Predicate Devices

CELL-DYN® 1700 System, K870233

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard hematology analysis techniques (impedance, colorimetry) and mentions a microprocessor controlling the system, but there is no mention of AI or ML.

Therapeutic

No.
The device is a hematology analyzer used for classifying formed elements of blood, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

The device is a hematology analyzer intended to classify formed elements of blood, providing various parameters related to White Blood Cells, Platelets, Red Blood Cells, and Hemoglobin. These measurements are used by healthcare professionals to aid in the diagnosis of various medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single unit device" with hardware components like transducers, electrodes, an LED light source, and a light-sensitive diode for analyzing blood samples. The software controls these hardware components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used to classify formed elements of EDTA anti-coagulated blood. This involves analyzing biological samples (blood) in vitro (outside the body).
Device Description: The description details how the device aspirates, dilutes, mixes, and analyzes whole blood specimens using techniques like impedance and colorimetry. These are all processes performed on biological samples in vitro.
Clinical Laboratory Setting: The intended user/care setting is a clinical laboratory, which is where in vitro diagnostic testing is performed.
Performance Studies: The performance studies describe testing performed on blood samples to demonstrate the device's accuracy and equivalence to other hematology analyzers and manual methods. This further supports its use in in vitro diagnostics.

The core function of the device is to analyze blood components outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CELL-DYN® 1200 System is a multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anti-coagulated blood:

White Blood Cell Parameters:
WBC -- White Blood Cell or leukocyte count
GRAN -- Granulocyte absolute count
%GRAN -- Granulocyte percent
LYM - Lymphocyte absolute count
%L - Lymphocyte percent
MID - Mid-range absolute count
%M - Mid-range percent

Red Blood Cell Parameters:
RBC -- Red Blood Cell or erythrocyte count
HCT -- Hematocrit
MCV -- Mean Corpuscular Volume
RDW -- Red Cell Distribution Width

Hemoglobin Parameters:
HGB -- Hemoglobin Concentration
MCH -- Mean Cell Hemoglobin
MCHC -- Mean Cell Hemoglobin Concentration

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 US.

Product codes (comma separated list FDA assigned to the subject device)

GKZ

Device Description

The CELL-DYN® 1200 System is a single unit device with a stand alone printer used in the clinical laboratory setting. The Analyzer aspirates, dilutes, mixes and analyzes each whole blood specimen. The computer in the Analyzer controls all system processing, provides the primary operator interface with the system, and controls the optional printer, which generates reports.

The CELL-DYN® 1200 System is a multi-parameter, automated hematology analyzer designed to use EDTA-anticoagulated whole blood specimens to count, size and classify cells by using an focused flow impedance transducer, equipped with two non-corrosive electrodes to measure WBCs, and PLTs. The HGB is measured colorimetrically in the HGB transducer by an LED light source and a light sensitive diode. The analyzer is menu-driven and controlled by a microprocessor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratory setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The data compiled to support the claim that the CELL-DYN® 1200 System is substantially equivalent to the CELL-DYN® 1700 and the manual differential includes background, carryover, precision, correlation, linearity, and flagging data. Equivalence is demonstrated between the CELL-DYN® 1200 System and the CELL-DYN® 1700 System for the following measured parameters: White Blood Cell (WBC), three part WBC Differential sub-populations, Red Blood Count (RBC), Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Red Cell Distribution Width (RDW), Platelet Count (PLT), Mean Platelet Volume (MPV). Background, carryover, precision, correlation, and linearity data show performance to manufacturer's specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

CELL-DYN® 1700 System, K870233, Manual Differential

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

Summary

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CELL-DYN® 1200 System JUN 23 1999 II. 510(k) Summary per 21 CFR807.92 Abbreviated 510(k) Notification

K991142

| Submitted By: | Abbott Laboratories
5440 Patrick Henry Drive
Santa Clara, CA 95054 |
|----------------------|--------------------------------------------------------------------------|
| Contact Person: | Janice E. Brown
(408) 567-3521 |
| Date Prepared: | April 2, 1999 |
| Proprietary Name: | CELL-DYN® 1200 System |
| Common Name: | Automated Hematology Analyzer |
| Classification Name: | Automated Differential Cell Counter
21 CFR 864.5220 |
| Predicate Devices: | CELL-DYN® 1700 System, K870233
Manual Differential |

Description of Device:

The CELL-DYN® 1200 System is a single unit device with a stand alone printer used in the clinical laboratory setting. The Analyzer aspirates, dilutes, mixes and analyzes each whole blood specimen. The computer in the Analyzer controls all system processing, provides the primary operator interface with the system, and controls the optional printer, which generates reports.

The CELL-DYN® 1200 System is a multi-parameter, automated hematology analyzer designed to use EDTA-anticoagulated whole blood specimens to count, size and classify cells by using an focused flow impedance transducer, equipped with two non-corrosive electrodes to measure WBCs, and PLTs. The HGB is measured colorimetrically in the HGB transducer by an LED light source and a light sensitive diode. The analyzer is menu-driven and controlled by a microprocessor.

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II. 510(k) Summary per 21 CFR807.92 (cont.):

Intended Use:

The CELL-DYN® 1200 System is a multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anti-coagulated blood:

White Blood Cell Parameters:	Red Blood Cell Parameters:
WBC -- White Blood Cell or leukocyte count	RBC -- Red Blood Cell or erythrocyte count
GRAN -- Granulocyte absolute count	HCT -- Hematocrit
%GRAN -- Granulocyte percent	MCV -- Mean Corpuscular Volume
LYM - Lymphocyte absolute count	RDW -- Red Cell Distribution Width
%L - Lymphocyte percent
MID - Mid-range absolute count	Hemoglobin Parameters:
%M - Mid-range percent	HGB -- Hemoglobin Concentration
Platelet Parameters:	MCH -- Mean Cell Hemoglobin
PLT - Platelet Count	MCHC -- Mean Cell Hemoglobin Concentration
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 US.

Technological Characteristics:

The CELL-DYN® 1200 System utilizes the following technologies: optical absorbance methods; focused flow impedance; microprocessors for systems control, data acquisition, and data analysis; video keypads, liquid crystal display (LCD), optional printer and an on-line LIS interface.

Similarities and Differences:

The following table describes the various parameters, subsystems and interfering substances of the CELL-DYN® 1200 System as compared to the predicate device the CELL-DYN® 1700 System.

The two systems are similar in that:

a) Both systems provide quantitation of the hemogram parameters in EDTAanticoagulated human whole blood specimens.

b) Both systems will accept specimens presented manually by the operator.

c) Both systems automatically aspirate the specimen and present it for automated processing.

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II. 510(k) Summary per 21 CFR807.92 (cont.):

Similarities and Differences (cont'd):

The two systems are similar in that:

d) Both systems utilize optical absorbance methods.

e) Both systems use microprocessors for systems control, data acquisition, and data analysis.

f) Both systems accept input from keypads and output data to a video screen, diskette, optional printer, and on-line LIS.

g) Both systems provide distributional flags to assist in data review.

The two systems are different in that:

a) The CELL-DYN® 1200 System utilizes a focused flow impedance measurement, while the CELL-DYN® 1700 System utilizes impedance.

b) The CELL-DYN® 1700 utilizes both a keyboard and a hard drive for data operations, while the CELL-DYN® 1200 utilizes keypads and a diskette.

c) The CELL-DYN® 1200 uses a cyanide free hemoglobin reagent while the CELL-DYN® 1700 utilizes a cyanide containing hemoglobin reagent.

d) The CELL-DYN® 1200 utilizes a liquid crystal monochrome display while the CELL-DYN® 1700 utilizes high resolution color monitor.

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:

: :

II.___________________________________________________________________________________________________________________________________________________________________________ 510(k) Summary per 21 CFR807.92 cont.:

Table: Comparison of the CELL-DYN® 1200 to the CELL-DYN® 1700

	CELL-DYN® 1200	CELL-DYN® 1700 K870233
Intended Use	The CELL-DYN® 1200 System is a
multi-parameter, automated hematology
analyzer intended to classify the
following formed elements of EDTA
anti-coagulated blood:	Same
Measurement(s)
and (Parameters)	Focused Flow Impedance	Impedance
	• White Blood Cell (WBC) Count	• White Blood Cell (WBC) Count
	• Lymphocyte # and %	• Lymphocyte # and %
	• Mid Cells # and %	• Mid Cells # and %
	• Granulocyte # and %	• Granulocyte # and %
	• Red Blood Cell (RBC) Count	• Red Blood Cell (RBC) Count
	• Red Cell Distribution Width (RDW)	• Red Cell Distribution Width (RDW)
	• Mean Corpuscular Volume (MCV)	• Mean Corpuscular Volume (MCV)
	• Platelet (PLT) Count	• Platelet (PLT) Count
	• Mean Platelet Volume (MPV)	• Mean Platelet Volume (MPV)
	• Plateletcrit (PCT)**	• Plateletcrit (PCT)**
	• Platelet Distribution Width (PDW)**	• Platelet Distribution Width (PDW)**
	** for laboratory use only; not reportable
in US	** for laboratory use only; not reportable
in US
	Optical Absorbance	Optical Absorbance
	• Hemoglobin (HGB)	• Hemoglobin (HGB)
	Calculated values:	Using Modified Cyanmethemoglobin
Calculated values:
	• Hematocrit (HCT)	• Same
	• Mean Cell Hemoglobin (MCH)
	• Mean Cell Hemoglobin
Concentration (MCHC)
Device Description	Main Components:	Same
	• Analyzer w/integrated display/keypad
Interface
(Data Output/
Data Input)	Data Output:
• ¼ VGA LCD Display, High Resolution
Monochrome
• Printer (optional)
• RS232 LIS Interface Port

4

,

II. Table: Comparison of the CELL-DYN® 1200 to the CELL-DYN® 1700

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510(k) Summary per 21 CFR807.92 cont .: II.

Table: Comparison of the CELL-DYN® 1200 to the CELL-DYN® 1700

Equivalency Data:

The data compiled to support the claim that the CELL-DYN® 1200 System is substantially equivalent to the CELL-DYN® 1700 and the manual differential includes background, carryover, precision, correlation, linearity, and flagging data. Equivalence is demonstrated between the CELL-DYN® 1200 System and the CELL-DYN® 1700 System for the following measured parameters: White Blood Cell (WBC), three part WBC Differential sub-populations, Red Blood Count (RBC), Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Red Cell Distribution Width (RDW), Platelet Count (PLT), Mean Platelet Volume (MPV). Background, carryover, precision, correlation, and linearity data show performance to manufacturer's specifications.

Conclusion:

The conclusion of the testing performed on the CELL-DYN® 1200 System at Abbott Laboratories, Santa Clara, CA demonstrates the device is as safe and effective and performs as well as or better than the CELL-DYN® 1700 System.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

JUN 23 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janice E. Brown Regulatory Affairs Manager Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054

Re: K991142 Trade Name: CELL-DYN® 1200 System Regulatory Class: II Product Code: GKZ Dated: April 2, 1999 Received: April 5, 1999

Dear Mr. Brown:

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 (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 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 yitro 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 Putman

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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CELL-DYN® 1200 System

VI. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_ Kgy 1147

Device Name: CELL-DYN® 1200 System

Indications For Use:

The CELL-DYN® 1200 is a multi-parameter hematology analyzer intended to classify the following formed elements of EDTA anti-coagulated blood:

White Blood. Cell Parameters: WBC - White Blood Cell or leukocyte count GRAN -- Granulocyte absolute count %GRAN -- Granulocyte percent LYM - Lymphocyte absolute count %L - Lymphocyte percent MID – Mid-range absolute count %M - Mid-range 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 Corpuscular Volume RDW -- Red Cell Distribution Width

Hemoglobin Parameters: HGB - Hemoglobin concentration MCH -- Mean Cell Hemoglobin MCHC - Mean Cell Hemoglobin Concentration

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

Pitu E. Malvin

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