ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER

K991839 · Abx Diagnostics · GKZ · Aug 11, 1999 · Hematology

Device Facts

• Record ID: K991839
• Device Name: ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
• Applicant: Abx Diagnostics
• Product Code: GKZ · Hematology
• Decision Date: Aug 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations. The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

Device Story

Benchtop clinical laboratory instrument; analyzes whole blood samples. Uses cytochemistry, focused flow impedance, light scattering, and fluorescence to perform complete blood counts, differential leucocyte counts, and reticulocyte counts. Microprocessor-driven system; provides flags and alarms for abnormal cell populations. IRF parameter calculated as sum of medium and high RNA content reticulocytes (%). Used by laboratory personnel to monitor erythropoietic activity; output assists clinicians in identifying abnormal cell populations and assessing patient hematological status.

Clinical Evidence

Clinical study using 203 whole blood samples (100 normal, 103 abnormal reticulocyte counts). Samples processed on ABX PENTRA 120 RETIC and SYSMEX R-3000 analyzer. Data supports substantial equivalence for the IRF parameter. Additional precision and accuracy studies conducted.

Technological Characteristics

Benchtop automated hematology analyzer. Sensing principles: cytochemistry, focused flow impedance, light scattering, and fluorescence. Microprocessor-controlled. In vitro diagnostic use. No specific material standards or connectivity protocols detailed.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to provide complete blood counts, differential leucocyte counts, and reticulocyte counts (including immature reticulocyte fraction) to monitor erythropoietic activity in patients.

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 RETIC Automated Hematology Analyzer (K990311)
• Sysmex IRF clinical parameter (K971736)

Reference Devices

• SYSMEX R-3000 analyzer

Submission Summary (Full Text)

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K99/839

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# Premarket Notification [510(k)] Summary

ABX Diagnostics, Inc. Company: 34 Bunsen Drive Irvine, CA 92618 Phone: [phone] FAX: [phone] Contact Person: Franck Brouzes Date Prepared: May 21, 1999

#### ABX™ PENTRA 120 RETIC Automated Hematology Trade Name: Analyzer

| Common Name: | Automated cell counter and<br>Automated differential cell counter |
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| Classification Name: | Automated cell counter (864.5200) and<br>Automated differential cell counter (864.5220) |

#### Substantial Equivalence:

The ABX PENTRA 120 RETIC Automated Hematology Analyzer is substantially equivalent to the ABX PENTRA 120 RETIC Automated Hematology Analyzer (K990311, cleared to market March 31, 1999) and to the Sysmex™ IRF clinical parameter (K971736, cleared to market August 26, 1997).

#### Description:

The ABX PENTRA 120 RETIC Automated Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leucocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light scattering, and fluorescence. The instrument is microprocessor driven.

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Image /page/1/Picture/3 description: The image is a logo for ABX Diagnostics. The logo is a stylized "ABX" in a bold, sans-serif font, with the letters stacked vertically. The "A" is at the top, the "B" is in the middle, and the "X" is at the bottom. The word "DIAGNOSTICS" is written in a smaller, sans-serif font below the letters. The logo is black and white.

Indications For Use:

The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count, differential leucocyte count as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF) is to monitor erythropoietic activity in patients.

#### Comparison to Predicate Devices:

ABX PENTRA 120 RETIC Automated Hematology Analyzer is identical to the ABX PENTRA 120 RETIC Hematology Analyzer with respect to the reagents and controls, measuring principles, principles of operation, hardware, and software. The ABX PENTRA 120 RETIC Automated Hematology Analyzer labeling was modified to include an additional parameter for reticulocyte counts: the IRF parameter. With respect to this parameter, the IRF parameter is substantially equivalent to the Sysmex R-Series IRF parameter. ABX Diagnostics defines the IRF parameter as the sum of the medium and high RNA content reticulocytes (as %). Sysmex Corporation defines the IRF parameter as the sum of the middle fluorescence ratio and the high fluorescence ratio.

### Discussion of Performance Data:

The determination of substantial equivalence was based on an assessment of clinical performance data from published studies and from a clinical study using whole blood samples from 100 patients with normal reticulocyte counts and 103 patients with abnormal counts. In the clinical study, samples were processed in the ABX PENTRA 120 RETIC Automated Hematology Analyzer and the SYSMEX R-3000 analyzer. Clinical data support substantial equivalence for the IRF parameter. Additional studies were conducted to assess the precision and accuracy of the ABX PENTRA 120 RETIC Automated Hematology Analyzer.

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Image /page/2/Picture/3 description: The image is a logo for ABX Diagnostics. The logo is a black square with the letters "ABX" in white. The letters are stylized and overlapping. The word "DIAGNOSTICS" is printed in small letters below the square.

Conclusions:

All studies confirmed that the IRF clinical parameter of the ABX PENTRA 120 RETIC Automated Hematology Analyzer de substantially equivalent to the Sysmex IRF clinical parameter.

Prepared By: Patricia Amtower Consultant, ProMedica International

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 11 1999

Mr. Franck Brouzes Vice President ABX Diagnostics, Inc. 34 Bunsen Drive Irvine, California 92618

Re: K991839

> Trade Name: ABX™ PENTRA 120 RETIC Automated Hematology Analyzer Regulatory Class: III Product Code: GKZ Dated: May 27, 1999 Received: May 28, 1999

Dear Mr. Brouzes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrlv/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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Attachment 1

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K991839

Device Name: ABX™ PENTRA 120 RETIC Automated Hematology Analyzer

Indications For Use:

The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

Peter E. Madson

(Division Sign-Off)
Division of Clinical Laboratory Devices K991839
510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRFR 801.109)

OR

Over-The-Counter Use -------