CELL-DYN EMERALD SYSTEM
Device Facts
| Record ID | K081495 |
|---|---|
| Device Name | CELL-DYN EMERALD SYSTEM |
| Applicant | Abbott Laboratories |
| Product Code | GKZ · Hematology |
| Decision Date | Feb 4, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
Indications for Use
The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
Device Story
The CELL-DYN Emerald is a benchtop automated hematology analyzer for clinical laboratories. It processes K2EDTA-anticoagulated human whole blood samples via manual open-tube aspiration. The device utilizes electrical impedance technology for cell counting and sizing, and LED-based spectrophotometry for hemoglobin measurement. It performs a 3-part white blood cell (WBC) differential and measures 16 parameters, including RBC, MCV, HCT, RDW, HGB, MCH, MCHC, PLT, and MPV. The system includes a built-in monitor, keypad, and data module for processing. It outputs results as histograms, dispersional data alerts, suspect parameter messages, and critical limit flags. Data is managed via an internal microprocessor and can be transmitted to a Laboratory Information System (LIS) via RS232 or Ethernet. The device assists clinicians by providing rapid hematological profiles to support diagnostic decision-making. It features password protection and uses an enzymatic cleaner reagent.
Clinical Evidence
Substantial equivalence supported by internal and external clinical trials comparing the CELL-DYN Emerald to the CELL-DYN 1800. Evidence includes performance data for background, correlation, precision, linearity, and carryover. No specific numerical sensitivity/specificity metrics provided in the summary.
Technological Characteristics
Benchtop analyzer; electrical impedance for cell counting/sizing; LED-based hemoglobin analysis; cyanide-free differential lyse reagent; enzymatic cleaner. Connectivity: RS232, Ethernet, USB. Interface: Touch screen, keypad, bar code reader. Microprocessor: Freescale Coldfire. Dimensions: 35cm x 25cm x 35cm.
Indications for Use
Indicated for in-vitro diagnostic use in clinical laboratories for automated hematology analysis of human whole blood specimens.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
- Abbott CELL-DYN® 1800 System (K030513)
Related Devices
- K110381 — CELL-DYN EMERALD 22 SYSTEM · Abbott Laboratories · Dec 22, 2011
- K014203 — ABX MICROS 60 HEMATOLOGY ANALYZER · Abx Diagnostics · Feb 28, 2002
- K190294 — CELL-DYN Emerald 22 AL System · Abbott Laboratories · Mar 15, 2019
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number: K081495
B. Purpose for Submission: New hematology analyzer
C. Measurand: CBC, 3-part differential
D. Type of Test: 16 quantitative hematology parameters
E. Applicant: Abbott Laboratories
F. Proprietary and Established Names:
- Proprietary Name: CELL-DYN Emerald™
- Established Name: Automated Differential Cell Counter
G. Regulatory Information:
1. Regulation section: 21 CFR 864.5220
2. Classification: Class II
3. Product code: GKZ
4. Panel: Hematology (81)
H. Intended Use:
1. Intended use(s):
The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
2. Indication(s) for use: same as the Intended Use
3. Special conditions for use statement(s): N/A
4. Special instrument requirements: N/A
I. Device Description:
The CELL-DYN Emerald system is a bench top analyzer with built-in monitor and
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data station. The analyzer aspirates blood from an opened collection tube held up to the aspiration probe. It provides automated CBC, leukocyte 3-part differential. The system provides three histograms (WBC, RBC, PLT), Dispersional Data Alerts, Suspect Parameter Messages, and Critical Limit Fagging.
# J. Substantial Equivalence Information:
1. Predicate device name(s): Abbott CELL-DYN 1800
2. Predicate 510(k) number(s): K030513
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device CELL-DYN Emerald | Predicate CELL-DYN 1800 |
| Intended Use | Automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories | Same |
| Principle of Measurement | - Electrical impedance - Modified methemoglobin analysis | Same |
| IVD Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MID%, MID#, GRA%, GRA# | Same |
| Sampling mechanism | Manual open tube | Same |
| Sample identification | - Alphanumeric sample identification - Handheld bar code scanner | Same |
| Sample type | Whole blood | Same |
| Reagents | Diluent, CN-Free Lyse reagent | Same |
| Throughput | Approximately 60 seconds | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device CELL-DYN Emerald | Predicate CELL-DYN 1800 |
| | | |
| Anticoagulant | K2EDTA | K3EDTA |
| Sample aspiration volume | - Open mode: 9.8 μL | - Open mode: 30 μL - Predilute: 40 μL |
| Data input | Keypad (internal) | Keyboard (external) |
| Password protection | Yes | No |
| Reagents | Cleaner (with enzyme) | Detergent |
# K. Standard/Guidance Document Referenced (if applicable):
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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
L. Test Principle:
CBC analysis is based on the electrical impedance counting and absorption spectrophotometry. Electrical impedance is used to count and size WBCs, RBCs, and PLTs. This method counts and sizes cells by detecting and measuring changes in electrical resistance when a cell suspended in a conductive liquid passes through a small aperture. The system counts the individual cells and provides cell size distribution. Hemoglobin is measured using a methemoglobin chromagen formed using the cyanide-free lytic reagent. The methemoglobin is measured photometrically at 555 nm.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
- Short-term imprecision: The study was performed at the internal site at least 4 times on 3 CD-Emerald instruments, and 1 CD-Emerald instrument at each of the 3 external sites with normal fresh blood. Each imprecision data set was based on 31 runs of the same specimen.
Fresh Blood Imprecision (n=31)
| Measurand (units)* | Ranges Tested | Observed %CV (to be reported as a Range) | %CV (95% Confidence Limit) |
| --- | --- | --- | --- |
| WBC (K/μL) | 4.7-10.2 | 1.5-3.4 | 3.5 |
| RBC (M/μL) | 4.2-5.4 | 0.7-1.9 | 2.0 |
| HGB (g/dL) | 12.2-16.1 | 0.4-1.8 | 2.1 |
| HCT (%) | 35.7-50.7 | 0.9-1.6 | 1.7 |
| MCV (fL) | 73.4-96.0 | 0.3-0.8 | 0.8 |
| RDW (%) | 11.8-17.0 | 2.1-3.4 | 3.3 |
| PLT (K/μL) | 185.2-387 | 2.8-5.8 | 6.1 |
| MPV (fL) | 7.6-9.0 | 1.3-2.6 | 2.7 |
| LYM % | 13.1-50.1 | 1.7-5.0 | 5.4 |
| MID % | 6.3-11.0 | 3.4-7.3 | 8.1 |
| GRA % | 43.1-75.8 | 1.1-3.0 | 2.9 |
| *Results are expressed in Standard (US) units. | | | |
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- Long-term imprecision: Tri-level CELL-DYN 16 Control (2 lots) were tested in duplicate on 6 CD-Emerald instruments for the duration of the study. Statistical analysis, as defined in CLSI EP5-A2 and EP-15-A2 was used to estimate the repeatability and within-device imprecision by standard deviation and $\% \mathrm{CV}$ of measurands listed on the commercial control package insert.
Commercial Control Imprecision
| Control Level | Average CV%1 |
| --- | --- |
| WBC x 109/L | |
| Low | 5.4 |
| Normal | 3 |
| High | 2.4 |
| RBC x 1012/L | |
| Low | 2 |
| Normal | 1.8 |
| High | 1.7 |
| HGB g/dL | |
| Low | 3 |
| Normal | 1.8 |
| High | 1.6 |
| HCT % | |
| Low | 2.2 |
| Normal | 1.9 |
| High | 1.8 |
| MCV fL | |
| Low | 1 |
| Normal | 0.9 |
| High | 0.8 |
| Control Level | Average CV%1 |
| --- | --- |
| MCH pg | |
| Low | 2.9 |
| Normal | 1.6 |
| High | 1.4 |
| MCHC g/dL | |
| Low | 2.9 |
| Normal | 1.6 |
| High | 1.4 |
| RDW % | |
| Low | 3.4 |
| Normal | 3 |
| High | 2.8 |
| PLT X 109/L | |
| Low | 10.4 |
| Normal | 4.9 |
| High | 4 |
| MPV fL | |
| Low | 3.5 |
| Normal | 1.8 |
| High | 1.6 |
| Control Level | Average CV%1 |
| --- | --- |
| LYM % | |
| Low | 5.6 |
| Normal | 1.5 |
| High | 1.9 |
| MID% | |
| Low | 9.7 |
| Normal | 5.1 |
| High | 2.9 |
| GRA % | |
| Low | 2.9 |
| Normal | 1.5 |
| High | 2.4 |
| LYM# | |
| Low | 10.5 |
| Normal | 3.2 |
| High | 3.6 |
| MID# | |
| Low | 19.1 |
| Normal | 6.5 |
| High | 4.2 |
| GRA# | |
| Low | 5.2 |
| Normal | 3.6 |
| High | 2.7 |
1Values are the sample count-weighted averages of the individual instrument and individual lot $\% \mathrm{CV}$
b. Linearity/assay reportable range/analytical measuring range: Simple manipulations (concentration/dilution) of fresh whole blood from normal donors were done to generate certain low and high analytical range for correlation samples. The unmodified specimen results were taken as truth, and the dilution ratios provided calculated expected values. The means of the dilution replicates were plotted against the calculated expected results. In
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addition, commercially available linearity kits from R&D Systems was assayed and analyzed. The correlation coefficient (r) values of >0.975 for WBC, RBC, HGB, and PLT were obtained in the study.
c. Carryover: Carryover was performed on 3 CD-Emerald instruments, at least three times per instruments for WBC, RBC, HGB, and PLT measurands. Fresh whole blood samples with High Target Values (HTV) were tested in triplicates; followed by 3 aspirations of whole blood Low Target Value (LTV) samples. Carryover (%) was calculated using the following equation:
$$
\text{Carryover} (\%) = (\mathrm{LTV1 - LTV3}) / (\mathrm{HTV3 - LTV3}) \times 100
$$
% Carryover (95% CI) was obtained for the following parameters:
| Measurands (Units) | Low Target Value | High Target Value | % Carryover (95% Confidence Limit) |
| --- | --- | --- | --- |
| WBC (K/μL) | >0 and <3 | >90 | <1% |
| RBC (M/μL) | >0 and <1.5 | >6.20 | <1% |
| HGB (g/dL) | >0 and <5.0 | >22.0 | <1% |
| PLT (K/μL) | >0 and <100 | >900 | <2.2% |
d. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A
e. Detection limit: N/A
f. Analytical specificity: N/A
g. Assay cut-off: N/A
2. Comparison studies:
a. Method comparison with predicate device: Clinical samples were analyzed on the test instruments and compared against predicate devices for both CBC and differentials. Correlation was also determined by comparing the differential results obtained by the CD-Emerald to those by manual microscopy. The CD-Emerald's WBC Overall Flagging ability was evaluated by comparing their results against the predicate's results.
- Correlation to CD-1800:
The internal Abbott site obtained the following results on 330 blood samples.
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| Comparability (Correlation) to CD-1800 Internal Site | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Data Range | | | |
| Measurand* | r-value | Min | Max | Intercept | Slope |
| WBC (K/μL) | 0.997 | 0.4 | 42.3 | 0.578 | 0.905 |
| RBC (M/μL) | 0.993 | 1.31 | 7.38 | -0.147 | 1.032 |
| HGB (g/dL) | 0.997 | 4.8 | 24.4 | 0.222 | 1.004 |
| HCT (%) | 0.993 | 14.7 | 66.9 | -0.158 | 1.036 |
| MCV (fL) | 0.921 | 63.6 | 119.6 | -12.170 | 1.175 |
| RDW (%) | 0.758 | 11.8 | 20.9 | 6.320 | 0.558 |
| PLT (K/μL) | 0.990 | 2.0 | 1039.0 | 1.212 | 1.044 |
| MPV (fL) | 0.912 | 6.8 | 11.5 | 2.641 | 0.580 |
| LYM (%) | 0.970 | 4.0 | 75.6 | 1.240 | 1.011 |
| MID (%) | 0.761 | 1.6 | 17.8 | 1.560 | 0.895 |
| GRA (%) | 0.972 | 21.9 | 94.4 | -1.782 | 0.990 |
| * Results are expressed in Standard (US) units. Correlation coefficient, established by Passing-Bablok regression analysis. | | | | | |
The external laboratory GA-Atlanta obtained the following results on 569 blood samples.
| Comparability (Correlation) to CD-1800 External Site | | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Data Range | | | |
| Measurand* | r-value | Min | Max | Intercept | Slope |
| WBC (K/μL) | 0.997 | 0.4 | 82.5 | 0.602 | 0.895 |
| RBC (M/μL) | 0.992 | 1.36 | 6.81 | -0.270 | 1.074 |
| HGB (g/dL) | 0.994 | 4.3 | 19.6 | -0.230 | 1.038 |
| HCT (%) | 0.988 | 12.9 | 57.5 | -0.810 | 1.032 |
| MCV (fL) | 0.943 | 60.7 | 110.1 | -8.067 | 1.097 |
| RDW (%) | 0.750 | 10.9 | 26.4 | 4.467 | 0.690 |
| PLT (K/μL) | 0.982 | 4.0 | 958.0 | 5.554 | 0.995 |
| MPV (fL) | 0.916 | 6.0 | 10.9 | 2.582 | 0.561 |
| LYM (%) | 0.986 | 2.5 | 76.9 | 1.057 | 1.034 |
| MID (%) | 0.819 | 1.7 | 19.8 | 2.005 | 0.979 |
| GRA (%) | 0.982 | 12.6 | 95.7 | -7.150 | 1.048 |
| * Results are expressed in Standard (US) units. Correlation coefficient, established by Passing-Bablok regression analysis. | | | | | |
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- Correlation of to manual microscopy:
| Measurand | Range Tested* | Replicates | r-value† | Slope | Y-intercept |
| --- | --- | --- | --- | --- | --- |
| GRA% | 23.15 – 95.70% | 180 | 0.932 | 0.943 | 1.302 |
| MID% | 1.800 – 19.25% | 180 | 0.874 | 0.612 | 3.350 |
| LYM% | 2.500 – 62.10% | 180 | 0.943 | 0.989 | 3.317 |
| * Results are expressed in traditional US units. These values do not represent the analytical measurement range, which is provided in another table. † Correlation coefficient, established by Passing-Bablock regression analysis. | | | | | |
- WBC Overall Flagging ability
Out of Normal Range (Distributional)
PLUS Normals with No Flags
| | | CD EMERALD | | |
| --- | --- | --- | --- | --- |
| | | Normal | Abnormal | |
| CD 1800 | Normal | 730 | 19 | 749 |
| | Abnormal | 18 | 1402 | 1420 |
| | | 748 | 1421 | 2169 |
| Agreement | | 98.29% | | |
| Sensitivity | | 98.73% | | |
| Specificity | | 97.46% | | |
| Positive Predictive Value | | 98.66% | | |
| Negative Predictive Value | | 97.59% | | |
| CD1800 Flagging rate | | 65.47% | | |
| CD Emerald flagging rate | | 65.51% | | |
b. Matrix comparison: N/A
3. Clinical studies:
a. Clinical Sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): N/A
4. Clinical cut-off: N/A
5. Expected values/Reference range:
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Whole blood samples were collected from 270 males and females. The manufacturer recommends the laboratory to establish their reference ranges.
| Reference Ranges | | | | |
| --- | --- | --- | --- | --- |
| Measurand | Units | Sex | N | Range |
| WBC | K/μL | M/F | 270 | 4.70-10.30 |
| RBC | M/μL | M/F | 270 | 4.03 - 5.46 |
| HGB | g/dL | M/F | 270 | 12.40 - 16.90 |
| HCT | % | M/F | 270 | 36.60 - 48.30 |
| MCV | fL | M/F | 270 | 81.50 - 96.80 |
| MCH | pg | M/F | 270 | 27.50 - 33.10 |
| MCHC | g/dL | M/F | 270 | 32.40 - 35.70 |
| RDW | % | M/F | 270 | 11.80 - 14.90 |
| PLT | K/μL | M/F | 270 | 165.00 - 385.00 |
| MPV | fL | M/F | 270 | 7.20 - 10.20 |
| LYM% | % | M/F | 270 | 12.70 - 47.80 |
| MID% | % | M/F | 270 | 6.30 - 14.00 |
| GRA% | % | M/F | 270 | 43.50 - 78.90 |
N. Instrument Name: CELL-DYNN Emerald
O. System Descriptions:
1. Modes of Operation: manual open tube
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X or No ☐
3. Specimen Identification: manual entry, handheld bar code scanner
4. Specimen Sampling and Handling: Manual open tube
5. Calibration: Abbott commercial calibrator, fresh whole blood
6. Quality Control: Abbott commercial control materials
P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above
Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
