D3 HEMATOLOGY ANALYZER, MODEL D3

K071562 · Drew Scientific, Inc. · GKZ · Dec 11, 2007 · Hematology

Device Facts

• Record ID: K071562
• Device Name: D3 HEMATOLOGY ANALYZER, MODEL D3
• Applicant: Drew Scientific, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Dec 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended 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).

Indications for Use

Indicated for in vitro diagnostic testing of whole blood specimens to provide complete blood counts and leukocyte differential counts in a clinical laboratory setting.

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

• DataCell 18MS (K945678)

Submission Summary (Full Text)

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# 510(k) Summary for D3 Hematology Analyzer

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is : _ 1071562

#### 1. APPLICANT

DREW Scientific, Inc. 4230 Shilling Way DALLAS, Texas 75237

DEC 1 1 2007

Contact Person: Roger BOURREE

Telephone: [phone]

Fax: [phone]

2nd June 2007 Date Prepared:

#### 2. DEVICE NAME

| Proprietary Name: | D3 Hematology Analyzer |
|----------------------|-----------------------------------------------|
| Common/Usual Name: | Automated differential cell counter |
| Classification Name: | Automated differential cell counter |
| | (21 CFR §864.5220) |
| Device Class | Class II : Special Controls Guidance Document |
| Product Code: | GKZ , Counter, Differential Cell |

## PREDICATE DEVICE 3.

DREW Scientific, Inc. DataCell 18MS (K945678)

Section 5-1

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#### 4. 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 leucocyte differential count using the impedance & spectrophotometry techniques.

#### 5. INTENDED USE

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

## TECHNOLOGICAL CHARACTERISTICS & SUBSTANTIAL EQUIVALENCE 6.

The D3 Hematology Analyzer can be considered substantially equivalent to the already cleared device DATACELL 18MS (K945678) with respect to the indications for use, the hematological parameters for complete blood count and differential leukocyte count, and the principles of operation (fundamental scientific technology).

The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :

| | Predicate device<br>(K945678) | New Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DATACELL 18MS<br>Hematology Analyzer | D3 Hematology Analyzer |
| Manufacturer | Drew Scientific, Inc<br>(Previously: DANAM<br>Electronics) | Drew Scientific, Inc. |
| Instrument | Hematology Analyzer, CBC +<br>3 part differential | Identical |
| Analyzer<br>description | Analyzer with built-in<br>computer | Stand-alone touch screen<br>analyzer |
| Measurement<br>Principle: | | |
| WBC | Impedance | Identical |
| RBC | Impedance | Identical |
| Hgb | Spectrophotometer | Identical |
| MCV | Derived from RBC cell size<br>distribution | Volume integration |
| | Predicate device<br>(K945678) | New Device |
| Device Name | DATACELL 18MS<br>Hematology Analyzer | D3 Hematology Analyzer |
| HCT | Calculation | Volume integration |
| Plt | Impedance | Identical |
| RBC Wavelength | 540nm | 555nm |
| Mode | Open Tube | Identical |
| | | |
| Parameters: | | |
| Leukocyte | 16 parameters | 16/ 18 parameters |
| | WBC Total White Blood<br>Cells count<br>LYM% Lymphocytes in<br>percentage<br>LYM# Lymphocytes total<br>count<br>MID% MID cells in<br>percentage<br>MID# MID Cell total count<br>GRA% Granulocytes in<br>percentage<br>GRA# Granulocytes total<br>count | Identical |
| Erythrocyte | RBC<br>Red Blood Cells count<br>Hgb<br>Hemoglobin<br>Hct<br>Hematocrit<br>MCV<br>Mean Corp. Volume<br>MCH<br>Mean Corpuscular<br>Hemoglobin<br>MCHC Mean Corpuscular<br>Hemoglobin Concentration<br>RDW : Red Blood cells<br>Distribution Width | Identical |
| Thrombocyte | PLT<br>Platelet count<br>MPV<br>Mean Platelet Volume | Identical<br>PDW* Platelet Distribution<br>Width<br>PCT*<br>Thrombocrit<br>*For investigation use only in<br>the United States of America. |
| Throughput | 60 samples/hour | Identical |
| Sample Type | Whole blood | Identical |
| | Predicate device<br>(K945678) | New Device |
| Device Name | DATACELL 18MS<br>Hematology Analyzer | D3 Hematology Analyzer |
| Specimen<br>sample volume | 135.0 µl (whole blood),<br>65.0 µl (whole blood in<br>samples saver mode) | 10.0 µl (whole blood), |
| | 25µl of whole blood diluted<br>into 6.0ml of diluent for<br>prediluted sample mode | 25.0 µl of whole blood diluted<br>into 0.5 ml of diluent for<br>prediluted sample mode |
| Anti-coagulant | EDTA K2 / K3 | Identical |
| Identification<br>patient samples | Manual entry (alphanumeric),<br>Bar codes reader (optional) | Identical |
| Display | LCD Computer screen | Integrated Touch Screen |
| Computer | External computer | Integrated stand-alone |
| Reagents<br>(analysis &<br>cleaning) | Individually packaged<br>reagents : | Identical reagents, packaged<br>differently : |
| | DREW EX-ISO (Diluent, 20L)<br>DREW, EX-LYSE (500 ml)<br>DREW, EZ-CLEAN<br>(Cleaner, 5L or 10L) | D3 Pac, consisting of :<br>- DREW, EX-ISO (Diluent, 4L)<br>- DREW, EX-Lyse (120ml)<br>- DREW EZ-CLEAN<br>(Cleaner, 500 ml) |
| Quality Controls | EX-TROL | Identical |
| Calibrators | EX-CAL | Identical |

05

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Section 5-3

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## 7. PERFORMANCE TESTING

The non-clinical studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines.

Accuracy, Repeatability, Linearity, Carryover , Sample Stability studies demonstrated acceptable performance per the manufacturers specifications.

The device meets with the UL 61010-1 standard of the International Electro-technical Commission on electrical equipment for measurement, control, and laboratory use. Further more, is compliant with the IEC 60601-1-2 standard for Electromagnetic Compatibility.

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## 8. CONCLUSIONS FOR PERFORMANCE TESTING

The Performance Testing conclude that the safety and effectiveness of the device is not compromised, meeting all acceptance criteria and demonstrating that the devices are substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple and recognizable, conveying the department's role in providing essential services to the American public.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 1 2007

Drew Scientific, Inc C/O Roger Bourree 4230 Shilling Way, Dallas, Texas 75237

Re: K071562

Trade/Device Name: D3 Hematology Analyzer, Model D3 Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: June 7, 2007 Received: June 7, 2007

Dear Mr. Bourree:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in 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 requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

> Sincerely vours. Robert L Becker, Jr .. D. PhD. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K071562

Device Name: DREW D3 Hematology Analyzer

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.

Prescription Use__X Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Auchim Bautista
Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safet

K071562

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