The CELL-DYN® 3200 System has three main modules: the Analyzer, which identifies, mixes, and presents specimens for processing, aspirates, dilutes and analyzes each whole blood specimen. The Data Module, which controls all system processing; and the Display Station, which provides the primary operator interface with the system and generates reports automatically or on demand.

AI/ML Overview

Here is an analysis of the provided information, structured to address your specific questions:

The provided documents do not contain a table of acceptance criteria or reported device performance in a format that directly maps to typical AI/software performance metrics (e.g., sensitivity, specificity, AUC). Instead, the studies described are focused on demonstrating "substantial equivalence" of the CELL-DYN® 3200 System to existing predicate devices for various hematological parameters. This typically involves accuracy, precision, and linearity data compared against manufacturer's specifications and predicate device performance.

Given the nature of the device (a hematology analyzer) and the era of the submission (1997), the evaluation methodology is characteristic of medical devices that provide quantitative measurements rather than AI-driven diagnostic interpretations. Therefore, many of your questions regarding AI-specific assessments (e.g., MRMC studies, human-in-the-loop, training set details) are not directly applicable or answerable from the provided text.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a direct table of acceptance criteria and performance metrics (like sensitivity/specificity) is not present. Instead, the "acceptance criteria" are implied by the requirement to demonstrate substantial equivalence to predicate devices and adherence to "manufacturer's specifications" for accuracy, precision, and linearity for each parameter.

The following table summarizes the parameters for which substantial equivalence was demonstrated and the predicate devices used for comparison, which implicitly define the performance standard (acceptance criteria).

Hematological Parameter	Predicate Device(s) for Substantial Equivalence	Reported Device Performance
White Blood Cell (WBC)	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Red Blood Cell (RBC)	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Hemoglobin (HGB)	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Platelet (PLT)	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
WBC Differential	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Mean Corpuscular Hemoglobin (MCH)	Abbott CELL-DYN® 3500R System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Mean Corpuscular Volume (MCV)	CELL-DYN® 4000 System, manual microhematocrit method (NCCLS H7-A2), Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Red Cell Distribution Width (RDW)	CELL-DYN® 4000 System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
Mean Platelet Volume (MPV)	CELL-DYN® 4000 System, Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.
All Hemogram parameters	Technicon H 3 RTC	Data supported substantial equivalence for accuracy, precision, and linearity.

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

Sample Size: The specific sample size used for the "test set" (i.e., the samples used in the equivalency studies) is not explicitly stated in the provided documents.
Data Provenance: The documents do not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Number of Experts: For WBC differential parameters, the NCCLS H20-A, "Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods," Approved Voluntary Standard 1992 was used "to arbitrate differences in the differential." This standard outlines the methodology for establishing a reference leukocyte differential count, which typically involves multiple trained technologists reviewing blood smears. The exact number of experts/technologists used in this specific study and their qualifications are not explicitly stated in the provided text.
Qualifications of Experts: Not specified beyond the reference to the NCCLS H20-A standard.

4. Adjudication Method

For the white cell differential parameters, the NCCLS H20-A standard was used for arbitration. This standard details a process for establishing a reference differential count, which usually involves a consensus or weighted average from multiple expert reviews of stained blood smears (e.g., 500-cell or 200-cell manual counts). The specific "adjudication method" (e.g., 2+1, 3+1) within that standard, as applied to this study, is not explicitly detailed in the provided text. For other parameters, comparison was made against predicate devices or a manual method (microhematocrit for MCV), implying the predicate device's or manual method's result served as the "ground truth" or reference for comparison, rather than an independent expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating reader performance (e.g., radiologists, pathologists) with and without AI assistance, which is not applicable to a hematology analyzer that provides quantitative measurements. The studies focused on quantitative agreement with predicate devices and reference methods.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies are effectively standalone performance evaluations. The CELL-DYN® 3200 System is an automated analyzer designed to provide results directly. Its performance was evaluated by comparing its outputs (WBC, RBC, HGB, etc.) against established methods (predicate devices, manual microhematocrit, NCCLS standard for differentials). There is no "human-in-the-loop" component described in this context for generating the primary analytical results. The "human-in-the-loop" would be the clinical laboratory professional operating the device and interpreting its output, but the performance testing here is of the device's measurement capabilities themselves.

7. The Type of Ground Truth Used

The ground truth used varied by parameter:

WBC, RBC, HGB, PLT, MCH, RDW, MPV, all hemogram parameters: The results from the predicate devices (Abbott CELL-DYN® 3500R System, CELL-DYN® 4000 System, Technicon H 3 RTC) served as the primary reference or "ground truth" for demonstrating substantial equivalence. This is a form of comparative measurement against an accepted standard.
WBC Differential parameters: The NCCLS H20-A "Reference Leukocyte Differential Count" standard was used for arbitration, which implies an expert consensus or reference method defined by the standard.
MCV: The manual microhematocrit method (NCCLS H7-A2) was used as a reference for comparison, in addition to the CELL-DYN® 4000 System. This is a reference standard method.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. Hematology analyzers of this type are not typically "trained" in the machine learning sense with a distinct training set. They are designed based on physical principles (flow cytometry, laser optical scatter, colorimetry) and algorithms are developed to process these signals. Any "training" or calibration would be part of the device's engineering and internal validation, not a separate, disclosed "training set" like in modern AI models. The 510(k) summary focuses on the performance of the final, developed device.

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

Not Applicable / Not Provided. As noted above, the concept of a "training set" with established ground truth as used in contemporary AI/ML is not relevant to this type of device and submission. The "ground truth" in development would likely refer to highly characterized reference materials and established analytical methods used during the engineering and validation phases of the device.

Summary

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SEP 1 6 1997

510(k) Notification

510(k) Summary Of Safety And Effectiveness Information Supporting A Substantially Equivalent Determination

The following information as presented in the Premarket Notification 510(k) for the CELL-DYN® 3200 System Hematology Analyzer constitutes data supporting a substantially-equivalent determination.

Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Abbott the CELL-DYN® 3500R Multi-Parameter Automated Hematology Analyzer, #K955715 System for the White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin concentration (HGB), Platelet count (PLT), WBC differential parameters and the calculated parameter of Mean Corpuscular Hemoglobin (MCH). Substantial equivalence is also demonstrated between the CELL-DYN® 3200 System and the CELL-DYN® 4000 System for Mean Corpuscular Volume (MCV), Red Cell Distribution Width (RDW), and Mean Platelet Volume (MPV). Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Technicon H 3 RTC #K930148 for the hemogram and white cell (WBC) differential parameters. Additional data was collected to demonstrate the comparison of the Mean Corpuscular Volume (MCV) of the CELL-DYN® 3200 System to the manual microhematocrit method, NCCLS H7-A2. The NCCLS H20-A, "Reference Leukocyte Differential Count (Proportional) and Evaluation of Instrumental Methods," Approved Voluntary Standard 1992 for the white cell differential parameters was used to arbitrate differences in the differential.

Intended Use:

The CELL-DYN ® 3200 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

Device Description:

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specimens and report the following hematological parameters:
White Blood Cell Parameters:	Red Blood Cell Parameters:
WBC -- White Blood Cell	RBC -- Red Blood Cell or erythrocyte count
NEU -- Neutrophil absolute count	HCT -- Hematocrit
%N -- Neutrophil percent	MCV -- Mean Corpuscular Volume
LYM -- Lymphocyte absolute count	RDW -- Red Cell Distribution Width
%L -- Lymphocyte percent	Hemoglobin Parameters:
MONO -- Monocyte absolute count	HGB -- Hemoglobin concentration
%M -- Monocyte percent	MCH -- Mean Corpuscular Hemoglobin
EOS -- Eosinophil absolute count	MCHC -- Mean Corpuscular HemoglobinConcentration
%E -- Eosinophil percent	Platelet Parameters:
BASO -- Basophil absolute count	PLT -- Platelet Count
%B -- Basophil percent	MPV -- Mean Platelet Volume
	*PDW -- Platelet Distribution Width
	*PCT -- Plateletcrit

The CELL-DYN® 3200 is designed to analyze K2EDTA-anticoagulated whole blood C. 11 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------

These parameters are provided for laboratory use only and are not reportable in the US

Principles of Operation:

The analyzer counts, sizes and classifies blood cells by the combination of a flow cytometry method, laser optical scatter, and colorimetric method. The CELL-DYN® 3200 System uses a Helium-Neon laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures.
For the WBC parameters, whole blood is diluted with a reagent to preserve cell integrity. Data are simultaneously collected for four angles (0°, 10°, 90°, and 90°D) of light scatter as each cell passes through the laser beam. For the RBC and the PLT parameters, whole blood is diluted with a reagent that prepares the cells for measurement. The dilution is split and measured by laser optical scatter at (0° and 10°).

For the hemoglobin parameters, whole blood is diluted with a cyanide free reagent and the hemoglobin is measured optically by absorbance (540nm).

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510(k) Notification

Similarities and Differences:

The CELL-DYN® 3200 System has similarities to one or more of the methods of determination for hemogram and automated WBCs differential parameters used by the following hematology analyzers:

Abbott CELL-DYN® 3000 Series, Sysmex™ NE Series, Technicon H1™ Series, and Abbott CELL-DYN® 4000. The CELL-DYN® 3200 is similar to the Abbott CELL-DYN® 3000 Series. Sysmex™ NE Series: Technicon H1™ Series; and Abbott CELL-DYN® 4000 in that they use optical scatter to count and differentiate WBCs. WBCs are counted and classified by the Abbott CELL-DYN® 3000 Series Systems and the CELL-DYN® 4000 System in a very similar manner using four simultaneously collected angles of scattered laser light.

The CELL-DYN® 3200 is different from the Coulter® Counters (Model ZBI, S-Plus Series and STKS), and the CELL-DYN® 4000 System in that they use impedance for counting and sizing RBCs and PLTs. The CELL-DYN® 3200 and the Sysmex™ NE series are different in that the Sysmex uses Focused Flow Impedance to count and size RBCs and PLTs. The CELL-DYN® 3200 is different from the Technicon H*1™ series and the CELL-DYN® 4000 System in that they both use Injection Metering to measure RBCs and PLTs optically. The CELL-DYN® 4000 System is different in that it counts RBCs and PLTs by both the optical and impedance methods and compares the data as an internal quality check. They are different in that the Abbott CELL-DYN® 3000 Series Systems use a helium neon laser, while the CELL-DYN® 4000 System uses an Argon-ion laser to collect optical scatter data.

Equivalency Data:

The data complied to support the claim that the CELL-DYN® 3200 System is substantially equivalent to the Abbott CELL-DYN® 3500R System includes background, accuracy, precision, linearity, comprehensive flagging and carryover. Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Abbott the CELL-DYN® 3500R System Multi-Parameter Automated Hematology Analyzer, #K955715 for the White Blood Cell (WBC), Red Blood Cell (RBC), Hemoglobin concentration (HGB), Platelet count (PLT), WBC differential parameters and the calculated parameter of Mean Corpuscular Hemoglobin (MCH). Substantial equivalence is also demonstrated between the CELL-DYN® 3200 System and the CELL-DYN® 4000 System for Mean Corpuscular Volume (MCV), Red Cell Distribution Width (RDW), and Mean Platelet Volume (MPV). Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Technicon H 3TM RTX #K930148 for the hemogram and white cell (WBC) differential parameters.

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The data supports the claim that the CELL-DYN® 3200 System is substantially equivalent to the Abbott CELL-DYN® 3500R System for the White Blood Cell (WBC) count, Red Blood Cell (RBC) count, Hemoglobin concentration (HGB), Platelet (PLT) count, WBC differential parameters and the calculated parameter of Mean Corpuscular Hemoglobin (MCH). The data supports the claim that the CELL-DYN® 3200 System is substantially equivalent to CELL-DYN® 4000 System for MCV, RDW and MPV. The accuracy, precision, and linearity data shows performance to manufacturer's specifications. Substantial equivalence is demonstrated between the CELL-DYN® 3200 System and the Technicon H 3 RTC #K930148 for the hemogram and WBC differential parameters. The accuracy, precision, and linearity data shows performance to manufacturer's specifications.

Conclusion:

The CELL-DYN® 3200 System shows an evolution of the technologies used on one or more of the currently available analyzers to count, size, and classify whole blood cells and their related parameters, and more specifically to the technologies used on the Abbott CELL-DYN® 3500R System and the CELL-DYN® 4000 System.

The 510(k) Summary was prepared and submitted by:

Sue E. Luptovic Sr. Regulatory Affairs Specialist Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara, CA 95054

Phone: 408 567-3389 Fax: 408 982-4863

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sue E. Luptovic Senior Requlatory Affairs Specialist Abbott Diagnostics Requlatory Affairs Abbott Laboratories SEP 1 6 1997 100 Abbott Park Road Abbott Park, Illinois 60064 Re : K972354

Trade Name: Abbott CELL-DYN 3200 System Regulatory Class: II Product Code: GKZ Dated: June 20, 1997 Received: June 24, 1997

Dear Ms. Luptovic:

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 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 reqistration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst 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 requirement, 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 Reqister. 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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Page 2

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 qeneral 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K972354
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Device Name:

Indications For Use:

CELL-DYN 3200 System

510(k) Notification

ﻧﺎ ﺑﮭﯿﻨﯿﮉﯾﭩﺮ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﯽ ﻣﺠﻤﻮﻋﯽ ﺁﺑﺎﺩﯼ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ

The CELL-DYN® 3200 System is a fully automated hematology analyzer intended for invitro diagnostic use in the clinical laboratory.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cita E. Madim

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

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.”