(28 days)
Not Found
No
The device description focuses on the physical characteristics and functionality of a blood collection tube, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for collecting, anticoagulating, transporting, and storing blood specimens for diagnostic measurement of hematological parameters, not for treating any condition or disease.
No
This device is a blood collection and storage tube designed to prepare blood samples for hematological analysis, not to perform the analysis itself or interpret results for diagnostic purposes.
No
The device description clearly details a physical blood collection tube with a plastic reservoir, cap, and K2EDTA coating. It is a hardware device for collecting and transporting blood specimens.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to collect, anticoagulate, transport, and store skin puncture blood specimens for the measurement of specific hematological parameters and Whole Blood Lead testing. These measurements are performed in vitro (outside the body) on the collected blood sample.
- Device Description: The device is a tube designed to hold a blood specimen and contains an anticoagulant (K2EDTA) to prepare the sample for analysis. This is a typical characteristic of devices used for in vitro diagnostic testing.
- Compatibility with Hematology Instruments: The description highlights the device's compatibility with high throughput hematology instruments, which are used to perform in vitro diagnostic tests on blood samples.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device, by facilitating the collection and preparation of blood samples for diagnostic testing, falls under this definition.
N/A
Intended Use / Indications for Use
BD Microtainer® MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematology parameters:
White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelets, 5-part White Blood Cell (WBC) differentials (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
BD Microtainer® MAP Microtube for Automated Process consists of a plastic reservoir and a lavender cap indicating the presence of K2EDTA. The interior surface of the reservoir is spray-coated with K-EDTA solution, which is then dried. The upper edge of the reservoir serves as a collector for blood specimen. The plastic reservoir is a one piece design - reservoir and extender, which were previously two separate components in the predicate device (K940905).
The integrated extender gives the tube an external dimension of a standard tube (13x75mm), while maintaining the same internal characteristics for low specimen volume range and K2EDTA blood to additive ratio as the predicate. The lavender cap features a penetrable septum.
These integrated features; one piece reservoir/extender and penetrable cap adapts the tube for compatibility with high throughput hematology instruments. Once the blood specimen is collected and mixed adequately, there is no longer a need to remove the cap, transfer the sample to a suitable container or add an additional component to fit tube racks.
BD MAP can be directly processed on high throughput hematology instruments. Markings on the reservoir indicate a blood specimen fill range of 250uL. There is also a tube marking for specimen fill (375uL) when the tube is processed in automated mode.
While BD MAP is adaptable to automated processing: the tube remains compatible with automated instruments when processed in the manual mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
510(k) Summary Of Safety and Effectiveness
JAN 2 1 2010
- l. General Information
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92.
Establishment:
r
P
| • | Address: | Becton, Dickinson and Company
BD Diagnostics, Preanalytical Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885 |
|--------|------------------------|---------------------------------------------------------------------------------------------------------------------------|
| • | Registration Number: | 2243072 |
| • | Contact Person: | Julie Tom Wing
Regulatory Affairs Specialist
Telephone no.: 201-847-4260
Fax No. 201-847-4858 |
| • | Date of Summary: | December 23, 2009 |
| Device | | |
| • | Trade Name: | BD Microtainer® MAP Microtube for Automated
Process |
| • | Classification Name: | Tubes, Vials, Systems, Serum Separators,
Blood Collection |
| • | Classification: | Class II |
| • | Performance Standards: | None Established under 514 of the Food, Drug
and Cosmetic Act |
Special 510 (k): Premarket Notification BD Microtainer® MAP Microtube for Automated Process
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence
- · Device Description
ੇ
BD Microtainer® MAP Microtube for Automated Process consists of a plastic reservoir and a lavender cap indicating the presence of K2EDTA. The interior surface of the reservoir is spray-coated with K-EDTA solution, which is then dried. The upper edge of the reservoir serves as a collector for blood specimen. The plastic reservoir is a one piece design - reservoir and extender, which were previously two separate components in the predicate device (K940905).
The integrated extender gives the tube an external dimension of a standard tube (13x75mm), while maintaining the same internal characteristics for low specimen volume range and K2EDTA blood to additive ratio as the predicate. The lavender cap features a penetrable septum.
These integrated features; one piece reservoir/extender and penetrable cap adapts the tube for compatibility with high throughput hematology instruments. Once the blood specimen is collected and mixed adequately, there is no longer a need to remove the cap, transfer the sample to a suitable container or add an additional component to fit tube racks.
BD MAP can be directly processed on high throughput hematology instruments. Markings on the reservoir indicate a blood specimen fill range of 250uL. There is also a tube marking for specimen fill (375uL) when the tube is processed in automated mode.
While BD MAP is adaptable to automated processing: the tube remains compatible with automated instruments when processed in the manual mode.
- · Intended Use
BD Microtainer® MAP Microtube for Automated Process with K2 EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematology parameters:
White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelets, 5-part White Blood Cell (WBC) differentials (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.
2
- · Synopsis of Performance Study Results
Mechanical, simulated use and clinical testing were performed to demonstrate the device's safety and effectiveness.
III. Predicate Device Summary Table
- · Substantial Equivalence
.
. "
Based on comparison of the device features, materials, intended use and performance, BD Microtainer® MAP Microtube for Automated Process with K2EDTA is shown to be substantially equivalent to the commercially available predicate device indicated in the table below.
The predicate device, K number, and clearance date are also identified in the table below.
| Manufacturer | Predicate Device | K-Number | Clearance Date |
|---|---|---|---|
| Becton, | |||
| Dickinson and | |||
| Company | BD Microtainer® | ||
| K2EDTA tube with | |||
| Microgard TM | |||
| Closure and | |||
| Extender | K940905 | August 02, 1994 |
Julie Tom Wing
12/23/2009
Date
Julie Pom Wing Regulatory Affairs Specialist Becton, Dickinson and Company BD Diagnostics, Preanalytical Systems
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
JAN 2 1 2010
Becton, Dickinson & Co. BD Diagnostics, Preanalytical c/o Ms. Julie T. Wing Regulatory Affairs Specialist 1 Becton Drive, MC 300 Franklin Lakes, NJ 07417-1880
Re: K093972
Trade/Device Name: BD Microtainer® MAP Microtube for Automated Process Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: January 15, 2010 Received: January 19, 2010
Dear Ms. Wing:
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 iddinous for use stated in the enclosure) to legally marketed predicate devices marketed in internate 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, Or to 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such. additional controls. Existing major regulations affecting your device can be found in Title 2 to Code of Federal Regulations (CFR), Parts 800 to 895. 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
4
Page 2 - Ms. Julie T. Wing
CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K093972
Device Name: BD Microtainer® MAP Microtube for Automated Process
Indications For Use:
BD Microtainer® MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematological parameters:
White Blood Cells (WBC), Red Blood Cells (RBC), Hernoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), White Blood Cell (WBC) differentials (Neutrophils, Platelets, 5-part Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.
Prescription Use × (Part 21 CFR 801 Subpart.D) AND/OR Over-The-Counter Use (21 CFR 807 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)
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety.
510(k) K093972