(32 days)
The CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM #, MON %, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.
The CELL-DYN Emerald 22 AL is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
The CELL-DYN Emerald 22 AL analyzer is a bench top analyzer, consisting of the main analyzer, autoloader module, and touch screen display. Sample analysis may be performed in open or closed mode. The CELL-DYN Emerald 22 AL is equipped with a sample loader that provides continuous automated closed mode sampling for up to 50 closed tube samples, one at a time. The analyzer is also equipped with a tube holder assembly that allows the use of open tube sampling.
The CELL-DYN Emerald 22 AL is designed to automatically perform the following:
- a) Aspirate and dilute whole blood
- b) Count, size and classify cells present in a whole blood specimen
- c) Measure the hemoglobin concentration of a whole blood specimen
- d) Analyze the raw data that is collected
- e) Output results to the display, printer and laboratory information system
Three types of measurements are used to count, size and classify blood cells and to measure hemoglobin. The three types of measurements are:
- a) Electrical Impedance Counting
- b) Absorption Spectrophotometry
- c) Optical Flow Cytometry
The electrical impedance counting is used for WBC, RBC and PLT measurements. The absorption spectrophotometry is used for HGB measurement. The optical flow cytometry is used for WBC differential. HCT is derived from the volume of the RBCs that are counted during the measurement cycle.
The provided text discusses the CELL-DYN Emerald 22 AL System, an automated hematology analyzer, and its substantial equivalence to the predicate device, CELL-DYN Emerald 22 (K110381).
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document states that a variety of non-clinical design verification analyses were performed to demonstrate substantial equivalence and that "all predetermined acceptance criteria were met." However, the specific numerical acceptance criteria for each performance metric (e.g., specific ranges for background noise, percentages for carryover, R-squared values or other correlation coefficients for linearity, CV% for imprecision) are not explicitly detailed in a table format within the provided text.
The reported device performance is broadly stated as: "Results of this testing demonstrated substantial equivalence between the CELL-DYN Emerald 22 AL System and the CELL-DYN Emerald 22 System with respect to analytical performance and that the addition of the sample loader module does not impact functional performance."
The types of studies performed, for which acceptance criteria were met, include:
- Background
- Carryover
- Linearity
- Short-Term Imprecision
- Long-Term Imprecision
- Method Comparison
- Blood Tube Type Study
- Mode-to-Mode Equivalency
- Data Invalidation Clogging Rate
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each of the non-clinical design verification analyses. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an automated hematology analyzer, and the studies described are analytical performance studies. These types of studies typically involve comparisons against reference methods or established standards rather than expert-established ground truth in the way a diagnostic imaging AI might. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like radiologists is not applicable in this context. The ground truth for analytical performance studies would be based on the accuracy of the reference method used for comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given that the studies are analytical performance comparisons against reference methods (e.g., comparing measurements from the new device against those from the predicate device or a gold standard method), an adjudication method (like 2+1, 3+1) is not applicable. Adjudication is typically used in clinical studies where expert consensus is needed to resolve discrepancies in interpretation, which is not the nature of these analytical studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes a hematology analyzer, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance and associated effect sizes is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are essentially "standalone" in the context of device performance. The non-clinical design verification analyses (Background, Carryover, Linearity, Imprecision, Method Comparison, etc.) evaluate the automated analyzer's performance directly, independent of human interaction for result generation. The device itself is an automated system providing quantitative measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the analytical performance studies, the ground truth for parameters like cell counts (WBC, RBC, PLT), hemoglobin, and differential percentages would likely be established by:
- Reference methods: Highly accurate and precise laboratory methods, often considered "gold standards" for specific hematology parameters (e.g., manual cell counts, specialized spectrophotometry for HGB).
- Predicate Device Comparison: A significant part of the evaluation is demonstrating substantial equivalence to the predicate device (CELL-DYN Emerald 22), implying the predicate's performance serves as a comparative "ground truth" standard.
8. The sample size for the training set
The document describes non-clinical validation studies for an automated hematology analyzer, not an AI model that requires a "training set" in the machine learning sense. The device is based on established technologies (Electrical Impedance Counting, Absorption Spectrophotometry, Optical Flow Cytometry). Therefore, the concept of a "training set" for an algorithm is not directly applicable as it would be for a deep learning model.
9. How the ground truth for the training set was established
As explained above, the device's operational principles are physical and chemical measurements rather than a machine learning algorithm requiring a "training set" with ground truth established through annotation or clinical outcomes. Therefore, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 15, 2019
Abbott Laboratories Madhu Gill Regulatory Affairs Specialist 4551 Great America Pkwy Santa Clara, California 95054
Re: K190294
Trade/Device Name: CELL-DYN Emerald 22 AL System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: February 8, 2019 Received: February 11, 2019
Dear Madhu Gill:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Takeesha Taylor-bell -S
Takeesha Taylor-Bell Chief. Hematology Branch Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190294
Device Name CELL-DYN Emerald 22 AL System
Indications for Use (Describe)
The CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM #, MON %, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.
The CELL-DYN Emerald 22 AL is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21CFR 807.92
The assigned 510(k) number is: K190294
| I | Submitter | Abbott Laboratories4551 Great America PkwySanta Clara, CA 95054Phone: (408) 567-3701; Fax: (408) 567-3657Contact Person: Madhu GillDate Prepared: February 12, 2019 |
|---|---|---|
| II | Device | Trade Name: CELL-DYN Emerald 22 AL SystemCommon Name: Automated Hematology AnalyzerDevice Classification: Class II GKZ – Automated Differential CellCounter (21 CFR 864.5220)Trade Marks: CELL-DYN Emerald is a trademark of Abbott Laboratorie |
| III | Predicate Deviceand 510(k)number | The predicate device is CELL-DYN Emerald 22 system, K110381,cleared December 22, 2011. |
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IV. Intended Use/ Indications for Use
The CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM #, MON%, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anticoagulated whole blood. The CELL-DYN Emerald 22 AL is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
V. Device Description
The CELL-DYN Emerald 22 AL analyzer is a bench top analyzer, consisting of the main analyzer, autoloader module, and touch screen display. Sample analysis may be performed in open or closed mode. The CELL-DYN Emerald 22 AL is equipped with a sample loader that provides continuous automated closed mode sampling for up to 50 closed tube samples, one at a time. The analyzer is also equipped with a tube holder assembly that allows the use of open tube sampling.
The CELL-DYN Emerald 22 AL is designed to automatically perform the following:
- a) Aspirate and dilute whole blood
- b) Count, size and classify cells present in a whole blood specimen
- c) Measure the hemoglobin concentration of a whole blood specimen
- d) Analyze the raw data that is collected
- e) Output results to the display, printer and laboratory information system
Three types of measurements are used to count, size and classify blood cells and to measure hemoglobin. The three types of measurements are:
- a) Electrical Impedance Counting
- b) Absorption Spectrophotometry
- c) Optical Flow Cytometry
The electrical impedance counting is used for WBC, RBC and PLT measurements. The absorption spectrophotometry is used for HGB measurement. The optical flow cytometry is used
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for WBC differential. HCT is derived from the volume of the RBCs that are counted during the measurement cycle.
The CELL-DYN Emerald 22 AL provides the following parameters:
White Blood Cell Parameters
- WBC White Blood Cell or leukocyte count .
- LYM % Lymphocyte percent* ●
- LYM # Lymphocyte absolute number* ●
- . MON % Monocyte percent*
- . MON # Monocyte absolute number*
- NEU % Neutrophil percent*
- NEU # Neutrophil absolute number*
- EOS% Eosinophil percent*
- EOS # Eosinophil absolute number*
- BAS % Basophil percent*
- . BAS # Basophil absolute number*
- WBC differential parameters are measured and reported in DIF mode only.
Red Blood Cell Parameters
- RBC Red Blood Cell or erythrocyte count
- HCT Hematocrit ●
- MCV Mean Cell Volume
- RDW Red Blood Cell Distribution Width
Hemoglobin Parameters
- HGB Hemoglobin concentration ●
- . MCH Mean Cell Hemoglobin
- MCHC Mean Cell Hemoglobin Concentration
Platelet Parameters
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- . PLT Platelet count
- MPV Mean Platelet Volume .
VI. Summary of Substantial Equivalence:
Table 4.1 below compares the CELL-DYN Emerald 22 AL with the predicate device, CELL-DYN Emerald 22 (K110381).
Table 4.1: Similarities and differences between CELL-DYN Emerald 22 AL System and CELL-DYN Emerald 22 System (K110381).
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
|---|---|---|---|---|
| Similarities | ||||
| Intended Use/Indicationsfor Use | The CELL-DYN Emerald 22 Systemis a quantitative multi-parameterautomated hematology analyzerdesigned for in-vitro diagnostic use inclinical laboratories for enumerationof the following parameters: WBC,LYM%, LYM #, MON%, MON #,NEU%, NEU #, EOS%, EOS #,BAS%, BAS #, RBC, HCT, MCV,RDW, HGB, MCH, MCHC, PLT,MPV in K2EDTA anti-coagulatedwhole blood.The CELL-DYN Emerald 22 isindicated for use to identify patientswith hematologic parameters withinand outside of established referenceranges. | The CELL-DYN Emerald 22 ALSystem is a quantitative multi-parameter automated hematologyanalyzer designed for in-vitrodiagnostic use in clinical laboratoriesfor enumeration of the followingparameters: WBC, LYM%, LYM #,MON%, MON #, NEU%, NEU #,EOS%, EOS #, BAS%, BAS #, RBC,HCT, MCV, RDW, HGB, MCH,MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.The CELL-DYN Emerald 22 AL isindicated for use to identify patientswith hematologic parameters withinand outside of established referenceranges. | ||
| Item | Predicate device, CELL-DYN | Modified device, CELL-DYN | ||
| Emerald 22 (K110381) | Emerald 22 AL | |||
| WBCdifferential | 5-part differential | 5-part differential | ||
| Parameters | White Blood Cells: | White Blood Cells: | ||
| WBC | WBC | |||
| LYM% | LYM% | |||
| LYM # | LYM # | |||
| MON% | MON% | |||
| MON # | MON # | |||
| NEU% | NEU% | |||
| NEU # | NEU # | |||
| EOS% | EOS% | |||
| EOS # | EOS # | |||
| BAS% | BAS% | |||
| BAS # | BAS # | |||
| Red Blood Cells: | Red Blood Cells: | |||
| RBC | RBC | |||
| HCT | HCT | |||
| MCV | MCV | |||
| RDW | RDW | |||
| Hemoglobin: | Hemoglobin: | |||
| HGB | HGB | |||
| MCH | MCH | |||
| MCHC | MCHC | |||
| Platelets: | Platelets: | |||
| PLT | PLT | |||
| MPV | MPV | |||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
| Technology | Optical differential by LED 455nmElectric impedanceSpectrophotometry by LED 555nm | Optical differential by LED 455nmElectric impedanceSpectrophotometry by LED 555nm | ||
| Sample Type | K2EDTA anticoagulated humanwhole blood for all parameters | K2EDTA anticoagulated humanwhole blood for all parameters | ||
| Reagents | CELL-DYN Emerald 22 DiluentCELL-DYN Emerald 22 LyseCELL-DYN Emerald 22 EasyCleaner | CELL-DYN Emerald 22 DiluentCELL-DYN Emerald 22 LyseCELL-DYN Emerald 22 EasyCleaner | ||
| Controls andCalibrator | CELL-DYN 22 Plus ControlCELL-DYN 22 Plus Calibrator | CELL-DYN 22 Plus ControlCELL-DYN 22 Plus Calibrator | ||
| Histograms | WBC, PLT, RBC | WBC, PLT, RBC | ||
| Scatterplot | WBC | WBC | ||
| AlphanumericSpecimen ID | Feature Available | Feature Available | ||
| Differences | ||||
| Sampleloadingmechanism | Individual uncapped tube samples aremanually presented to the sampleprobe for aspiration. | Autoloader assembly was added toallow for loading up to 50 closed tubesamples at a time. The autoloaderassembly includes the followingmodules/components:- Sample racks- Loader- Transfer/mixer- Unloader- Internal bar code reader- Frames and covers | ||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
| PrintedCircuit BoardAssembly(PCBA)(SystemBoard) | The PCBA controls three motors.Two motors are used to the drivesampling module and one to drivesyringes. The micro-processor is CPU5272. The CPU compiler isMetrowerks. | A new PCBA that controls sevenmotors was implemented. Theadditional four motors are to drive thefollowing autoloader functions: load,transfer, mix, and eject. The newCPU is Phytec CPU Freescalei.MX27, ARM926EJ, 400MHz+.The CPU complier is Codeblocks +gcc. The source code was adapted forthe new CPU and compiler. | ||
| Instrumentsize | Height: 13.8 inches (35 cm)Width: 9.8 inches (25 cm)Depth: 13.8 inches (35 cm)Weight: ~24.2 lbs. (11 kg) | Height: 16.1 inches (41 cm)Width: 19.7 inches (50 cm)Depth: 17.0 inches (43 cm)Weight: ~55 lbs. (25 kg) | ||
| Samplingmodule | The sampling module utilizes a bluntaspiration sampling probe.Components of the sample moduleinclude:- Sampling probe- Probe rinsing head- Probe motor and belt | The sampling module contains thefollowing modifications to allow forcap piercing in closed mode andneedle cleaning:- Trocar type needle- Needle rinsing head- Needle motor and belt | ||
| Open tubeoperation | Open tube sampling is performed bymanually presenting an openedsample tube to the sampling probe foraspiration. | Tube Holder assembly was added tohold the opened sample tube forsample aspiration to prevent needleexposure. The addition of the tubeholder assembly includes:- Fixed station and sensors- Open tube sheath- Open tube holder | ||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
| Source ofvacuum forcleaning | The sampling probe is cleaned via thevacuum created by the wastesyringes. | Needle cleaning is managed by astronger vacuum source created by apump. An in-line filter was added toprevent particles from entering thepump. | ||
| Dilution andCountingmodule | Diluent for RBC/PLT dilution and forcleaning the needle share the sameflow path. The inner diameter for thedrain hole of the chamber is 1.2mm. | The RBC/PLT diluent path fordilution was modified using anadditional valve to separate diluentflow to the rinsing head and theRBC/PLT chamber. The innerdiameter for the waste draining holewas increased from 1.2 to 1.6 mm toaccommodate for cap coring. | ||
| Incubationduration | Incubation time for Resistive count is15.5 seconds and for Optic count is20.5 seconds. | Incubation time for Resistive count is18.5 seconds and for Optic count is24 seconds.The longer incubation time is theconsequence of the change in diluentpath. | ||
| Dead volumefor sampling | There is no minimum volumerequirement. | The minimum volume of samplerequired is 500 uL for standard tubesand 250 uL for capillary tubes. | ||
| Sampleaspirationvolume | 17 uL of blood sample is aspiratedduring sampling cycle and used fortesting. | |||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | |||
| Reagentconsumptionvolume | Information on reagent consumptionis provided in the CELL-DYNEmerald 22 Operator's Manual(Section 4, Table 4.4). | Information on reagent consumptionis provided in the CELL-DYNEmerald 22 AL Operator's Manual(Section 4, Table 4.5). Additionalvolume of reagent is needed for thecleaning cycle/process, compared toCELL-DYN Emerald 22. | ||
| Fluidic cycles | No cap piercing and needle cleaningwith pump. | The fluidic cycles were adapted toaccommodate the changed fluidicconfiguration required for cappiercing. | ||
| Throughput | Throughput is 45 per hour (opentube). Sample cycle takes 74 secondsto complete in open mode. | |||
| USB ports | No USB hub. 2 USB ports in the backof the instrument for USB thumbdrive and printer. | The USB hub PCB provides 3 USBports located for convenience in thefront of the instrument for externalthumb drive and keyboardconnections. | ||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
| User Interface | User Interface was designed for a smaller screen size.5.4" LCD touch screen with physical numeric keypad on the front. | User Interface was designed for a bigger screen size that allows displaying of more data and ease of navigation.8.4" LCD touch screen with on screen alpha numeric keypad. Action buttons are rearranged. New autoloader and worklist screens. There is no physical keypad on the front. | ||
| Operating system | The system utilizes operating system OSE Epsilon. | The system utilizes operating system OSE Delta. | ||
| Fluidics interface | Commands for open tube fluidic configuration. | Same commands for open tube fluidic configuration and new commands to manage the pump functionality. | ||
| Patient ID and demographic information management | Single input of patient samples at a time. | A worklist is provided to process a batch of patient samples manually or via the Laboratory Information System (LIS). | ||
| Rack management | No rack management. | Added rack management module | ||
| Tube holder management | No tube holder management. | Added module to detect the presence of open tube assembly and adjust sampling depth in tubes. | ||
| Item | Predicate device, CELL-DYNEmerald 22 (K110381) | Modified device, CELL-DYNEmerald 22 AL | ||
| Flagging | Flags are detailed in the CELL-DYNEmerald 22 Operator's Manual,Section 3, Sub-section InstrumentAlarms, Operational Alerts, andParameter Data Flags | Same flagging rules. HGB flaggingbug was fixed. PLT suspicion flagwas added to address potentialcarryover due to the grooves in thenew Trocar needle. |
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VII. Summary of Analytical Performance
To demonstrate that the CELL-DYN Emerald 22 AL System is substantially equivalent to the CELL-DYN Emerald 22 System, the following non-clinical design verification analyses were performed and evaluated:
- a. Background
- b. Carryover
- c. Linearity
- d. Short-Term Imprecision
- Long-Term Imprecision e.
- Method Comparison f.
- Blood Tube Type Study g.
- h. Mode-to-Mode Equivalency
- i. Data Invalidation Clogging Rate
Results of this testing demonstrated substantial equivalence between the CELL-DYN Emerald 22 AL System and the CELL-DYN Emerald 22 System with respect to analytical performance and that the addition of the sample loader module does not impact functional performance.
VIII. Summary of Clinical Testing
Not applicable.
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IX. Conclusion:
The CELL-DYN Emerald 22 AL and its predicate device, CELL-DYN Emerald 22 (K110381), have the same Intended Use, Indications for Use, fundamental technology, principles of operation, specimen type, Analytical Measurement Range (AMR), reagents, calibrator, controls, parameters and comparable performance characteristics. The modifications consist of a larger analyzer with a slightly slower throughput, slightly larger sample aspiration volumes, slightly larger incubation duration, different operating system and user interface. Analytical performance and software verification, and human factor validation testing were conducted to characterize the performance of the CELL-DYN Emerald 22 AL and all predetermined acceptance criteria were met. The results of this testing demonstrated that the device is as safe, as effective, and performs as well as or better than the CELL-DYN Emerald 22 and is suitable for the labeled indication for use. Predicate device clinical validation testing was used for Emerald 22 AL as no variation in performance was found between the predicate and modified device. The difference in technological characteristics between the predicate device and CELL-DYN Emerald 22 AL do not raise different question of safety and effectiveness.
§ 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.”