this submission demonstrates good precision as assessed by NCCLS EP5-A.

Total Imprecision ranged from between 1.1 and 3.9 CV% for Leukocytes, and 3.1 to 7.4 CV% for Platelet counting.

Accuracy / bias assessment (NCCLS EP 9-A) showed no evidence of significant bias. Good correlation was demonstrated between the PENTRA 120 and the Abbott CD 4000 for leukocyte enumeration (R2=0.995) for all WBC results compared. Similarly, the correlation for platelet counting between the PENTRA 120 and the Baker 9110 Plus was excellent (R2=0.99) for all platelet results compared.

Linearity assessment data supports a Total White Cell count linearity claim increase of upto 150 X 10 /uL; and a Platelet count linearity range up to 2000 X 10 /uL. This data was generated according to FDA guidelines.

The data presented in this submission for the option SPS (Slide Preparation System) demonstrated that the correlation of the results obtained between the manual and the SPS method is excellent. All the pathologies were correctly identified.

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#### Conclusions for non clinical and clinical tests :

The clinical testing for the PENTRA 120 concerning the WBC and PLT focused on linearity, accuracy and precision. Whilst the clinical testing on the SPS (Slide Preparation System) focused on the accuracy between the manual method of smearing slides and those obtained with the SPS (Slide Preparation System).

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.

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three lines representing the staff and a wavy line representing the snake.

Food and Drug Administration 2098 Gaither Road Rockville .MD 20850

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

JUL 2: 9 2002

Re: k022200

> Trade/Device Name: ABX PENTRA 120/120 RETIC Hematology Analyzers Option: Slide Preparation System (SPS) Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ, GKJ, KPA Dated: June 28, 2002 Received: July 5, 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, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ABX Diagnostics

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PENTRA 120/120 RETIC [Option SPS ] Abbreviated 510(k): Device Modification -

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

ABX PENTRA 120/120 RETIC Hematology Analyzers Device Name: Option : SPS (Slide Preparation System)

KO22200

Indications For Use:

The ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories.

The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET) for the in vitro diagnostic use in clinical laboratories. The clinical use in the ABX PENTRA 120 RETIC Hematology Analyzer of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

The option of the SPS (Slide Preparation System) smears and stains on a clean microscope slide.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | OR | | Over-The-Counter Use | |
|-----------------------|--|----|--|----------------------|--|
| (Per 21 CRFR 801.109) | | | | | |

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K022300 |
|---------------|---------|
|---------------|---------|

ABX Diagnostics (Horiba Group)
Section 4-1