The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.

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

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

Device Description

The PENTRA DX 120 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, reticulocyte and NRBC 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 Evolution (Slide Preparation System) smears and stains the slides.

AI/ML Overview

The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)

The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.

Performance Metric	Acceptance Criteria (Implicit/General Statement)	Reported Device Performance
Precision (NRBC)	"good precision in accordance with EP5-A (NCCLS guidelines)"	"good precision ... and is entirely acceptable for the NRBC"
Linearity (NRBC/100 WBC Count)	"linearity limits claim... are entirely supported"	"entirely supported by the clinical data provided in this submission."
Accuracy (Inter-procedural Correlation - NRBC)	No specific numerical criteria stated, but implied to show no significant bias.	"showed no evidence of significant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r^2 ranging between 0.96 - 0.98."
Differentiation (True/False Positives/Negatives - NRBC)	Implied to be comparable to predicate systems.	"provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems."
Sample Stability (NRBC)	Implied to assure relative sample stability over 24 hours.	"assures a relative sample stability over a 24 hour period at both room temperature and 4°C."
Carry Over (NRBC)	Implied to be less than 1%.	"supporting a Carry Over claim of <1%"
Overall Clinical Testing	"met all acceptance criteria."	"Clinical testing met all acceptance criteria."

Note: The text explicitly states that "Clinical testing met all acceptance criteria," but the specific numerical targets for these criteria are not detailed in the provided document.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study is referred to as "clinical data" and "clinical studies."

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

This information is not provided in the text. The ground truth for accuracy studies was established by comparison to predicate devices and multiparameter flow cytometry.

4. Adjudication Method for the Test Set

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC comparative effectiveness study is not mentioned and is not applicable to an automated hematology analyzer, which performs calculations and classifications automatically without human intervention for the primary analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data described is for the standalone device (ABX PENTRA DX 120 Hematology Analyzer) without human intervention in the primary measurement and analysis of blood parameters. The device is an "Automated Hematology Analyzer."

7. The Type of Ground Truth Used

For the NRBC parameter accuracy, the ground truth was established by comparison/correlation with predicate devices (ABBOTT CD 4000, SYSMEX XE-2100) and multiparameter flow cytometry.

8. The Sample Size for the Training Set

This information is not provided in the text. Automated hematology analyzers typically don't have "training sets" in the same sense as machine learning or AI algorithms with distinct training phases documented in 510(k)s from this era, but rather are developed and validated against a range of clinical samples during their engineering and design process.

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

This information is not provided in the text. Given the nature of the device (automated hematology analyzer) and the era of the submission (2005), the concept of a separate "training set" with established ground truth as understood in modern AI/ML studies is less applicable or explicitly described in this document. Development would involve extensive testing against validated methods.

Summary

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

APR 2 6 2005

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 : K050719

Company: Horiba ABX 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 (tlawton@fr.abx.fr)

Date Prepared: 14th March 2005

Device Name:

Trade/Proprietary Name:	ABX PENTRA DX 120 Hematology Analyzer
Common or Usual Name:	Automated cell counter and
	Automated differential cell counter
Device Class	Class II : Special Controls Guidance Document
Classification Name:	Automated cell counter (§864.5200) and
	Automated differential cell counter (§864.5220)
Product Code:	GKZ
Optional device name :
Trade/Proprietary Name:	SPS Evolution (Slide Preparation System)
Common or Usual Name:	Slide Preparation System
Device Class	Class I : exempt
Classification Name:	Automated Slide Stainer : §864.3800
	Automated Slide Spinner : §864.5850
Product Code:	KPA
	GKJ

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

Substantial Equivalence:

The ABX PENTRA DX 120 is considered comparable to the predicate device ABX PENTRA 120 cleared to market under K962633, K990311, K991839 and K022200.

The fundamental scientific technology for the analyzer itself has not changed. Including, hematological parameters for complete blood count, differential leucocyte count, reticulocyte counting, the reagents and controls, measuring principles, and the principles of operation are the same as previously cleared by the FDA.

Whilst the SPS Evolution (Slide Preparation System) is considered substantially equivalent to the SPS used on the ABX PENTRA 120.

For the validation of the NRBC parameter on the ABX PENTRA DX 120 the following different predicate devices were used during the clinical evaluation of the NRBC parameter :

ABBOTT CD 4000 (K961439) SYSMEX XE-2100 (K992875)

Description:

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

Intended Use :

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

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

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

Determination of substantial equivalence :

The ABX PENTRA DX 120 in this submission is substantially equivalent to the predicate device the ABX PENTRA 120 with respect to the indications for use, the hematological parameters for complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and the principles of operation (fundamental scientific technology).

The ABX PENTRA DX 120 provides an additional parameter, the nucleated red blood cell count (NRBC) having comparable measurement techniques of nucleic acid fluorescence to both predicate devices.

Discussion of Performance Data:

The studies and data analysis carried out in accordance with appropriate indications given by the FDA guidelines were compiled to support the claims in this submission.

NRBC :

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

The linearity limits claim for the NRBC/100 WBC Count parameter are entirely supported by the clinical data provided in this submission.

Accuracy (Inter-procedural Correlation) showed no evidence of sigmificant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r2 ranging between 0.96 - 0.98.

The HoribaABX Pentra DX120 provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems.

This study data assures a relative sample stability over a 24 hour period at both room temperature and 4°C.

No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry Over claim of <1%.

Platelet parameter : The submission supports an extended range claim for Platelets with Hgb<2g/dl of 0 -2800 x 10°/mm³.

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

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 61010-1 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.

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

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 stylized eagle with three lines representing its wings or feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

APR 2 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromédecine Rue du Caducée-BP 7290 34184 Montpellier cedex 4 FRANCE

Re: K050719

Trade/Device Name: ABX PENTRA DX 120 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated cell counter and differential cell counter Regulatory Class: II Product Code: GKZ, KPA, GKJ Dated: March 14, 2005 Received: March 21, 2005

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 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). 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.

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

Page 2 -

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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerph

Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for HORIBA ABX Diagnostics. The word "HORIBA" is in large, bold, black letters, followed by "ABX" in a smaller, less bold font. Below the logo, the word "Diagnostics" is written in a smaller font.

ABX PENTRA DX 120 [Option SPS Evolution]

510(k): Device Modification

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

ABX PENTRA DX 120 Hematology Analyzer Device Name: Option : SPS Evolution (Slide Preparation System)

Indications For Use:

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

The option of the SPS Evolution (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
(Per 21 CRFR 801.109)

Over-The-Counter Use

Division Sign-off

Office of In Vitro Diagnostic Device
Evaluation and Safety

K050719

HORIBA ABX, FRANCE

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.”