The VEGA 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 VEGA RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

Device Description

The VEGA 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 text describes the VEGA RETIC Automated Hematology Analyzer and its performance assessment for 510(k) clearance. However, it does not explicitly state "acceptance criteria" in a tabulated format. Instead, it discusses the study conducted to demonstrate "substantial equivalence" to predicate devices, which implies meeting performance benchmarks comparable to those devices.

Here's an interpretation of the performance data as "acceptance criteria" and how the study addresses them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Discussion of Performance Data" and "Conclusions" sections, the implied acceptance criteria are that the VEGA RETIC performs comparably to the SYSMEX R-3000 for reticulocyte analysis and to the VEGA Hematology Analyzer for CBC and differential counts, meeting certain standards for correlation, precision, linearity, stability, and carry-over.

Acceptance Criteria (Implied)	Reported Device Performance
Correlation with Predicate Device (SYSMEX R-3000) for Reticulocyte Counts: High correlation between absolute/proportional reticulocyte counts and absolute erythrocyte counts.	Performance data comparing the VEGA RETIC and SYSMEX R-3000 demonstrated that the absolute/proportional reticulocyte counts and absolute erythrocyte counts generated on clinical specimens tested with each procedure are highly correlated.
Precision (Within-run, Between-run, Between-day): Similar to publicly available data for SYSMEX R-3000.	Performance data demonstrated that the within-run, between-run, and between-day precision characteristics of the two procedures (VEGA RETIC and SYSMEX R-3000) are very similar.
Assay Linearity for Reticulocyte Counts: Linear over a broad range of values.	The VEGA RETIC Automated Hematology Analyzer provides linear absolute/proportional reticulocyte count data over a broad range of values.
Sample Carry-over Effect: Minimal carry-over from high to low reticulocyte count samples.	Performance data indicate that very little sample carry-over occurs.
Sample Stability: Reliable estimates for reticulocyte counts after storage (e.g., 48 hours at 4°C) and for erythrocyte counts after storage (e.g., 72 hours at ambient or 4°C).	Samples stored up to 48 hours at 4°C provide reliable estimates of absolute/proportional reticulocyte counts, and samples stored up to 72 hours at ambient or 4°C provide reliable estimates of erythrocyte counts. (Note: the original text mentions erythrocyte counts for 72 hours, not reticulocyte)

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

Sample Size: 200 human whole blood samples.
Data Provenance: The data used for comparative equivalence testing primarily focused on human whole blood samples. The document does not specify the country of origin, but given the submission is to the FDA, it is highly likely to be U.S. or internationally applicable clinical data. The study is prospective in the sense that these 200 samples were processed and then compared, implying a planned data collection for this evaluation rather than solely analyzing pre-existing records.

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

The document does not provide information regarding:

The number of experts used.
The qualifications of those experts.

The ground truth for the comparison was established by the predicate device (SYSMEX R-3000) and the VEGA Hematology Analyzer, which themselves are established and cleared devices. The study focuses on correlation between the devices rather than direct comparison to a human expert's judgment of cell counts.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method involving human experts for the test set. The comparison is directly between the new device and predicate devices.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done.
This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that supports human readers in interpreting images. Its output is quantitative measurements (cell counts) rather than qualitative interpretations requiring human review and potential AI enhancement.

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

Yes, a standalone performance evaluation was conducted. The VEGA RETIC Automated Hematology Analyzer is designed to operate as a standalone instrument, providing complete blood counts, differential leukocyte counts, and reticulocyte counts without direct human intervention in the primary measurement process. The study evaluates the device's performance (correlation, precision, linearity, stability, carry-over) independently against predicate devices, which is a standalone assessment.

7. The Type of Ground Truth Used

The ground truth for the reticulocyte analysis was based on the performance of the legally marketed predicate device, the SYSMEX R-3000 Automated Reticulocyte Analyzer. For CBC and differential counts, the ground truth was based on the VEGA Hematology Analyzer. This is essentially a "predicate device comparison" as the ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a specific "training set" or its size. As this is a 510(k) submission focused on demonstrating substantial equivalence to existing devices, the focus is on verification and validation against those predicate devices, rather than a de novo development process that might extensively detail training sets for machine learning models.

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

Since no training set information is provided, the method for establishing its ground truth is also not described. For an automated device like this, the "ground truth" for its internal calibration and operational algorithms would typically be established during its development using reference methods and extensive internal validation, but these details are not part of this 510(k) summary.

Summary

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K990311

Premarket Notification [510(k)] Summary

Company: ABX Diagnostics, Inc. 34 Bunsen Drive Irvine, CA 92618 Phone: (949) 453-0500 FAX: (949) 453-0600 Contact Person: Franck Brouzes Date Prepared: January 18, 1999

Trade Name: VEGA RETIC Automated Hematology Analyzer

Common Name:	Automated cell counter andAutomated differential cell counter
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Classification Name:	Automated cell counter (864.5200) andAutomated differential cell counter (864.5220)
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Substantial Equivalence:

The VEGA RETIC Automated Hematology Analyzer is substantially equivalent to the following devices:

VEGA Hematology Analyzer (K962633, cleared to market November 4, 1996). .
SYSMEX R-3000 Automated Reticulocyte Analyzer (K912494, cleared for market . September 10, 1991).

Description :

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Indications For Use:

The VEGA 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 VEGA RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

Comparison to Predicate Devices:

VEGA RETIC Automated Hematology Analyzer is essentially identical to the VEGA Hematology Analyzer with respect to the indications for use for the hematological parameters for complete blood count and differential leucocyte count. The reagents and controls and the technological characteristics (cytochemistry, focused flow impedance and light scattering) are the same.

VEGA RETIC Automated Hematology Analyzer is similar to the SYSMEX R-3000 with respect to the indications for use for the reticulocyte count. The reagents and controls are similar. The technological characteristics are similar: both systems use a fluorescent dye and argon optical laser bench to measure forward scattered light and forward fluorescence.

Discussion of Performance Data:

The determination of substantial equivalence is based on an assessment of clinical performance data comparing results from 200 human whole blood samples processed in the VEGA RETIC Automated Hematology Analyzer and in the SYSMEX R-3000 with respect to correlation between the two procedures.

In addition the within-run, between run, and between-day precision of the VEGA RETIC Automated Hematology Analyzer was evaluate using three commercially available control specimens having low, normal and high reticulocyte counts. These results were compared to publicly available data for the SYSMEX R-3000.

The following additional performance assessments were made: assay linearity, sample stability over time at ambient and low temperatures, and the carry-over effect from a high reticulocyte count sample to a low reticulocyte count sample.

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Conclusions:

Performance data comparing the VEGA RETIC Automated Hematology Analyzer and the SYSMEX R-3000 demonstrated that the absolute/proportional reticulocyte counts and absolute erythrocyte counts generated on clinical specimens tested with each procedure are highly correlated. Additionally performance data demonstrated that the within-run, between run, and between-day precision characteristics of the two procedure are very similar. The VEGA RETIC Automated Hematology Analyzer provides linear absolute/proportional reticulocyte count data over a broad range of values. Performance data indicate that very little sample carry-over occurs and that samples stored up to 48 hours at 4°C provide reliable estimates of absolute/proportional reticulocyte counts and samples stored up to 72 hours at ambient or 4°C provide reliable estimates of erythrocyte counts.

Prepared By: Patricia Amtower Consultant, ProMedica International

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Public Health Service

MAR 3 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Franck Brouzes Vice President ABX Diagnostics, Inc. 34 Bunsen Drive Irvine, California 92618

Re: K990311

Trade Name: ABX™ PENTRA 120 RETIC Automated Hematology Analyzer Regulatory Class: II Product Code: GKZ Dated: January 28, 1999 Received: February 1, 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.

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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/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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K 990311

Device Name: VEGA RETIC Automated Hematology Analyzer

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)

Over-The-Counter Use

Peter E. Mhum

(Division Sign-Off)
Division of Clinical Laboratory Devices K990311
510(k) Number

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.”