Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard molecular diagnostic techniques (PCR, lateral flow) and automated processes, with no mention of AI or ML.

Therapeutic

No

The device is described as an "in vitro diagnostic test" intended to "aid in the diagnosis of RSV infection" by detecting viral RNA. It does not provide treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the Accula RSV Test is a "molecular in vitro diagnostic test" and is "intended as an aid in the diagnosis of RSV infection".

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of a reusable Dock (hardware) and a single-use disposable test cassette (hardware/reagents), in addition to the automated testing process. This indicates it is a hardware-based system with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Accula RSV Test is a "molecular in vitro diagnostic test."
Purpose: The test is designed to detect RSV viral RNA in a nasal swab specimen to aid in the diagnosis of RSV infection. This is a diagnostic purpose performed outside of the body (in vitro).
Device Description: The description details a system that performs nucleic acid amplification and detection using reagents and a disposable test cassette, which are characteristic components of in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Accula RSV Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Accula RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude RSV virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Product codes (comma separated list FDA assigned to the subject device)

OCC

Device Description

The Accula RSV Test is a semi-automated, colorimetric, multiplex reverse-transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect respiratory syncytial virus (RSV) viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, a novel Mesa Biotech PCR nucleic acid amplification technology named OscARTM, and hybridization-based visual detection into a completely self-contained and automated system. The Accula RSV system consists of a small reusable Dock to drive the automated testing process, and a single-use disposable test cassette that contains all the enzymes and reagents.

The Accula RSV Test Kit contains all the materials needed to run a test, except for the Accula Dock, which is provided separately. The Accula RSV Test Kit contains the following components.

Puritan Rayon Swabs for nasal swab collection (25) ●
Accula Nasal Swab Buffer (25)
Accula Transfer Pipettes (25)
Accula RSV Test Cassettes (25)
RSV Positive Control Swab (1)
Negative Control Swab (1)
Instructions for Use
Quick Reference Guide

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal swabs

Indicated Patient Age Range

children and adults

Intended User / Care Setting

Clinical lab and point of care

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A total of 749 subjects were enrolled in this study. Of those, 55 specimens are unevaluable (i.e. failed to meet inclusion/exclusion criteria, were not transported to the reference laboratory per the conditions required by the clinical protocol, had an invalid result for the comparative method, or had two invalid results on the Accula RSV Test. A total of 694 specimens were considered evaluable. The performance of the Accula RSV Test for RSV as compared to a FDA-cleared molecular comparator is presented in the table below.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Prospective Clinical Study:

Study Type: Multi-site prospective study
Sample Size: 694 evaluable specimens from 749 enrolled subjects.
Two nasal swabs were collected per subject. One was tested with the Accula RSV Test, and the other was transported for testing using a comparator method (FDA-cleared molecular RSV assay). Discrepant results were analyzed using an alternative FDA-cleared molecular assay.
Key Results:
| Accula RSV Test | | Comparator | Positive | Negative | Total |
|---|---|---|---|---|---|
| Positive | | | 129 | 24ª | 153 |
| Negative | | | 14ᵇ | 527 | 541 |
| Total | | | 143 | 551 | 694 |
ª RSV was detected in 22/24 False Positives specimens using an alternative FDA-cleared molecular RSV assay.
ᵇ RSV was not detected in 12/14 False Negative specimens using an alternative FDA-cleared molecular RSV assay.

Reproducibility Studies:

Study Type: Reproducibility study with contrived nasal swabs at three CLIA-waived sites and one moderately complex site.
Sample Size: Each sample type (RSV Negative, RSV Low Positive, RSV Moderate Positive) had 30 observations per site (2 operators x 1 run x 3 swabs x 5 non-consecutive days) for a total of 120 (Low Pos RSV), 121 (Mod Pos RSV), and 119 (True Neg) across all sites.
Key Results: Agreement was 100% across all sites, operators, and days. No significant differences observed within run, between sites, or between operators.
Percent Agreement and 95% CI:
- Low Pos RSV: 100% (120/120) (95.9%, 100%)
- Mod Pos RSV: 100% (121/121) (96.0%, 100%)
- True Neg: 100% (119/119) (95.9%, 100%)

Limit of Detection (LoD):

Study Type: Determination of LoD.
Sample Size: Two RSV A subtype strains and two RSV B subtype strains were tested in 20 replicates for each concentration.
Key Results:
- RSV A2 (300 TCID50/mL): 20/20 positive
- RSV A Long (300 TCID50/mL): 20/20 positive
- RSV B1 (10 TCID50/mL): 20/20 positive
- RSV B 18537 (0.5 PFU/mL): 19/20 positive (LoD defined as 19/20 positive).

Analytical Reactivity (Inclusivity):

Study Type: Inclusivity verification.
Sample Size: Nine RSV strains (RSV-A and RSV-B subtypes) tested in triplicate.
Key Results: All strains showed 100% detection (3/3 positive) at approximately 2X LoD concentration.

Analytical Specificity (Cross-Reactivity):

Study Type: Cross-reactivity testing.
Sample Size: 41 potentially cross-reacting organisms tested in triplicate.
Key Results: All 41 organisms were negative (0/3 positive) at the concentrations tested, indicating no cross-reactivity.

Interfering Substances:

Study Type: Assessment of potential interfering substances.
Sample Size: Two RSV strains tested in triplicate with each interfering substance at "worst case" concentrations.
Key Results: The Accula RSV Test performance was not negatively affected by the potentially interfering substances tested, with 100% agreement with expected results for all samples (negative controls and RSV-spiked samples).

CLIA Waiver Studies:

Study Type: Evaluation of performance at ten intended use sites by non-laboratory personnel. This study reiterates the prospective clinical study findings for CLIA waiver.
Sample Size: 694 evaluable specimens.
Key Results: Same as the Prospective Clinical Study, demonstrating performance in a CLIA-waived setting.

Performance Near the Cut-off:

Study Type: Study to demonstrate consistent detection of Low Positive samples at LoD by untrained intended users.
Sample Size: Each site tested 60 samples (30 replicates of RSV Low Positive and 30 replicates of True Negative). Total 90 from 3 sites.
Key Results: Untrained users accurately performed and interpreted the test at the LoD level.
- RSV Positive: 90/90
- RSV Negative: 90/90

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: 90.2% (95% CI: 84.2% - 94.1%)
Specificity: 95.6% (95% CI: 93.6% - 97.1%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161375

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.

(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Summary

0

510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K181443

1.	Sponsor/Applicant Name and Address
	Company Name:	Mesa Biotech, Inc.
	Address:	6190 Cornerstone Court, Suite 220
		San Diego, CA 92121
	Telephone:	858-800-4929
	Contact Person:	Barbara Stevens
		Regulatory Consultant
	Date Summary Prepared:	05/25/2018
2.	Device Name and Classification
	Trade Name:	Accula RSV Test
	Classification of Device:	21 CFR 866.3980, Respiratory viral
panel multiplex nucleic acid assay
	Product Code	OCC

3. Predicate Device

K161375, Alere i RSV Assay

4. Device Description

Operating Principle

The Accula RSV Test is a semi-automated, colorimetric, multiplex reverse-transcription polymerase chain reaction (RT-PCR) nucleic acid amplification test to qualitatively detect respiratory syncytial virus (RSV) viral RNA from unprocessed nasal swabs that have not undergone prior nucleic acid extraction. The system integrates nucleic acid extraction, reverse transcription, a novel Mesa Biotech PCR nucleic acid amplification technology named OscARTM, and hybridization-based visual detection into a completely self-contained and automated system. The Accula RSV system consists of a small reusable Dock to drive the automated testing process, and a single-use disposable test cassette that contains all the enzymes and reagents.

1

RSV Kit Contents

The Accula RSV Test Kit contains all the materials needed to run a test, except for the Accula Dock, which is provided separately. The Accula RSV Test Kit contains the following components.

Puritan Rayon Swabs for nasal swab collection (25) ●
Accula Nasal Swab Buffer (25)
Accula Transfer Pipettes (25)
Accula RSV Test Cassettes (25)
RSV Positive Control Swab (1)
Negative Control Swab (1)
Instructions for Use
Quick Reference Guide

Indications for Use 5.

The Accula RSV Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA. The Accula RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude RSV virus infection and should not be used as the sole basis for treatment or other patient management decisions.

6. Comparison to Predicate Device

The following table provides a comparison of the characteristics of the Accula RSV Test to the predicate device, the Alere i RSV assay.

| Item | 510(k) Device:
Mesa Biotech
Accula RSV Test | Predicate Device:
Alere i RSV
(K161375) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Accula RSV Test
performed on the Accula Dock
is a molecular in vitro
diagnostic test utilizing
polymerase chain reaction
(PCR) and lateral flow
technologies for the
qualitative, visual detection of
respiratory syncytial virus
(RSV) viral RNA. The Accula
RSV Test uses a nasal swab
specimen collected from | The Alere i RSV assay
performed on the Alere i
Instrument is a rapid,
molecular, in vitro diagnostic
test utilizing an isothermal
nucleic acid amplification
technology for the qualitative
detection of respiratory
syncytial virus (RSV) viral
RNA in direct nasopharyngeal
swabs and nasopharyngeal
swabs eluted in viral transport |
| | patients with signs and
symptoms of respiratory
infection. The Accula RSV
Test is intended as an aid in the
diagnosis of RSV infection in
children and adults in
conjunction with clinical and
epidemiological risk factors.
Negative results do not
preclude RSV virus infection
and should not be used as the
sole basis for treatment or
other patient management
decisions. | media from patients with signs
and symptoms of respiratory
infection. It is intended for use
as an aid in the diagnosis of
RSV in children 60 years in
conjunction with clinical and
epidemiological risk factors. |
| Assay Targets | Respiratory syncytial virus | Respiratory syncytial virus |
| Sample Type | Nasal swab | Nasopharyngeal swab |
| Assay Results | Qualitative | Qualitative |
| Intended Users and
Use Locations | Clinical lab and point of care | Clinical lab and point of care |
| Nucleic Acid
Purification | No | No |
| RSV Target | L viral polymerase gene | NS2 gene and nucleocapsid
gene N |
| Internal Control | Yes | Yes |
| Positive and
Negative Control
Swabs | Yes | Yes |
| Assay Technology | PCR amplification and visual
identification of amplification
products by hybridization to a
test strip. | Isothermal nucleic acid
amplification and detection of
specific amplification products
using molecular beacon probes |
| Detection | Multiplex assay using dyed
microparticle conjugates to
specifically detect and identify
amplification reaction
products. | Multiplex assay using
fluorescently-labeled
molecular beacons to
specifically identify amplified
RNA targets. |
| | Visual interpretation of the
presence or the absence of
colored lines on a test strip. | Optical detection of
fluorescence |
| Instrument | Amplification controlled by
the Accula Dock.
No detection by the
instrument. | Amplification and detection
performed on the Alere i
instrument |

2

3

Performance Summary 7.

Expected Values

The prevalence of respiratory syncytial virus (RSV) varies from year to year, with outbreaks occurring during the fall and winter months. The RSV positivity rate is dependent upon many factors, including specimen collection, test method, and geographic location. Prevalence varies throughout the RSV season and from location to location.

The Accula RSV prospective clinical study was conducted during the 2017-2018 RSV season. The following table shows the prevalence of RSV observed in three subject age categories.

	Prospective Clinical Study during the 2017/2018 RSV Season
Age Group	Number of Nasal
Swab Specimens	Number of RSV
Positives	RSV Positivity Rate
≤ 5 Years of Age	371	134	36.1%
6 to 18 Years of Age	134	9	6.7%
≥ 19 Years of Age	189	10	5.3%
Total	694	153	22.0%

Prospective Clinical Study: Accula™ RSV Test vs. a FDA-Cleared Molecular RSV Assav:

Clinical performance characteristics of the Accula RSV Test were evaluated in a multi-site prospective study during the 2017-2018 RSV seasons in the U.S. A total of ten investigational sites participated in the study. To be enrolled in the study, patients had to be presenting at the participating study centers with RSV-like symptoms. Two nasal swabs were collected, one from each nostril, from each subject using standard collection methods. One nasal swab was eluted in 5 mL of Accula Nasal Swab Buffer and tested with the Accula RSV Test according to the product instructions. The other nasal swab was eluted with 3 mL universal transport media (UTM) and transported to a central reference laboratory for testing using the comparator method. All discrepant results were analyzed using an alternative FDA-cleared molecular assay at the reference laboratory.

4

A total of 749 subjects were enrolled in this study. Of those, 55 specimens are unevaluable (i.e. failed to meet inclusion/exclusion criteria, were not transported to the reference laboratory per the conditions required by the clinical protocol, had an invalid result for the comparative method, or had two invalid results on the Accula RSV Test. A total of 694 specimens were considered evaluable. The performance of the Accula RSV Test for RSV as compared to a FDA-cleared molecular comparator is presented in the table below.

| Accula RSV

Test	Comparator	Positive	Negative	Total
Positive		129	24a	153
Negative		14b	527	541
Total		143	551	694
Sensitivity:	90.2% (95% CI: 84.2% - 94.1%)
Specificity:	95.6% (95% CI: 93.6% - 97.1%)

Accula RSV Test Performance Compared to FDA-cleared Molecular Comparator

ª RSV was detected in 22/24 False Positives specimens using an alternative FDA-cleared molecular RSV assay

b RSV was not detected in 12/14 False Negative specimens using an alternative FDA-cleared molecular RSV assay

Reproducibility Studies

The reproducibility study was performed to demonstrate the reproducibility of the Accula RSV Test with contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United States. The objective of the study was to demonstrate reproducibility of the assay in the hands of multiple users at multiple sites over multiple non-consecutive days.

The test panel consisted of three samples at varying virus concentrations (i.e. RSV Negative, RSV Low Positive, and RSV Moderate Positive). Each positive sample was prepared by spiking the RSV-A2 strain into clinical matrix. The targeted concentration for the Moderate Positive sample was approximately 3X the LoD, and the targeted concentration for the Low Positive sample was approximately 1X the LoD (C95 concentration). The Negative sample contained no RSV virus.

Samples were provided to testing operators in panels of 3 samples (RSV Low Positive, RSV Moderate Positive, and Negative). Samples were blinded and randomized. Each operator tested one panel per day, testing a maximum of three samples at a time. Each sample was tested in triplicate (from separate swabs): 2 operators x 1 run x 3 swabs x 5 non-consecutive days = 30 observations for each site per sample type. Results are reported as percent agreement: actual result/expected result x 100. Agreement was 100% across all sites, operators, and days. There were no significant differences observed within run, between sites, or between operators. Agreement by site is shown in the table below.

5

	Site
Sample
Category	ADP		GVP		LBC		NAZ		Overall Percent
Agreement and
95% CI
	Percen
t
Agree
ment	Coun
t	Percent
Agreeme
nt	Coun
t	Percent
Agreeme
nt	Count	Percent
Agreeme
nt	Coun
t
Low Pos
RSV	100%	30/30	100%	30/30	100%	30/30	100%	30/30	100%
(120/120)
(95.9%, 100%)
Mod Pos
RSV	100%	30/30	100%	30/30	100%	31/31*	100%	30/30	100%
(121/121)
(96.0%, 100%)
True Neg	100%	30/30	100%	30/30	100%	29/29*	100%	30/30	100%
(119/119)
(95.9%, 100%)
* One negative swab was mistakenly spiked with MP RSV

Site to Site Reproducibility: Percent Agreement and Total Counts (Observed/Expected)

Limit of Detection

Multiple analyte levels were tested in 20 replicates until the LoD was determined (the level at which at least 19/20 results are positive). Two RSV A subtype strains and two RSV B subtype strains were tested in replicates of twenty (20) for each concentration. Virus was serially diluted into a pooled negative clinical matrix and spiked onto a swab to create the contrived samples for each technical replicate for LoD determination.

Results are summarized in the table below.

Limit of Detection: Observed Positives/Number of Replicates

Virus	LOD level	Observed Positives/ Replicates
RSV A2	300 TCID50/mL	20/20
RSV A Long	300 TCID50/mL	20/20
RSV B1	10 TCID50/mL	20/20
RSV B 18537	0.5 PFU/mL	19/20

Analytical Reactivity

Inclusivity verification was evaluated for the Accula RSV test at Mesa Biotech. The panel consisted of nine (9) RSV strains, representing both RSV-A and RSV-B subtypes. Each strain was tested in triplicate at a concentration of approximately 2X LoD. Virus was diluted in pooled clinical matrix and spiked onto a swab to create contrived swab samples. Test results are shown in the table below.

| Identification Code | Subtype | Test Level * | Percent Detection
(# Positive / 3) |
|---------------------|---------|---------------|---------------------------------------|
| RSV 2012-10 | RSV-B | 1 PFU/mL | 100% (3/3) |
| RSV 2012-11 | RSV-B | 1 PFU/mL | 100% (3/3) |
| RSV A 12/2014 | RSV-A | 600 TCID50/mL | 100% (3/3) |
| RSV A 3/2015 | RSV-A | 600 TCID50/mL | 100% (3/3) |

Inclusivity Results by RSV Strain: Target Conceptrations and Test Results

6

| Identification Code | Subtype | Test Level * | Percent Detection
(# Positive / 3) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|---------------------------------------|
| RSV B 12/2014 | RSV-B | 20 TCID50/mL | 100% (3/3) |
| RSV 2006 Isolate | RSV-A | 600 TCID50/mL | 100% (3/3) |
| RSV CH93(18)-18 | RSV-B | 20 TCID50/mL | 100% (3/3) |
| RSV 9320 | RSV-B | 20 TCID50/mL | 100% (3/3) |
| RSV B 3/2015 | RSV-B | 20 TCID50/mL | 100% (3/3) |
| * Concentration of contrived sample after 10uL of virus dilution Spiked onto Swab and Swirled in 5mL
pooled clinical matrix assuming 100% viral elution recovery. | | | |

Analytical Specificity (Cross-Reactivity)

Cross-reactivity was performed by testing 41 potentially cross-reacting organisms with the Accula RSV Test. Each organism was diluted in a clinical matrix and tested in triplicate. The organisms, concentrations, and test results are shown in the table below. All 41 organisms were negative at the concentrations tested.

| Organism
Key # | Organism Name RSV Pos / 3) |
|-------------------|----------------- | 1 | Adenovirus Type 1 | 2 | Adenovirus Type 7 | 3 | Coronavirus | 4 | Coronavirus | 5 | Cytomegalovirus | 6 | Cytomegalovirus | 7 | Cytomegalovirus | 8 | Echovirus | 9 | Enterovirus | 10 | Human Metapneumovirus | 11 | Measles virus | 12 | Mumps virus | 13 | Parainfluenza Type 1 | 14 | Parainfluenza Type 2 | 15 | Parainfluenza Type 3 | 16 | Rhinovirus | 17 | Rhinovirus | 18 | Rhinovirus | 19 | Epstein-Barr virus | 20 | Bordetella pertussis | 21 | Candida albicans | 22 | Escherichia coli | 23 | Haemophilus influenzae | 24 | Klebsiella pneumoniae | 25 | Lactobacillus sp. | 26 | Legionella longbeachae | 27 | Moraxella catarrhalis | 28 | Mycobacterium | Test Level | Test Results (# of
-----------|--------------------|------------------------------------|
| 5.10E+05 TCID50/mL | 0/3 |
| 3.31E+04 TCID50/mL | 0/3 |
| 1.10E+04 TCID50/mL | 0/3 |
| 2.95E+05 TCID50/mL | 0/3 |
| 1.10E+04 TCID50/mL | 0/3 |
| 1.90E+04 TCID50/mL | 0/3 |
| 2.52E+04 TCID50/mL | 0/3 |
| 2.95E+05 TCID50/mL | 0/3 |
| 1.04E+04 TCID50/mL | 0/3 |
| 1.01E+04 TCID50/mL | 0/3 |
| 2.95E+05 TCID50/mL | 0/3 |
| 9.75E+04 TCID50/mL | 0/3 |
| 2.52E+04 TCID50/mL | 0/3* |
| 1.10E+04 TCID50/mL | 0/3 |
| 1.18E+04 TCID50/mL | 0/3 |
| 3.31E+04 TCID50/mL | 0/3 |
| 3.31E+04 TCID50/mL | 0/3 |
| 3.02E+04 TCID50/mL | 0/3 |
| 3.98E+07 cp/mL | 0/3 |
| 4.22E+06 cfu/ml | 0/3 |
| 9.80E+05 cfu/ml | 0/3 |
| 1.92E+07 cfu/ml | 0/3 |
| 1.20E+06 cfu/ml | 0/3 |
| 4.15E+07 cfu/ml | 0/3 |
| 3.00E+06 cfu/ml | 0/3 |
| 9.65E+06 cfu/ml | 0/3 |
| 1.99E+05 cfu/ml | 0/3 |
tuberculosis | 3.62E+06 cfu/ml | 0/3 |

7

Test Results of Possible Cross-Reactive Organisms
Organism
Key #	Organism Name	Test Level	Test Results (# of
RSV Pos / 3)
29	Neisseria gonorrhoeae	6.30E+06 cfu/ml	0/3
30	Neisseria meningitidis	1.28E+06 cfu/ml	0/3
31	Neisseria subflava	7.30E+06 cfu/ml	0/3
32	Proteus vulgaris	2.07E+07 cfu/ml	0/3
33	Pseudomonas aeruginosa	6.05E+05 cfu/ml	0/3
34	Staphylococcus aureus	6.95E+07 cfu/ml	0/3
35	Staphylococcus epidermidis	3.24E+07 cfu/ml	0/3
36	Streptococcus pneumonia	2.09E+06 cfu/ml	0/3
37	Streptococcus pyogenes	2.72E+07 cfu/ml	0/3
38	Streptococcus salivarius	2.32E+06 cfu/ml	0/3
39	Mycoplasma pneumoniae	2.81E+05 CCU/ml	0/3
40	Influenza A/California/07/2009	2.15E+04 TCID50/mL	0/3
41	Influenza
B/Massachusetts/2/2012	5.00E+05 TCID50/mL	0/3
*Replicate 3 of Organism # 13 Parainfluenza Type 1 was repeated due to an Invalid.

Interfering Substances

To assess substances with the potential to interfere with the performance of the Accula RSV Test, two (2) RSV strains were tested in replicates of three (3) with each interfering substance at the "worst case" concentration. For each sample, virus was diluted into a pooled negative clinical matrix to achieve a 1.5X LoD concentration. Each RSV strain was tested with an interferent concentration representing the highest concentration likely to be found in a respiratory sample. Additionally, each strain was tested without the interfering substance as a control. Potential interferents, their concentrations, samples tested, and test results are summarized in the table below. The Accula RSV Test performance is not negatively affected by the potentially interfering substances tested.

Interfering Substances - Agreement of Observed/Expected
Potential Interferent	Interferent
Concentration for
Making Contrived
Swab	Sample Tested	% Agreement with
Expected Results
Controls	NA	Negative	100% (2/2)
	NA	RSV A2 at 450 TCID50/ml	100% (3/3)
	NA	RSV B1 at 15 TCID50/mL	100% (3/3)
Blood (Human)	1% (v/v)	Negative	100% (3/3)
	1% (v/v)	RSV A2 at 450 TCID50/ml	100% (3/3)
	1% (v/v)	RSV B1 at 15 TCID50/mL	100% (3/3)
Phenylephrine nasal spray	Neat	Negative	100% (3/3)
	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
	Neat	RSV B1 at 15 TCID50/mL	100% (3/3)
Oxymetazoline nasal
spray	Neat	Negative	100% (3/3)
	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
Interfering Substances - Agreement of Observed/Expected
Potential Interferent	Interferent
Concentration for
Making Contrived
Swab	Sample Tested	% Agreement with
Expected Results
	Neat	RSV B1 at 15 TCID50/mL	100% (3/3)
	Neat	Negative	100% (3/3)
Ocean Saline Nasal Spray	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
	Neat	RSV B1 at 15 TCID50/mL	100% (3/3)
	Neat	Negative	100% (3/3)
Chloraseptic Max	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
	Neat	RSV B1 at 15 TCID50/mL	100% (3/3)
	Neat	Negative	100% (3/3)
Nasacort (Triamcinolone,
nasal corticosteroid)	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
	Neat	RSV B1 at 15 TCID50/mL	100% (3/3)
Zicam (Nasal gel,	Neat	Negative	100% (3/3) *
homeopathic allergy relief	Neat	RSV A2 at 450 TCID50/ml	100% (3/3)
medicine)	Neat	RSV B1 at 15 TCID50/mL	100% (3/3) **
	1 lozenge/5mL	Negative	100% (3/3)
Cepacol (throat lozenge)	1 lozenge/5mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	1 lozenge/5mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	5 mg/mL	Negative	100% (3/3)
Mucin, Type II	5 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	5 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	1.6 mg/mL	Negative	100% (3/3)
Beclomethasone	1.6 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	1.6 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	3.2 mg/mL	Negative	100% (3/3)
Budesonide	3.2 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	3.2 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	30 mg/mL	Negative	100% (3/3)
Dexamethasone	30 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	30 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3) *
	1.6 mg/mL	Negative	100% (3/3)
Flunisolide	1.6 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	1.6 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
Fluticasone Propionate	0.25 mg/mL	Negative	100% (3/3)
	0.25 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	0.25 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	1 mg/mL	Negative	100% (3/3)
Mometasone furoate	1 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	1 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
	20 mg/mL	Negative	100% (3/3)
Mupirocin (antibiotic)	20 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
Interfering Substances - Agreement of Observed/Expected
Potential Interferent	Interferent
Concentration for
Making Contrived
Swab	Sample Tested	% Agreement with
Expected Results
	20 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
Tobramycin
(antibacterial)	75 mg/mL	Negative	100% (3/3)
	75 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	75 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
Triamcinolone	0.05 mg/mL	Negative	100% (3/3)
	0.05 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3) *
	0.05 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
Zanamivir (anti-viral
drug)	50 mg/mL	Negative	100% (3/3) *
	50 mg/mL	RSV A2 at 450 TCID50/ml	100% (3/3)
	50 mg/mL	RSV B1 at 15 TCID50/mL	100% (3/3)
*One replicate was repeated due to an invalid result
** Two replicates were repeated due to invalid results

8

9

CLIA Waiver Studies

The performance of the Accula RSV Test was evaluated at ten intended use sites by nonlaboratory personnel in a prospective clinical study during the 2017-2018 RSV season in the U.S. Nasal swabs were collected from patients with RSV-like symptoms and were tested with the Accula RSV Test and the comparator method, a FDA-cleared molecular RSV assay. All specimens generating discrepant results were investigated by testing with an alternative FDAcleared molecular assay. The performance of the Accula RSV test compared with the comparator method is presented in the table below.

Accula RSV Test Performance Compared to FDA-cleared Molecular Comparator

| Accula RSV

Test	Comparator	Positive	Negative
Positive	129	24a	153
Negative	14b	527	541
Total	143	551	694
Sensitivity:	90.2% (95% CI: 84.2% - 94.1%)
Specificity:	95.6% (95% CI: 93.6% - 97.1%)

ª RSV was detected in 22/24 False Positives specimens using an alternative FDA-cleared molecular RSV assay

b RSV was not detected in 12/14 False Negative specimens using an alternative FDA-cleared molecular RSV assay

Performance Near the Cut-off

Three CLIA-waived sites that participated in the prospective clinical study also participated in the Near-Cutoff study. The testing was performed by three (3) untrained intended operators at each of the sites. This study was conducted to demonstrate that untrained intended users could

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perform the Accula RSV Test and consistently detect Low Positive samples at the Limit of Detection (LoD).

The test panel consisted of two contrived samples: RSV Low Positive and a True Negative. The Low Positive sample was prepared using the RSV-A2 strain spiked into negative clinical matrix at a concentration of approximately 1X LoD (C95 concentration). The Negative sample was prepared from negative clinical matrix with no RSV virus. Samples were applied to swabs, coded and blinded to the testing operators. Swab specimens were presented to the intended use operators throughout the course of a normal working day and were masked as subject samples. Testing took place during the course of two weeks on non-consecutive days, while the clinical study was in progress. Each site ultimately tested a panel of 60 samples: 30 replicates of each sample.

Test results are shown in the table below. The study demonstrates that untrained use operators are able to accurately perform and interpret the Accula RSV Test at the level of the LoD.

Site	Sample Type
	RSV Positive	RSV Negative
ADP	30/30	30/30
GVP	30/30	30/30
LBC	30/30	30/30
Total	90/90	90/90

Near-Cutoff Study Test Results: Agreement of Observed/Expected

Conclusion 8.

The information presented in this Premarket Notification demonstrates that the performance of the Accula RSV Test is substantially equivalent in intended use, technological characteristics, and performance to the predicate device.

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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November 23, 2018

Image /page/12/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

Mesa Biotech, Inc. Barbara Stevens Regulatory Consultant 6190 Cornerstone Court, Suite 220 San Diego, CA 92121

Re: K181443

Trade/Device Name: Accula RSV Test Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OCC Dated: May 25, 2018 Received: May 31, 2018

Dear Barbara Stevens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

13

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure