(30 days)
The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.
The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly (comprised of Hemogard™ stopper and shield components) and a measured quantity of K2EDTA additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield.
The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube, and the second dimension represents the length of the tube.
This document is a 510(k) summary for the PAXgene® Blood DNA Tube (K231469), comparing it to a predicate device (K142821). The primary change in the subject device is a revised draw volume specification.
Here's the information regarding acceptance criteria and the supporting study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K142821) | Reported Device Performance (Subject Device K231469) | Comparison |
|---|---|---|---|
| Draw Volume Specification | +10% to -19% of the labelled draw volume | +10% to -25% of the labelled draw volume | The difference extends the lower specification limit for blood draw volume of the PAXgene® Blood DNA Tube. |
Note: The document explicitly states that all other characteristics (General Description, Indications for Use, Device Design, Device Materials, Packaging and Sterility) are identical between the subject and predicate devices. Therefore, the "acceptance criteria" for these would be identical to the predicate's specifications, and the "reported performance" of the subject device is stated to be identical.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical evidence" and "shelf-life testing" to support the revised draw volume specification. However:
- Specific sample sizes for the clinical study are NOT provided.
- Data provenance (e.g., country of origin, retrospective or prospective) is NOT provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- This information is NOT provided in the document. The study appears to be a performance validation of a blood collection tube, not one requiring expert interpretation of diagnostic output.
4. Adjudication Method
- This information is NOT applicable/not provided for this type of device validation study (a blood collection tube). Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation of medical images or diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared. The PAXgene® Blood DNA Tube is a blood collection device, not an AI diagnostic.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm-only performance study was NOT done. This is not an AI diagnostic device. The performance validation is for the physical blood collection tube itself.
7. The Type of Ground Truth Used
The ground truth for the performance of the device (specifically regarding the revised draw volume specification) appears to be established through:
- Clinical evidence: Implies direct measurement and analysis of blood DNA collected using the tubes.
- Shelf-life testing: Verifies that the device maintains its performance over its specified shelf life, which includes its ability to draw the specified volume and preserve DNA quality.
8. The Sample Size for the Training Set
- This information is NOT applicable/not provided. The device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is NOT applicable. As it's not an AI device, there is no "training set" or ground truth established for training. The "ground truth" (or acceptable performance) for the device's function is established through the physical and chemical properties and laboratory performance testing.
§ 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.