The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.

Device Description

The ABX MICROS 60 device is a benchtop, clinical laboratory instruments that analyze in-vitro samples of whole blood specimens. The device operates in a complete blood count (CBC) and 3 part DIFF (LMG). As either a closed tube / closed system (CT/CS) or open tube/open system (OT/OS). The ABX MICROS 60 can evaluate 5,8, 16 or 18 hematology parameters depending on its internal configuration.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the ABX MICROS 60 Hematology Analyzer based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses that the device met acceptance criteria, but specific quantitative criteria for each parameter are not explicitly detailed in a separate table. Instead, general statements about meeting guidelines and correlations are provided.

Performance Metric	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Precision	In accordance with EPS-A (NCCLS guidelines)	"good precision... and is entirely acceptable for all parameters." No change to claimed limits.
Linearity	Supported by clinical data	WBC (0-100 x 10³/mm³), RBC (0-8.0 x 10⁹/mm³), HGB (0-26g/dl), HCT (0-80%), PLT with Hgb>2g/dl (0-2,200 x 10³/mm³), PLT with Hgb<2g/dl (0-4000 x 10³/mm³) - "entirely supported by the clinical data"
Accuracy (Inter-procedural Correlation)	Good correlation with predicate device (R > 0.95)	"demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000 provided good correlation of R>0.95 for all parameters." No change to claimed limits.
Safety and Effectiveness	Device is not compromised	"The clinical studies conclude that the safety and effectiveness of the devices is not compromised. Clinical testing met all acceptance criteria." "All clinical and non clinical tests show appropriate levels of safety and effectiveness."
Electrical Equipment Standard	Meets IEC 1010-1	Device "meets with the IEC 1010-1 standard"
Electromagnetic Compatibility	Meets EN 61326	Device "meets with... the EN 61326 standard"

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

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical data provided in this submission" and "clinical studies," but no specific sample size (number of patients or specimens) is given for the test set used to evaluate linearity and accuracy.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

Number and Qualifications of Experts: Not mentioned. For a hematology analyzer, ground truth typically refers to reference methods performed by trained laboratory personnel or comparison to a predicate device. The document states "Accuracy (Inter-procedural Correlation) demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000," implying the Abbott CD 4000 served as the reference/ground truth for accuracy assessment.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable or not described. This type of adjudication is more common in studies involving subjective interpretation (e.g., medical imaging reads). For an automated hematology analyzer, performance is typically assessed by comparing its quantitative results against a reference method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, an MRMC study was not done. This type of study would involve human readers interpreting cases with and without AI assistance, which is not relevant for an automated hematology analyzer like the ABX MICROS 60. The device performs automated analysis without human interpretation in the loop.

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

Standalone Performance: Yes, the entire performance evaluation described is for the device in standalone mode. The ABX MICROS 60 is an "automated cell counter and automated differential cell counter" and a "fully automated (microprocessor controlled) multi-parameter hematology analyzer." The performance data presented (precision, linearity, accuracy) are for the device operating independently.

7. The Type of Ground Truth Used:

Ground Truth Type:
- For precision and linearity, the ground truth would typically be established by repeated measurements on stable samples and statistical analysis to ensure reproducibility and accurate measurement across concentration ranges.
- For accuracy (inter-procedural correlation), the ground truth was established by comparison to a legally marketed predicate device, the ABBOTT CD 4000 (K961439).

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable or not stated. Hematology analyzers like the ABX MICROS 60 typically rely on established physical principles (e.g., impedance, optical scattering) and calibrated reagents rather than machine learning algorithms trained on a dataset. Therefore, the concept of a "training set" in the context of AI/ML is not directly relevant here. The device is "based on the same fundamental technology" as predicate devices.

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

Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the AI/ML sense. The device's operation is based on established scientific principles rather than being trained on a dataset.

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 : H030799

Company: ABX Diagnostics Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:

Contact Person: Tim Lawton (tlawton@fr.abx.fr)

Date Prepared: 07 March, 2003

Device Name:

Trade/Proprietary Names:	ABX MICROS 60 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 MICROS 60 is based on the same fundamental technology as the predicate devices cleared to market under K014203.

The use of a predicate device to show the clinical capability was ABBOTT CD 4000 (K961439).

Description:

Intended Use :

The ABX MICROS 60 is a fully automated (microprocessor controlled) multi-parameter hematology analyzer intended for in in-vitro diagnostic use in the clinical laboratory environment.

Compared to the previous 510k submissions, there is no change to the intended use

Determination of substantial equivalence :

The ABX MICROS 60 the released software version 1.6 is substantially equivalent to the already cleared device MICROS 60 v1.4 (K992511) with respect to the indications for use, the hematological parameters for complete blood count and 3 part differential leucocyte count, and the principles of operation (fundamental scientific technology).

Discussion of Performance Data:

This submission is 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 EPS-A (NCCLS guidelines) and is entirely acceptable for all parameters. No change to the claimed limits is being made in this submission.

The linearity claim for the parameters WBC (0-100 x 103/ mm3), RBC (0 - 8.0 x 109/ mm"). HGB(0 - 26g/dl). HCT (0 - 80%). PLT with Hgb>2g/dl (0 - 2,200 x 10 / mm )

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and PLT with Hgb<2g/dl (0 – 4000 x 103/ mm3) are entirely supported by the clinical data provided in this submission.

Accuracy (Inter-procedural Correlation) demonstrated no evidence of significant bias between the MICROS 60 and the Abbott CD 4000 provided good correlation of R>0.95 for all parameters. No change to the claimed limits is being made in this submission.

The clinical studies conclude that the safety and effectiveness of the devices is not compromised.

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 Drug Administration 2098 Gaither Road Rockville MD 20850

APR 0 8 2003

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

Re: K030799

Trade/Device Name: ABX Micros 60 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: March 7, 2003 Received: March 13, 2003

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). 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

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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MICROS 60

Special 510(k): Device Modification

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

ABX MICROS 60 Hematology Analyzer Device Name:

Indications For Use:

(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

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 030799

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.”