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510(k) Data Aggregation
(299 days)
Longhorn Vaccines and Diagnostics LLC
PrimeStore MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.
The PrimeStore MTM device consists of a storage tube with an O-ring and lip seal containing 1.5 mL of the stabilization solution. These components are intended to inactivate Influenza A and Mycoplasma tuberculosis, lyse cells, disrupt/lyse lipid membranes, denatures proteins, inactivates enzymes, and stabilize Influenza A RNA and M. tuberculosis DNA. The transport device is designed for storage of specimens between 36-77 °F (2-25 °C).
The media contains the following reagents:
- o Guanidine thiocyanate
- o TCEP
- Sodium Citrate ●
- N-Lauroylsarcosine sodium (NLS) ●
- Antifoam A, TRIS ●
- EDTA ●
- Ethanol (molecular grade)
- HCl ●
- Nuclease-free water ●
The PrimeStore MTM device is intended for the stabilization, transportation, and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA, and infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA. The acceptance criteria and the studies proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | Mycobacterium Tuberculosis (MTB): - Recoverable concentration where at least 95% of replicates are within a 3 Ct range. | MTB: - At 10¹ CFU/mL, 25 of 25 replicates had recoverable concentrations, and all fell within the 3 Ct range. Average CT = 34.0, S.D. = 0.98. - At 10⁴ CFU/mL and 10² CFU/mL, all 25 replicates met the acceptance criteria. |
| Influenza A (Flu A): - Recoverable concentration where at least 95% of replicates are within a 3 Ct range. | Flu A: - At 10² TCID50/mL, 25 of 25 replicates had recoverable concentrations; one replicate had a high Ct value outside the 3 Ct range, but the overall concentration still met the criterion. Average CT = 34.5, S.D. = 0.88. | |
| Stability | MTB: - +/- 3.0 Ct from time zero for 36 days at 4°C and 27°C, without loss of detection signal. | MTB: - DNA from MTB in PrimeStore MTM showed a variation of 1.6 Ct or less over 36 days at both 4°C and 27°C. Positive samples not stored in PrimeStore MTM demonstrated degraded DNA as time and temperature increased. |
| Flu A: - +/- 3.0 Ct from time zero for 29 days at 4°C and for 8 days at 27°C, without loss of detection signal. | Flu A: - RNA from Influenza A in PrimeStore MTM showed a variation of 2.7 Ct over 29 days at 4°C and a variation of 2.0 Ct over 8 days at 27°C. Positive samples not stored in PrimeStore MTM demonstrated degraded RNA as time and temperature increased. | |
| Inactivation | MTB: - No growth in all samples after 42 days of incubation, requiring a specific sputum-to-PrimeStore MTM ratio and minimum exposure time. | MTB: - At 1.5 x 10⁶ CFU/mL, no growth was observed across all ratios (1:3, 1:2, 1:1) and all time points (1 to 180 minutes). - At 1.5 x 10⁸ CFU/mL, inactivation was successful (no growth) with a ratio of at least 1:3 sputum to PrimeStore MTM and a minimum of 60 minutes exposure time. Intermittent growth was observed at other ratios and shorter exposure times. |
| Flu A: - Demonstrate rapid inactivation (e.g., log reduction) within specified timelines, while noting potential cytotoxicity of the media at high concentrations. | Flu A: - PrimeStore MTM showed cytotoxicity on MDCK cells when diluted 1:100 but not at 1:1,000. - Rapidly inactivated Influenza A virus with a >4.0 log reduction in concentration at 10 seconds. - Viral CPE could not be observed at |
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