(64 days)
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No
The description focuses on traditional hematology analysis methods (impedance, focused flow, spectrophotometry) and does not mention AI or ML.
No
This device is an in-vitro diagnostic hematology analyzer that counts and classifies blood cells, which is used for diagnostic purposes and not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CELL-DYN® 1200 System is an "automated multi-parameter hematology analyzer intended for in-vitro diagnostic use." It then lists various blood parameters it classifies, which are used to aid in clinical diagnosis.
No
The device description clearly outlines hardware components and physical processes (aspiration, dilution, mixing, impedance, focused flow, spectrophotometry) used to analyze blood samples. It is a physical hematology analyzer system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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)..."
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
in the clinical hematology laboratory, medical clinic and/or Physicians Office Laboratory (POL)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 when used either in a POL or in a Clinical Laboratory includes background, carryover, accuracy, precision, 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.”
0
- (cont'd)
510(k) SUMMARY CELL-DYN® 1200 System
Intended Use
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.
Principles of Operation
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.
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
OR
Over-The-Counter Use