The CELL-DYN® 1200 System is an automated multi-parameter hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physicians Office Laboratory (POL) 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
CT* - 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.

Device Description

The CELL-DYN 1200 System counts, sizes, and classifies blood cells by impedance and focused flow methods, which incorporates electrical resistance and electronic sizing principles. Each specimen is aspirated, diluted and mixed before the hematology parameters are measured. The CELL-DYN 1200 System utilizes a spectrophotometric method for hemoglobin concentration, which is measured optically by absorbance at 540nm +20nm. The system incorporates the coincidence loss principle for each cell that is counted.

AI/ML Overview

The CELL-DYN® 1200 System is an automated multi-parameter hematology analyzer used for in-vitro diagnostic purposes in various clinical settings. The provided text outlines its intended use, principles of operation, and equivalency data to support its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the CELL-DYN® 1200 System. Instead, it indicates that "Equivalency Data" was compiled to support the claim of substantial equivalence when used in a Physician's Office Laboratory (POL) or Clinical Laboratory. This equivalency was demonstrated through studies on:

Background
Carryover
Accuracy
Precision
Linearity
Quality Control

Furthermore, "Correlation equivalence is demonstrated between the CELL-DYN 1200 System and the CELL-DYN 1700 System for the following measured parameters: White Blood Count (WBC), WBC differential sub populations, Red Blood Count (RBC), Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Platelet Count (PLT), Mean Platelet Volume (MPV), and Red Cell Distribution Width (RDW)."

Therefore, the acceptance criteria implicitly appear to be performance characteristics (accuracy, precision, linearity, etc.) that are comparable to the CELL-DYN 1700 predicate device, and the reported device performance is that it met these equivalence standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Comparable Background characteristics to predicate device	Demonstrated equivalence to predicate device
Comparable Carryover characteristics to predicate device	Demonstrated equivalence to predicate device
Comparable Accuracy to predicate device	Demonstrated equivalence to predicate device
Comparable Precision to predicate device	Demonstrated equivalence to predicate device
Comparable Linearity to predicate device	Demonstrated equivalence to predicate device
Comparable Quality Control to predicate device	Demonstrated equivalence to predicate device
Correlation Equivalence for WBC, WBC differential, RBC, HGB,	Demonstrated correlation equivalence to CELL-DYN 1700 System for
MCV, PLT, MPV, RDW to predicate device (CELL-DYN 1700 System)	all listed parameters.

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

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "data compiled to support the claim" was gathered.

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

The provided text does not specify the number of experts used or their qualifications for establishing ground truth. As this is a hematology analyzer, the ground truth would typically be established by established laboratory methods and potentially expert review of blood smears, but this is not detailed in the given summary.

4. Adjudication Method for the Test Set

The provided text does not describe an adjudication method for the test set. Given the nature of a hematology analyzer, ground truth is typically established by reference methods or expert consensus on manual differential counts, rather than an adjudication process between multiple readers in the way an imaging study might.

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

The provided text does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI systems where human readers interpret images. For a hematology analyzer, the comparison is typically between the device's measurements and established reference methods or a predicate device.

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

The provided text describes a standalone performance evaluation implicitly. The "Equivalency Data" and "Correlation equivalence" studies evaluate the CELL-DYN 1200 System's performance (WBC, RBC, HGB, etc.) against a predicate device (CELL-DYN 1700) and established performance parameters (accuracy, precision, linearity). This is a direct measure of the device's output without human intervention during the measurement process.

7. Type of Ground Truth Used

The ground truth used for this device would likely be established through:

Reference methods: Established laboratory techniques for measuring blood parameters (e.g., manual differential counts, spectrophotometry for hemoglobin, flow cytometry).
Predicate device (CELL-DYN 1700 System): The performance of the predicate device serves as a benchmark for "correlation equivalence."

The text explicitly states "Correlation equivalence is demonstrated between the CELL-DYN 1200 System and the CELL-DYN 1700 System," indicating that the predicate device's performance was a key component of establishing the "truth" for comparison.

8. Sample Size for the Training Set

The provided text does not specify the sample size for a training set. Hematology analyzers of this type are typically "trained" during their development and calibration phase using a wide range of blood samples with known characteristics. However, the 510(k) summary focuses on the equivalency testing rather than the initial development and training.

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

The provided text does not describe how the ground truth for any training set was established. As with the test set, any "training" (calibration, algorithm development) would have relied on highly characterized samples with ground truth established through established reference laboratory methods.

Summary

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(cont'd)

510(k) SUMMARY CELL-DYN® 1200 System

Intended Use

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 CT* - 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.

Principles of Operation

Similarities and Differences

The CELL-DYN 1200 System operating in the POL is the same as the CELL-DYN 1200 System operated in the Clinical Laboratory.

Equivalency Data

The data compiled to support the claim that the CELL-DYN 1200 System is substantially equivalent when used either in a POL or in a Clinical Laboratory includes background, carryover, accuracy, precision,

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510(k) SUMMARY CELL-DYN® 1200 System

Equivalency Data (cont'd)

linearity and quality control. Correlation equivalence is demonstrated between the CELL-DYN 1200 System and the CELL-DYN 1700 System for the following measured parameters: White Blood Count (WBC), WBC differential sub populations, Red Blood Count (RBC), Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Platelet Count (PLT), Mean Platelet Volume (MPV), and Red Cell Distribution Width (RDW).

Conclusion

The modified device has demonstrated comparable performance characteristics to the predicate device when operated in the POL environment and supports the labeling change to include placement in POLS.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present.

SEP 2 4 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: K992444 Trade Name: CELL-DYN® 1200 System Regulatory Class: II Product Code: GKZ Dated: July 21, 1999

Received: July 22, 1999

Dear Ms. 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 Flectronic Product

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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 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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Indications for Use Statement 14.

10(k) Number (if known): K992444

Device Name:

CELL-DYN® 1200 System

Indications for Use:

The CELL-DYN 1200 System is an automated, multi-parameter hematology analyzer intended for invitro diagnostic use in the clinical hematology laboratory, medical clinic and/or Physician's Office Laboratory (POL) 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	Hemoglobin Parameters:
MID – Mid-range absolute count	HGB – Hemoglobin Concentration
%M - Mid-range percent	MCH – Mean Cell Hemoglobin
Platelet Parameters:	MCHC – Mean Cell Hemoglobin Concentration
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.

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Melin

Over-The-Counter Use

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.”