The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Device Description

The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement of leukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology. Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical laser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive, informative, and attractive user interface. A START button allows one-touch operation for ease of use. The 'Abacus 5' analyzer's unique software system supports the use of many commonly used external printers with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000 patient, QC, and calibration result records including flags and graphical scatter diagrams and histograms. The system software is field-upgradeable to ensure up-to-date operation. An automatic optional Autosampler is available (sold separately) for automated processing of up to 100 sample tubes for increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexible connectivity options.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Diatron Abacus 5, Automated Hematology Analyzer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it makes a general statement about meeting requirements and substantiating equivalence to the predicate device.

What is present:
The "Substantial Equivalence: Similarities" and "Substantial Equivalence: Differences" sections compare the Abacus 5 against the predicate device (Abbott CELL-DYN® 3700) across various technical and functional aspects. This comparison indirectly implies that the Abacus 5's performance across these characteristics is considered equivalent or acceptable relative to the predicate.

What is missing (typical for a detailed acceptance criteria table):

Specific numerical ranges or thresholds for accuracy, precision, linearity, carryover, etc., for each of the measured parameters (WBC, LYM%, RBC, HGB, etc.).
The actual measured values or statistical correlations observed in the study for these parameters.

Given the information, a table of acceptance criteria and reported performance cannot be fully constructed with quantitative values. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Functional and Performance Requirements: Device design met functional and performance requirements in accordance with Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells.	"All required software and system verification and validation procedures have been executed and analyzed per FDA recommended standards and the Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells. All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. All performance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2, that is included with this submission. All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device."
Substantial Equivalence: Performance is substantially equivalent to the predicate device (Abbott CELL-DYN® 3700, K991605) based on similarities in: - Indication for Use - Sampling Mechanisms - Sample Processing - Sample ID - Methodology (e.g., Impedance for WBC, Photometric for HGB, Laser-based flow cytometry for 5-part diff) - WBC Differential parameters - Sample Type - Main Parameters measured - QC, Calibration, Flags/Alerts, Barcode Reader, External Printing, Data Input/Output, Microprocessors. Differences in methodology (RDWsd calculation vs. derivation), parameters (RDWcv measured, no RETC/IRF vs. vice versa), throughput, sample aspiration volume, reagents, calibrator/controls, data storage, LIS interface, keyboard, barcode reader, and peripheral ports were considered minor and did not raise new questions of safety or effectiveness.	The document asserts that "Diatron concludes...that the Diatron, Abacus 5 is substantially equivalent to the tested predicate device and has demonstrated to be a safe and effective product to be marketed in the United States." This implies that the device's performance across the listed criteria aligned sufficiently with that of the predicate device. Specific quantitative comparisons that would demonstrate substantial equivalence are stated to be in the Validation Report (A5-05-0020-02).

Acceptance Criteria (Implied)

Reported Device Performance

Functional and Performance Requirements: Device design met functional and performance requirements in accordance with Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells.

"All required software and system verification and validation procedures have been executed and analyzed per FDA recommended standards and the Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells. All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. All performance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2, that is included with this submission. All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device."

Substantial Equivalence: Performance is substantially equivalent to the predicate device (Abbott CELL-DYN® 3700, K991605) based on similarities in: - Indication for Use - Sampling Mechanisms - Sample Processing - Sample ID - Methodology (e.g., Impedance for WBC, Photometric for HGB, Laser-based flow cytometry for 5-part diff) - WBC Differential parameters - Sample Type - Main Parameters measured - QC, Calibration, Flags/Alerts, Barcode Reader, External Printing, Data Input/Output, Microprocessors. Differences in methodology (RDWsd calculation vs. derivation), parameters (RDWcv measured, no RETC/IRF vs. vice versa), throughput, sample aspiration volume, reagents, calibrator/controls, data storage, LIS interface, keyboard, barcode reader, and peripheral ports were considered minor and did not raise new questions of safety or effectiveness.

The document asserts that "Diatron concludes...that the Diatron, Abacus 5 is substantially equivalent to the tested predicate device and has demonstrated to be a safe and effective product to be marketed in the United States." This implies that the device's performance across the listed criteria aligned sufficiently with that of the predicate device. Specific quantitative comparisons that would demonstrate substantial equivalence are stated to be in the Validation Report (A5-05-0020-02).

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

The provided 510(k) summary does not specify the exact sample size used for the test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance and accuracy summary data" in an internal document, "Validation Report of Abacus 5 Hematology Instrument, Revision 2."

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

The 510(k) summary does not provide information on the number of experts used, their qualifications, or how ground truth was established for the "test set." For devices like automated hematology analyzers, ground truth often involves comparison to highly accurate reference methods or manual microscopy performed by skilled technicians or pathologists. This information is absent from the summary.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically assesses how human readers' performance changes with and without AI assistance, which is not applicable to a standalone automated hematology analyzer like the Abacus 5. The device's purpose is to automate cell counting, not augment human interpretation in the same way an AI imaging tool might.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was implicitly done. The "Performance" section explicitly states: "All performance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2...All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device."

This indicates that the device's performance, as an automated analyzer, was tested and evaluated on its own (i.e., "algorithm only") to demonstrate its accuracy against the predicate device. The device itself is designed for automated measurement without human intervention in the primary measurement process, although human interpretation of results and flags is part of its intended use.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in the summary. For hematology analyzers, ground truth often involves:

Reference Method Comparison: Comparing results to accepted reference methods (e.g., manual differential counts by trained technologists/pathologists, or flow cytometry for certain cell populations).
Predicate Device Comparison: Due to the nature of a 510(k) submission, a significant aspect of "truth" establishing is demonstrating equivalence to a legally marketed predicate device (Abbott CELL-DYN® 3700 in this case). This means the predicate device's performance serves as a de facto benchmark for acceptable "truth."

The summary refers to "performance and accuracy data" that "substantiate equivalence to the selected predicate device," strongly suggesting that comparison to the predicate device's results formed a key part of establishing the device's validated "truth."

8. Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size for a training set. Hematology analyzers, especially those from 2012, might not rely on "training sets" in the same way as modern AI/machine learning algorithms. Their operation is based on fixed algorithms derived from biophysical principles (impedance, light scatter/absorption). If any parameter tuning or algorithm development involved data, it's not detailed here.

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

Since the mechanism of "training" (in the machine learning sense) is not described, the summary does not specify how ground truth for a training set was established. Modern AI/ML-driven medical devices would typically provide this detail. For this device, "ground truth" during development would likely have referred to standard clinical samples analyzed by established reference methods to refine the physics-based algorithms and ensure accurate mapping of electrical impedance and optical scatter data to cell parameters.

Summary

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K112755

MAR 2 7 2012

510(k) Summary

Submitter	Diatron US Inc.14026 W. 107th StreetLenexa, Kansas 66215-2005
Contact Person	Michael Switzer, Director, Quality AssuranceP: 954-790-9550F: 954-827-2644E: mike.switzer@diatron.com
Date Prepared	March 19,2012
Trade Name	Abacus 5, Automated Hematology Analyzer
Classification	Class IIAutomated Differential Cell Counter21 CFR §864.5220
Product Code	GKZ
PredicateDevice(s)	The subject device is equivalent to the following device: Abbott CELL-DYN® 3700 (K991605)
DeviceDescription	The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinicallaboratories. It provides precise and accurate 5-part differential measurement using a laser based opticalmeasurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement ofleukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of thehemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology.Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using opticallaser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive,informative, and attractive user interface. A START button allows one-touch operation for ease of use.The 'Abacus 5' analyzer's unique software system supports the use of many commonly used externalprinters with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000patient, QC, and calibration result records including flags and graphical scatter diagrams andhistograms. The system software is field-upgradeable to ensure up-to-date operation. An automaticoptional Autosampler is available (sold separately) for automated processing of up to 100 sample tubesfor increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity usingthe HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexibleconnectivity options.
Intended Use	The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzerdesigned for in-vitro -diagnostic use in clinical laboratories for enumeration of the following parameters inK3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%,NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT andMPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters withinand outside of established reference ranges.
Functional andSafety Testing	To verify that device design met it's functional and performance requirements, a representative sampleof the device underwent software and system verification and validation testing, in accordance withClass II Special Controls Guidance Document: Premarket Notifications for Automated Differential CellCounters for Immature or Abnormal Blood cells. A risk and hazard analysis was performed per ISO14971.
SubstantialEquivalence:Similarities	Item	Diatron Abacus 5	Abbott CELL-DYN 3700
	Indication for UseStatement	The Diatron Abacus 5 System is a quantitativemulti-parameter automated hematologyanalyzer designed for in-vitro -diagnostic use inclinical laboratories for enumeration of thefollowing parameters in K3EDTA anti-coagulatedvenous whole blood samples: WBC, LYM%,LYM#, MON%, MON#, NEU%, NEU%, EOS%,EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PLT and MPV.The Diatron Abacus 5 is indicated for use toidentify patients with hematologic parameterswithin and outside of established referenceranges.	The Diatron Abacus 5 Systemis a quantitative multi-parameter automatedhematology analyzer designedfor in-vitro -diagnostic use inclinical laboratories forenumeration of the followingparameters in K3EDTA anti-coagulated venous whole bloodsamples: WBC, LYM%, LYM#,MON%, MON#, NEU%, NEU#,EOS%, EOS#, BAS%, BAS#,RBC, HGB, HCT, MCV, MCH,MCHC, RDWcv, RDWsd, PLTand MPV. The Diatron Abacus5 is indicated for use to identifypatients with hematologicparameters within and outside

	Sampling Mechanisms	- manual sampling (one sample at a time )- autosampler sampling- cap piercing function for closed tubes- interchangeable sample adapters for differenttube types- automatic aspiration of specimen andpresentation for automated processing	of established reference ranges.Same
	Sample Processing	Open vial mode, closed vial mode andautosampler	Same
	Sample ID	Manual and Barcode	Same
	Methodology	WBC = ImpedanceNEU = CalculatedNEU% = OpticalLYM = CalculatedLYM% = OpticalMON = CalculatedMON% = OpticalEOS = CalculatedEOS% = OpticalBAS = CalculatedBAS% = OpticalRBC = ImpedanceHGB = PhotometricHCT = CalculatedMCV = DerivedMCH = CalculatedMCHC = CalculatedRDWcv = DerivedRDWsd = CalculatedPLT = ImpedanceMPV = Derived	Same
	WBC Differential	NEU%, LYM%, MON%, EOS%, BAS%	Same
	Sample Type	K3 EDTA anticoagulated venous whole blood	Same
	Parameters	WBC, NEU, NEU%, LYM, LYM%, MON,MON%. EOS, EOS%, BAS, BAS%, RBC, HGB,HCT, MCV, MCH, MCHC, RDWcv, RDWsd,PLT, MPV	Same
	QC	Maintains QC files, generates Levey-JenningsCharts	Same
	Calibration	Manual calibration and SW supportedcalibration in automatic mode	Same
	Flags/Alerts	Dispersional data alerts, suspect parametermessages and suspect population flags toassist in data review	Same
	Barcode Reader	Built-in barcode readers in the autosampler	Same
	External Printing	External printing capabilities with a compatibleprinter	Same
	Data Input/Ouput	Accept input from the keyboard and send dataoutput to the video screen, hard drive andprinter	Same
	Microprocessors	Use microprocessors for systems control, dataacquisition and data analysis	Same
SubstantialEquivalence:Differences	Item	Diatron Abacus 5	Abbott CELL-DYN 3700
	Methodology	Uses the impedance method for WBC; theRDWsd is calculated	Uses simultaneous optical andimpedance measurements for WBC;the RDWsd is derived
	Parameters	Measures RDWcv; does not measureRETC, %RETC, IRF	Does not measure RDWcv; measuresRETC, %RETC, IRF
	Throughput	60 samples per hour	90 samples per hour
	Sample Aspiration	Open Vial Mode - 110µl	Open Vial Mode - 130 µl
	Volume	Closed Vial Mode - 110 µl	Closed Vial Mode - 240 µl
		Autosampling - 110 µl	Autosampling - 355 µl
	Reagents	Manufactured specifically for the Abacus 5	Manufactured specifically for the Cell-Dyn 3700; also has a specific RETC
Calibrator andControls	Recommends R&D Systems Calibratorand Controls	Abbott CELL-DYN Calibrator andControls
Data Storage	100,000 records including flags, scatterand histograms, QC records	10,000 records including flags, scatterand histograms
Interface to On-lineLIS	Bidirectional RS232 or Ethernet interfacing	Bidirectional RS232 interfacing
Keyboard	Optional keyboard, connected throughPS/2 or USB	Comes with keyboard connectedthrough PS/2
Barcode Reader	Optional manual barcode readerconnected via USB port	Manual barcode entry via keyboard
Peripheral Ports	1- PS/2 mouse port	1- VGA port
	1- PS/2 keyboard port	1- Audio port
	2- COM ports for LIS	1- USB port
	1- DVI-D port (unused)
	1- VGA port (unused)
	2- RJ45 Ethernet port for LIS
	4- USB 2.0 ports3- Audio jacks
Performance			All required software and system verification and validation procedures have been executed andanalyzed per FDA recommended standards and the Class II Special Controls Guidance Document:Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells.All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. Allperformance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2, that is included with thissubmission. All performance and accuracy data and data analysis in this submission support and.substantiate equivalence to the selected predicate device.(Abbott CELL-DYN 3700, K991605).
Conclusion			Diatron concludes, based on all information submitted and discussed in this submission and in thissummary, that the Diatron, Abacus 5 is substantially equivalent to the tested predicate device and hasdemonstrated to be a safe and effective product to be marketed in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Diatron US, Inc. c/o Mr. Michael Switzer Director, Quality Assurance 14026 W. 107th Street Lenexa, KS 66215

Re: K112755

Trade/Device Name: Abacus 5 Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: February 15, 2012 Received: February 17, 2012

Dear Mr. Switzer:

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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of

MAR 2 7 2012

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Page 2 - Mr. Michael Switzer

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

$\theta^2$ Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K112755

Device Name: Abacus 5

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112755.

Page 1 of 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.”