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510(k) Data Aggregation
(262 days)
Molecular Transport Media - MTM
The Molecular Transport Media - MTM is intended for the stabilization, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.
The MTM consists of a pre-filled plastic tube containing either 2 or 3 mL of proprietary liquid medium intended for viral nucleic acid stabilization and transportation and inactivation of nasopharyngeal swab specimens suspected of containing SARS-CoV-2. MTM is intended for use with standard diagnostic/identification techniques that have been adequately validated and found to be compatible with the MTM. The formulation of the MTM includes guanidine-free inactivation buffer, salts, a buffer to maintain a neutral pH, and distilled water.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
The document is a 510(k) Summary for the Molecular Transport Media - MTM. It describes non-clinical performance and shelf-life studies. No clinical studies were performed.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Molecular Transport Media - MTM:
| Study/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life (Physical Stability) | No changes in appearance (color, turbidity); colorless and clear liquid, without precipitate, for 18 months at 15-35°C. | Physically and visually examined at T=0, 3, 6, 9, 12, 15, and 18 months. For all lots and replicates at both 15°C and 35°C, the appearance remained colorless and clear liquid, without precipitate. |
| Shelf-Life (pH Stability) | pH measurements within an acceptable range of 8 +/- 1 for 18 months at 15-35°C. | pH was measured at T=0, 3, 6, 9, 12, 15, and 18 months. For all lots and replicates at both 15°C and 35°C, the pH measurements were within the acceptable pH range of 8 +/- 1. |
| Limit of Detection (LoD) Confirmatory | Lowest concentration of SARS-CoV-2 that contains measurable nucleic acids that can be repeatedly recovered with a greater than 95% accuracy (Implied from predicate comparison and confirmatory LoD methodology). Specifically, the goal was to confirm the preliminary LoD. | The confirmatory LoD for MTM was determined to be 1.35E+03 PFU. At this concentration, 19/20 to 20/20 replicates were positive across different lots and temperatures (15°C and 35°C) across all three viral targets (ORF1ab, N gene, S gene). This demonstrates consistency and reproducibility at this level. |
| Viral Nucleic Acid Stability | Positive detection for all samples tested, with Ct variation (ΔCt) less than ±3 Ct values for at least two of the three viral targets (ORF1ab, N gene, and S gene) at time points 7, 14, and 21 days post-inoculation, comparing to time point 0, for both 15°C and 35°C. | The MTM provided positive detection for all samples tested (3.00E+03 PFU initial concentration). The ΔCt calculation (Mean Ct Day 0 minus Mean Ct Day 7, 14, and 21) showed variation within acceptable limits (less than ±3 Ct values) for at least two of the three viral targets across all MTM lots at both 15°C and 35°C for 7, 14, and 21 days. This supports stability for 21 days at both temperature ranges. |
| Viral Inactivation (Cytotoxicity) | The lowest dilution to indicate normal cell growth (no Cytopathic Effect - CPE) should be determined to establish a non-cytotoxic dilution for subsequent viral inactivation studies. | The lowest dilution to indicate normal cell growth (no cytotoxicity) was determined to be the 1:10E+03 dilution in all lots at both 15°C and 35°C. No cytotoxicity was observed for dilutions from 1:10E+04 to 1:10E+08. |
| Viral Inactivation (PFU) | No plaque-forming units (PFUs) should be obtained after exposure to MTM, demonstrating effective inactivation of SARS-CoV-2. Specifically, the study aimed for inactivation at short exposure times (e.g., 5-15 minutes). | No PFUs were obtained after exposure times of 0, 5, and 15 minutes for all MTM lot numbers at both 15°C and 35°C. This supports SARS-CoV-2 inactivation at 5 minutes exposure with MTM at both temperature ranges. |
2. Sample Size Used for the Test Set and Data Provenance
- Shelf-Life Study (Physical & pH Stability):
- Test Set Sample Size: Three lots, with three replicates per lot, tested at 7 time points (T=0, 3, 6, 9, 12, 15, 18 months).
- Data Provenance: Not explicitly stated, but implies laboratory testing internal to the manufacturer or a contract lab. Prospective for the duration of the 18-month test.
- Limit of Detection (LoD) Study:
- Preliminary LoD Test Set Sample Size: Not clearly defined as a fixed "test set." It involved serial dilutions, with triplicate testing for each concentration for three lots.
- Confirmatory LoD Test Set Sample Size: 20 replicates for each of three SARS-CoV-2 concentrations (1.35E+04, 1.35E+03, and 1.35E+02 PFU) across different MTM lots and temperatures.
- Data Provenance: Not explicitly stated, but implies laboratory testing. The "pooled negative clinical nasal samples" suggest human specimens were used as matrix, but the virus stock was laboratory-prepared. Retrospective for the negative clinical samples, prospective for the spiked virus testing.
- Viral Nucleic Acid Stability Study:
- Test Set Sample Size: Not clearly defined as a fixed "test set." Triplicate rayon swabs per lot and per temperature condition (15°C and 35°C) at 4 time points (0, 7, 14, 21 days).
- Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled negative clinical nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.
- Viral Inactivation Study:
- Cytotoxicity Test Set Sample Size: Triplicate for each 10-fold serial dilution (1:10E+01 to 1:10E+08) for each of the three lots, at both 15°C and 35°C.
- Viral Inactivation Test Set Sample Size: Triplicate for each MTM lot number at 15°C and 35°C at three time points (0, 5, and 15 minutes post inoculation). Serially diluted (10-fold) to 1:10E+01 to 1:10E+08 in triplicate for plaque assay.
- Data Provenance: Not explicitly stated, but implies laboratory testing. Uses "pooled clinical negative nasal matrix." Retrospective for the negative clinical samples, prospective for the spiked virus testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document describes non-clinical laboratory studies. No human experts were used to establish ground truth in the context of clinical interpretation. The ground truth in these studies is based on quantifiable laboratory measurements (e.g., PFU counts, Ct values, pH, visual appearance) against pre-defined scientific criteria. For example, confirmation of presence/absence of virus based on TaqPath COVID-19 Combo Kit interpretation (Table 3), or visual assessment of CPE for cytotoxicity.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, quantifiable laboratory study, not a study involving human interpretation or adjudication of results. The results are based on direct measurements and adherence to pre-defined thresholds.
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 MRMC comparative effectiveness study was done. This is a device for molecular transport media, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Standalone performance was not done in the context of an AI algorithm. The device itself functions in a standalone manner as a transport medium; its performance attributes (nucleic acid stabilization, preservation, viral inactivation) are assessed directly.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Quantitative Laboratory Measurements:
- Limit of Detection: Defined by the ability to repeatedly detect SARS-CoV-2 RNA above a 95% accuracy threshold using a legally marketed molecular diagnostic kit (TaqPath COVID-19 Combo Kit) and measured Ct values.
- Viral Nucleic Acid Stability: Defined by positive detection of SARS-CoV-2 RNA and Ct variation (ΔCt) within ±3 Ct values, measured using the TaqPath COVID-19 Combo Kit.
- Viral Inactivation: Defined by the absence of plaque-forming units (PFUs) on Vero cells after exposure to the MTM, and by the absence of Cytopathic Effect (CPE) for cytotoxicity.
- Shelf-Life: Defined by objective physical characteristics (color, turbidity, precipitate) and measurable pH values within a specified range.
8. The Sample Size for the Training Set
No training set was used. This device is a molecular transport medium, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As no training set was used, no ground truth needed to be established for it.
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