ABX PENTRA 60 HEMATOLOGY ANALYZER

K992511 · Abx Diagnostics · GKZ · Oct 15, 1999 · Hematology

Device Facts

• Record ID: K992511
• Device Name: ABX PENTRA 60 HEMATOLOGY ANALYZER
• Applicant: Abx Diagnostics
• Product Code: GKZ · Hematology
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ 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; performs complete blood count (CBC) or CBC + 5-part differential leucocyte count. Used in clinical laboratory settings by trained personnel. Hardware includes pre-heated reagent block chambers and multi-distribution sampling system (MDSS) for reduced specimen volume. Output provides hematological indices for clinical assessment of patient blood status; aids in diagnosis and monitoring of hematological conditions.

Clinical Evidence

Clinical study compared ABX PENTRA 60 to VEGA predicate using 209 human blood samples (105 normal, 104 abnormal). Evaluated hematological indices, sample stability, assay linearity/sensitivity, carry-over, and precision (within-run, between-run, between-day) using low, normal, and high range controls.

Technological Characteristics

Benchtop hematology analyzer; microprocessor-driven. Principles: cytochemistry, focused flow impedance, halogen light transmission. Features: pre-heated reagent block chambers, multi-distribution sampling system (MDSS).

Indications for Use

Indicated for in vitro diagnostic testing of whole blood specimens to provide complete blood counts and 5-part differential leucocyte 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

• VEGA Hematology Analyzer (K962633)

Submission Summary (Full Text)

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OCT 1 5 1999

# 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 15, 1999
#### ABX PENTRA 60TM Hematology Analyzer Trade Name:

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

## Substantial Equivalence:

The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the VEGA Hematology Analyzer (K962633, cleared to market November 4, 1996).

Automated differential cell counter (864.5220)

#### Description:

The ABX PENTRA 60™ 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.

### Indications For Use:

The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

#### ABX Diagnostics, Inc.

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Comparison to Predicate Devices:

The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the already cleared device with respect to the indications for use, the hematological parameters for complete blood count and differential leucocyte count, and the principles of operation. It is different with respect to those modifications in hardware (mechanical and pneumatic) necessary to downsize the instrument, the added feature of pre-heated reagent block chambers, reduced specimen volume using a multi-distribution sampling system (MDSS), and slight changes in the reagents and the dilution ratios. The overall effect of these modifications on the safety and efficacy of the device have been evaluated in a clinical study. Software changes have been made to address the modifications and the new software has been validated.

## Discussion of Performance Data:

The determination of substantial equivalence is based on an assessment on performance data on various hematological indices using human blood samples processed in the ABX PENTRA 60™ Hematology Analyzer and in the VEGA Hematology Analyzer. The human blood samples included 105 clinical specimens from patients having a normal complete blood count and 104 from patients having at least one parameter outside the normal range. Clinical samples were also used to evaluate sample stability.

Assay linearity/sensitivity and carry-over were evaluated using commercially available low range and high (full) range specimens. Within-run, between-run, and between-day precision were evaluated using three commercially available control specimens having leukocvtes, erythrocvtes, platelets, and hemoglobin the low, normal and high range.

## Conclusions:

Performance data on various hematological parameters comparing the ABX PENTRA 60TM Hematology Analyzer and the VEGA Hematology Analyzer, assay linearity/sensitivity and carry-over studies and within-run, between run, and between-day precision studies indicate that the ABX PENTRA 60™ is substantially equivalent to the predicate device.

Prepared By: Patricia Amtower Consultant, ProMedica International

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 1999

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

Re: · K992511

Trade Name: ABX PENTRA 60™ Hematology Analyzer Regulatory Class: II Product Code: GKZ Dated: July 23, 1999 Received: July 27, 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 (OS) 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 992511

Device Name: ABX PENTRA 60™ Hematology Analyzer

Indications For Use:

The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

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

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