(273 days)
The TAP Blood Collection® Device is a lithium heparin coated single use device intended to collect capillary blood from the upper arm of adults (21 years of age or older). The TAP Blood Collection® Device is for measurement of HbAlc on blood specimens which can be collected by self-administration of the TAP Device by a layperson or by a healthcare worker in a healthcare setting. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin Alc (HbA1c) using tests intended for monitoring glycemic control.
The TAP Blood Collection® Device (herein “TAP Device”) is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to obtain a capillary blood sample from the upper arm. The device contains lithium heparin as an anticoagulant. The device is intended for self-administration by a layperson or by a healthcare worker. When the TAP Device is actuated, it collects the sample in an integrated reservoir and provides a visual indicator (fill indicator window) to the end user to confirm that the collection is complete and sufficient blood has been collected to conduct HbA1c testing. The sample collection time is 7 minutes or less and typically takes 2-3 minutes. The TAP Device is then sent to the laboratory for testing. The sample must be tested within 6 hours from time of collection or as indicated in the HbA1c test system package insert (whichever is less).
The provided text describes the TAP Blood Collection® Device, focusing on its re-submission for an expanded indication of use, specifically for self-administration by laypersons for HbA1c testing. The device itself (K161521) was previously cleared, and this submission (K190225) aims to add layperson use.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list "acceptance criteria" in a table format with specific numerical targets. Instead, it describes general performance goals for the additional testing supporting the layperson use indication. The reported device performance is presented as conclusions from these studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Usability: Laypeople can successfully use the device to self-collect | The usability study demonstrated that laypeople can successfully use the TAP Device to self-collect a blood sample according to the TAP Device written instructions for use. |
| Analytical Performance (Comparison): Self-collected samples are adequate for HbA1c testing and provide similar results to venous blood. | The analytical performance testing demonstrated that self-collected TAP Device samples provide similar HbA1c test results when compared to venous blood samples collected by a healthcare worker. |
| Analytical Performance (Repeatability/Precision): Sufficient repeatability for HbA1c testing with multiple self-collected samples. | The study also demonstrated sufficient repeatability for HbA1c testing when multiple samples are self-collected with the TAP Device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size for either the usability study or the analytical performance study. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is a blood collection device, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC comparative effectiveness study regarding human readers and AI assistance is not applicable and not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a blood collection device. Its primary function is to collect a blood sample. The "performance" being evaluated here is the ability to collect a suitable sample for laboratory analysis and the comparability of the collected sample to a standard collection method. There is no "algorithm only" performance that would be applicable to this type of device.
7. The Type of Ground Truth Used
- For the usability study, the "ground truth" was likely defined by successful completion of specified tasks by laypersons according to instructions. This would be assessed through observation and potentially questionnaires.
- For the analytical performance testing, the "ground truth" for HbA1c values was established by venous blood samples collected by a healthcare worker, considered the reference standard for HbA1c measurement.
8. The Sample Size for the Training Set
This information is not provided in the given text. The studies described are performance validation studies, not AI model training.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, there is no "training set" in the context of machine learning. The studies are evaluating the device's ability to facilitate sample collection and the quality of those samples.
§ 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.