(187 days)
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.
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.
The D3 Hematology Analyzer is a stand-alone benchtop clinical laboratory instrument that analyzes in-vitro samples of whole blood to provide complete blood count and leukocyte differential count using impedance and spectrophotometry techniques.
The following information regarding the acceptance criteria and the study proving the device meets these criteria is extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list a table of "acceptance criteria" with quantitative values. Instead, it states that "Accuracy, Repeatability, Linearity, Carryover, Sample Stability studies demonstrated acceptable performance per the manufacturers specifications." It also highlights substantial equivalence to the predicate device, DATACELL 18MS (K945678). The key performance aspect is that the device "meets all acceptance criteria and demonstrating that the devices are substantially equivalent to the predicate device."
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Repeatability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Linearity | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Carryover | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Sample Stability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Electrical Safety | UL 61010-1 standard compliance. | Meets UL 61010-1 standard. |
| EMC | IEC 60601-1-2 standard compliance. | Compliant with IEC 60601-1-2 standard. |
| Substantial Equiv. | Equivalent to predicate device (DATACELL 18MS, K945678) in performance. | Demonstrated substantial equivalence and met all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The non-clinical studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a "D3 Hematology Analyzer," suggesting an automated instrument rather than an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
The D3 Hematology Analyzer is described as a "fully automated (microprocessor controlled) quantitative hematology analyzer." This indicates that its performance is standalone (algorithm only) without human-in-the-loop directly influencing the output measurements. The performance studies listed (Accuracy, Repeatability, Linearity, Carryover, Sample Stability) describe the standalone performance of the device.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the document. For hematology analyzers, ground truth is typically established through reference methods, manual microscopic differentials performed by trained technologists/pathologists, or validated control materials. However, the document does not specify which of these was used.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. Given that the device is a hematology analyzer, and the phrase "training set" is usually associated with AI/machine learning models, it's possible that traditional calibration and validation methods were used rather than an AI-specific training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, the method for establishing its ground truth is also not detailed.
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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: 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 18MSHematology Analyzer | D3 Hematology Analyzer |
| Manufacturer | Drew Scientific, Inc(Previously: DANAMElectronics) | Drew Scientific, Inc. |
| Instrument | Hematology Analyzer, CBC +3 part differential | Identical |
| Analyzerdescription | Analyzer with built-incomputer | Stand-alone touch screenanalyzer |
| MeasurementPrinciple: | ||
| WBC | Impedance | Identical |
| RBC | Impedance | Identical |
| Hgb | Spectrophotometer | Identical |
| MCV | Derived from RBC cell sizedistribution | Volume integration |
| Predicate device(K945678) | New Device | |
| Device Name | DATACELL 18MSHematology 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 BloodCells countLYM% Lymphocytes inpercentageLYM# Lymphocytes totalcountMID% MID cells inpercentageMID# MID Cell total countGRA% Granulocytes inpercentageGRA# Granulocytes totalcount | Identical | |
| Erythrocyte | RBCRed Blood Cells countHgbHemoglobinHctHematocritMCVMean Corp. VolumeMCHMean CorpuscularHemoglobinMCHC Mean CorpuscularHemoglobin ConcentrationRDW : Red Blood cellsDistribution Width | Identical |
| Thrombocyte | PLTPlatelet countMPVMean Platelet Volume | IdenticalPDW* Platelet DistributionWidthPCT*Thrombocrit*For investigation use only inthe United States of America. |
| Throughput | 60 samples/hour | Identical |
| Sample Type | Whole blood | Identical |
| Predicate device(K945678) | New Device | |
| Device Name | DATACELL 18MSHematology Analyzer | D3 Hematology Analyzer |
| Specimensample volume | 135.0 µl (whole blood),65.0 µl (whole blood insamples saver mode) | 10.0 µl (whole blood), |
| 25µl of whole blood dilutedinto 6.0ml of diluent forprediluted sample mode | 25.0 µl of whole blood dilutedinto 0.5 ml of diluent forprediluted sample mode | |
| Anti-coagulant | EDTA K2 / K3 | Identical |
| Identificationpatient 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 packagedreagents : | Identical reagents, packageddifferently : |
| 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 |
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 (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
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safet
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§ 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.”