The CELL-DYN 3200 System with Absolute and Percent Reticulocyte count is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories.
The CELL-DYN 3200® System with Absolute and Percent Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood: White blood Cell Parameters: WBC -- White Blood Cell or Leukocyte Count, NEU -- Neutrophil Absolute Count, %N -- Neutrophil Percent, LYM -- Lymphocyte Absolute Count, %L -- Lymphocyte Percent, MONO -- Monocyte Absolute Count, %M -- Monocyte Percent, EOS -- Eosinophil Absolute Count, %E -- Eosinophil Percent, BASO -- Basophil Absolute Count, %B -- Basophil Percent, Platelet Parameters: PLT -- Platelet Count, MPV -- Mean Platelet Volume, *PDW -- Platelet Distribution Width, *PCT -- Plateletcrit. Red Blood Cell Parameters: RBC -- Red Blood Cell or Erythrocyte Count, HCT -- Hematocrit, MCV -- Mean Cell Volume, RDW -- Red Cell Distribution Width, Hemoglobin Parameters: HGB -- Hemoglobin Concentration, MCH -- Mean Cell Hemoglobin, MCHC -- Mean Cell Hemoglobin Concentration, Reticulocyte Parameters: RETIC ABS -- Reticulocyte Absolute, RETIC% -- Reticulocyte Percent of RBC Count. * Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

Device Description

The CELL-DYN 3200 System has three main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; 2) the Data Module, which automatically analyzes, stores, and reports specimen results; 3) the Display Station, which consists of a color monitor and pressure-sensitive keypad for selecting the displayed commands that operate the system. The Analyzer and Data Module are housed in a single chassis. The Display Station is a stand-alone module. The analyzer counts, sizes and classifies blood cells by Optical Laser Light Scatter. 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 reticulocyte parameters, an off-line dilution of blood and Reticulocyte Reagent is prepared and stained for 15 minutes. The dilution is aspirated and the reticulocytes are counted in the WOC channel. Data are collected for scatter (0, 10, and 90 degree) as each cell passes through the laser beam. The CELL-DYN 3200 System is designed to analyze EDTAanticoagulated whole blood specimens and report the additional Absolute and Percent Reticulocyte Parameters.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the CELL-DYN 3200 System with Absolute and Percent Reticulocyte, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for each parameter (e.g., specific thresholds for linearity, precision, or accuracy). Instead, it makes a general statement: "The background, carryover, linearity, precision, and accuracy data shows performance to manufacturer's specifications."

The study's primary objective wasn't to meet specific performance targets against a ground truth, but rather to demonstrate substantial equivalence to a predicate device (CELL-DYN 4000 System). Therefore, the "reported device performance" is framed in terms of achieving equivalency in these performance characteristics.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Background	Performance "to manufacturer's specifications"	Data supports substantial equivalence to CELL-DYN 4000 System
Carryover	Performance "to manufacturer's specifications"	Data supports substantial equivalence to CELL-DYN 4000 System
Linearity	Performance "to manufacturer's specifications"	Data supports substantial equivalence to CELL-DYN 4000 System
Precision	Performance "to manufacturer's specifications"	Data supports substantial equivalence to CELL-DYN 4000 System
Accuracy	Performance "to manufacturer's specifications"	Data supports substantial equivalence to CELL-DYN 4000 System
Reticulocyte Percent (RETIC %)	Substantial equivalence to CELL-DYN 4000 System performance	Demonstrated substantial equivalence to CELL-DYN 4000 System
Reticulocyte Absolute (RETIC ABS)	Substantial equivalence to CELL-DYN 4000 System performance	Demonstrated substantial equivalence to CELL-DYN 4000 System

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

Sample Size: Not explicitly stated. The document mentions "The data compiled to support the claim..." but does not provide specific numbers of samples tested.
Data Provenance: The data was collected at an "internal Abbott Diagnostics Division site." This suggests retrospective analysis of samples processed at their facility, or prospective data collection specifically for this study at their internal site. The country of origin is implicitly the USA, where Abbott Laboratories (Santa Clara, CA) is located.

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

This information is not provided in the document.
Given that the study focuses on substantial equivalence to another automated hematology analyzer (CELL-DYN 4000), the "ground truth" for the test set would likely be the measurements obtained from the predicate device itself, rather than expert human interpretation of blood smears.

4. Adjudication Method for the Test Set:

This information is not provided.
Since the comparison is made against an automated predicate device, human adjudication a traditional sense (e.g., 2+1 review of discrepant cases) would likely not apply in the same way as it would for imaging diagnostics. The adjudication would involve comparing the numerical output of the new device against the numerical output of the predicate device.

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 was not done.
This device is an automated hematology analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply to this submission. The device performs the measurements automatically.

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

Yes, this was a standalone performance evaluation.
The CELL-DYN 3200 System is an automated device designed to count and classify blood cells. Its performance evaluation is inherently standalone, as it generates results independently without direct human interpretation of the primary data (optical scatter signals). The results are then compared to those generated by another standalone automated device (the predicate).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for this study was the measurements provided by the predicate device, the CELL-DYN 4000 System. The study aimed to demonstrate that the CELL-DYN 3200's measurements for reticulocyte parameters were equivalent to those of the legally marketed predicate.
While laboratory techniques like manual reticulocyte counts as a "true" reference method could theoretically be used, the document describes the comparison as being strictly between the new device and the predicate device.

8. The Sample Size for the Training Set:

This information is not provided in the document.
Automated hematology analyzers, especially from this era (2001), typically rely on pre-programmed algorithms and calibrated optical systems rather than machine learning models that require explicit "training sets" in the modern AI sense. While internal development and calibration would involve testing on numerous samples, these are generally not referred to as "training sets" in the context of conventional medical device submissions.

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

As noted above, the concept of a "training set" with an established "ground truth" in the AI sense does not explicitly apply to this conventional automated hematology analyzer.
For the calibration and development of such an analyzer, the "ground truth" would generally be established through reference methods (e.g., manual microscopy, highly controlled reference materials) and extensive empirical testing to ensure accurate measurement of cell properties based on optical scatter. This process would occur during the device's design and manufacturing, not typically as part of a premarket notification for substantial equivalence, which often focuses on comparison to an existing device.

Summary

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KD12934

510(k)Summary	CELL-DYN 3200 System with Absolute and Percent Reticulocyte
	Submitted by:	Abbott Laboratories5440 Patrick Henry DriveSanta Clara, CA 95054
	Contact Person:	John DeanPhone: (408) 567-3430Fax: (408) 567-3523
	Date Prepared:	August 30, 2001
	Proprietary Name	CELL-DYN 3200 System with Absolute andPercent Reticulocyte
	Common Name:	Automated Hematology Analyzer
	Classification Name:	Automated Differential Cell Counter(21 CRF 864.5220)
	Predicate Device:	CELL-DYN 4000 System, K961439/S1

Intended Use:

Device Description:

The analyzer counts, sizes and classifies blood cells by Optical Laser Light Scatter. 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.

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For the reticulocyte parameters, an off-line dilution of blood and Reticulocyte Reagent is prepared and stained for 15 minutes. The dilution is aspirated and the reticulocytes are counted in the WOC channel. Data are collected for scatter (0, 10, and 90 degree) as each cell passes through the laser beam.

The CELL-DYN 3200 System is designed to analyze EDTAanticoagulated whole blood specimens and report the additional Absolute and Percent Reticulocyte Parameters.

The CELL-DYN 3200 System is designed to classify the following formed elements of EDTA-anticoagulated blood:

White blood Cell Parameters:	Red Blood Cell Parameters:
WBC -- White Blood Cell orLeukocyte Count	RBC -- Red Blood Cell orErythrocyte Count
NEU -- Neutrophil AbsoluteCount	HCT -- Hematocrit
%N -- Neutrophil Percent	MCV -- Mean Cell Volume
LYM -- Lymphocyte AbsoluteCount	RDW -- Red Cell DistributionWidth
%L -- Lymphocyte Percent	Hemoglobin Parameters:
MONO -- Monocyte AbsoluteCount	HGB -- HemoglobinConcentration
%M -- Monocyte Percent	MCH -- Mean Cell Hemoglobin
EOS -- Eosinophil Absolute Count	MCHC -- Mean Cell HemoglobinConcentration
%E -- Eosinophil Percent
BASO -- Basophil Absolute Count
%B -- Basophil Percent
Platelet Parameters:PLT -- Platelet Count	Reticulocyte Parameters:
MPV -- Mean Platelet Volume	RETIC ABS-- ReticulocyteAbsolute
*PDW -- Platelet DistributionWidth	RETIC% -- ReticulocytePercent of RBC Count
*PCT -- Plateletcrit

Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

** For Laboratory Use Only, therefore it is not reportable.

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Similarities and Differences:

The CELL-DYN 3200 and the CELL-DYN 4000 System are similar in that both systems enumerate reticulocytes in EDTA-anticoagulated whole blood using New Methylene Blue N dye and optical laser scatter. The two Reticulocyte Reagents enable both the CELL-DYN 3200 and the CELL-DYN 4000 Systems to count and classify reticulocytes. Blood specimens for the CELL-DYN 3200 are externally stained in an off-line preparation step with New Methylene Blue N that requires incubation prior to measurement, while the CELL-DYN 4000 system automatically aliquots Reticulocyte Reagent containing the dye when CBC + RETC or CBC + RETC, Resistant RBC test is selected. They are different in that the Analyzer and Data Module of the CELL-DYN 3200 are housed in a single chassis while the CELL-DYN 4000 has a stand-alone data station consisting of a monitor, CPU and keyboard.

Equivalency Data:

The data compiled to support the claim that the CELL-DYN 3200 System with Reticulocyte Percent (RETIC %) and Reticulocyte Absolute (RETIC ABS) parameters is substantially equivalent to the CELL-DYN 4000 System includes: background, carryover, linearity, precision, and accuracy. The data supports the claim that the CELL-DYN 3200 System with RETIC % and RETIC ABS parameters is substantially equivalent to the CELL-DYN 4000 System.

The background, carryover, linearity, precision, and accuracy data shows performance to manufacturer's specifications. Data was collected at an internal Abbott Diagnostics Division site.

Conclusion:

The CELL-DYN 3200 System with RETIC % and RETIC ABS parameters demonstrates substantial equivalence to the predicate device.

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Image /page/3/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 image of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Dean Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054

Re: K012934

Trade/Device Name: CELL-DYN® 3200 System with Absolute and Percent Reticulocyte Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: August 30, 2001 Received: August 31, 2001

SEP 2 8 2001

Dear Mr. Dean:

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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K012934 5 10(k) Number (if known):

Device Name: CELL-DYN® 3200 System with Absolute and Percent Reticulocyte

Indications for Use:

The CELL-DYN 3200® System with Absolute and Percent Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood:

White blood Cell Parameters:	Red Blood Cell Parameters:
WBC -- White Blood Cell or Leukocyte Count	RBC -- Red Blood Cell or Erythrocyte Count
NEU -- Neutrophil Absolute Count	HCT -- Hematocrit
%N -- Neutrophil Percent	MCV -- Mean Cell 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 Cell Hemoglobin
EOS -- Eosinophil Absolute Count	MCHC -- Mean Cell Hemoglobin Concentration
%E -- Eosinophil Percent	Reticulocyte Parameters:
BASO -- Basophil Absolute Count	RETIC ABS -- Reticulocyte Absolute
%B -- Basophil Percent	RETIC% -- Reticulocyte Percent of RBC Count
Platelet Parameters:
PLT -- Platelet Count
MPV -- Mean Platelet Volume
*PDW -- Platelet Distribution Width
*PCT -- Plateletcrit

Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

(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 CFR 801.109)

OR	Over-The Counter Use
(Division/Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K 010934

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.”