(374 days)
Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
Biosci™ ITM contains a detergent and a protein denaturant to inactivate Flu A, lyse cells, disrupt lipid membranes, denature proteins and enzymes, and stabilize influenza A RNA. Therefore, Biosci™ ITM is not intended to be used for culture-based techniques. A specimen bag is also provided for safe transportation of specimens, as well as providing appropriate biosafety warning. Biosci™ ITM has different configurations: - A screw-cap tube filled with 1.0, 2.0, or 3.0 mL of Biosci™ ITM . - A screw-cap tube filled with a range of media and package with an oropharyngeal swab for . oropharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a nasopharyngeal swab for nasopharyngeal specimen collection - . A screw-cap tube filled with a range of media and package with a mid-turbinate swab for mid-turbinate specimen collection
Here's a breakdown of the acceptance criteria and study details for the Biosci™ Inactivated Transport Medium, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | Not explicitly stated as a numerical criterion, but implied to be sufficient for detection. Demonstrated sensitivity for Flu A. | 0.2 TCID50/mL for Flu A (H1N1 ATCC VR-1736) |
| Viral Stability (Flu A RNA) | Ct value variation within +/- 3.0 Ct compared to Day 0. | For 14 days at 2-8°C: |
| Day 7 variation: -0.29 Ct | ||
| Day 14 variation: -0.68 Ct. | ||
| For 14 days at 25°C: | ||
| Day 7 variation: -0.17 Ct | ||
| Day 14 variation: -0.65 Ct. | ||
| All within +/- 3.0 Ct. | ||
| Inactivation (Flu A) | >4.0 log reduction in Flu A titer. | >4.0 log reduction in Flu A titer at 10, 20, and 30 seconds incubation. (For concentrations 1.2 x 10^7 and 1.2 x 10^8 TCID50/mL). |
2. Sample Size Used for the Test Set and Data Provenance
- Limit of Detection: 24 positive replicates were used.
- Viral Stability: Not explicitly stated as a number of replicates per time point for the stability study, but Flu A was diluted at 5x LoD and spotted onto swabs. The study involved incubation at two temperatures (2-8ºC and 25ºC) for 0, 7, and 14 days. This implies multiple samples for each time point and condition.
- Inactivation: Multiple starting concentrations of Flu A (1.2 x 10^7, 1.2 x 10^8, 1.2 x 10^9 TCID50/mL) were tested. For each concentration, samples were incubated for 10, 20, and 30 seconds. Control groups included Flu A only, Flu A and matrix, matrix only, and Biosci™ ITM only.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "negative pooled nasopharyngeal clinical matrix," suggesting the use of clinical samples, but the study design is analytical (laboratory-based) rather than clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This device is a transport medium for stabilizing microbial nucleic acids, not an interpretative diagnostic device that requires expert review for ground truth in the same way an imaging AI algorithm would.
- The ground truth for the analytical studies (LoD, Viral Stability, Inactivation) was established based on laboratory assays (RT-PCR and cell culture-based assay for CPE), not human expert consensus. Therefore, no "experts" in the traditional sense of human readers for images or clinical diagnoses were used.
4. Adjudication Method for the Test Set
- Not applicable. The ground truth was established by laboratory measurements, not human interpretation requiring adjudication.
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
- No. This is an analytical study for a transport medium device, not an AI diagnostic algorithm, so an MRMC study is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a transport medium, not an algorithm. Its performance is evaluated in standalone, laboratory-based analytical studies as described above.
7. The Type of Ground Truth Used
- The ground truth for the studies was established through laboratory assays:
- LoD and Viral Stability: Quantified Flu A RNA using a "validated RT-PCR assay."
- Inactivation: Measured viral viability by observing the "cytopathic effect (CPE)" on MDCK cell lines.
8. The Sample Size for the Training Set
- Not applicable. This is a transport medium device, not an AI/machine learning algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
§ 866.2950 Microbial nucleic acid storage and stabilization device.
(a)
Identification. A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.