(259 days)
The TAP Blood Collection® Device is a lithium heparin coated single intended to be used to collect capillary blood from the upper arm of adults (21 years of age or older) by a healthcare worker. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin A1c (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 use 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 document describes the TAP Blood Collection® Device, its indications for use, and the studies conducted to demonstrate its safety and effectiveness.
Here’s a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a separate table with pass/fail thresholds. However, it presents various performance metrics and concludes that the device is "equivalent" or "no significant differences" exist compared to established methods. We can infer the de-facto acceptance criteria from the reported performance which demonstrates equivalence to venipuncture blood samples for HbA1c testing.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| HbA1c Equivalence to Venipuncture | Method Comparison: Mean percentage bias observed between TAP Device and venipuncture for HbA1c was -0.1% with a 95% Confidence Interval of (-0.4%, 0.2%). Correlation coefficient (r) was 0.9878, indicating no significant differences. |
| Lot-to-Lot Variability: No significant difference in HbA1c test results across production lots | Lot-to-Lot Variability: Within lot imprecision ranged from 0.87% to 2.09% CV. Between lot imprecision ranged from 0.0% to 0.89% CV. Total imprecision ranged from 1.20% to 2.09% CV. (Combined site results for 72 subjects, 200 TAP collections). Confirmed no significant difference. |
| Inter-Operator Variability: No significant difference in HbA1c test results across operators | Inter-Operator Variability: Within operator imprecision ranged from 1.22% to 1.73% CV. Between operator imprecision ranged from 0.0% to 0.94% CV. Total imprecision ranged from 1.44% to 1.73% CV. (Combined site results for 67 subjects, 195 TAP collections). Confirmed no significant difference. |
| Analyte Stability (HbA1c) for 6 hours | Analyte Stability Study: Average TAP percent differences in HbA1c measured after 3 hours (0.4%) and 6 hours (-1.5%) supported the recommendation that samples can be analyzed within 6 hours. |
| Usability (Ease of Use by healthcare workers) | Usability Study: 95.5% of respondents agreed TAP Device actuation and collection was easy to execute. 92.5% of respondents agreed TAP Device extraction was easy to execute. Results demonstrated the device was easy to use with provided instructions. |
| Clinical Safety | Pivotal Study: No significant adverse events reported. Minimal, clinically insignificant dermal responses (erythema, edema). Pain from TAP Device collection significantly less than venipuncture (Wong-Baker Pain Rating Scale). |
| Sample Collection Time | Sample Quality Studies: Mean collection time of 209 TAP Devices was 3 minutes and 21 seconds. |
| Sample Volume Yield | Sample Quality Studies: Mean blood volume extracted from TAP Devices was 104.6 µl. |
| Clotting Rate (not affecting HbA1c) | Sample Quality Studies: 19 small clots out of 209 samples (9%) were observed, which "have been shown not to have an effect on HbA1c determinations." |
| Hemolysis (not affecting HbA1c) | Sample Quality Studies: Average free plasma hemoglobin of 102.5 mg/dL for 69 TAP Device samples, which "had no effect on HbA1c determinations." |
| Shelf-life Stability, Package Integrity, Shipping | Bench Testing: Performed with passing results. Confirms stability and full functionality. |
| Heparin Potency | Bench Testing: Studies conducted to support specifications and confirm full functionality. |
| Biocompatibility and Sterility | Biocompatibility and Sterility Studies: Found to be compliant through third-party testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Pivotal Study: 143 participants.
- Data Provenance: Prospective study conducted at multiple hospital clinic sites by healthcare workers. The country of origin is not explicitly stated but implied to be the USA given the FDA submission. Participants spanned representative age, gender, ethnicity, race, and health status (healthy and diabetic).
- Analyte Stability Study: "multiple TAP Device samples were collected" and "A total of two or three samples were tested from each participant." The exact number of participants is not given.
- Data Provenance: Prospective study. Country of origin not explicitly stated.
- Usability Study: The number of participants is not explicitly stated, but it assessed "intended users of the product."
- Data Provenance: Prospective study. Country of origin not explicitly stated.
- Sample Quality Studies (Collection time, volume, clotting, hemolysis):
- Collection time, volume, clotting: 209 TAP Devices.
- Hemolysis: 69 TAP Device blood samples.
- Data Provenance: Not explicitly stated whether these were distinct studies or part of the pivotal study, but implied to be prospective. Country of origin not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
The ground truth for the HbA1c levels was established by venipuncture blood samples analyzed in a clinical laboratory using "HbA1c analyzers." The document does not specify the number of experts or their qualifications for interpreting these venipuncture samples, as it relies on standard clinical laboratory procedures and FDA-cleared analyzers. The "healthcare workers" collected samples, but the analysis establishing the "ground truth" (the comparator) was performed by laboratory instruments.
4. Adjudication Method for the Test Set:
Not applicable in the typical sense of expert adjudication for diagnostic imaging or clinical endpoints. The primary comparison in the pivotal study was between HbA1c levels derived from the TAP Device and those from venipuncture, both analyzed by standard laboratory methods. Discrepancies would be handled by statistical methods (bias, correlation).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a blood collection system, not an AI-assisted diagnostic tool that requires human interpretation of outputs. The studies focused on device performance (e.g., sample equivalence, variability between lots/operators) and usability by healthcare workers, not on improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical blood collection tool. Its "performance" is measured by the quality and accuracy of the sample it collects when analyzed by an external laboratory process, not by an internal algorithm's standalone output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the primary effectiveness evaluation (HbA1c levels) was established using venipuncture blood samples analyzed by FDA-cleared HbA1c analyzers in a clinical laboratory. This represents a recognized standard method for measuring HbA1c.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical blood collection device, not an algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 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.