(82 days)
The CELL-DYN 1800 System has the same intended use as previously cleared for the CELL-DYN 1700 System, K870233. The CELL-DYN 1800 System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The CELL-DYN 1800 System is an automated, multiparameter hematology analyzer designed to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.
The CELL-DYN 1800 System is a benchtop analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module. The CELL-DYN 1800 open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.
The CELL-DYN 1800 System's acceptance criteria and performance are based on its substantial equivalence to the predicate device, the CELL-DYN 1700 System. The study conducted was an in-house clinical trial comparing the two devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CELL-DYN 1800 System are implicit in its claim of substantial equivalence to the CELL-DYN 1700 System. Therefore, the reported device performance for the CELL-DYN 1800 System is that its performance metrics (background, correlation, precision, linearity, sensitivity and specificity, and carryover) are comparable to or meet the established performance of the CELL-DYN 1700 System.
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance (CELL-DYN 1800) |
|---|---|---|
| Background | Performance comparable to CELL-DYN 1700 System | Data supports substantial equivalence |
| Correlation | Strong correlation with CELL-DYN 1700 System for all measured parameters | Data supports substantial equivalence |
| Precision | Precision comparable to CELL-DYN 1700 System across relevant ranges | Data supports substantial equivalence |
| Linearity | Linearity comparable to CELL-DYN 1700 System across relevant ranges | Data supports substantial equivalence |
| Sensitivity and Specificity | Sensitivity and specificity comparable to CELL-DYN 1700 System for detecting relevant hematological conditions | Data supports substantial equivalence |
| Carryover | Carryover rates comparable to or better than CELL-DYN 1700 System | Data supports substantial equivalence |
| Intended Use | Same intended use as CELL-DYN 1700 System: multiparameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories | Meets intended use; reports sixteen parameters of EDTA-anticoagulated blood |
| Safety and Effectiveness | No new questions of safety and effectiveness compared to CELL-DYN 1700 System | Differences noted (cyanide-free reagent, barcode, etc.) do not pose new questions of safety and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The document mentions "The data compiled supports the claim that the CELL-DYN 1800 System is substantially equivalent to the CELL-DYN 1700 System and includes data for background, correlation, precision, linearity, sensitivity and specificity, and carryover." However, the exact number of samples or patients used in this comparison is not provided.
- Data Provenance: The study was an "in-house clinical trial." This implies the data was collected by Abbott Laboratories. The country of origin of the data is not specified, but since Abbott Laboratories is US-based and the submission is to the FDA, it is likely that parts of the clinical trial took place in the US or under US regulatory standards. The study design is implied to be prospective for the collection of data to evaluate the CELL-DYN 1800 against the CELL-DYN 1700.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a comparison study of two automated hematology analyzers, the "ground truth" would likely be established through reference methods (e.g., manual microscopy or established instruments) rather than expert consensus on interpretation. The document does not specify the number of experts or their qualifications for establishing ground truth, as the comparison is primarily analytical and technical against a predicate device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for the test set. The evaluation is based on direct comparison of measurements and performance characteristics between the two devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance and equivalence of an automated hematology analyzer, not on human reader performance with or without AI assistance. The device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study primarily represents a standalone performance evaluation. The CELL-DYN 1800 System is itself an automated analyzer. The "algorithm only" performance is essentially what is being evaluated through parameters like correlation, precision, linearity, sensitivity, specificity, and carryover, comparing its automated results to those of the predicate device.
7. The Type of Ground Truth Used
The ground truth implicitly used for the comparison is the measurements and performance of the predicate device, the CELL-DYN 1700 System, which is itself a "legally marketed predicate device" and therefore assumed to have established analytical performance. Additionally, standard reference methods for hematology parameters (e.g., volumetric metering as the ICSH Method for cell counting, LED Hemoglobin analysis) would typically be considered the ultimate ground truth for the measurements these devices perform.
8. The Sample Size for the Training Set
This information is not provided. The document describes a clinical trial for comparison between the 1800 and 1700 systems, but it does not mention a separate "training set" for the development of the CELL-DYN 1800. Automated hematology analyzers typically rely on pre-defined algorithms and calibration, rather than machine learning models that require a distinct training set in the same way an AI/ML device would.
9. How the Ground Truth for the Training Set Was Established
Since no explicit "training set" is described for an AI/ML model, the establishment of ground truth for such a set is not applicable in the provided context. The "ground truth" for the development and calibration of the CELL-DYN 1800's algorithms would have been established through extensive analytical validation using reference materials, spiked samples, and clinical specimens measured against established reference methods, a standard practice in in vitro diagnostic device development.
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| 510(k)Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements ofSMDA 1990 and 21 CFR 807.92. | |
|---|---|---|
| The assigned 510(k) number is: | K030513 | |
| CELL-DYN® 1800 System | ||
| Submitted by | Abbott Laboratories5440 Patrick Henry DriveSanta Clara, CA 95054 | |
| Contact Person | John DeanPhone (408) 567-3430Fax | (408) 567-3523 |
| Date Prepared | February 14, 2003 | |
| Proprietary Name | CELL-DYN® 1800 System | |
| Common Name | Automated Hematology Analyzer | |
| Classification Name | Automated Differential Cell Counter(21 CFR 864.5220) | |
| Predicate Device | Abbott CELL-DYN 1700 System, K870233 | |
| DeviceDescription | The CELL-DYN 1800 System is a benchtop analyzerconsisting of the main analyzer with data module, displaystation, and printer. The main analyzer, data module, anddisplay station are housed in a single chassis. The printer is astand-alone module. The CELL-DYN 1800 open sampler isequipped to aspirate blood from a collection tube that has beenopened and is held under the open sample aspiration probe. | |
| IntendedUse | The CELL-DYN 1800 System has the same intended use aspreviously cleared for the CELL-DYN 1700 System, K870233 | |
| The CELL-DYN 1800 System is a multiparameter, automatedhematology analyzer designed for in vitro diagnostic use inclinical laboratories. |
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| Similarities | ||
|---|---|---|
| And | ||
| Differences |
The CELL-DYN 1800 System and the CELL-DYN 1700 System are similar in that:
- a) Both systems accept open specimens presented manually by the operator.
- Both systems automatically aspirate the specimen and present b) it for automated processing.
- c) Both systems use microprocessors for systems control, data acquisition, and data analysis.
- d) Both systems accept input from keyboard and send data output to: video screen, hard drive, and printer; and both systems provide RS232 Interface to an on-line LIS.
- e) Both systems provide Dispersional Data Alerts, Suspect Parameter Messages, and Suspect Population Flags to assist in data review.
- f) Both Systems use electrical impedance on the von Behrens Transducer for counting and sizing cells.
- Both systems use LED Hemoglobin analysis. g)
- Both systems use Volumetric Metering as the Reference ICSH h) Method.
The CELL-DYN 1800 System and the CELL-DYN 1700 System are different in that:
- The CELL-DYN 1800 System uses Cyanide-Free differential a) lyse reagent, while the CELL-DYN 1700 uses a cyanidecontaining lytic agent.
- b) The CELL-DYN 1800 System is capable of inputting specimen information from a bar code through a hand held bar code scanner, while the CELL-DYN 1700 System does not have bar code scanning capabilities.
- c) The CELL-DYN 1800 is capable of data output to both a dot matrix printer and an inkjet printer, while the CELL-DYN 1700 is only capable of data output to a dot matrix printer.
- d) The CELL-DYN 1800 is a smaller and more compact system than the CELL-DYN 1700 System.
- e) The CELL-DYN 1800 has a High Resolution Color Monitor (LCD), while the CELL-DYN 1700 has a High Resolution Color Monitor (CRT).
- f) The CELL-DYN 1800 has a Patient Data Storage of 10.000 Run Cycles, while the CELL-DYN 1700 has a Patient Data Storage of 5,000 Run Cycles.
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| Clinical StudyProtocol | The Clinical Study Protocol for the CELL-DYN 1800 is foundin Attachment E. |
|---|---|
| EquivalencyData Summary | The CELL-DYN 1800 System is a multi-parameter, automatedhematology analyzer for in vitro diagnostic use in clinicallaboratories. The CELL-DYN 1800 System, which includesreagents and software, was compared in an in-house clinicaltrial to the CELL-DYN 1700 System. The data compiledsupports the claim that the CELL-DYN 1800 System issubstantially equivalent to the CELL-DYN 1700 System andincludes data for background, correlation, precision, linearity,sensitivity and specificity, and carryover. The data supportingthe claim that the CELL-DYN 1800 is substantially equivalentto the CELL-DYN 1700 is found in Attachment F. |
| Conclusion | The CELL-DYN 1800 System is substantially equivalent to theCELL-DYN 1700 (predicate device). The differences noted donot pose new questions of safety and effectiveness. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird, composed of three stylized profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. John Dean Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054
MAY 12 2003
Re: K030513 Trade/Device Name: CELL-DYN® 1800 System Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: February 14, 2003 Received: February 19, 2003
Dear Mr. Dean:
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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K 03 0513
Device Name:
CELL-DYN® 1800 System
Indications for Use:
The CELL-DYN 1800 System is an automated, multiparameter hematology analyzer designed to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K030513 |
|---|---|
| --------------- | --------- |
§ 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.”