(87 days)
The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material.
The VACUETTE® EDTA K2 Gel Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Greiner VACUETTE® EDTA K2 Gel Tubes:
This 510(k) summary is for a medical device (blood collection tube) and focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance criteria against predefined numerical targets. Therefore, the "acceptance criteria" are implied by the performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VACUETTE® EDTA K2 Gel Tubes) |
|---|---|
| Similar sensitivity and recovery at lower detection limits for HIV and HCV quantitation. | Demonstrated similar sensitivity and recovery at the lower detection limits for both HIV and HCV quantitation. |
| Substantially equivalent results in HIV and HCV quantitation. | Demonstrated substantially equivalent results in HIV and HCV quantitation. |
| No significant effect of plasma separation delay (within 24 hours) on HIV or HCV results. | No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 24 hours for HIV or HCV. |
| No significant difference in HIV or HCV results between fresh vs. once-frozen samples or specific freeze/thaw cycles. | No difference in HIV or HCV results within or between the two tube types for fresh versus once frozen samples or when plasma samples were exposed to 5 freeze/thaw cycles for HIV or 1 freeze/thaw cycle for HCV. (This implies performance comparable to the predicate for these conditions). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of patient samples or replicates) used for the tests. It only mentions "samples from these tubes" which were used in PCR assays.
- Data Provenance: Not explicitly stated, but the mention of "WHO standards" suggests an international or standardized approach. The study was conducted by Greiner Vacuette North America, Inc. It's likely these were prospective studies conducted for the purpose of this submission, but it's not explicitly labeled as "prospective" or "retrospective."
- Country of Origin: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This information is not provided.
- Qualifications of Experts: This information is not provided.
- Note: Given the nature of a blood collection device study focused on PCR assay performance, ground truth would likely be established by lab technicians/scientists following validated PCR protocols, rather than medical experts in the traditional sense (e.g., radiologists). The "ground truth" here is the accurate quantification of HIV and HCV using established PCR methods.
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not provided. Adjudication as typically understood in image analysis (e.g., 2+1) is not applicable to this type of laboratory-based quantitative comparison. The "adjudication" would be inherent in the standard laboratory protocols and quality control measures for PCR assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation (e.g., radiology AI). This device is a blood collection tube, and the "effectiveness" is measured by the performance of subsequent analytical assays (PCR), not human reader performance.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in essence, the study conducted represents a "standalone" evaluation of the device's impact on the sample. The performance is assessed directly through laboratory assays (PCR) using samples collected in the device, without an "human-in-the-loop" interpretation step that would involve a human user's decision-making in the context of the device's output. The device itself (the tube) doesn't have an "algorithm" in the conventional sense, but its physical and chemical properties are tested in isolation regarding their effect on sample integrity for PCR.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth is the quantification of HIV and HCV RNA/DNA using established PCR assay methods, validated by "WHO standards" at lower detection limits. The "truth" is the accurate and consistent measurement of these viral loads. The comparison is made against the performance of the predicate device under the same conditions.
8. Sample Size for the Training Set
- Sample Size for Training Set: This information is not provided. For a medical device like a blood collection tube, there isn't typically a "training set" in the machine learning sense. The device itself isn't "trained." If any initial development or optimization involved testing, the details are not included in this summary. The studies described are validation studies for the final product.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning context for this device. The rigorous laboratory testing and comparison to WHO standards would serve as the basis for understanding and demonstrating the performance characteristics of the VACUETTE® EDTA K2 Gel Tubes.
§ 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.