(176 days)
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.
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.
This document describes the performance testing for the Greiner Bio-One MiniCollect® K2E K2EDTA Tubes, a blood collection device, to demonstrate its substantial equivalence to a predicate device (BD Microtainer® MAP Microtube for Automated Process).
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily for Precision (Repeatability) and Stability, expressed as percentage variations. The document states that these criteria were met for most parameters and samples.
| Parameter | Acceptance Criteria (Repeatability CV%) | Performance (Repeatability Study Conclusion) | Acceptance Criteria (Stability %) | Performance (Stability Study Conclusion) |
|---|---|---|---|---|
| WBC (White blood cells) | 15% | "acceptable variation" | 15% | 25/25 samples met criteria at 12 and 15 hours. |
| RBC (Red blood cells) | 6% | "acceptable variation" | 6% | 25/25 samples met criteria at 12 and 15 hours. |
| HGB (Hemoglobin) | 7% | "acceptable variation" | 7% | Not explicitly stated here, but implied to be acceptable as part of overall evaluation. (The table only lists MCH and MCHC, not HGB for stability criteria). Based on the context of the document it can be interpreted that HGB passed. |
| HCT (Hematocrit) | 6% | "acceptable variation" | 6% | 25/25 samples met criteria at 12 and 15 hours. |
| MCV (Mean cellular volume) | (Not specified here) | "acceptable variation" | 2.3% | 15/25 samples met criteria at 12 hours, 0/25 met criteria at 15 hours. |
| MCH (Mean cellular hemoglobin) | (Not specified here) | "acceptable variation" | 2.7% | 25/25 samples met criteria at 12 and 15 hours. |
| MCHC (Mean cellular hemoglobin concentration) | (Not specified here) | "acceptable variation" | 2.2% | 16/25 samples met criteria at 12 hours, 5/25 met criteria at 15 hours. |
| Platelets (PLT) | 25% | "acceptable variation" | 25% | 25/25 samples met criteria at 12 and 15 hours. |
| RDW (Red blood cell distribution width) | (Not specified here) | "acceptable variation" | 4.6% | 20/25 samples met criteria at 12 hours, 13/25 met criteria at 15 hours. |
| Lymphocytes (LYM) | (Not specified here) | "acceptable variation" | 16% | 25/25 samples met criteria at 12 and 15 hours. |
| Neutrophils (NEU) | (Not specified here) | "acceptable variation" | 22.4% | 25/25 samples met criteria at 12 and 15 hours. |
| Monocytes (MON) | (Not specified here) | "acceptable variation" | 27.9% | 24/25 samples met criteria at 12 and 15 hours. |
| Eosinophils (EOS) | (Not specified here) | "acceptable variation" | 37.1% | 23/25 samples met criteria at 12 and 15 hours. |
| Basophils (BAS) | (Not specified here) | "acceptable variation" (with statistical deviations noted) | 38.5% | 18/25 samples met criteria at 12 hours, 21/25 met criteria at 15 hours. (Note the "Met criteria" indicates improvement between 12 and 15 for Basophils, which is unusual for stability studies.) This might indicate a typo or specific behavior of this parameter. |
Important Note on Performance: While the document broadly states "acceptable variation" for repeatability and varying success rates for stability, it highlights that MCV and MCHC did not meet stability acceptance criteria for a significant number of samples at 15 hours, and RDW also showed reduced acceptance at 15 hours. Despite this, the overall conclusion states "results generated in the clinical performance testing for method comparison, for precision and for stability demonstrate equivalent performance." This implies that the observed deviations were deemed acceptable within the overall context of substantial equivalence, possibly due to their clinical insignificance or the nature of the parameters.
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison: Blood specimens collected from "both adult and pediatric donors." The exact number of donors is not explicitly stated. The study was conducted at "three external clinical sites." The provenance (e.g., country of origin) is not specified, but the phrase "external clinical sites" often implies prospective data collection for such studies. It is a prospective study.
- Precision Repeatability: "26 donors" for repeatability, and "30 donors" for reproducibility (between-lot) for venous blood collections. This also appears to be prospective data.
- Stability: Blood samples collected from "25 adult donors." This is also prospective data.
- Data Provenance: The document does not explicitly state the country of origin. Given the company is Greiner Bio-One GmbH (Austria) and the contact is in North Carolina, USA, it's possible the clinical sites were in Europe or the US, or both. It is a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (blood collection tube for hematology parameters) does not rely on expert adjudication for ground truth, unlike imaging AI. The "ground truth" for this device is the quantitative measurement of hematology parameters using a reference method (the predicate device) or established laboratory methods.
- Ground Truth Establishment: The comparison is made against the predicate device (BD Microtainer® K2EDTA Tube) and presumably, measurements are taken on validated laboratory analyzers. The "truth" is the measured value of the hematology parameters.
- No Human Experts for Ground Truth: There were no human experts performing qualitative assessment for which a "ground truth" or consensus would be needed. The evaluation is purely quantitative.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, the ground truth is established by quantitative laboratory measurements, not by human expert assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This study is for a medical device (blood collection tube), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study and
effects on human reader performance are not relevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI algorithm. It is a physical medical device. The "standalone" performance is the device's ability to collect and preserve blood samples for accurate measurement of hematology parameters. This was precisely what the Method Comparison, Precision, and Stability studies evaluated directly.
7. The Type of Ground Truth Used
The ground truth for this study is quantitative laboratory measurements of hematology parameters.
- For the Method Comparison, the predicate device (BD Microtainer® K2EDTA Tube) served as the comparator/reference.
- For Precision and Stability, the "truth" is the consistent and stable measurement of the parameters over time and between lots, with acceptance criteria defined as a tolerable percentage of variation from the initial or average measurements, or from the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical device, this question is irrelevant.
§ 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.