(122 days)
- The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tutter The specimens are used for clinical laboratory assays involving the use of patient serum.
- The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
The Teco Blood Collection Devices include: Vacu Lab Plain Tube; Vacu Lab Gel & Clot Activator Tube;
- The Vacu Lab Plain Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, and (3) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
- The Vacu Lab Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance (Teco Tubes vs. Predicate) |
|---|---|
| Correlation coefficient (r) ≥ 0.95 for all comparative studies of chemistry analytes. | All comparison studies yielded a correlation coefficient ≥ 0.95. |
| Equivalent results to predicate device for specific chemistry analytes (e.g., total protein, albumin, bilirubin, AST, ALT, ALP, r-GT, cholesterol, potassium, glucose, creatinine, etc.). | The Vacu Lab Plain Tube demonstrated equivalent results to the predicate device for all tested analytes. |
| No significant difference from fresh specimens and 72-hour stored specimens at 2-8℃. | All results showed no significant difference from fresh specimens and 72 hours stored at 2-8℃. |
| Shelf-life of at least 24 months (2 years). | The shelf life was claimed to be 2 years based on accelerated aging studies. |
| No significant difference in results after accelerated aging (equivalent to 2 years real-time). | The results of comparison studies after accelerated aging did not show any significant difference from the results of the BD Vacutainer™ Plus SST™ Tubes. |
2. Sample Size Used for the Test Set and Data Provenance
- Study I (Vacu Lab Plain Tube): 66 paired samples from outpatients. The country of origin is not explicitly stated, but the company is based in the USA, suggesting US patients. The study is prospective in nature as samples were collected specifically for this evaluation.
- Study II (Vacu Lab Plain Tube): 25 randomly collected outpatient blood samples. The country of origin is not explicitly stated. The study is prospective.
- Study III (Vacu Lab Gel & Clot Activator Tube): 70 paired samples from outpatients. The country of origin is not explicitly stated. The study is prospective.
- Study IV (Vacu Lab Gel & Clot Activator Tube): 25 randomly collected outpatient blood samples. The country of origin is not explicitly stated. The study is prospective.
- Stability Studies: Not specified, but involved comparing "fresh specimens" to "72 hours stored at 2-8℃" specimens. Likely a subset of the clinical samples.
- Shelf-life Studies: 25 outpatient blood specimens were collected after the devices underwent accelerated aging. The country of origin is not explicitly stated. The study is prospective for data collection post-aging.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies are method comparison studies for blood collection devices. The "ground truth" is established by comparing the results obtained from the new device (Teco tubes) against a legally marketed predicate device (BD Vacutainer™ Plus SST™ Tube), which is assumed to provide accurate results for the chemistry analytes. There are no human experts establishing a "ground truth" diagnosis in this context; rather, the performance is assessed against an established analytical method.
4. Adjudication Method for the Test Set
This is not applicable for this type of device and study. Adjudication refers to resolving disagreements among multiple expert readers in diagnostic studies. Here, the comparison is analytical, between two types of blood collection tubes measured by automated chemistry analyzers.
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
This is not applicable. This document describes the evaluation of blood collection tubes, not an AI-powered diagnostic device or a system involving human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a blood collection tube, which is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in these studies is implicitly defined by the results obtained from the legally marketed predicate device (BD Vacutainer™ Plus SST™ Tube). The Teco tubes are compared against this established product using standard clinical laboratory chemistry assays. The goal is to demonstrate "substantial equivalence" in analytical performance.
8. The Sample Size for the Training Set
This is not applicable. As these are blood collection tubes being physically evaluated, there is no "training set" in the context of machine learning or AI models. The studies described are clinical performance evaluations.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.