The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

Device Description

The ABX PENTRA 60™ 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.

AI/ML Overview

The document describes the ABX PENTRA 60™ Hematology Analyzer and its comparison to a predicate device, the VEGA Hematology Analyzer (K962633), to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative table format with specific thresholds (e.g., "accuracy > 95%"). Instead, it describes performance studies demonstrating comparability to the predicate device. The primary "acceptance criterion" appears to be substantial equivalence to the predicate device, demonstrated through various performance evaluations.

Performance Metric	Reported Device Performance	Notes
Clinical Performance (Comparison to Predicate Device)	Performance data on various hematological indices using human blood samples processed in both the ABX PENTRA 60™ and the VEGA Hematology Analyzer. The overall effect of modifications (hardware, reagents, dilution ratios) on safety and efficacy was evaluated in a clinical study.	The document states "Performance data on various hematological parameters comparing the ABX PENTRA 60™ Hematology Analyzer and the VEGA Hematology Analyzer... indicate that the ABX PENTRA 60™ is substantially equivalent to the predicate device." Specific numerical results (e.g., correlation coefficients, mean differences) are not provided in this summary.
Assay Linearity/Sensitivity	Evaluated using commercially available low-range and high (full) range specimens.	Studies were performed; specific quantitative results are not detailed.
Carry-over	Evaluated using commercially available low-range and high (full) range specimens.	Studies were performed; specific quantitative results are not detailed.
Precision (Within-run)	Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range.	Studies were performed; specific quantitative results (e.g., CV%) are not detailed.
Precision (Between-run)	Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range.	Studies were performed; specific quantitative results are not detailed.
Precision (Between-day)	Evaluated using three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin in the low, normal, and high range.	Studies were performed; specific quantitative results are not detailed.
Sample Stability	Evaluated using clinical samples.	Studies were performed; specific details on the stability parameters are not detailed.
Software Validation	New software has been validated to address modifications.	The nature and extent of validation are not detailed.

2. Sample Sizes used for the Test Set and Data Provenance:

Sample Size for Clinical Comparison:
- 105 clinical specimens from patients with normal complete blood count.
- 104 clinical specimens from patients with at least one parameter outside the normal range.
- Total:* 209 human blood samples for predicate device comparison.
Sample Size for Linearity/Sensitivity and Carry-over: "Commercially available low range and high (full) range specimens." (Number not specified)
Sample Size for Precision: "Three commercially available control specimens having leukocytes, erythrocytes, platelets, and hemoglobin the low, normal and high range." (Number of runs/days not specified)
Data Provenance: "Human blood samples" and "clinical specimens." The country of origin is not explicitly stated, but the company is based in Irvine, CA, suggesting the samples were likely from the US, though this is not confirmed. The study appears to be retrospective in the sense that the samples were already collected and then analyzed on both devices, or prospective in analyzing new samples on both. Given the phrasing, it's more likely a direct comparison study on a set of clinical samples.

3. Number of Experts used to establish the ground truth for the test set and their qualifications:

The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of diagnostic image interpretation. The "ground truth" for hematology analyzers is typically considered the reference method or the predicate device's results, which are themselves subject to established clinical laboratory standards. There is no mention of radiologists, pathologists, or other human experts manually reviewing the blood samples to establish a "ground truth" against which the device's performance was compared beyond the predicate device.

4. Adjudication Method for the test set:

Not applicable in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used for interpreting subjective findings like medical images where human consensus is needed to establish ground truth for an AI system. For a hematology analyzer, the comparison is against the predicate device's quantitative results or established control values.

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:

Not applicable. This is a standalone diagnostic laboratory instrument, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study examining reader improvement with AI assistance was not performed.

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

Yes, this entire study describes the standalone performance of the ABX PENTRA 60™ Hematology Analyzer. It is an automated instrument that provides complete blood count and leukocyte differential count without direct human interpretation of individual cellular images or raw data. The "algorithm" here refers to the device's inherent cytochemistry, flow impedance, and light transmission principles, and its microprocessor-driven analysis.

7. The type of ground truth used:

The primary "ground truth" used for establishing substantial equivalence was:

Predicate Device Performance: The results from the CE-cleared VEGA Hematology Analyzer (K962633). The ABX PENTRA 60™'s performance was compared directly to this device for various hematological indices.
Commercially Available Controls/Specimens: Used for evaluating linearity, carry-over, and precision. These controls have known or expected values.

8. The sample size for the training set:

The document does not specify a separate training set or details about how the internal algorithms of the ABX PENTRA 60™ were trained. This is typical for a 510(k) summary for a traditional laboratory instrument, where the focus is on the validation of the final product's performance against a predicate and established methods rather than detailing the internal development/training of the proprietary analytical methods.

9. How the ground truth for the training set was established:

Since a training set is not explicitly mentioned or detailed, the method for establishing its "ground truth" is also not described. The instrument's underlying principles (cytochemistry, flow impedance, light transmission) are well-established analytical techniques in hematology, rather than a machine learning model that requires explicit "ground truth" labeling during a training phase in the AI sense.

Summary

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OCT 1 5 1999

Premarket Notification [510(k)] Summary

ABX Diagnostics, Inc. Company: 34 Bunsen Drive Irvine, CA 92618 Phone: (949) 453-0500 FAX: (949) 453-0600 Contact Person: Franck Brouzes Date Prepared: May 15, 1999

ABX PENTRA 60TM Hematology Analyzer Trade Name:

Common Name:	Automated cell counter andAutomated differential cell counter
Classification Name:	Automated cell counter (864.5200) and

Substantial Equivalence:

The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the VEGA Hematology Analyzer (K962633, cleared to market November 4, 1996).

Automated differential cell counter (864.5220)

Description:

Indications For Use:

The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

ABX Diagnostics, Inc.

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Image /page/1/Picture/0 description: The image is a black and white logo for ABX Diagnostics. The logo features the letters "ABX" in a stylized, interconnected design. Below the letters, the word "IAGNOSTICS" is written in a simple, sans-serif font. The logo is simple and modern.

Comparison to Predicate Devices:

The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the already cleared device with respect to the indications for use, the hematological parameters for complete blood count and differential leucocyte count, and the principles of operation. It is different with respect to those modifications in hardware (mechanical and pneumatic) necessary to downsize the instrument, the added feature of pre-heated reagent block chambers, reduced specimen volume using a multi-distribution sampling system (MDSS), and slight changes in the reagents and the dilution ratios. The overall effect of these modifications on the safety and efficacy of the device have been evaluated in a clinical study. Software changes have been made to address the modifications and the new software has been validated.

Discussion of Performance Data:

The determination of substantial equivalence is based on an assessment on performance data on various hematological indices using human blood samples processed in the ABX PENTRA 60™ Hematology Analyzer and in the VEGA Hematology Analyzer. The human blood samples included 105 clinical specimens from patients having a normal complete blood count and 104 from patients having at least one parameter outside the normal range. Clinical samples were also used to evaluate sample stability.

Assay linearity/sensitivity and carry-over were evaluated using commercially available low range and high (full) range specimens. Within-run, between-run, and between-day precision were evaluated using three commercially available control specimens having leukocvtes, erythrocvtes, platelets, and hemoglobin the low, normal and high range.

Conclusions:

Performance data on various hematological parameters comparing the ABX PENTRA 60TM Hematology Analyzer and the VEGA Hematology Analyzer, assay linearity/sensitivity and carry-over studies and within-run, between run, and between-day precision studies indicate that the ABX PENTRA 60™ is substantially equivalent to the predicate device.

Prepared By: Patricia Amtower Consultant, ProMedica International

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 1999

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

Re: · K992511

Trade Name: ABX PENTRA 60™ Hematology Analyzer Regulatory Class: II Product Code: GKZ Dated: July 23, 1999 Received: July 27, 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 (OS) 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 Butman

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 992511

Device Name: ABX PENTRA 60™ Hematology Analyzer

Indications For Use:

The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

(PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CRFR 801.109)

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.”