(79 days)
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 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.
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.
The CELL-DYN® 1200 System is an automated hematology analyzer intended to classify formed elements of EDTA anti-coagulated blood. Its acceptance criteria and performance are compared to its predicate device, the CELL-DYN® 1700, and manual differential methods.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for the CELL-DYN® 1200. Instead, it demonstrates substantial equivalence to the predicate device, the CELL-DYN® 1700, and manual differential for various parameters. The reported performance is implicitly that the CELL-DYN® 1200 performs "as well as or better than" the CELL-DYN® 1700.
| Parameter | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Measured Parameters | Must demonstrate substantial equivalence to the CELL-DYN® 1700 and manual differential. | Equivalence is demonstrated for WBC, three-part WBC Differential sub-populations (Granulocyte absolute count & percent, Lymphocyte absolute count & percent, Mid-range absolute count & percent), RBC, HGB, MCV, RDW, PLT, and MPV. |
| White Blood Cell (WBC) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Three-Part WBC Differential | Substantially equivalent to CELL-DYN® 1700 and manual method for Lymphocyte # & %, Mid Cells # & %, Granulocyte # & %. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700 for these sub-populations. |
| Red Blood Cell (RBC) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Hemoglobin (HGB) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. The CELL-DYN® 1200 uses a cyanide-free reagent, unlike the CELL-DYN® 1700's cyanide-containing reagent, suggesting a potential improvement in safety. |
| Mean Corpuscular Volume (MCV) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Red Cell Distribution Width (RDW) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Platelet Count (PLT) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Mean Platelet Volume (MPV) | Substantially equivalent to CELL-DYN® 1700 and manual method. | Performance demonstrated to be substantially equivalent to the CELL-DYN® 1700. |
| Calculated Values | Calculated values (HCT, MCH, MCHC) should be consistent with the underlying measured values. | Calculated values for HCT, MCH, and MCHC are listed as parameters for both devices, implying their derivation is similar and therefore their performance is implicitly linked to the measured parameters. |
| Background, Carryover, Precision, Correlation, Linearity, Flagging | Performance to manufacturer's specifications. | Data shows performance to manufacturer's specifications for these aspects. |
| Overall Performance | As safe and effective and performs as well as or better than the CELL-DYN® 1700 System. | The conclusion of the testing performed demonstrates the device is as safe and effective and performs as well as or better than the CELL-DYN® 1700 System. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "the data compiled to support the claim" includes various studies (background, carryover, precision, correlation, linearity, and flagging data). However, the specific sample sizes used for these test sets are not explicitly detailed in the provided information.
The data provenance is stated as testing "at Abbott Laboratories, Santa Clara, CA." This suggests the data was collected internally by the manufacturer. The document does not specify if the data was retrospective or prospective, nor does it explicitly mention the country of origin of the data beyond the testing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document mentions "manual differential" as a predicate method for comparison. However, it does not specify the number of experts or their qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for any of the test sets, including the manual differential comparison.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test set evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an automated hematology analyzer, which performs measurements without human reader interpretation in the primary analysis phase. The comparison is between the automated device and a predicate automated device, as well as a "manual differential" which would involve human review but not in the context of an MRMC study designed to evaluate AI-assisted human reading. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was done. The entire evaluation of the CELL-DYN® 1200 System, including background, carryover, precision, correlation, linearity, and flagging data, represents the standalone performance of the algorithm and hardware without human intervention during the measurement process. The comparison to the predicate device (another automated analyzer) and the manual differential also serves to establish its standalone performance relative to existing methods.
7. The Type of Ground Truth Used:
The primary ground truth used for comparison and validation appears to be:
- Predicate Device Performance: The CELL-DYN® 1700 System, an already legally marketed and established automated hematology analyzer.
- Manual Differential: This would typically involve microscopic examination of blood smears by trained laboratory personnel, considered the gold standard for certain aspects of blood cell classification at the time. "Manual differential" serves as a ground truth for the "three-part WBC differential" parameters.
- Manufacturer's Specifications: For metrics like background, carryover, precision, correlation, and linearity.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. Automated hematology analyzers like the CELL-DYN® 1200 are typically "rule-based" or "physics-based" systems utilizing focused flow impedance and optical absorbance, rather than algorithms that require extensive machine learning training data in the modern sense. Therefore, the concept of a "training set" as understood in current AI/machine learning contexts is not directly applicable to this device's reported evaluation.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" or a machine learning-based algorithm, this question is not applicable based on the provided information. The device's design and operational principles are outlined based on established physical and chemical measurement techniques rather than data-driven learning.
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CELL-DYN® 1200 System JUN 23 1999 II. 510(k) Summary per 21 CFR807.92 Abbreviated 510(k) Notification
| Submitted By: | Abbott Laboratories5440 Patrick Henry DriveSanta 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 Counter21 CFR 864.5220 |
| Predicate Devices: | CELL-DYN® 1700 System, K870233Manual 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 theseparameters. 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 amulti-parameter, automated hematologyanalyzer intended to classify thefollowing formed elements of EDTAanti-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 reportablein US | ** for laboratory use only; not reportablein US | |
| Optical Absorbance | Optical Absorbance | |
| • Hemoglobin (HGB) | • Hemoglobin (HGB) | |
| Calculated values: | Using Modified CyanmethemoglobinCalculated values: | |
| • Hematocrit (HCT) | • Same | |
| • Mean Cell Hemoglobin (MCH) | ||
| • Mean Cell HemoglobinConcentration (MCHC) | ||
| Device Description | Main Components: | Same |
| • Analyzer w/integrated display/keypad | ||
| Interface(Data Output/Data Input) | Data Output:• ¼ VGA LCD Display, High ResolutionMonochrome• Printer (optional)• RS232 LIS Interface PortData Input:• Keypad | • High Resolution Color Monitor |
| • Keypad | ||
| • Keyboard | ||
| Specimen Type | EDTA (K3, K2) Anticoagulated HumanWhole Blood | Same |
| CELL-DYN® 1200 | CELL-DYN® 1700 K870233 | |
| Sampling | • Direct sampling of a well mixed wholeblood specimen from an open or closedcollection tube that has been identifiedand presented manually by the operator. | Same |
| Dilution | • Automatic dilution of the aspiratedsample and presentation of eachdilution for measurement. | Same |
| OperatingPrinciples | • Enumeration and sizing of WBCs,RBCs, and PLTs by impedance | Same |
| • HGB is measured by opticalabsorbance. | Same | |
| PotentialInterferingSubstances | • WBC | Same |
| • NRBCs | ||
| • Lyse Resistant RBCs | ||
| • PLT clumps | ||
| • Cryoglobulin and cryofibrinogen | ||
| RBC | Same | |
| • Elevated WBCs | ||
| • Increased # giant PLTs | ||
| • Autoagglutination | ||
| • In vitro hemolysis | ||
| HGB | Same | |
| • Elevated WBC | ||
| • Increased plasma substances(triglycerides, bilirubin, in vivohemolysis) | ||
| • Lyse Resistant RBCs | ||
| MCV | Same | |
| • Elevated WBCs | ||
| • Increased # giant PLTs | ||
| • Hyperglycemia | ||
| • In vitro hemolysis | ||
| CELL-DYN® 1200 | CELL-DYN® 1700 K870233 | |
| PotentialInterferingSubstances Cont. | PLT• WBC fragments• Increased # giant PLTs• Microcytic RBCs• PLT clumping• Cryoglobulins• In vitro hemolysis | Same |
| • MPV• None Stated | Same |
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,
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
prescription ✓
§ 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.”