(176 days)
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No
The document describes a blood collection tube and its performance characteristics, with no mention of AI or ML technology.
No.
This device is designed for collecting, transporting, storing, and evaluating capillary blood specimens for diagnostic purposes, not for treating a disease or condition.
No
The device is a blood collection tube used to collect, transport, store, and evaluate blood specimens for hematology parameters. It is not an instrument that provides a diagnosis.
No
The device description clearly states it is a physical blood collection tube with integrated collection devices and additives, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tubes are used to "collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils." These are specific diagnostic parameters measured from a biological specimen (blood) in vitro (outside the body).
- Device Description: The description details a device designed to interact with a biological specimen (blood) and contains additives (K2EDTA) that affect the specimen for subsequent analysis.
- Performance Studies: The document describes clinical performance testing comparing the device to a predicate device for various hematology parameters. This type of testing is standard for IVD devices to demonstrate their performance for diagnostic purposes.
- Key Metrics: The key metrics listed (Bias, Correlation, SD, CV%) are all relevant to evaluating the performance of a diagnostic test or sample collection device used for diagnostic testing.
- Predicate Device: The mention of a predicate device (BD Microtainer® MAP Microtube for Automated Process) which is also a blood collection tube used for diagnostic testing further supports the classification of this device as an IVD.
The device is a blood collection tube specifically designed to prepare a blood sample for in vitro diagnostic testing of hematology parameters. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
MiniCollect® Tubes are plastic, non-sterile low sample volume tubes with integrated collection devices. The closure is color-coded to identify the additives which are present in varying concentrations depending on the tube type and stated volumes. The caps of the MiniCollect® Tubes are pierceable for automated instruments with cap-piercing functionalities.
The interior of the tube wall is coated with dipotassium EDTA binds calcium ions thus blocking the coagulation cascade.
Two product versions are available: MiniCollect® Tubes with optional 13x75 mm carrier tubes (clear, amber) MiniCollect® Complete, pre-assembled with 13x75 mm carrier tubes
The product is to be used by appropriately trained healthcare professionals in accordance with these instructions.
Mentions image processing
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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
The method comparison consisted of blood specimens collected from both adult and pediatric donors.
Intended User / Care Setting
The product is to be used by appropriately trained healthcare professionals in accordance with these instructions.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench
The MiniCollect® K2E K2EDTA Tubes are manufactured and tested in conformity to a variety of standards, internal specifications and in comparison to the predicate device.
- Durability of the container during centrifugation: Based on ISO 6710 and GP39-A6, Passed.
- No leakage of container: Based on ISO 6710 and GP39-A6, Passed.
- Closure Resealing: Based on GP39-A6 and internal test protocol spp0284, Passed.
- Transport stability: Based on ASTM D4169, Passed.
Performance Testing - Clinical
The performance evaluation was conducted at three external clinical sites. Clinical performance testing was performed to demonstrate substantial equivalence to the predicate tube by performing Method Comparison, Precision Repeatability and Stability studies.
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Method Comparison: Purpose was to demonstrate substantial equivalence of the MiniCollect® K2EDTA Tube to the BD Microtainer® (2EDTA Tube. Blood specimens collected from both adult and pediatric donors were used. Capillary, venous and heel stick samples had one measurement for each parameter on the control tube. Deming regression was performed for each analyte. Parameters tested: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Basophils, Basophils.
- Results: Bias criteria were met at all medical decision points for all parameters. Regression line criteria were not met in two cases (BAS, EOS). For Basophils, the correlation (r) was below acceptance, but statistical deviations were minor. For Eosinophils, the 95% CI for the y-intercept did not include 0, but was very close; statistical deviations were minor. Overall, each parameter passed the acceptance criteria for bias.
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Precision Repeatability and Reproducibility: Purpose was to demonstrate precision and repeatability. Study performed on venous blood collections including within-tube, between-lot precision testing. Parameters tested: WBC, RBC, HCT, PLT. Mixed models were fit to estimate variability.
- Repeatability Study Conclusion: Repeatability of tested hematology parameters on 26 donors collected in MiniCollect® K2EDTA tubes showed acceptable variation compared to the predicate tubes.
- Reproducibility (between-lot) Study Conclusion: Aim to evaluate variation on 30 donors using multiple lots of the evaluation tube. Results demonstrate between-lot representative hematology results.
- Variance Component Analysis Conclusion: Acceptable level of variability compared to predicate tubes.
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Stability: Purpose was to evaluate equivalence of hematology results when specimens collected in MiniCollect® K2EDTA Tubes and control tubes were stored at room temperature. Samples from 25 adult donors were tested at time zero (to), 12 hours post collection, and 15 hours post collection.
- Parameters with acceptance criteria: WBC (15%), RBC (6%), HGB (7%), HCT (6%), MCV (2.3%), MCH (2.7%), MCHC (2.2%), Platelets (25%), RDW (4.6%), Lymphocytes (16%), Neutrophils (22.4%), Monocytes (27.9%), Eosinophils (37.1%), Basophils (38.5%).
- Results: All evaluation tubes (25/25) met stability acceptance criteria for WBC, RBC, HCT, MCH, PLT, LYM and NEU at 12 and 15 hours.
- MON: 24/25 samples at 12 and 15 hours.
- EOS: 23/25 samples at 12 and 15 hours.
- RDW: 20/25 at 12 hours, 13/25 at 15 hours.
- BAS: 18/25 at 12 hours, 21/25 at 15 hours.
- MCHC: 16/25 at 12 hours, 5/25 at 15 hours.
- MCV: 15/25 at 12 hours, 0/25 at 15 hours.
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.
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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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 25, 2019
Greiner Bio-One NA Inc. Manfred Abel Quality System & Regulatory Affairs Manager 4238 Capital Drive Monroe, North Carolina 28110
Re: K182078
Trade/Device Name: MiniCollect K2E K2EDTA Tubes Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: August 1. 2018 Received: August 2, 2018
Dear Manfred Abel:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182078
Device Name MiniCollect® K2E K2EDTA Tubes
Indications for Use (Describe)
MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5. PREMARKET NOTIFICATION 510(K)SUMMARY
1. SUBMITTER
| Applicant Name: | Greiner Bio-One GmbH
Bad Haller Strasse 32
4550 Kremsmuenster,
Austria |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Manfred Abel, M.S., MBA
Greiner Bio-One NA Inc.
4238 Capital Drive
Monroe, NC 28110
704 261 7823
Manfred.Abel@gbo.com |
| Establishment registration number: | 8020040 |
| Date prepared: | Jan 24, 2019 |
| 2. DEVICE | |
| Trade Name: | MiniCollect® K2E K2EDTA Tubes |
| Common name: | Blood Collection Tubes |
| Classification:
Name:
Product Code:
Regulation No:
Class:
Regulation Medical Specialty:
510k Review Panel: | Tubes, Vials, System, Serum Separator, Blood Collection
JKA
862.1675
II
Clinical Chemistry
Hematology |
3. PREDICATE DEVICE
BD Microtainer® MAP Microtube for Automated Process (K093972)
4. DEVICE DESCRIPTION
MiniCollect® Tubes are plastic, non-sterile low sample volume tubes with integrated collection devices. The closure is color-coded to identify the additives which are present in varying concentrations depending on the tube type and stated volumes. The caps of the MiniCollect® Tubes are pierceable for automated instruments with cap-piercing functionalities.
The interior of the tube wall is coated with dipotassium EDTA binds calcium ions thus blocking the coagulation cascade.
Two product versions are available: MiniCollect® Tubes with optional 13x75 mm carrier tubes (clear, amber) MiniCollect® Complete, pre-assembled with 13x75 mm carrier tubes
The product is to be used by appropriately trained healthcare professionals in accordance with these instructions.
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5. INDICATION FOR USE
MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGT, MCV, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| | Evaluation Device
MiniCollect® K2E K2EDTA
Tubes | Predicate Device
BD Microtainer® MAP Microtube for
Automated Process |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Status | Under Review | K093972 |
| Classification | Class II | Class II |
| Regulation | 862.1675 | 862.1675 |
| Classification Product Code | JKA | JKA |
| Intended Use | MiniCollect® K2E K2EDTA
Tubes are non-evacuated blood
collection devices, used to
collect, transport, store, and
evaluate capillary blood
specimens for the following
hematology parameters: WBC,
RBC, HGB, HCT, MCV, MCH,
MCHC, Platelets, RDW,
Lymphocytes, Neutrophils,
Monocytes, Eosinophils and
Basophils. | BD Microtainer® MAP Microtube for
Automated Process with K2EDTA is used
to collect, anticoagulate, transport and
store skin puncture blood specimens for
measurements of the following
hematological 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 Cells
(WBC) differentials (Neutrophils,
Lymphocytes, Monocytes, Eosinophils,
Basophils), Reticulocytes and Whole
Blood Lead testing. |
| Manufacturer | Greiner Bio-One (GBO) | Becton Dickinson & Company. |
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| Device characteristics
| All data as detailed as known: | ||
|---|---|---|
| Evaluation Device | ||
| MiniCollect® K2E K2EDTA Tubes | Predicate device | |
| BD Microtainer® MAP Microtube | ||
| for Automated Process | ||
| Tube Dimension | 13 x 75mm | 13 x 75mm |
| Draw Volume | 0.25 - 0.5 mL | 0.25 - 0.5 mL |
| Closure | Cap with pierceable membrane | BD Microgard closure |
| Closure Color | Lavender | Lavender |
| Closure material(s) | PE (rigid component), | |
| TPE (soft component) | Plastic | |
| Collection tube feature / | ||
| material | With integrated collection scoop / | |
| PP | With integrated collection scoop / | |
| plastic | ||
| Carrier/Extender Tube | PET | Plastic |
| Storage Condition | 4 -25 °C |