(187 days)
No
The summary describes a standard automated hematology analyzer using established techniques (impedance & spectrophotometry) and makes no mention of AI, ML, or related concepts.
No.
The device is described as an in vitro diagnostic analyzer used for testing whole blood specimens, which provides analytical results rather than delivering a therapeutic effect to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the DREW D3 Hematology Analyzer is "used for the in vitro diagnostic testing of whole blood specimens."
No
The device is described as a "stand-alone benchtop, clinical laboratory instrument" and analyzes samples using "impedance & spectrophotometry techniques," which are hardware-based methods. It also mentions compliance with hardware safety and EMC standards (UL 61010-1, IEC 60601-1-2).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly indicates that the device is intended for diagnostic testing performed outside of the body (in vitro) on biological specimens (whole blood).
N/A
Intended Use / Indications for 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.
Product codes
GKZ
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.
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
Not Found
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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: 214-210-4900
Fax: 214-210-4950
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
05 001
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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
(K945678) | New Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DATACELL 18MS
Hematology Analyzer | D3 Hematology Analyzer |
| Manufacturer | Drew Scientific, Inc
(Previously: DANAM
Electronics) | Drew Scientific, Inc. |
| Instrument | Hematology Analyzer, CBC +
3 part differential | Identical |
| Analyzer
description | Analyzer with built-in
computer | Stand-alone touch screen
analyzer |
| Measurement
Principle: | | |
| WBC | Impedance | Identical |
| RBC | Impedance | Identical |
| Hgb | Spectrophotometer | Identical |
| MCV | Derived from RBC cell size
distribution | Volume integration |
| | Predicate device
(K945678) | New Device |
| Device Name | DATACELL 18MS
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
Cells count
LYM% Lymphocytes in
percentage
LYM# Lymphocytes total
count
MID% MID cells in
percentage
MID# MID Cell total count
GRA% Granulocytes in
percentage
GRA# Granulocytes total
count | Identical |
| Erythrocyte | RBC
Red Blood Cells count
Hgb
Hemoglobin
Hct
Hematocrit
MCV
Mean Corp. Volume
MCH
Mean Corpuscular
Hemoglobin
MCHC Mean Corpuscular
Hemoglobin Concentration
RDW : Red Blood cells
Distribution Width | Identical |
| Thrombocyte | PLT
Platelet count
MPV
Mean Platelet Volume | Identical
PDW* Platelet Distribution
Width
PCT*
Thrombocrit
*For investigation use only in
the United States of America. |
| Throughput | 60 samples/hour | Identical |
| Sample Type | Whole blood | Identical |
| | Predicate device
(K945678) | New Device |
| Device Name | DATACELL 18MS
Hematology Analyzer | D3 Hematology Analyzer |
| Specimen
sample volume | 135.0 µl (whole blood),
65.0 µl (whole blood in
samples saver mode) | 10.0 µl (whole blood), |
| | 25µl of whole blood diluted
into 6.0ml of diluent for
prediluted sample mode | 25.0 µl of whole blood diluted
into 0.5 ml of diluent for
prediluted sample mode |
| Anti-coagulant | EDTA K2 / K3 | Identical |
| Identification
patient samples | Manual entry (alphanumeric),
Bar codes reader (optional) | Identical |
| Display | LCD Computer screen | Integrated Touch Screen |
| Computer | External computer | Integrated stand-alone |
| Reagents
(analysis &
cleaning) | Individually packaged
reagents : | Identical reagents, packaged
differently : |
| | DREW EX-ISO (Diluent, 20L)
DREW, EX-LYSE (500 ml)
DREW, EZ-CLEAN
(Cleaner, 5L or 10L) | D3 Pac, consisting of :
- DREW, EX-ISO (Diluent, 4L)
- DREW, EX-Lyse (120ml)
- DREW EZ-CLEAN
(Cleaner, 500 ml) |
| Quality Controls | EX-TROL | Identical |
| Calibrators | EX-CAL | Identical |
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2
Section 5-3
3
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 (240) 276-0377. 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 (800) 638-2041 or (240) 276-3150 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
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Office of In Vitro Diagnostic Device Evaluation and Safet
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