(32 days)
Not Found
No
The description focuses on standard hematology analysis techniques (electrical impedance, spectrophotometry, optical flow cytometry) and automated sample handling. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an automated hematology analyzer designed for in-vitro diagnostic use to enumerate blood parameters and identify patients with hematologic parameters within and outside of established reference ranges. It is not used for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for in-vitro diagnostic use in clinical laboratories" and "is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges." This clearly indicates its role in diagnosing conditions.
No
The device description clearly outlines hardware components including a bench top analyzer, autoloader module, touch screen display, and mechanisms for aspirating, counting, sizing, classifying, and measuring blood components using electrical impedance, absorption spectrophotometry, and optical flow cytometry. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The CELL-DYN Emerald 22 AL System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories..."
This statement clearly identifies the device as being intended for in-vitro diagnostic purposes.
N/A
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 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.
Product codes
GKZ
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 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
. PLT Platelet count
MPV Mean Platelet Volume .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical design verification analyses were performed and evaluated:
a. Background
b. Carryover
c. Linearity
d. Short-Term Imprecision
e. Long-Term Imprecision
f. Method Comparison
g. Blood Tube Type Study
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CELL-DYN Emerald 22 system, K110381
Reference Device(s)
Not Found
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)
Not Found
§ 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
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
1
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
2
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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3
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 Laboratories
4551 Great America Pkwy
Santa Clara, CA 95054
Phone: (408) 567-3701; Fax: (408) 567-3657
Contact Person: Madhu Gill
Date Prepared: February 12, 2019 |
|-----|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II | Device | Trade Name: CELL-DYN Emerald 22 AL System
Common Name: Automated Hematology Analyzer
Device Classification: Class II GKZ – Automated Differential Cell
Counter (21 CFR 864.5220)
Trade Marks: CELL-DYN Emerald is a trademark of Abbott Laboratorie |
| III | Predicate Device
and 510(k)
number | The predicate device is CELL-DYN Emerald 22 system, K110381,
cleared December 22, 2011. |
4
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
5
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
6
- . 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-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 22 AL | | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | | | |
| Intended Use/
Indications
for Use | The CELL-DYN Emerald 22 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 is
indicated for use to identify patients
with hematologic parameters within
and outside of established reference
ranges. | 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. | | |
| Item | Predicate device, CELL-DYN | Modified device, CELL-DYN | | |
| | Emerald 22 (K110381) | Emerald 22 AL | | |
| WBC
differential | 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-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 22 AL | | |
| Technology | Optical differential by LED 455nm
Electric impedance
Spectrophotometry by LED 555nm | Optical differential by LED 455nm
Electric impedance
Spectrophotometry by LED 555nm | | |
| Sample Type | K2EDTA anticoagulated human
whole blood for all parameters | K2EDTA anticoagulated human
whole blood for all parameters | | |
| Reagents | CELL-DYN Emerald 22 Diluent
CELL-DYN Emerald 22 Lyse
CELL-DYN Emerald 22 Easy
Cleaner | CELL-DYN Emerald 22 Diluent
CELL-DYN Emerald 22 Lyse
CELL-DYN Emerald 22 Easy
Cleaner | | |
| Controls and
Calibrator | CELL-DYN 22 Plus Control
CELL-DYN 22 Plus Calibrator | CELL-DYN 22 Plus Control
CELL-DYN 22 Plus Calibrator | | |
| Histograms | WBC, PLT, RBC | WBC, PLT, RBC | | |
| Scatterplot | WBC | WBC | | |
| Alphanumeric
Specimen ID | Feature Available | Feature Available | | |
| Differences | | | | |
| Sample
loading
mechanism | Individual uncapped tube samples are
manually presented to the sample
probe for aspiration. | Autoloader assembly was added to
allow for loading up to 50 closed tube
samples at a time. The autoloader
assembly includes the following
modules/components:
- Sample racks
- Loader
- Transfer/mixer
- Unloader
- Internal bar code reader
- Frames and covers | | |
| Item | Predicate device, CELL-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 22 AL | | |
| Printed
Circuit Board
Assembly
(PCBA)
(System
Board) | The PCBA controls three motors.
Two motors are used to the drive
sampling module and one to drive
syringes. The micro-processor is CPU
- The CPU compiler is
Metrowerks. | A new PCBA that controls seven
motors was implemented. The
additional four motors are to drive the
following autoloader functions: load,
transfer, mix, and eject. The new
CPU is Phytec CPU Freescale
i.MX27, ARM926EJ, 400MHz+.
The CPU complier is Codeblocks +
gcc. The source code was adapted for
the new CPU and compiler. | | |
| Instrument
size | 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) | | |
| Sampling
module | The sampling module utilizes a blunt
aspiration sampling probe.
Components of the sample module
include:
- Sampling probe
- Probe rinsing head
- Probe motor and belt | The sampling module contains the
following modifications to allow for
cap piercing in closed mode and
needle cleaning: - Trocar type needle
- Needle rinsing head
- Needle motor and belt | | |
| Open tube
operation | Open tube sampling is performed by
manually presenting an opened
sample tube to the sampling probe for
aspiration. | Tube Holder assembly was added to
hold the opened sample tube for
sample aspiration to prevent needle
exposure. The addition of the tube
holder assembly includes: - Fixed station and sensors
- Open tube sheath
- Open tube holder | | |
| Item | Predicate device, CELL-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 22 AL | | |
| Source of
vacuum for
cleaning | The sampling probe is cleaned via the
vacuum created by the waste
syringes. | Needle cleaning is managed by a
stronger vacuum source created by a
pump. An in-line filter was added to
prevent particles from entering the
pump. | | |
| | Dilution and
Counting
module | Diluent for RBC/PLT dilution and for
cleaning the needle share the same
flow path. The inner diameter for the
drain hole of the chamber is 1.2mm. | The RBC/PLT diluent path for
dilution was modified using an
additional valve to separate diluent
flow to the rinsing head and the
RBC/PLT chamber. The inner
diameter for the waste draining hole
was increased from 1.2 to 1.6 mm to
accommodate for cap coring. | |
| | | Incubation
duration | Incubation time for Resistive count is
15.5 seconds and for Optic count is
20.5 seconds. | Incubation time for Resistive count is
18.5 seconds and for Optic count is
24 seconds.
The longer incubation time is the
consequence of the change in diluent
path. |
| Dead volume
for sampling | | | There is no minimum volume
requirement. | The minimum volume of sample
required is 500 uL for standard tubes
and 250 uL for capillary tubes. |
| | | | Sample
aspiration
volume | 17 uL of blood sample is aspirated
during sampling cycle and used for
testing. |
| | | Item | | Predicate device, CELL-DYN
Emerald 22 (K110381) |
| Reagent
consumption
volume | Information on reagent consumption
is provided in the CELL-DYN
Emerald 22 Operator's Manual
(Section 4, Table 4.4). | Information on reagent consumption
is provided in the CELL-DYN
Emerald 22 AL Operator's Manual
(Section 4, Table 4.5). Additional
volume of reagent is needed for the
cleaning cycle/process, compared to
CELL-DYN Emerald 22. | | |
| | Fluidic cycles | No cap piercing and needle cleaning
with pump. | | The fluidic cycles were adapted to
accommodate the changed fluidic
configuration required for cap
piercing. |
| | | Throughput | | Throughput is 45 per hour (open
tube). Sample cycle takes 74 seconds
to complete in open mode. |
| USB ports | | | No USB hub. 2 USB ports in the back
of the instrument for USB thumb
drive and printer. | The USB hub PCB provides 3 USB
ports located for convenience in the
front of the instrument for external
thumb drive and keyboard
connections. |
| | Item | | Predicate device, CELL-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 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-DYN
Emerald 22 (K110381) | Modified device, CELL-DYN
Emerald 22 AL | | |
| Flagging | Flags are detailed in the CELL-DYN
Emerald 22 Operator's Manual,
Section 3, Sub-section Instrument
Alarms, Operational Alerts, and
Parameter Data Flags | Same flagging rules. HGB flagging
bug was fixed. PLT suspicion flag
was added to address potential
carryover due to the grooves in the
new Trocar needle. | | |
7
8
9
10
11
12
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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.