← Product Code [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) · K071562

# D3 HEMATOLOGY ANALYZER, MODEL D3 (K071562)

_Drew Scientific, Inc. · GKZ · Dec 11, 2007 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K071562

## Device Facts

- **Applicant:** Drew Scientific, Inc.
- **Product Code:** [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ.md)
- **Decision Date:** Dec 11, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5220
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

## Device Story

D3 Hematology analyzer is a stand-alone benchtop instrument for clinical laboratories; performs in-vitro analysis of whole blood samples. Uses electrical impedance for cell counting/sizing (WBC, RBC, Plt) and spectrophotometry (cyanmethemoglobin) for hemoglobin measurement. Provides 16 quantitative hematology parameters including 3-part leukocyte differential. Operator performs manual sample handling via front-mounted needle; alphanumeric specimen entry (barcode reader optional). System features integrated touch screen and embedded firmware (OS Epsilon). Results displayed on-screen; used by clinicians for hematological assessment. Benefits include rapid CBC/differential turnaround (under one minute) and automated quality control tracking via Levy-Jennings graphs.

## Clinical Evidence

Bench testing only. Studies included accuracy, repeatability, linearity, carryover, and sample stability. Results demonstrated acceptable performance per manufacturer specifications. No clinical prospective or retrospective studies were required for this 510(k) submission.

## Technological Characteristics

Benchtop hematology analyzer; impedance sensing for WBC, RBC, PLT; spectrophotometry (555nm) for Hgb; volume integration for MCV/HCT. Integrated touch screen interface. Stand-alone operation. Reagents: D3 Pac (Diluent, Lyse, Cleaner). Compliant with UL 61010-1 (electrical safety) and IEC 60601-1-2 (EMC).

## Regulatory 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

- DataCell 18MS ([K945678](/device/K945678.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K071562

B. Purpose for Submission:
Original Traditional 510(k)

C. Manufacturer and Instrument Name:
DREW Scientific, Inc., D3 Hematology analyzer

D. Type of Test or Tests Performed:
16 Quantitative hematology parameters

E. System Descriptions:

1. Device Description:
The D3 Hematology analyzer is a stand-alone benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leukocyte 3-part differential count using the impedance and spectrophotometry techniques.

2. Principles of Operation:
The impedance principle of electrical resistance is used for cell counting and sizing of WBCs, RBCs, and Plts. This is combined with optical absorbance of cyanmethemeglobin for hemoglobin. The technology combines to give a full CBC with 3-part differential in just under one minute.

3. Modes of Operation:
Open Tube

4. Specimen Identification:
Specimen identification is manual alphanumeric entry. A bar-code reader is an optional accessory.

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5. Specimen Sampling and Handling:

Manual sample handling using a sampling needle on the front of the instrument.

6. Calibration:

Calibration is automatic or manual using DREW EX-CAL manufactured by R&D Systems.

7. Quality Control:

Quality control is performed using DREW EX-TROL control materials (high, normal and low levels), manufactured by R&D Systems. The D3 stores up to 100 results per control batch for 6 different Lots. Results of each lot can be viewed as tables or through Levy-Jennings graphs.

8. Software:

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:

Yes ☐ X or No ☐
Software documentation was provided at a Moderate Level of Concern.

F. Regulatory Information:

1. Regulation section:

21 CFR 864.5220, Automated differential cell counter

2. Classification:

Class II

3. Product code:

GKZ

4. Panel:

Hematology (81)

G. Intended Use:

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1. Indication(s) for Use:

The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

2. Special Conditions for Use Statement(s):

N/A

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

DATACELL 18MS PLUS (K945678)

2. Comparison with Predicate Device:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Instrument | Hematology Analyzer, CBC + 3 part differential | Same  |
|  Measurement Principle: WBC, RBC, Plt. | Impedance | Same  |
|  Mode: | Open Tube | Same  |
|  Parameters: Leukocyte | WBC, LYM%, LYM#, MID%, MID#, GRA%, GRA# | Same  |
|  Parameters: Erythrocyte | RBC#, Hgb, Hct, MCV, MCH, MCHC, RDW | Same  |
|  Parameters:Thrombocyte | PLT, MPV | Same  |
|  Sample Type | Whole Blood | Same  |
|  Anti-coagulant | EDTA K2/ K3 | Identical  |
|  Quality Controls | Manufactured by: R&D Systems (K843962) for DREW Scientific, EX-TROL | Same  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Calibrators | Manufactured by R&D Systems (K003991) for DREW Scientific, EX-CAL | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Measurement Principle: MCV | Volume integration | Derived from RBC cell size distribution  |
|  Measurement Principle: HCT | Volume integration | Calculation  |
|  RBC Wavelength | 555nm | 540nm  |
|  Specimen Sample Volume | 10.0 μl (whole blood) | 135.0 μl (whole blood)  |
|   |  25.0 μl of whole blood diluted into 0.5 ml of diluent for prediluted sample mode | 65.0 μl (whole blood in samples saver mode) 25 μl of whole blood into 6.0 ml of diluent for prediluted sample mode  |
|  Patient Management | No worklist Uni-directional LIS | Worklist, Uni-directional LIS  |
|  Software Operating System | OS Epsilon embedded firmware | DOS  |
|  Memory Capacity | Last 1,000 analyses (demographics, results, & histograms) | 100,000 results without histograms, 5000 results with histograms  |
|   |  QC: 6 levels (100 results per level) | QC: 8 lots/3 levels (100 results per lot for each of the 3 levels)  |
|  QC Package | Backup onto USB key | 8 controls assays (3 levels per lot)  |
|   |  6 controls single level | 100 results per lot (3 levels per lot)  |
|   |  100 results per control | Levy Jennings plot  |
|   |  Levy Jennings plot | Assay values can be  |
|   |  Assay values can be |   |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Display | loaded several ways: a) manually, b) via USB key | loaded several ways: a) manually, b) via modem, c) via diskette  |
|   |  Integrated Touch Screen | LCD Computer Screen  |
|  Computer | Integrated stand-alone computer | Built in computer  |
|  Power Requirement | 90 to 265 VAC 50/60Hz | 120 VAC +/- 10% 60Hz  |
|  Maximum Power Consumption | 50W | 300W  |

I. Special Control/Guidance Document Referenced (if applicable):

Guidance for Industry

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy: Table 1

Correlation may be evaluated with respect to DREW DATACELL 18MS+ using human blood samples, for all the measured parameters including 3 part differential.

|  PARAMETERS | R  |
| --- | --- |
|  WBC (K/μl) | > 0.95  |
|  LYM (%) | > 0.95  |
|  MIDS (%) | > 0.90  |
|  GRA (%) | > 0.95  |
|  RBC (M/μL) | > 0.95  |
|  HGB (g/dL) | > 0.95  |
|  HCT (%) | > 0.95  |
|  MCV (fL) | > 0.95  |
|  PLT (K/μl) | > 0.95  |

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Accuracy: Table 2

Correlation was established by Drew Scientific using a DREW DATACELL 18MS and 124 blood samples for all the measured parameters.

|   | Data Range |   |   |
| --- | --- | --- | --- |
|  PARAMETERS | Minimum | Maximum | R  |
|  WBC (K/μl) | 1.1 | 26.2 | 0.998  |
|  LYM (%) | 2.3 | 63.1 | 0.989  |
|  MIDS (%) | 1.4 | 22.2 | 0.956  |
|  GRA (%) | 24.9 | 94.8 | 0.988  |
|  RBC (M/μL) | 1.01 | 7.13 | 0.997  |
|  HGB (g/dL) | 3.0 | 20.1 | 0.997  |
|  HCT (%) | 8.7 | 62.7 | 0.992  |
|  MCV (fL) | 61.0 | 115.0 | 0.979  |
|  RDW (%) | 11.2 | 30.5 | 0.830  |
|  PLT (K/μl) | 57 | 917 | 0.974  |
|  MPV (fL) | 6.5 | 13.5 | 0.804  |

Accuracy: Table 3

An independent external laboratory obtained the following results based on 77 samples.

|   | Data Range |   |   |
| --- | --- | --- | --- |
|  PARAMETERS | Minimum | Maximum | R  |
|  WBC (K/μl) | 4.3 | 16.8 | 0.996  |
|  LYM (%) | 7.8 | 48.1 | 0.973  |
|  MIDS (%) | 3.2 | 8.8 | 0.937  |
|  GRA (%) | 44.9 | 88.5 | 0.974  |
|  RBC (M/μL) | 2.76 | 6.24 | 0.983  |
|  HGB (g/dL) | 9.0 | 16.2 | 0.990  |
|  HCT (%) | 27.8 | 50.3 | 0.968  |
|  MCV (fL) | 70.0 | 101.0 | 0.962  |
|  RDW (%) | 11.0 | 15.7 | 0.757  |
| --- | --- | --- | --- |
|  PLT (K/μl) | 91 | 439 | 0.977  |
|  MPV (fL) | 6.3 | 13.0 | 0.923  |

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b. Precision/Reproducibility: Table 4

Repeatability or simple precision was evaluated by Drew Scientific using a normal whole blood for 20 replicates. Repeatability is expressed as coefficient of variation (CV).

|  Parameters | Level | Mean | CV%  |
| --- | --- | --- | --- |
|  WBC | ≥ to 6.0 × (K/μL) | 7.98 | 2.0  |
|  LYM% | ≥ to 15 % | 32.23 | 2.9  |
|  MID% | ≥ to 5 % | 7.94 | 3.5  |
|  GRA% | ≥ to 50 % | 59.83 | 1.5  |
|  RBC | ≥ to 4.0 × (M/μL) | 5.168 | 1.0  |
|  HGB | ≥ to 12.0 g/dL | 15.46 | 0.6  |
|  HCT | ≥ to 35.0 % | 42.93 | 1.0  |
|  MCV | ≥ to 80 fL | 83.07 | 0.4  |
|  RDW | ≥ to 12 % | 13.24 | 3.3  |
|  PLT | ≥ to 200× (K/μL) | 307.2 | 3.6  |
|  MPV | ≥ to 7 fL | 7.72 | 1.2  |

Precision: Table 5

Two independent external laboratories using D3 analyzer obtained the following results using normal controls

|  Laboratory A (10 replicates - normal control)  |   |   |   |
| --- | --- | --- | --- |
|  Parameters | Level | Mean | CV%  |
|  WBC | ≥ to 6.0 × (K/μL) | 7.59 | 1.4  |
|  LYM% | ≥ to 15 % | 25.88 | 1.6  |
|  MID% | ≥ to 5 % | 6.61 | 3.1  |
|  GRA% | ≥ to 50 % | 67.51 | 0.5  |
|  RBC | ≥ to 4.0 × (M/μL) | 4.573 | 1.0  |
|  HGB | ≥ to 12.0 g/dL | 13.63 | 1.0  |
|  HCT | ≥ to 35.0 % | 39.90 | 1.0  |
| --- | --- | --- | --- |
|  MCV | ≥ to 80 fL | 87.26 | 0.3  |
|  RDW | ≥ to 12 % | 14.88 | 2.2  |
|  PLT | ≥ to 200× (K/μL) | 221.6 | 2.7  |
|  MPV | ≥ to 7 fL | 7.36 | 2.9  |

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Precision: Table 6 Inter-laboratory Precision

Split fresh human samples were analyzed on duplicate at two independent external laboratories within the same time frame. Inter-laboratory precision was calculated using ISO 5725-2 procedure.

|  Parameter |   | WBC | LYM % | MID% | GRA%  |
| --- | --- | --- | --- | --- | --- |
|  Mean |   | 6.90 | 26.03 | 6.35 | 67.5  |
|  Est. of repeatability variance | S_{r}^{2} | 0.0100 | 0.5625 | 0.0250 | 0.392  |
|  Est. between laboratory variance | S_{L}^{2} | 0.0000 | 0.5000 | 0.0675 | 1.705  |
|  Estimate reproducibility variance | S_{R}^{2} | 0.0100 | 1.0625 | 0.0925 | 2.097  |
|   |  S_{r} | 0.1000 | 0.7500 | 0.1581 | 0.626  |
|   |  S_{R} | 0.1000 | 1.0308 | 0.3041 | 1.448  |
|   |  CV% | 1.45% | 3.96% | 4.79% | 2.14%  |
|  CV% claim |   | < 2.5% | < 5% | < 10% | < 3%  |
|  Parameter |   | RBC | Hgb | HCT | MCV  |
| --- | --- | --- | --- | --- | --- |
|  Mean |   | 4.565 | 14.00 | 41.48 | 90.9  |
|  Est. of repeatability variance | S_{r}^{2} | 0.0062 | 0.0050 | 0.4625 | 0.012  |
|  Est. between laboratory variance | S_{L}^{2} | 0.0001 | 0.0025 | 0.0000 | 0.775  |
|  Estimate reproducibility variance | S_{R}^{2} | 0.0063 | 0.0075 | 0.4625 | 0.787  |
|   |  S_{r} | 0.0791 | 0.0707 | 0.6801 | 0.111  |
|   |  S_{R} | 0.0795 | 0.0866 | 0.6801 | 0.887  |
|   |  CV% | 1.74% | 0.62% | 1.64% | 0.98%  |
|  CV% claim |   | < 2% | < 1.5% | < 2% | < 1%  |
|  Parameter |   | PLT  |
| --- | --- | --- |
|  Mean |   | 287.8  |
|  Est. of repeatability variance | S_{r}^{2} | 151.25  |
|  Est. between laboratory variance | S_{L}^{2} | 0.00  |
|  Estimate reproducibility variance | S_{R}^{2} | 151.25  |
|   |  S_{r} | 12.30  |
|   |  S_{R} | 12.30  |
|   |  CV% | 4.27%  |
|  CV% claim |   | < 5%  |

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c. Linearity: Table 7

Linearity was established by Drew Scientific using a commercial linearity kit, each level was measured five times. In the case of MCV, latex spheres were used.

|  Parameters (Units) | Overall measured range  |
| --- | --- |
|  WBC (K/μL) | 0.6 – 117.6  |
|  RBC (M/μL) | 0.25 – 7.98  |
|  HGB (g/dL) | 0.6 – 23.12  |
|  HCT (%) | 2.2 – 71.0  |
|  MCV (fL) | 43 - 231  |
|  PLT (K/μL) | 7 - 2,806  |

d. Carryover: Table 8

Carryover was evaluated by Drew Scientific by analyzing three human samples with a high concentration, followed by (3) x runs from low (human) concentration samples. The test was repeated three times and the highest value is reported below.

|   | WBC | RBC | HGB | PLT  |
| --- | --- | --- | --- | --- |
|  High concentration value | 22.7 | 5.93 | 19.4 | 638  |
|  Low concentration value | 3.2 | 2.13 | 6.8 | 85  |
|  Measured carry-over (%) | 0 | 1.34% | 0.80% | 1.50%  |
|  Maximum carry-over (%) | <2.0 | <2.0 | <2.0 | <2.0  |

The percentage of carry-over between samples is calculated with the following formula:

$$
\text{Carry-over} = \frac{(\text{Low concentration 1}) - (\text{low concentration 3})}{(\text{High concentration 3}) - (\text{low concentration 3})} \times 100
$$

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e. Interfering Substances: Table 9 Interferences

|  Parameter | Specimen |  | Typical Findings  |
| --- | --- | --- | --- |
|  WBC | Nucleated RBC
Cryo-globulins
Platelet aggregation | (+)
(+)
(+) | NRBC on smear
Platelet aggregates on smear  |
|  |   |   |   |
|  RBC | Cold Agglutinin
Severe Microcytosis
Fragmented RBC
Leukocytes (>100.000/μL) | (-)
(-)
(-)
(+) | ↑MCV (increase), ↓HCT (decrease), red cell clumping on smear.
Elevation of WBC count  |
|  |   |   |   |
|  HGB | Leukocytes (>100,000/μL)
Lipemia
Abnormal Protein | (+)
(+)
(+) | Elevation of Hgb
↑MCHC (increase), “milky” appearance of plasma
↑MCHC (increase), Lyses Hgb/WBC sample turn cloudy.  |
|  |   |   |   |
|  HCT | Cold Agglutinin
Leukocytes (>100,000/μL)
Abnormal Red Cell Fragility | (-)
(+)
(?)
(?) | ↑MCV (increase), ↓HCT (decrease), red cell clumping on smear.
Elevation of WBC, ↑HCT  |
|  |   |   |   |
|  PLT | Pseudothrombocytopenia
Platelet Aggregation
Increased Microcytosis | (-)
(-)
(+)
(-) | Platelet Satellitism on smear
Platelet Aggregates on smear
↓MCV (decrease),  |

Table 5-14. Possible Interferences of Samples

$(+)$: Instrument count is affected by an increased result.

2. Other Supportive Instrument Performance Data Not Covered Above:

N/A

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K071562](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K071562)

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