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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA 120/120 RETIC Hematology Analyzer and its SPS option, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes improvements to the device, specifically the increase of linearity ranges for White Blood Cell (WBC) and Platelet (PLT) counts. For the SPS (Slide Preparation System), the focus was on the correlation of results between manual and automated methods.

Device Performance for ABX PENTRA 120/120 RETIC:

Test / Metric	Acceptance Criteria (Implied)	Reported Device Performance
WBC Linearity	(Not explicitly stated, but implies meeting previous standard and extending)	Linearity claim increase up to 150 x 10^3/uL
Platelet Linearity	(Not explicitly stated, but implies meeting previous standard and extending)	Linearity range up to 2000 x 10^3/uL
WBC Imprecision (Total CV%)	(Not explicitly stated, but typically below a certain threshold for diagnostic devices)	Ranged from 1.1% to 3.9%
Platelet Imprecision (Total CV%)	(Not explicitly stated, but typically below a certain threshold for diagnostic devices)	Ranged from 3.1% to 7.4%
WBC Accuracy / Bias (Correlation with predicate)	Good correlation expected (e.g., R^2 > 0.95 or 0.98)	R^2 = 0.995 (with Abbott CD 4000)
Platelet Accuracy / Bias (Correlation with predicate)	Good correlation expected (e.g., R^2 > 0.95 or 0.98)	R^2 = 0.99 (with Baker 9110 Plus)

Device Performance for SPS (Slide Preparation System):

Test / Metric	Acceptance Criteria (Implied)	Reported Device Performance
Correlation of results (Manual vs. SPS)	Excellent correlation expected	Excellent correlation demonstrated
Identification of pathologies	Correct identification of all pathologies	All pathologies were correctly identified

General Acceptance:

Clinical testing met all acceptance criteria.
The device meets the IEC 1010-1 standard for electrical equipment for measurement, control, and laboratory use.
All clinical and non-clinical tests show appropriate levels of safety and effectiveness.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests (e.g., how many samples were used for linearity assessment, imprecision, or accuracy). The document mentions "all WBC results compared" and "all platelet results compared," suggesting a comprehensive comparison across the tested range.
- Data Provenance: Not specified (e.g., country of origin, specific hospitals). The studies are described as "clinical testing." "Retrospective or prospective" is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. For automated hematology analyzers, ground truth often comes from established predicate devices and internal validation standards (e.g., reference methods, manual microscopy by trained professionals). For the SPS, the "manual method" served as the comparison, implying human expert evaluation.
Adjudication method for the test set:
- Not mentioned.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for diagnostic imaging AI systems where human interpretation is a primary output. The ABX PENTRA is an automated analyzer, and the SPS automates slide preparation, not interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (linearity, imprecision, accuracy) for the ABX PENTRA 120/120 RETIC represents the standalone performance of the algorithm/instrument. For the SPS, its function is automated slide preparation, which is inherently a "standalone" or automated process that is then evaluated against a manual process.
The type of ground truth used:
- For the ABX PENTRA 120/120 RETIC (WBC and PLT counts): The ground truth was established by comparison to predicate devices (ABBOTT CD 4000 for leukocytes and BAKER 9110 Plus for platelets), which are considered established and accurate methods. Linearity data was "generated according to FDA guidelines," implying recognized reference standards.
- For the SPS: The ground truth was the "manual method" of smearing and staining slides, which would involve human expertise in microscopy for evaluation.
The sample size for the training set:
- Not mentioned. As this is an automated analyzer dealing with fundamental blood cell counts and not a machine learning model in the contemporary sense, the concept of a distinct "training set" for algorithm development as seen in AI is not directly applicable in the same way. The device is likely calibrated and validated through engineering and typical quality control samples.
How the ground truth for the training set was established:
- Not applicable in the context of "training set" for an AI model. For general instrument calibration and validation, ground truth would be established using reference materials, assayed controls, and comparisons to established, highly accurate (often manual or predicate) methods.

Summary

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Premarket Notification [510(k)] Summary

ABX Diagnostics

Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 - France Tél. : 33 (0) 4 67 14 15 16 Fax : 33 (0) 4 67 14 15 17

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 (tlawton@fr.abx.fr)

Date Prepared: June 28, 2002

Device Name:

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

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 (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" (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 (800) 638-2041 or (301) 443-6597 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 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)

Signature
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K022300
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ABX Diagnostics (Horiba Group)
Section 4-1

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.”