MiniCollect K2E K2EDTA Tubes

K182078 · Greiner Bio-One Na, Inc. · JKA · Jan 25, 2019 · Clinical Chemistry

Device Facts

• Record ID: K182078
• Device Name: MiniCollect K2E K2EDTA Tubes
• Applicant: Greiner Bio-One Na, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jan 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Pediatric

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, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.

Device Story

MiniCollect® K2E K2EDTA Tubes are non-evacuated, plastic blood collection tubes with integrated collection scoops; interior walls are spray-coated with dipotassium EDTA to prevent coagulation. Designed for use by trained healthcare professionals in clinical settings to collect capillary blood specimens. Tubes feature color-coded, pierceable caps compatible with automated hematology analyzers. Once collected, samples are transported and stored in the tubes until analysis. The device facilitates the evaluation of hematology parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, Platelets, RDW, and 5-part differentials). By providing a stable, anticoagulated sample, the device enables accurate laboratory testing, supporting clinical decision-making for hematological conditions.

Clinical Evidence

Clinical performance evaluated at three sites comparing MiniCollect® K2EDTA tubes to the predicate. Studies included method comparison (Deming regression), precision (repeatability/reproducibility), and stability (room temperature storage). Method comparison showed bias criteria met at medical decision points for all parameters. Precision studies (WBC, RBC, HCT, PLT) demonstrated acceptable variability. Stability testing confirmed equivalence for primary parameters at 12 and 15 hours, with some variations noted in secondary parameters (MCV, MCHC) at later time points.

Technological Characteristics

Plastic (polypropylene/PET) non-evacuated tubes; 13x75 mm dimensions; 0.25–0.5 ml draw volume. Interior coated with K2EDTA (spray-coated/dried). Closure: Polyethylene/Thermoplastic Elastomer with pierceable membrane. Non-sterile, single-use. Compatible with standard hematology analyzers.

Indications for Use

Indicated for use by trained healthcare professionals to collect, transport, store, and evaluate capillary blood specimens for hematology parameters in patients requiring blood analysis.

Regulatory Classification

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.

Predicate Devices

• BD Microtainer® MAP Microtube for Automated Process (K093972)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## SECTION 5. PREMARKET NOTIFICATION 510(K)SUMMARY

### 1. SUBMITTER

| Applicant Name: | Greiner Bio-One GmbH<br>Bad Haller Strasse 32<br>4550 Kremsmuenster,<br>Austria |
|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Manfred Abel, M.S., MBA<br>Greiner Bio-One NA Inc.<br>4238 Capital Drive<br>Monroe, NC 28110<br>704 261 7823<br>[e-mail] |
| Establishment registration number: | 8020040 |
| Date prepared: | Jan 24, 2019 |
| 2. DEVICE | |
| Trade Name: | MiniCollect® K2E K2EDTA Tubes |
| Common name: | Blood Collection Tubes |
| Classification:<br>Name:<br>Product Code:<br>Regulation No:<br>Class:<br>Regulation Medical Specialty:<br>510k Review Panel: | Tubes, Vials, System, Serum Separator, Blood Collection<br>JKA<br>862.1675<br>II<br>Clinical Chemistry<br>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<br>MiniCollect® K2E K2EDTA<br>Tubes | Predicate Device<br>BD Microtainer® MAP Microtube for<br>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<br>Tubes are non-evacuated blood<br>collection devices, used to<br>collect, transport, store, and<br>evaluate capillary blood<br>specimens for the following<br>hematology parameters: WBC,<br>RBC, HGB, HCT, MCV, MCH,<br>MCHC, Platelets, RDW,<br>Lymphocytes, Neutrophils,<br>Monocytes, Eosinophils and<br>Basophils. | BD Microtainer® MAP Microtube for<br>Automated Process with K2EDTA is used<br>to collect, anticoagulate, transport and<br>store skin puncture blood specimens for<br>measurements of the following<br>hematological parameters:<br>White Blood Cells (WBC), Red Blood<br>Cells (RBC), Hemoglobin (HgB),<br>Hematocrit (HCT), Mean corpuscular<br>volume (MCV), Mean corpuscular<br>Hemoglobin (MCH), Mean Corpuscular<br>hemoglobin concentration (MCHC),<br>Platelets, 5 -part White Blood Cells<br>(WBC) differentials (Neutrophils,<br>Lymphocytes, Monocytes, Eosinophils,<br>Basophils), Reticulocytes and Whole<br>Blood Lead testing. |
| Manufacturer | Greiner Bio-One (GBO) | Becton Dickinson & Company. |

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| Device characteristics<br>All data as detailed as known: | | |
|----------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Evaluation Device<br>MiniCollect® K2E K2EDTA Tubes | Predicate device<br>BD Microtainer® MAP Microtube<br>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),<br>TPE (soft component) | Plastic |
| Collection tube feature /<br>material | With integrated collection scoop /<br>PP | With integrated collection scoop /<br>plastic |
| Carrier/Extender Tube | PET | Plastic |
| Storage Condition | 4 -25 °C | <25°C |
| Anticoagulant | K2EDTA<br>(Ethylenediaminetetraacetic Acid<br>Dipotassium Dihydrate) | K2EDTA<br>(Ethylenediaminetetraacetic Acid<br>Dipotassium Dihydrate) |
| Interior Coating of Additive | Spray-coated and dried | Spray-coated and dried |
| Shelf Life | 534 days | 540 days |
| Use | Single use only | Single use only |
| Tube sterility | Non-sterile | Non-sterile |

| Packaging Configuration, Materials and Dimensions | | |
|---------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------|
| All data as detailed as known: | | |
| Rack / shelf pack quantity / material | 50 MiniCollect® tubes or<br>MiniCollect® Complete,<br>Polystyrene black | 50 BD Microtainer® MAP Microtube<br>tubes |
| Case quantity / material | 10 racks (500 tubes)<br>MiniCollect® tubes / corrugated<br>board | N/A |
| Case quantity / material | 10 racks (500 13x75mm tubes)<br>MiniCollect® Complete /<br>corrugated board | 4 shelf packs (200 BD Microtainer® MAP<br>Microtube tubes) |
| Master case / material | 4 cases (2000 MiniCollect®<br>tubes or MiniCollect® Complete)<br>/ corrugated board | N/A |

As above comparison table shows the evaluation device and the predicate device have the same fundamental technology and technological characteristics. The intended use of the MiniCollect® K2E K2EDTA Tubes is similar to the predicate device. Both devices are intended to collect, transport, store and evaluate capillary blood specimens for hematology tests. The used materials are the same or at least comparable in regards to safety and effectiveness of the device. Based on the intended use, device features, principles of operation, and technological characteristics we believe MiniCollect® K2E K2EDTA Tubes are substantially equivalent to the predicate device.

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#### PERFORMANCE DATA 7.

#### A. 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.

| Requirement | Based on: | Pass/Fail |
|---------------------------------------------------|--------------------------------------------|-----------|
| Durability of the container during centrifugation | ISO 6710 and GP39-A6 | Pass |
| No leakage of container | ISO 6710 and GP39-A6 | Pass |
| Closure Resealing | GP39-A6 and internal test protocol spp0284 | Pass |
| Transport stability | ASTM D4169 | Pass |

#### B. Performance Testing - Clinical

The performance evaluation of the MiniCollect® K2EDTA Tubes was based on applicable standards, guidance documents, statistical evaluation and accepted medical decision points. The study was conducted at three external clinical sites. Clinical performance testing was performed to demonstrate that blood specimens collected in Greiner Bio-One MiniCollect® K2EDTA blood collection tubes produced test results are substantially equivalent to the predicate tube by performing the following studies: Method Comparison, Precision Repeatability and Stability. Results were evaluated in accordance with the associated Statistical Analysis Plan for MiniCollect® K2EDTA Tubes. Data generated from the studies were compared to the acceptance criteria for the Evaluation Tube and Control Tube.

The following abbreviations for the parameters are used.

| Parameter | Abbreviation |
|-----------------------------------------------|--------------|
| WBC (White blood cells) | WBC |
| RBC (Red blood cells) | RBC |
| HGB (Hemoglobin) | HGB |
| HCT (Hematocrit) | HCT |
| MCV (Mean cellular volume) | MCV |
| MCH (Mean cellular hemoglobin) | MCH |
| MCHC (Mean cellular hemoglobin concentration) | MCHC |
| Platelets | PLT |
| RDW (Red blood cell distribution width) | RDW |
| Lymphocytes | LYM |
| Neutrophils | NEU |
| Monocytes | MON |
| Eosinophils | EOS |
| Basophils | BAS |

### Method Comparison,

#### Method Comparison 2

The purpose of the method comparison with the predicate device was to demonstrate that the evaluation tube (MiniCollect® K2EDTA Tube) is substantially equivalent to the control tube (BD Microtainer® (2EDTA Tube). The method comparison consisted of blood specimens collected from both adult and pediatric donors. Capillary, venous and heel stick samples had one measurement for each parameter on the control tube. For the MiniCollect® K2EDTA Tubes, Deming regression was performed for each analyte to account for error in both evaluation and control tube measurements. The estimates and 95% confidence intervals for the bias were expressed in terms of the percent difference (CV%) and the difference in values (Abs).

Comparison testing was performed on the following hematology analytes: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Basophils, Basophils to meet the substantial equivalence requirements.

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As per the CLSI EP09, the bias criteria were met at all medical decision points for all parameters. The regression line criteria were not met in two cases (BAS, EOS) across the data for all sites. One case was for Basophils where the correlation (r) was below the acceptance criteria. The values for Basophils are typically in the range of 0.00-0.10, but can only be measured to the nearest 0.01 at 2 sites or to the nearest 0.1 at one site. This causes to be either 0 or at least as large as the rounding error. These differences can be relatively large and cause the correlation coefficient to be small. This also causes the 95% Cl for the slope to be contained in the interval 0.9 - 1.1. The other regression line that did not meet the acceptance criteria was for Eosinophils. The 95% CI for the y-intercept did not include 0, but was so close, that the upper limit is reported as -0.000 due to rounding. In each of these cases, the statistical deviations were minor and did not lead to deviations in the estimated bias of the analytes.

Overall, each parameter passed the acceptance criteria for bias and there does not appear to be a difference in the measurement of any parameter values between evaluation and control tubes

### Precision Repeatability and Reproducibility

The purpose of the study was to demonstrate the precision of assay results including repeatability . The study was performed on venous blood collections including within-tube, between-lot precision testing. The following parameters were tested: WBC, RBC, HCT, PLT. For the MiniCollect® K2EDTA Tubes, mixed models were fit to estimate the variability within for different subjects. Estimates of the SD and CV% were computed for the evaluation tubes and compared to the acceptance criteria below.

| Parameter | Acceptance<br>Criteria |
|-----------|------------------------|
| WBC | 15% |
| RBC | 6% |
| HGB | 7% |
| HCT | 6% |
| PLT | 25% |

### Repeatability Study Conclusion

The repeatability, of the representative hematology parameters tested on 26 donors collected in MiniCollect® K2EDTA tubes showed acceptable variation compared to the predicate tubes.

### Reproducibility (between-lot) Study Conclusion

The aim of the study was to evaluate any variation on 30 donors in the measurements generated from blood collected in multiple lots of the evaluation tube, tested on a single instrument under the same conditions, to demonstrate reproducibility of the test results obtained. The results generated in this study show en-lot variability, and therefore demonstrate between-lot representative hematology results obtained from specimens collected in the MiniCollect® K2EDTA tubes.

### Variance Component Analysis Conclusion

The aim of the analysis was to evaluate any variation in the representative hematological results generated with specimens collected in MiniCollect® K2EDTA tubes compared to the predicate tubes. The analysis demonstrates an acceptable level of variability.

### Stability

The purpose of the study was to evaluate the equivalence of hematology results in specimens collected in MiniCollect® K2EDTA Tubes and in control tubes when the specimens were stored at room temperature. Evaluation tubes using blood samples collection from 25 adult donors were tested at three-time points, i.e. time zero (to). 12 hours post collection, and 15 hours post collection.

| Parameter | Acceptance Criteria |
|-----------|---------------------|
| WBC | 15% |
| RBC | 6% |
| HGB | 7% |
| HCT | 6% |

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| 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% |

All evaluation tubes (25/25) met stability acceptance criteria for WBC, RBC, HCT, MCH, PLT, LYM and NEU at 12 and 15 hours. For the evaluation tubes, stability acceptance criteria were met in 24/25 samples at 12 and 15 hours for MON and in 23/25 samples at 12 and 15 hours for EOS. For RDW. 20/25 and 13/25 samples met the acceptance criterion at 12 and 15 hours, respectively. The acceptance criterion was met in 18/25 samples at 12 hours and in 21/25 samples at 15 hours for BAS. For MCHC, 16/25 tubes met the criterion at 12 hours and 5/25 met the criterion at 15 hours. Lastly, 15/25 tubes met the criterion at 12 hours and 0/25 met the criterion at 15 hours for MCV.

#### Discussion / Conclusion 8.

The comparison between the evaluation device and the predicate device shows that they have the same fundamental technology and technological characteristics. The intended use of the MiniCollect® K2E K2EDTA Tubes is equivalent to the predicate device and the used materials are the same or at least comparable in regards to safety and effectiveness of the device.

The performance bench testing based on applicable standards and internal specifications demonstrates that acceptance criteria were met.

The evaluation device. MiniCollect® K2EDTA Tube was compared to the predicate device, when blood collected in each tube was analyzed for representative hematology parameters. The results generated in the clinical performance testing for method comparison, for precision and for stability demonstrate equivalent performance.

#### 9. Substantial equivalency

The submitted information in this premarket notification shows that MiniCollect® K2E K2EDTA Tubes is comparable to the predicate device in design, function and intended use and meets established performance criteria. Therefore, MiniCollect® K2E K2EDTA Tubes is substantially equivalent to the predicate device.