Copan Universal Transport Medium (UTM-RT) System

K232357 · Copan Italia Spa · JSM · Apr 25, 2024 · Microbiology

Device Facts

• Record ID: K232357
• Device Name: Copan Universal Transport Medium (UTM-RT) System
• Applicant: Copan Italia Spa
• Product Code: JSM · Microbiology
• Decision Date: Apr 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

Copan Universal Transport Medium (UTM-RT®) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT® can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. UTM-RT® is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT® is intended for use with compatible molecular assays.

Device Story

System consists of tube containing 3mL transport medium, optionally supplied with flocked nylon swab; used for collection/transport of clinical specimens (viruses, chlamydiae, mycoplasma, ureaplasma) from collection site to laboratory. Medium maintains microorganism viability for culture and preserves nucleic acid integrity for molecular assays. Used in clinical settings; operated by healthcare professionals. Output is stabilized specimen in transport medium; processed by laboratory staff using standard culture or molecular diagnostic procedures. Benefits include maintained specimen viability and nucleic acid stability during transport, facilitating accurate downstream diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies evaluated Influenza A, Influenza B, and RSV nucleic acid recovery in simulated nasopharyngeal/nasal fluid matrix. Samples stored at 2–8°C and 22–28°C for up to 96 hours. Performance measured by cycle threshold (Ct) values using an FDA-cleared molecular assay. Acceptance criteria (ΔCt < 3) met for all tested lots, including new, middle-aged, and expired (up to 18 months) media.

Technological Characteristics

Polypropylene tube with screw cap; 3mL transport medium (Modified Hank's Balanced Salts, HEPES, BSA, antibiotics/antifungals, L-cysteine, gelatin, phenol red, sucrose, L-glutamic acid). Nylon-flocked swab on plastic shaft with break point. Optional glass beads. Non-automated, standalone collection/transport device. Sterilized. Compatible with molecular assays and culture.

Indications for Use

Indicated for collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma, or ureaplasma, and stabilization of unprocessed upper respiratory specimens suspected of containing respiratory viral nucleic acids for use with compatible molecular assays.

Regulatory Classification

Identification

A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Predicate Devices

• Merit Medical Systems Cultura Collection and Transport System (K201674)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K232357

B Applicant

Copan Italia S.p.A.

C Proprietary and Established Names

Copan Universal Transport Medium (UTM-RT) System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JSM, LIO | Class I, reserved | 21 CFR 866.2390 – Transport Culture Medium | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain substantial equivalence determination for the Copan Universal Transport Medium (UTM-RT) for a new Intended Use claim of stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids (to add on to the existing Intended Use of the previously cleared device) under the same device name.

B Measurand:

Not applicable

C Type of Test:

Non-propagating Transport Device with culture medium

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.

UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.

C Special Conditions for Use Statement(s):

Rx – For Prescription Use Only

Do not freeze specimens intended to be processed for nucleic acids investigations. Stability of nucleic acids when frozen in UTM-RT has not been evaluated and validated.

D Special Instrument Requirements:

Not Applicable

IV Device/System Characteristics:

A Device Description:

The candidate device, Copan UTM-RT, is provided in a screw capped, conical bottom, polypropylene tube filled with 3mL of UTM-RT transport medium. Copan UTM-RT is supplied in either of two (2) configurations, namely, medium tube alone in a paper-film peel pouch (bulk configuration), or medium tube accompanied by sterile flocked swab in a peel pouch for specimen collection (kit configuration). In the kit configuration, the flocked swab is available in three (3) shapes—i.e., regular, minitip, and minitip flexible—that are suitable for specimen collection from various sites on patient, including the upper respiratory cavity. Further, the medium tube for both the swab configurations above can be provided with or without glass beads inside. The medium tube with beads will be distinguished from tube without beads by the wording “with beads” written in the product description on tube and external labels, as well as in other labeling materials.

The screw cap of the UTM-RT medium tube has a unique internal molded design that is able to capture a swab shaft when the shaft is broken off into the tube and cap is closed. The flocked specimen collection swab (provided sterile in a paper-peel pouch with UTM-RT medium in the kit configuration) has a tip flocked with nylon fiber and a solid plastic shaft with a molded breaking point. The nylon flocked swab along with its plastic shaft is the only component that may come in transient (typically &lt; 1 minute) contact with patient tissue (e.g., mucosal surfaces) during use in specimen collection. After the specimen is collected, the swab shaft is broken off at the breaking point such that the swab with the collected specimen remains within the medium tube.

B Principle of Operation:

The UTM-RT medium is designed to maintain the integrity and viability of viruses, chlamydiae, mycoplasma, or ureaplasma and the integrity of nucleic acids for upper respiratory viruses.

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Composition of the UTM-RT medium:
Modified Hank's Balanced Salts
BEPEs Buffer 1M
Bovine Serum Albumin
Vancomycin
L-Cysteine Hydrochloride
Amphotericin B
Sodium Bicarbonate
Colistin
Gelatin
Phenol Red
Sucrose
Distilled Water
L-Glutamic Acid

Specimens preserved in UTM-RT transport media are suitable for testing with subsequent culture procedure (all clinical specimens) or molecular amplification (limited to upper respiratory clinical specimens suspected of containing nucleic acids from respiratory viruses).

V Substantial Equivalence Information:

A Predicate Device Name(s):
Merit Medical Systems Cultura Collection and Transport System

B Predicate 510(k) Number(s):
K201674

C Comparison with Predicate(s):

| Device & Predicate Device(s): | Device (K232357) | Predicate (K201674) |
| --- | --- | --- |
| Device Trade Name | Copan Universal Transport Medium (UTM-RT) System | Merit Medical Systems Cultura Collection and Transport System |
| Manufacturer | Copan Italia S.p.A. | Merit Medical Systems, Inc. |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays. | The Merit Cultura Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus. |

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| Device & Predicate Device(s): | Device (K232357) | Predicate (K201674) |
| --- | --- | --- |
| Tube and cap material | Plastic | Same |
| Swab material | Various flocked nylon applicators on a plastic shaft with break point | Same |
| Media Volume | 3 mL | Same |
| Single use device | Yes | Same |
| Principle of operation | Culture-based medium for maintenance of target microorganism viability and integrity. The specimen can be tested with culture- based technique and/or with PCR-based technique. | Same |
| General Device Characteristic Differences | | |
| Shelf-life | 18 months | 12 months |
| Media list of ingredients | Hank’s Balanced Salt Solution, bovine serum albumin, L-cysteine, gelatin, L-glutamic acid, HEPES buffer, phenol red, sucrose, vancomycin, amphotericin B and colistin | Hank’s Balanced Salt Solution (HBSS), Fetal Bovine Serum (FBS), D-glucose, Phenol Red, Gentamicin sulfate and Amphotericin B |
| Specimen transport conditions and storage time | Up to 96 hours at 2–25°C. | Up to 120 hours at 2–25°C. |

VI Standards/Guidance Documents Referenced:

Not applicable to the current studies.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility; Linearity; Analytical Specificity/Interference; Assay Reportable Range; Traceability; Expected Values (Controls, Calibrators, or Methods); Assay Cut-off:

Not Applicable

2. Stability/Shelf life:

The previously cleared device (K042970) has a shelf-life of 18-months. For the candidate device, no changes were made to the manufacturing of the UTM-RT transport medium or kit components, and no extension of the shelf-life was claimed. The existing shelf-life stability validation data from the original clearance remains appropriate to support an 18-month shelf life claim for the candidate device.

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3. Detection Limit:

# Performance Testing - Culture Recovery Studies:

Performance of the Copan Universal Transport Medium (UTM-RT) System was evaluated by culture-based recovery studies for viral and bacterial test strains under and the results were deemed acceptable during the clearance of the original device, K042970. Since the medium tube (container), UTM-RT media composition, and other kit components remain unchanged, and no extension of the specimen stability is being claimed, a new set of performance evaluation for specimen stability via culture recovery is not required for the current candidate device (K232357).

# Performance Testing - Nucleic Acid Stability Studies:

To support the new intended use claim, "UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays", the sponsor conducted fresh studies to determine the LoD of molecular detection of three (3) representative target viral nucleic acids—namely, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV)—followed by specimen stability studies in the candidate transport medium system. These stability studies, performed both in cold $(2 - 8^{\circ}\mathrm{C})$ and at room temperature $(22 - 28^{\circ}\mathrm{C})$ , utilized variously aged lots (as available) of UTM-RT provided in medium tubes with and without glass beads as shown below in Table 1.

Table 1: Use of UTM-RT media lots in stability studies

| UTM-RT | Number of lots used (as available) | Lot age designation | Lot age (in months from production) at testing |
| --- | --- | --- | --- |
| With Beads | Four (4) | New | 1–4.2 |
| | Two (2) | Middle-Aged | 12.9–13.5 |
| | Nine (9) | Old / Expired | 20.3–22.7 |
| Without Beads | Three (3) | New | 0.8–1.4 |
| | Three (3) | Middle-Aged | 11.1–13.3 |
| | Three (3) | Old / Expired | 18.7–19.6 |

Further, the LoD and stability studies with the candidate device were performed in an artificial nasopharyngeal/nasal (referred to as "NPS/NS") fluid matrix. This simulated matrix was previously qualified as an appropriate matrix when used with Copan UTM/VTM since this was shown to be equivalent to clinical nasopharyngeal and anterior nasal matrices in Sample Matrix and Transport Media Equivalency studies performed to support clearance of the Cepheid Xpert Xpress CoV-2/Flu/RSV plus Assay (K231481). Therefore, the use of the same simulated matrix to support this transport medium candidate device was deemed appropriate, and the studies were designed and conducted accordingly.

As shown in the following summary Tables 2-4, the freshly performed stability tests with representative viral targets (as indicated above) demonstrated specimen stability for up to 96 hours during storage and/or transport at a temperature range of $2 - 25^{\circ}\mathrm{C}$ in UTM-RT tubes with or without glass beads. Samples were tested using a compatible, representative, FDA-cleared molecular assay (i.e., Cepheid Xpert Xpress CoV-2/Flu/RSV plus Assay in combination with GeneXpert Dx) following the molecular assay's package insert. The cycle threshold (Ct) values were used to assess performance and calculate the difference in Ct values $(\Delta \mathrm{Ct})$ at tested time

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points relative to baseline (Time 0). Results were considered acceptable if a $\Delta \mathrm{Ct} &lt; 3$ was observed. Additionally, these studies established acceptable performance of the candidate device for UTM-RT medium aged up to 18 months by incorporating lots of different ages at the time of testing.

Table 2: Overall stability data for Influenza A1/A2 virus in lots of UTM-RT per specimen storage time and temperature, all tests PASSED preset acceptance criteria $(\Delta Ct &lt; 3)$ .

| Virus | Beads | Lot age of UTM-RT at testing | UTM-RT lot | Time point | ΔCt* (average Time x - T0) at 22-28°C storage | ΔCt* (average Time x - T0) at 2-8°C storage |
| --- | --- | --- | --- | --- | --- | --- |
| Flu A1 | YES | New | 2400409 LAB | 72 hrs. | 0.6 | -0.4 |
| | | | | 96 hrs. | 0.6 | 0.4 |
| | | | 2319013 | 72 hrs. | 0.6 | -0.1 |
| | | | | 96 hrs. | 0.4 | 0.7 |
| | | | 2318982 | 72 hrs. | 0.6 | 0.5 |
| | | | | 96 hrs. | 0.8 | 0.5 |
| | | | 2317477 | 72 hrs. | 0.3 | 0.3 |
| | | | | 96 hrs. | 0.9 | 0.7 |
| | | Middle-Aged | 2301907 | 72 hrs. | -0.2 | 0 |
| | | | | 96 hrs. | 0.3 | 0.2 |
| | | | 2301790 | 72 hrs. | 0.9 | 0.5 |
| | | | | 96 hrs. | 0.9 | 0.5 |
| | | Old / Expired | 2211427 | 72 hrs. | 0.2 | 0.2 |
| | | | | 96 hrs. | 0.5 | 0.1 |
| | | | 2211110 | 72 hrs. | 0.6 | 0.1 |
| | | | | 96 hrs. | 0.5 | 0.3 |
| | | | 2207355 | 72 hrs. | 0.1 | 0.1 |
| | | | | 96 hrs. | 0.4 | 0 |
| | NO | New | B400273 | 72 hrs. | 0.9 | 0.5 |
| | | | | 96 hrs. | 0.8 | 0.8 |
| | | | B400416 | 72 hrs. | 0.7 | 0.4 |
| | | | | 96 hrs. | 0.8 | 0.6 |
| | | | B400266 | 72 hrs. | 1 | 0.5 |
| | | | | 96 hrs. | 1 | 0.8 |
| | | Middle-Aged | B300767 | 72 hrs. | 0.7 | 0.4 |
| | | | | 96 hrs. | 1.4 | 0.9 |
| | | | B302525 | 72 hrs. | 0.3 | 0 |
| | | | | 96 hrs. | 0.7 | 0.2 |
| | | | B302734 | 72 hrs. | 0.7 | 0.6 |
| | | | | 96 hrs. | 1.1 | 0.8 |
| | | Old / Expired | B203103 | 72 hrs. | 0.5 | 0.4 |
| | | | | 96 hrs. | 0.6 | 0.3 |
| | | | B203226 | 72 hrs. | 0.5 | -0.1 |
| | | | | 96 hrs. | 0.6 | 0.4 |
| | | | B203262 | 72 hrs. | 0.3 | 0.1 |
| | | | | 96 hrs. | 0.4 | 0 |
| | YES | New | | 72 hrs. | 0.5 | -0.3 |

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| Virus | Beads | Lot age of UTM-RT at testing | UTM-RT lot | Time point | ΔCt* (average Time x - T0) at 22-28°C storage | ΔCt* (average Time x - T0) at 2-8°C storage |
| --- | --- | --- | --- | --- | --- | --- |
| Flu A2 | | | 2400409 LAB | 96 hrs. | 0.4 | 0.5 |
| 2319013 | 72 hrs. | 0.4 | 0.1 |
| 96 hrs. | 0.3 | 0.6 |
| 2318982 | 72 hrs. | 0.5 | 0.7 |
| 96 hrs. | 0.6 | 0.7 |
| 2317477 | 72 hrs. | 0.2 | 0.2 |
| 96 hrs. | 0.6 | 0.7 |
| Middle-Aged | 2301907 | 72 hrs. | -0.1 | 0.1 |
| 96 hrs. | 0.3 | 0.2 |
| 2301790 | 72 hrs. | 0.7 | 0.4 |
| 96 hrs. | 0.8 | 0.5 |
| Old / Expired | 2211427 | 72 hrs. | 0.2 | 0.3 |
| 96 hrs. | 0.5 | 0.2 |
| 2211110 | 72 hrs. | 0.6 | 0.3 |
| 96 hrs. | 0.6 | 0.4 |
| 2207355 | 72 hrs. | 0.2 | 0.3 |
| 96 hrs. | 0.6 | 0.2 |
| NO | New | B400273 | 72 hrs. | 0.7 | 0.3 |
| 96 hrs. | 0.6 | 0.8 |
| B400416 | 72 hrs. | 0.5 | 0.3 |
| 96 hrs. | 0.8 | 0.7 |
| B400266 | 72 hrs. | 0.7 | 0.4 |
| 96 hrs. | 0.7 | 0.6 |
| Middle-Aged | B300767 | 72 hrs. | 0.5 | 0.4 |
| 96 hrs. | 1.1 | 0.8 |
| B302525 | 72 hrs. | 0.2 | 0.1 |
| 96 hrs. | 0.5 | 0.3 |
| B302734 | 72 hrs. | 0.6 | 0.6 |
| 96 hrs. | 1 | 0.8 |
| Old / Expired | B203103 | 72 hrs. | 0.3 | 0.4 |
| 96 hrs. | 0.5 | 0.4 |
| B203226 | 72 hrs. | 0.6 | -0.1 |
| 96 hrs. | 0.7 | 0.6 |
| B203262 | 72 hrs. | 0.3 | 0 |
| 96 hrs. | 0.3 | 0 |

Note: The average Ct value is calculated for each time point X hrs. (Time $x$ ) starting with time 0 ( $T_0$ ) and the difference ( $\Delta Ct$ ) at each Time $x$ is then estimated relative to the average Ct at $T_0$ , i.e., (Time $x - T_0$ ), as indicated by the Asterisk (*).

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Table 3: Overall stability data for Influenza B virus in lots of UTM-RT per specimen storage time and temperature, all tests PASSED preset acceptance criteria ( $\Delta Ct &lt; 3$ ).

| Virus | Beads | Lot age of UTM-RT at testing | UTM-RT lot | Time point | ΔCt* (average Time x - T₀) at 22–28°C storage | ΔCt* (average Time x - T₀) at 2–8°C storage |
| --- | --- | --- | --- | --- | --- | --- |
| Flu B | YES | New | 2400409
LAB | 72 hrs. | -1.2 | -0.8 |
| | | | | 96 hrs. | -0.5 | -0.6 |
| | | | 2319013 | 72 hrs. | 1 | -0.4 |
| | | | | 96 hrs. | 1 | 0.1 |
| | | | 2318982 | 72 hrs. | 0.4 | 0.4 |
| | | | | 96 hrs. | 1 | 0 |
| | | | 2317477 | 72 hrs. | 0.1 | -0.2 |
| | | | | 96 hrs. | 0.8 | -0.4 |
| | | Middle-Aged | 2301907 | 72 hrs. | 0 | -0.4 |
| | | | | 96 hrs. | 0 | 0.2 |
| | | | 2301790 | 72 hrs. | 0 | -0.5 |
| | | | | 96 hrs. | -0.8 | -0.4 |
| | | Old / Expired | 2211429 | 72 hrs. | 0.4 | -0.6 |
| | | | | 96 hrs. | -0.4 | -1 |
| | | | 2212455 | 72 hrs. | -0.2 | -0.8 |
| | | | | 96 hrs. | -0.1 | -1 |
| | | | 2208203 | 72 hrs. | 0.5 | 0.2 |
| | | | | 96 hrs. | 0.2 | -0.1 |
| | NO | New | B400273 | 72 hrs. | 1.1 | 0.3 |
| | | | | 96 hrs. | 1 | -0.2 |
| | | | B400416 | 72 hrs. | 0 | 0.3 |
| | | | | 96 hrs. | -0.2 | -0.1 |
| | | | B400266 | 72 hrs. | 0.8 | 0.3 |
| | | | | 96 hrs. | -0.4 | 0 |
| | | Middle-Aged | B300767 | 72 hrs. | 0.8 | -0.1 |
| | | | | 96 hrs. | 0.8 | 0.4 |
| | | | B302525 | 72 hrs. | 0.3 | -0.6 |
| | | | | 96 hrs. | 0.2 | -0.6 |
| | | | B302734 | 72 hrs. | 1 | 0.5 |
| | | | | 96 hrs. | 0 | -0.4 |
| | | Old / Expired | B203103 | 72 hrs. | 0.4 | 0 |
| | | | | 96 hrs. | 0.1 | 0.1 |
| | | | B203226 | 72 hrs. | 0.3 | -0.1 |
| | | | | 96 hrs. | -0.8 | -0.5 |
| | | | B203262 | 72 hrs. | 1.1 | 0.1 |
| | | | | 96 hrs. | 0.1 | -0.3 |

Note: The average Ct value is calculated for each time point X hrs. (Time x) starting with time 0 (T₀) and the difference (ΔCt) at each Time x is then estimated relative to the average Ct at T₀, i.e., (Time x - T₀), as indicated by the Asterisk (*).

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Table 4: Overall stability data for Respiratory Syncytial virus (RSV) in lots of UTM-RT per specimen storage time and temperature, all tests PASSED preset acceptance criteria ( $\Delta Ct &lt; 3$ ).

| Virus | Beads | Lot age of UTM-RT at testing | UTM-RT lot | Time point | ΔCt* (average Time x - T0) at 22-28°C storage | ΔCt* (average Time x - T0) at 2-8°C storage |
| --- | --- | --- | --- | --- | --- | --- |
| RSV | YES | New | 2400409 LAB | 72 hrs. | 0.2 | -0.1 |
| | | | | 96 hrs. | 0.2 | -0.4 |
| | | | 2319013 | 72 hrs. | 0.4 | 0.2 |
| | | | | 96 hrs. | 0.1 | 0.2 |
| | | | 2318982 | 72 hrs. | -0.3 | 0 |
| | | | | 96 hrs. | 0.1 | -0.2 |
| | | | 2317477 | 72 hrs. | 0.5 | 0.3 |
| | | | | 96 hrs. | 0.6 | 0.2 |
| | | Middle-Aged | 2301907 | 72 hrs. | 0.4 | 0.4 |
| | | | | 96 hrs. | 0.4 | 0.4 |
| | | | 2301790 | 72 hrs. | -0.1 | 0 |
| | | | | 96 hrs. | 0.1 | -0.3 |
| | | Old / Expired | 2211426 | 72 hrs. | 0.6 | 0.1 |
| | | | | 96 hrs. | 0.5 | 0.2 |
| | | | 2212454 | 72 hrs. | 0.4 | 0.1 |
| | | | | 96 hrs. | 0.2 | 0.1 |
| | | | 2208079 | 72 hrs. | 0.2 | 0 |
| | | | | 96 hrs. | -0.1 | -0.3 |
| | NO | New | B400273 | 72 hrs. | -0.2 | 0 |
| | | | | 96 hrs. | 0.2 | -0.2 |
| | | | B400416 | 72 hrs. | -0.2 | 0 |
| | | | | 96 hrs. | 0 | -0.3 |
| | | | B400266 | 72 hrs. | 0.1 | 0.1 |
| | | | | 96 hrs. | 0.2 | 0 |
| | | Middle-Aged | B300767 | 72 hrs. | -0.1 | 0 |
| | | | | 96 hrs. | -0.1 | 0 |
| | | | B302525 | 72 hrs. | 0.3 | -0.1 |
| | | | | 96 hrs. | 0.5 | 0.4 |
| | | | B302734 | 72 hrs. | -0.1 | 0.3 |
| | | | | 96 hrs. | 0 | 0.1 |
| | | Old / Expired | B203103 | 72 hrs. | -0.2 | -0.3 |
| | | | | 96 hrs. | -0.1 | -0.2 |
| | | | B203226 | 72 hrs. | 0.9 | 1.1 |
| | | | | 96 hrs. | 1.1 | 1 |
| B203262 | | | 72 hrs. | 0.2 | 0.1 | |
| | | | 96 hrs. | 0.4 | 0.4 | |

Note: The average Ct value is calculated for each time point X hrs. (Time $x$ ) starting with time 0 ( $T_0$ ) and the difference ( $\Delta Ct$ ) at each Time $x$ is then estimated relative to the average Ct at $T_0$ , i.e., (Time $x - T_0$ ), as indicated by the Asterisk (*).

Of note, the performance parameters established in these studies pertain exclusively to the newly introduced claim of stability of respiratory viral nucleic acids in the candidate medium

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for subsequent testing in a compatible molecular assay. Especially, frozen storage of specimens in UTM-RT at or below $-70^{\circ}\mathrm{C}$ for testing with a molecular assay has not been validated and is not recommended. However, it is acceptable to store specimens in UTM-RT at or below $-70^{\circ}\mathrm{C}$ for subsequent processing using virus, chlamydiae, mycoplasma, and ureaplasma culture, as was previously cleared (K042970). This distinction is noted in device labeling.

## B Comparison Studies:

Method Comparison with Predicate Device; Matrix Comparison:

Not Applicable

## C Clinical Studies:

Clinical Sensitivity; Clinical Specificity; Other Clinical Supportive Data (if applicable):

Not Applicable

## D Clinical Cut-Off:

Not Applicable

## E Expected Values/Reference Range:

Not Applicable

## VIII Proposed Labeling:

The provided labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a decision of substantial equivalence.

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