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 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.

AI/ML Overview

The provided 510(k) summary for the ABX PENTRA 120 RETIC Automated Hematology Analyzer describes its performance against a predicate device, rather than explicit acceptance criteria and device performance in a table format. However, the document states that "All studies confirmed that the IRF clinical parameter of the ABX PENTRA 120 RETIC Automated Hematology Analyzer is substantially equivalent to the Sysmex IRF clinical parameter."

Here's an attempt to structure the information based on your request, acknowledging that specific numerical acceptance criteria and reported performance values are not detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Immature Reticulocyte Fraction (IRF) Parameter	Substantial equivalence to the Sysmex R-Series IRF parameter.	"All studies confirmed that the IRF clinical parameter of the ABX PENTRA 120 RETIC Automated Hematology Analyzer is substantially equivalent to the Sysmex IRF clinical parameter."
Precision	Not explicitly stated, but expected to be acceptable for a diagnostic device.	"Additional studies were conducted to assess the precision... of the ABX PENTRA 120 RETIC Automated Hematology Analyzer." (Results not detailed)
Accuracy	Not explicitly stated, but expected to be acceptable for a diagnostic device.	"Additional studies were conducted to assess the... accuracy of the ABX PENTRA 120 RETIC Automated Hematology Analyzer." (Results not detailed)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Size: 203 patients.
- 100 patients with normal reticulocyte counts.
- 103 patients with abnormal reticulocyte counts.
Data Provenance: Retrospective or prospective is not explicitly stated. The study involved "whole blood samples from 100 patients with normal reticulocyte counts and 103 patients with abnormal counts." The country of origin is not specified but is presumably where the clinical study was conducted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The comparison is made against the Sysmex R-3000 analyzer, which serves as the reference, rather than against expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. The study compares the device's output directly to a predicate device (Sysmex R-3000 analyzer), not against expert adjudication of individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

Not applicable. This is a study comparing an automated hematology analyzer to a predicate device, not an MRMC study involving human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was performed. The "Discussion of Performance Data" describes a clinical study where "samples were processed in the ABX PENTRA 120 RETIC Automated Hematology Analyzer and the SYSMEX R-3000 analyzer." This indicates the performance of the ABX PENTRA 120 RETIC as an automated system.

7. Type of Ground Truth Used

The "ground truth" for the performance study establishing substantial equivalence was the results obtained from a legally marketed predicate device, the Sysmex R-3000 analyzer, specifically its IRF parameter.

8. Sample Size for the Training Set

The document does not specify a separate training set. The performance data discussed relates to a clinical study used to demonstrate substantial equivalence, implying it was the main "test set" for this purpose.

9. How the Ground Truth for the Training Set Was Established

As no separate training set is mentioned, this information is not provided. The comparison was against the predicate device.

Summary

{0}------------------------------------------------

K99/839

Image /page/0/Picture/2 description: The image is a black square with the letters 'ALX' in white. The letters are stylized and overlapping, with the 'A' and 'L' connected at the top and the 'L' and 'X' connected at the bottom. The letters are bold and have a slightly rough, textured appearance. The overall design is simple and modern.

Premarket Notification [510(k)] Summary

ABX Diagnostics, Inc. Company: 34 Bunsen Drive Irvine, CA 92618 Phone: (949) 453-0500 FAX: (949) 453-0600 Contact Person: Franck Brouzes Date Prepared: May 21, 1999

ABX™ PENTRA 120 RETIC Automated Hematology Trade Name: Analyzer

Common Name:	Automated cell counter andAutomated differential cell counter
Classification Name:	Automated cell counter (864.5200) andAutomated 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:

{1}------------------------------------------------

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

Image /page/3/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 an abstract symbol that resembles a stylized eagle or bird in flight, composed of three wavy lines that suggest the feathers or wings of the bird.

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.

{4}------------------------------------------------

Page 2

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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

{5}------------------------------------------------

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 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)

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

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
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.(b)
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.”