The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a multi-parameter, automated. hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a fully automated hematology analyzer, including reporting of the ImmunoPlt (CD61) count, intended for in-vitro diagnostic use in the clinical laboratory of a hospital, medical clinic, or reference laboratory.

Device Description

The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, difutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is designed to analyze EDTAanticoagulated whole blood specimens and report the hematological parameters shown in the table on the following page.

AI/ML Overview

The provided text describes the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay, a multi-parameter automated hematology analyzer.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the "Equivalency Data" section "shows performance to manufacturer's specifications." However, the specific acceptance criteria (numerical thresholds) or the detailed reported performance values are not explicitly listed in the provided text. The text only broadly concludes that the data supports substantial equivalence to predicate devices and microscopy for low platelet counts.

Parameter Category	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Summary)
Overall Performance	(Implied: Substantial equivalence to predicate devices and manual microscopy for platelet counts < 50 K/μL)	Data compiled supports the claim of substantial equivalence.
Accuracy	Manufacturer's specifications (Not detailed)	Performance shown to manufacturer's specifications.
Precision	Manufacturer's specifications (Not detailed)	Performance shown to manufacturer's specifications.
Linearity	Manufacturer's specifications (Not detailed)	Performance shown to manufacturer's specifications.
Carryover	Manufacturer's specifications (Not detailed)	Performance shown to manufacturer's specifications.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The data compiled supports the claim..."

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

The document mentions "base microscopy (for platelet counts < 50 K/μL)" as a comparative method for equivalency data. This implies that microscopy was used as a ground truth for lower platelet counts. However, the number of experts and their qualifications (e.g., specific experience level of the microscopists) are not mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It implicitly refers to "base microscopy" for low platelet counts as a reference method but does not detail how potential discrepancies or subjective interpretations in microscopy were handled.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done as this device is an automated hematology analyzer and not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of an effect size for human readers improving with or without AI assistance.

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

Yes, a standalone study was done. The entire "Equivalency Data" section details the performance of the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay as an automated device. The comparison is made against existing automated systems (Abbott CELL-DYN® 4000 System) and a manual method (base microscopy). This demonstrates the algorithm's performance without direct human intervention in the interpretation of results beyond standard laboratory operation.

7. Type of Ground Truth Used:

The ground truth used for performance evaluation appears to be a combination of:

Predicate devices: The Abbott CELL-DYN® 4000 System (for general hematological parameters).
Manual Microscopy: Specifically for platelet counts lower than 50 K/μL.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set for the device's algorithms or operating parameters. It describes the device's principles of operation but not its development or the data used to train its internal models.

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

The document does not explicitly state how the ground truth for the training set was established. Since it is an automated hematology analyzer, the "training" would likely involve calibration using known reference materials and internal algorithms refined through extensive testing with reference methods. However, the specifics of this process are not described in the provided text.

Summary

{0}------------------------------------------------

JUN 2 9 1998

: *

KA8134a

510(k) Notification

CELL-DYN® 4000 ImmunoPl("" (CD61)

510(k) SUMMARY

CELL-DYN®4000 Multi-Parameter Automated Hematology Analyzer with Immunological (CD61) Platelet Count

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® 4000 System Hematology Analyzer with ImmunoPlt™ (CD61) Assay, constitutes data supporting a substantially equivalent determination.

The methods of determination are those used by the CELL-DYN@4000 System and the manual phase platelet method. These methods collectively perform one or more of the determinations which are combined in the CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay.

Intended Use

The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is a multi-parameter, automated. hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

Device Description

The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is designed to analyze EDTAanticoagulated whole blood specimens and report the hematological parameters shown in the table on the following page.

{1}------------------------------------------------

CELL-DYN® 4000 ImmunoPlt™ (CD61)

··············································································································································································

CELL-DYN®4000 System with ImmunoPlt™ (CD61) Assay:
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	*RBCO -- RBC Optical count
%N -- Neutrophil percent	RBCi -- RBC Impedance count
LYM -- Lymphocyte absolute count	HCT -- Hematocrit
%L -- Lymphocyte percent	MCV -- Mean Corpuscular Volume
MONO -- Monocyte absolute count	RDW -- Red Cell Distribution Width
%M -- Monocyte percent	NRBC -- Nucleated Red Blood Cell absolutecount
EOS -- Eosinophil absolute count	NR/W -- Nucleated Red Blood Cell percent ofWBC count
%E -- Eosinophil percent	Hemoglobin Parameters:
BASO -- Basophil absolute count	HGB -- Hemoglobin concentration
%B -- Basophil percent	MCH -- Mean Corpuscular Hemoglobin
*vWF -- Viable White Cell fraction	MCHC -- Mean Corpuscular HemoglobinConcentration
*BAND -- Band Neutrophil absolute count	Reticulocyte Parameters:
*%BD -- Band Neutrophil percent	RETC -- Reticulocyte concentration
*IG -- Immature Granulocyte absolute count	%R -- Reticulocyte percent of RBC count
*%IG -- Immature Granulocyte percent	IRF -- Immature Reticulocyte Fraction
*BLST -- Blast absolute count	Platelet Parameters:
*%BL -- Blast percent	PLT -- Platelet Count
*MONe -- non-Blast Monocyte absolute count	CD61 -- ImmunoPlt (CD61) Count
*%Me -- non-Blast Monocyte percent	PLTo -- Platelet Optical count
*LYMe -- non-Blast, non-variant Lymphocyteabsolute count	*PLTi -- Platelet Impedance count
*Le -- non-Blast, non-variant Lymphocytepercent	MPV -- Mean Platelet Volume
*VARL -- Variant Lymphocyte absolute count	*PLTs -- Small Platelets
*%VL -- Variant Lymphocyte percent	*PLTl -- Large Platelets
	*PDW -- Platelet Distribution Width
	*PCT -- Plateletcrit

CELL-DYN®4000 System with ImmunoPlt™ (CD61) Assay.

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

{2}------------------------------------------------

Principles of Operation

The analyzer counts, sizes and classifies blood cells by the combination of flow cytometry The analyzer Counts, Sizes and Fluorescence, with Focused Flow Impedance, and methous: Laser Optical Scatter and I harrosonol, ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Absorphon Specifolionista J. The Platelets. The CELL-DYN® 4000 System uses an Argonand fidorescence of the mires The Optical Bench detects light in the form of scatter from for last as the optical light source: "The Option is a more ally stained blood cells.
blood cell surfaces and internal structures, or fluorescent light from specially stained blood cen surfaces and MRBCs, whole blood is diluted with a reagent containing a red I on the WDC parameters simultaneously collected for four angles (0°, 7°, 90°, and 90°D) of Indorescent dye. Data are simultanes as ) cell passes through the laser beam. NRBCs, identified scatter and roce neee excluded automatically from the WBC count.

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 both laser optical scatter (7° and Cons for modeller. For the Injection Metering. For the ImmunoPlt (CD61) count, 90 ) and Pocused I 10w mipocares onund Monoclonal Antibody, CD61. Laser optical scatter is measured as described above and green fluorescence (FL1) is measured.

For the hemoglobin parameters, whole blood is diluted with a cyanide free reagent and the For the nemoglobin parameters, whole exorbance (540 mm). For the reticuloved and many the nemogroom is measures open is diluted with a reagent containing a green fluorescent dye. and of the RDCA D = and green fluorescence (FL1) as each cell passes through the laser beam.

Similarities and Differences

The CELL-DYN® 4000 System and the CELL-DYN® 4000 System with ImmunPlt™ (CD61) The CDD are similar in that they use Focused Flow Impedance to count and size RBCs and PLTs, Assay are similar in that they as a reasure RBCs and PLTs optically, and they compare optical and impedance data as an internal quality check. The CELL-DYN® 4000 System with GD61 mipodation as a a a a a fassy is different from the CELL-DYN® 4000 System in that it counts CD61 labeled platelets and measures the results optically and by fluorescence.

Equivalency Data

The data compiled supports the claim that the CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is substantially equivalent to the Abbott the CELL-DYN® 4000 System and to (base microscopy (for platelet counts < 50 K/μL). The data includes accuracy, precision, linearity, and carryover and shows performance to manufacturer's specifications.

રે ર

{3}------------------------------------------------

Conclusion

The CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay shows an evolution of the technologies used on one or more of the currently available analyzers to count, size, and classify toonloregios and their related parameters, and more specifically, to the technologies used on the Abbott CELL-DYN® 4000 System.

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

Janice E. Brown Regulatory Affairs Manager Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara, CA 95054

Phone: 408 567-3521 408 982-4863 Fax:

૩૯

{4}------------------------------------------------

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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.

10903 New Hampshire Avenue Silver Spring, MD 20993

JUN 20 2012

Abbott Laboratories c/o Ms. Janice E. Brown Regulatory Affairs Manager 5440 Patrick Henry Drive Santa Clara, CA 95054

Re: K981342

Trade/Device Name: CELL-DYN® 4000 ImmunoPlt (CD61) Assay Regulation Number: 21 CFR §864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: April 10, 1998 Received: April 13, 1998

Dear Ms. Brown:

This letter corrects our substantially equivalent letter of June 29, 1998.

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 (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 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); medical

{5}------------------------------------------------

device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Reena Philip

for

Maria M. Chan, Ph.D. Director Division Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

{6}------------------------------------------------

Clil.l.-DYN® 4000 Immunol'lt™ (CD61)

Page 1 of 1

K981342
510(k) Number (if known): #K060408

Device Name: CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay
1

Indications For Use:

Indications For Got.
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a filly automated hemstology
of the CELL-D Your with a of the ImmunoPlt (CD61) count, intended f The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a time adomation of the CBS
analyzer, including reporting of the ImmunePlt (CD61) count, intended for in-virro diagno analyzer, including reporting of the ImmunoFit (CDVF) South, a
the clinical laboratory of a hospital, medical clinic, or reference laboratory.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
:sion of Clinical Laboratory Devices
510(k) Number K981342

Prescription Use (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.”