The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

Device Description

The PENTRA 80 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, with an internal PC that performs further data processing and hosts the user interface.

AI/ML Overview

The provided text describes the ABX PENTRA 80 Hematology Analyzer and its performance in a 510(k) premarket notification. However, it does not contain a detailed table of acceptance criteria or performance metrics with specific numerical values for a direct comparison. The information is presented in a narrative format, highlighting that the device met certain standards and showed good correlation with a predicate device.

Here's an attempt to extract the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Acceptable for all parameters (in accordance with EP5-A NCCLS guidelines)	"good precision... and is entirely acceptable for all available parameters." (No specific numerical values provided in the summary, only a general statement of compliance with guidelines.)
Linearity	Supported by clinical data	WBC (0-120 x 10^3/μL), RBC (0 - 8.0 x 10^6/uL), HGB (0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/1 (0 - 1,900 x 10^3/μL), and PLT with Hgb<2g/1 (0 - 2,800 x 10^3/uL) "are entirely supported by the clinical data provided." (No specific linearity coefficients or statistical measures provided in the summary.)
Accuracy (Inter-procedural Correlation)	Strong correlation (e.g., R^2 > 0.95 with predicate device)	"no evidence of significant bias between the PENTRA 80 and the Abbott CD 4000 provided good correlation of R^2>0.95 for WBC, PLT, RBC, HGB, HCT parameters."
Leukocyte Differentiation	Good results on differentiation between true & false positives and true & false negatives	"provided good results on the differentiation between true & false positives and true & false negatives." (No specific sensitivity, specificity, or accuracy metrics provided.)
Sample Stability	Relative sample stability over a 48-hour period at 4°C	"assures a relative sample stability over a 48 hour period at 4°C."
Carry Over	<2% for WBC, RBC, HGB, PLT	"Carry Over claim of <2% for WBC, RBC, HGB, PLT."
Safety and Effectiveness	Device safety and effectiveness not compromised, meet acceptance criteria, comply with standards	"safety and effectiveness of the device is not compromised. Clinical testing met all acceptance criteria... meets with the IEC 1010-1 standard... As well as the EN 61326 standard... All clinical and non clinical tests show appropriate levels of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance
The document states that "The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines," and refers to "clinical data provided in this submission" and "clinical data of this study." However, no specific sample size for the test set is mentioned.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective for comparison with a predicate device (Abbott CD 4000).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study primarily focuses on comparing the new device's performance against a predicate device and established guidelines (NCCLS, IEC) for various hematological parameters. There is no mention of human expert reading or consensus to establish ground truth for differential cell counts in the summary.

4. Adjudication Method for the Test Set
Since there is no mention of experts establishing a ground truth for a test set in the traditional sense of medical image analysis or complex diagnoses, there is no adjudication method described. The 'ground truth' appears to be derived from the performance of a predicate device (Abbott CD 4000) or established laboratory reference methods against which the ABX PENTRA 80 was tested.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done as described for human readers. This device is an automated hematology analyzer, not an AI-assisted diagnostic tool designed to augment human interpretation in the way an MRMC study would typically evaluate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance discussed in the document is for the standalone algorithm/device (ABX PENTRA 80 Hematology Analyzer) without human-in-the-loop performance being explicitly measured for its diagnostic output. The device is described as "fully automated (microprocessor controlled)."

7. The Type of Ground Truth Used
The ground truth appears to be established through:

Comparison to a predicate device: Abbott CD 4000 (K961439) for accuracy and inter-procedural correlation.
Compliance with established laboratory guidelines/standards: EP5-A (NCCLS guidelines) for precision, and implied standard methods for linearity and other parameters.
Expected biological stability: For sample stability claims.

8. The Sample Size for the Training Set
The document does not mention a training set sample size. As a traditional automated laboratory instrument rather than a machine learning/AI diagnostic, the concept of a distinct 'training set' for the device's algorithms in the modern AI sense is not highlighted or described. The instrument's algorithms are likely based on established cytochemistry, impedance, and light transmission principles, calibrated and validated, rather than 'trained' on large datasets in the way current AI models are.

9. How the Ground Truth for the Training Set Was Established
Given the nature of the device as an automated analytical instrument and the lack of mention of a distinct training set in the AI sense, this information is not applicable or not provided in the summary. The "ground truth" for the device's operational principles would be rooted in fundamental scientific principles and established laboratory measurement techniques, rather than a dataset with annotated ground truth.

Summary

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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 : K024002

Company: ABX Diagnostics 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: November 27th, 2002

Device Name:

Trade/Proprietary Name:	ABX PENTRA 80 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

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Substantial Equivalence:

The ABX PENTRA 80 based on the same fundamental technology as the predicate device ABX PENTRA 60C+ cleared to market under K003677.

The use of a second predicate device to show its clinical capability compatibility was used ABBOTT CD 4000 (K961439).

Description:

Intended Use :

The PENTRA 80 is fully automated (microprocessor controlled) multi-parameter hematology analyzer intended for in in-vitro diagnostic use in the clinical laboratory environment.

Determination of substantial equivalence :

The PENTRA 80 is substantially equivalent to the already cleared device PENTRA 60C+ with respect to the indications for use, the hematological parameters for complete blood count and differential leukocyte count, and the principles of operation (fundamental scientific technology).

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Discussion of Performance Data:

The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines.

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

The linearity claim for the parameters WBC (0-120 x 103/μL), RBC (0 -- 8.0 x 10 /uL), HGB(0 -- 24g/dl), HCT (0 -- 67%), PLT with Hgb>2g/1(0 - 1,900 x 103/μL) and PLT with Hgb<2g/1 (0 - 2800 x 10 /uL) are entirely supported by the clinical data provided in this submission.

Accuracy (Inter-procedural Correlation) showed no evidence of significant bias between the PENTRA 80 and the Abbott CD 4000 provided good correlation of R2>0.95 for WBC, PLT, RBC, HGB, HCT parameters.

Leukocyte Differentiation provided good results on the differentiation between true & false positives and true & false negatives.

This study data assures a relative sample stability over a 48 hour period at 4°C.

No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry Over claim of <2% for WBC, RBC, HGB, PLT.

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 1010-1 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.

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Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Regulatory Affairs Manager ABX Parc Euromedecine Rue du Caducee BP 7290 34184 Montpellier Cedex 4 FRANCE

JAN 0 3 2003

Re: K024002

Trade/Device Name: ABX PENTRA 80 Hematology Analyzers Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: November 29, 2002 Received: December 4, 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. Iisting 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).

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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.

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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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PENTRA 80

Special 510(k): Device Modification

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

ABX PENTRA 80 Hematology Analyzers Device Name:

Indications For Use:

The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

(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 __________
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J. Reeves for S. Bautista

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number: K024002

ABX Diagnostics (Horiba Group)

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.”