The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

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

Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Focus Diagnostics' Simplexa™ Flu A/B & RSV Positive Control Pack is intended to be used as a control with the Simplexa™ Flu A/B & RSV Direct kit. This control is not intended for use with other assays or systems.

Device Description

The Simplexa™ Flu A/B & RSV Direct assay system is a real-time RT-PCR system that enables the direct amplification, delection and differentiation of human influenza A (Flu A) virus RNA, human influenza B (Flu B) virus RNA and RSV RNA from unprocessed nasopharyngeal swabs that have not undergone nucleic acid extraction. The system consists of the Simplexa™ Flu A/B & RSV Direct assay, the 3M Integrated Cycler (with Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories.

In the Simplexa™ Flu A/B & RSV Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify Flu A, Flu B, RSV and internal control RNA. The assay provides three results; conserved regions of influenza A viruses (matrix gene) influenza B viruses (matrix gene) and RSV (M gene) are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition.

The 3M Integrated Cycler is a rapid real-time Polymerase Chain Reaction thermocycler used for the identification of nucleic acid from prepared biological samples. The instrument utilizes disk media to contain and to process samples. The instrument uses real time flourometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Simplexa™ Flu A/B & RSV Direct assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, the reported performance data from the clinical studies serve as the basis for demonstrating the device's acceptable performance. For clarity, I've listed the reported performance as if those were the implicit acceptance targets for the study.

Target	Acceptance Criteria (Implicit from Reported Performance)	Reported Device Performance (Prospective Study)	Reported Device Performance (Retrospective Study)
Influenza A
Sensitivity	≥ 89.9%	97.1% (66/68)	96.2% (76/79) (PPA)
Specificity	≥ 96.4%	97.9% (639/653)	99.3% (143/144) (NPA)
Influenza B
Sensitivity	≥ 84.5%	100.0% (21/21)	97.6% (40/41) (PPA)
Specificity	≥ 99.2%	99.9% (697/698)	100.0% (182/182) (NPA)
RSV
Sensitivity (Combined)	≥ 20.7% (Site 1), ≥ 92.6% (Site 2), ≥ 59.6% (Site 3)	Site 1: 100.0% (1/1); Site 2: 98.6% (72/73); Site 3: 90.0% (9/10)	100.0% (12/12) (PPA)
Specificity (Combined)	≥ 96.1% (Site 1), ≥ 84.1% (Site 2), ≥ 77.5% (Site 3)	Site 1: 98.2% (323/329); Site 2: 89.5% (154/172); Site 3: 84.6% (115/136)	98.6% (208/211) (NPA)
Invalid Rate	< 1.2%	0.4% (3/722)	Not reported for retrospective study

Analytical Performance (Implicit acceptance criteria based on predicate device or general standards for molecular diagnostics):

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Limit of Detection (LoD)	Generally defined as ≥ 95% detection	Ranges from 0.005 TCID50/mL to 20 TCID50/mL depending on viral strain
Reproducibility (%CV)	Low variability, typically <5% (based on predicate)	Flu A: 0.4 to 1.5%; Flu B: 0.5 to 3.6%; RSV: 1.2 to 3.3%
Analytical Reactivity	All tested strains appropriately detected	All viral strains tested were appropriately detected
Cross-Reactivity	No cross-reactivity with closely related organisms, common pathogens, or normal flora	No cross-reactivity detected for Flu A, Flu B, or RSV
Interference	No evidence of interference from common substances in nasopharyngeal swabs	No evidence of interference caused by the substances tested
Inhibition by Other Microorganisms	No inhibitory effects	No inhibitory effects were confirmed for influenza A, influenza B, or RSV
Carry-over Contamination	No carry-over effect	No carry-over contamination effect was seen

2. Sample Size Used for the Test Set and Data Provenance

Prospective Study Test Set:
- Sample Size: 722 nasopharyngeal swabs.
- Data Provenance:
  - Country of Origin: Eastern United States, Mid-Western United States, and Australia.
  - Retrospective or Prospective: Prospective. Samples were collected from 10-Nov-2010 to 11-Mar-2011 (Eastern/Mid-Western US) and 17-Aug-2010 to 20-Oct-2010 (Australia).
Retrospective Study Test Set:
- Sample Size: 223 nasopharyngeal swabs.
- Data Provenance: "Retrospectively banked specimens from patients with signs and symptoms of viral respiratory tract infection." Specific country of origin is not detailed beyond "Three external testing sites." These were banked samples, implying retrospective use for this specific study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify an "expert" group to establish ground truth in the traditional sense of medical image or diagnostic interpretation. Instead, the ground truth was established by culture results.

Number of "Experts": Not applicable as ground truth was established by laboratory culture.
Qualifications of Those Experts: Not applicable. The "experts" were the laboratory processes and personnel performing the culture assays.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on culture results, which inherently serve as a definitive reference method for these types of assays, rather than a consensus among human interpreters. Discrepancies between the device and culture were sometimes resolved by further testing (e.g., FDA cleared NAT/DFA), but this isn't an "adjudication method" in the context of expert review.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretive AI devices where human readers provide an initial diagnosis, and the AI assists in improving their performance. This device is a molecular diagnostic assay, not an AI-assisted interpretive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study. The Simplexa™ Flu A/B & RSV Direct assay is a molecular diagnostic test that provides a direct result (detected/not detected) without human interpretive input beyond following the assay's operational procedures. The clinical agreement results compare the device's output directly against the culture gold standard.

7. The Type of Ground Truth Used

The primary ground truth used for both prospective and retrospective clinical studies was culture results.

For RSV, some discrepancies were confirmed using an FDA-cleared NAT (Nucleic Acid Test) or FDA-cleared DFA (Direct Fluorescent Antibody) test, which could be considered a secondary confirmation of the ground truth for those specific samples.

8. The Sample Size for the Training Set

The document does not provide a specific sample size for a "training set" for an algorithm. This device is a molecular diagnostic assay (RT-PCR system), not an AI/machine learning algorithm that requires a separate training set. The assay's parameters (e.g., probe-primers, thresholds for detection) would have been developed and optimized during its R&D phase, but this doesn't involve "training data" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted in point 8, this is not an AI/machine learning device that uses a "training set" with established ground truth in that context. The analytical and clinical performance established the validity of the assay.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. A curved, swooping line extends from the left side of the "F", arcing over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.

510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 implexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 1 of 7

Applicant	Focus Diagnostics, Inc.11331 Valley View StreetCypress, California 90630USA
Establishment Registration No.	2023365
	JUL 13 2012
Contact Person	Tara Vivianitel 562.240.6115fax 562.240.6530tviviani@focusdx.com
Summary Date	May 18, 2012
Proprietary Name	Simplexa™ Flu A/B & RSV DirectSimplexa™ Flu A/B & RSV Positive Control Pack
Generic Name	Respiratory Viral Panel
Classification	Class II, Special Controls
Regulation	§ 21 CFR 866.3980 - respiratory viral panel multiplex nucleic acidassay
Product Code	OCC - respiratory virus panel nucleic acid assay system
Predicate Devices	Prodesse, ProFlu+ Assay (K092500, K081030, K073029)
INTENDED USE

The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients and symptoms of respiratory tract infection in coniunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

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

If infection with a novel Influenza A virus is suspected based on current clinical and enideria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to the state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

INTENDED USE

Device Description

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510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 2 of 7

K120413

are targeted to identify these viruses in the specimen. An RNA internal control is used to detect RT-PCR failure and/or inhibition.

Predicate Device Information

Trade Name / Method	510(k)submitter	510(k)number	Decision Date	Panel	ProductCode(s)
ProFlu+	GenProbe(Prodesse)	K092500,K081030,K073029	08/20/200905/02/200801/04/2008	Microbiology(83)	OCC

Comparison to Predicate Device

	Device	Predicate
ItemName	Simplexa™ Flu A/B & RSV Direct	ProFlu+
Intended Use	The Focus Diagnostics Simplexa™ Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 H1N1 influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.	The ProFlu™+ Assay is a multiplex Real-Time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients. This test is intended for use to aid in the differential diagnosis of Influenza A, Influenza B and RSV viral infections in humans and is not intended to detect Influenza C.Negative results do not preclude influenza or RSV virus infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative RSV results be confirmed by culture. Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza
	Device	Predicate
ItemName	Simplexa™ Flu A/B & RSV Direct	ProFlu+
	If infection with a novel Influenza Avirus is suspected based on currentclinical and epidemiological screeningcriteria recommended by public healthauthorities, specimens should becollected with appropriate infectioncontrol precautions for novel virulentInfluenza viruses and sent to state orlocal health department for testing. Viralculture should not be attempted inthese cases unless a BSL 3+ facility isavailable to receive and culturespecimens.	viruses and sent to state or local healthdepartment for testing. Viral cultureshould not be attempted in these casesunless a BSL 3+ facility is available toreceive and culture specimens.
Assay Targets	Influenza A, Influenza B, RSV	Influenza A, Influenza B, RSV
Sample Types	NPS	NPS
ExtractionMethods	None	Roche MagNA Pure LC Total NucleicAcid Isolation Kit,Biomérieux NucliSENS easyMAG
AssayMethodology	PCR-based system for detecting thepresence / absence of viral RNA inclinical specimens	PCR-based system for detecting thepresence / absence of viral DNA/RNA inclinical specimens
DetectionTechniques	Multiplex assay using different reporterdyes for each target.	Multiplex assay using different reporterdyes for each target.
Influenza A ViralTarget	Well conserved region of the matrixgene	Matrix gene
Influenza B ViralTarget	Well conserved region of the matrixgene	Non-structural NS1 and NS2
RespiratorySyncytial ViralTarget	M gene.	Polymerase
LoD	Analytical sensitivity (LoD) as definedas the lowest concentration at which ≥95% of all replicates tested positive,ranges from 102 - 10-3 TCID50/mL.	Analytical sensitivity (LoD) as defined asthe lowest concentration at which ≥ 95%of all replicates tested positive,ranges from 102 - 10-1 TCID50/mL.
Reproducibility	Influenza A = %CV of 0.4 to 1.5Influenza B = %CV of 0.5 to 3.6RSV = %CV of 1.2 to 3.3	Influenza A = %CV of 1.4 to 5.3Influenza B = %CV of 0.7 to 3.1RSV = %CV of 1.5 to 8.3

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K120413 510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012

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PERFORMANCE CHARACTERISTICS

CLINICAL AGREEMENT - PROSPECTIVE STUDY

Three external testing sites and one internal site participated in a prospective clinical study. Reference results for influenza A, influenza B viruses and respiratory syncytial virus were generated using culture. Culture results were carried forward from the results obtained at the time of sample collection. A total of 722 nasopharyngeal swabs

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510(k) Summary Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 4 of 7

specimens were obtained from prospectively collected specimens with signs and symptoms of viral respiratory tract infection. Prospective samples were collected in Eastern United States from 10-November-2010 to 11-March-2011; the Mid-Western United States from 08-January-2011 and in Australia from 17-August-2010 to 20-October-2010. Of the 722 specimens were collected from female patients and 397 specimens were collected from male patents. A total of 327 specimens were from patients <5 years of age, 223 specimens were from patients between 5-22 years of age, 158 specimens were from patients between 22 to 60 years of age and 14 specimens were from patients >60 years of age, One (1) sample was excluded from the prospective analysis due to Invalid result for Flu A, three (3) samples were excluded due to an invalid result for Flu B and one (1) sample were excluded due to an invalid result for RSV. During the study the percentage of specimens with invalid results was 0.4% (3/722) with a 95% Cl of 0.1% to 1.2%.

Clinical Agreement - Flu A (Prospective - All sites combined)

Culture Result	Simplexa™ Results - Flu A		Sensitivity/Specificity
	n	Detected	Not Detected	95% CI
Detected	68	66	2	Sensitivity: 97.1%(66/68)95% CI: 89.9 to 99.2%
Not Detected	653	14	639	Specificity: 97.9%(639/653)95% CI: 96.4 to 98.7%

Clinical Agreement - Flu B (Prospective - All sites combined)

Culture Result	N	Simplexa™ Results - FluB		Sensitivity/Specificity95% CI
		Detected	Not Detected
Detected	21	21	0	Sensitivity: 100.0%(21/21)95% CI: 84.5 to 100.0%
Not Detected	698	1	697	Specificity: 99.9%(697/698)95% CI: 99.2 to 100.0%

Clinical Agreement - RSV (Prospective - Site 1)

Culture Result		Simplexa™ Results - RSV		Sensitivity/Specificity
		Detected	Not Detected	95% Cl ÷
Detected				Sensitivity: 100.0%(1/1)95% Cl: 20.7 to 100.0%
Not Detected	329		323	Specificity: 98.2%(323/329)95% CI: 96.1 to 99.2%

a) 4/6 samples were confirmed as RSV positive by an FDA cleared NAT

Clinical Agreement - RSV (Prospective - Site 2)

Culture Result	N	Simplexa™ Results – RSV		Sensitivity/Specificity
		Detected	Not Detected	95% CI
Detected	73	72	1a	Sensitivity: 98.6%(72/73)95% CI: 92.6 to 99.8%
Not Detected	172	18b	154	Specificity: 89.5%(154/172)95% CI: 84.1 to 93.3%

a) 1/1 sample confirmed as RSV positive by an FDA cleared DFA

b) 11/18 samples confirmed as RSV positive by an FDA cleared DFA

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510(k) Summarv Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012 Page 5 of 7

Clinical Agreement - RSV (Prospective - Site 3)
Culture Result		Simplexa™ Results - RSV		Sensitivity/Specificity
	N	Detected	Not Detected	95% CI
Detected	10	9	1	Sensitivity: 90.0%(9/10)95% CI: 59.6 to 98.2%
Not Detected	136	21a	115	Specificity: 84.6%(115/136)95% CI: 77.5 to 89.7%

a) 20/21 samples confirmed as RSV positive by an FDA cleared NAT

CLINICAL AGREEMENT - RETROSPECTIVE STUDY

Three external testing sites participated in a retrospective clinical study. Reference results for influenza B viruses and respiratory syncytial virus were generated using culture. Culture results were carried forward from the results obtained at the time of sample banking. A total of 223 nasopharyngeal swabs specimens were obtained from retrospectively banked specimens from patients with signs and symptoms of viral respiratory tract infection.

Culture Result	n	Simplexa™ Results – Flu A		PPA/NPA*
		Detected	Not Detected	95% CI
Detected	79	76	3	PPA: 96.2% (76/79)95% CI: 89.4 to 98.7%
Not Detected	144	1	143	NPA: 99.3% (143/144)95% CI: 96.2 to 99.9%

Clinical Agreement - Flu A (Retrospective - All sites combined)

PPA = Positive Percent Agreement, NPA = Negative Percent Agreement

Clinical Agreement - Flu B (Retrospective - All sites combined)

Culture Result	N	Simplexa™ Results - Flu B		PPA/NPA*
		Detected	Not Detected	95% CI
Detected	41	40	1	PPA: 97.6% (40/41)95% CI: 87.4 to 99.6%
Not Detected	182	0	182	NPA: 100.0% (182/182)95% CI: 97.9 to 100.0%

PPA = Positive Percent Agreement, NPA = Negative Percent Agreement

Clinical Agreement - RSV (Retrospective - All sites combined)

Culture Result . "		Simplexa™ Results - RSV		PPA/NPA*
		Detected	Not Detected	95% Cl
Detected	12	17		PPA: 100.0%(12/12)95% Cl: 75.7 to 100.0%
Not Detected	211		208	NPA: 98.6%(208/211)95% CI: 95.9 to 99.5%

PPA = Positive Percent Agreement, NPA = Negative Percent Agreement

ANALYTICAL SENSITIVITY/LIMIT OF DETECTION

The Limit of Detection (LoD) was determined for the Simplexa™ Flu AJB & RSV Direct assay using quantified stocks of influenza A, influenza B and RSV virus strains serially diluted in negative swab matrix. The lowest concentration with ≥95% detection (at least 19 out of 20 replicates) was determined to be the limit of detection for each assay,

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Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.Julv.2012 Page 6 of 7

Simplexa TM Flu A/B & RSV Direct Limit of Detection
Viral Strain	LoD (TCID50/mL)
Influenza A/PR/8/34 (H1N1)	0.005
Influenza A/Hong Kong/8/68 (H3N2)	10
Influenza A/Swine NY/02/2009 (H1N1)	0.1
Influenza B/Great Lakes/1739/54	2
Influenza B/Malaysia/2506/2004	20
RSV A2	1
RSV B CH93-18(18)	3

ANALYTICAL REACTIVITY / CROSS REACTIVITY

Analytical Reactivity

Different strains of influenza A including H1 and H3 subtypes, influenza B and RSV including A and B subtypes were evaluated. The most recent strains and geographically diverse strains were chosen. Quantified viral material was spiked into negative swab matrix at a sindle dilution with a concentration of approximately 1.0 x10 x10 x10 x10 TCIDsoml and assayed in triplicate. Ct values obtained during testing indicate all viral strains were tested near the LoD. All strains tested were appropriately detected.

Cross Reactivity (Analytical Specificity)

The Simplexa™ assay's analytical specificity was evaluated by testing the ability to exclusively identify influenza A virus and/or influenza B virus and/or RSV with no cross reactivity to organisms that are closely related, or cause similar clinical symptoms, or present as normal flora in the specimen types of interest.

The panel of thirty-two (32) potential cross reactants were into a swab matrix at clinically relevant concentrations. The unspiked matrix was also tested to serve as a baseline. Samples were tested in triplicate to screen for cross reactivity. If signal was detected in any detection channel (Flu A, Flu B, RSV) in any of the three replicates, an additional 5 replicates were tested for confirmation.

No cross reactivity was detected for Flu A, Flu B or RSV.

INTERFERENCE

The performance of this assay was evaluated with potentially interfering substances that may be present in nasopharyngeal swabs at the concentrations indicated in the table below. The potentially interfering substances were evaluated in a contrived sample that contained influenza A/PR/8/34 H1N1) at a concentration of 0.01 TCIDsomL and influenza B (influenza B/Malaysia/2506/2004) at a concentration of 40 TC/Ds/mL and RSV A2 at a concentration of 4 TCIDsomL. All strains were tested at two to four times the LoD. There was no evidence of interference caused by the substances tested.

Potential Interferents	Active Ingredient	InterferentConcentration
Afrin Nasal Spray	Oxymetazoline	15% (v/v)
Antibacterial, systemic	Tobramycin	4 µg/mL
Antibiotic, nasal ointment	Mupirocin	6.6 mg/mL
Blood	N/A	2%(v/v)
Purified Mucin Protein	Bovine Submaxillary Gland Type I-S	60 µg/mL
Nasal Corticosteroid - BeconaseAQ	Beclomethasone	5% (v/v)
Nasal Corticosteroid - Fluticasone	Fluticasone	5% (v/v)
Relenza Antiviral Drug	Zanamivir	3.3 mg/mL
Tamiflu Antiviral Drug	Oseltamivir	1 μΜ

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510(k) Summary

Simplexa™ Flu A/B & RSV Direct - REF MOL2650 Simplexa™ Flu A/B & RSV Positive Control Pack - REF MOL2660 Prepared Date: 12.July.2012

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Potential Interferents	Active Ingredient	InterferentConcentration
Zicam Nasal Gel	Luffa Opperculata, Galphimiaglauca, histaminumhydrochloricum	5% (v/v)

INHIBITION BY OTHER MICROORGANISMS

The Simplexa™ assay was evaluated by testing the ability to identify influenza B virus, and RSV when potentially inhibitory organisms are present.

The panel of thirty two (32) potentially inhibitory organisms was individually spiked into a low concentration (approximately 2 times LoD) of influenza A/PR/8/34 H1N1), influenza B (Influenza B/Malaysia/2506/2004) and RSV (A2). Samples were tested in triplicate to screen for inhibition. If signal was not detected in any detection channel (Flu A, Flu B, RSV) in any of the three replicates, an additional 5 replicates were tested for confirmation.

No inhibitory effects were confirmed for influenza A, influenza B, or RSV at the concentrations tested.

CARRY-OVER CONTAMINATION

An internal carry-over study searched for the presence of contamination in negative samples. The study was designed by alternately placing a high positive and a negative sample on each disc. The carryover effect was evaluated by comparing the observed negative rate for the negative sample with the expected rate under normal reproducibility conditions. No cary-over contamination effect was seen in the Flu A, Flu B or RSV channels.

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Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 1 3 2012

Focus Diagnostics, Inc. c/o Tara Viviani Regulatory Affairs Project Manager 11331 Valley View Street Cypress, California 90630

Re: K120413

Trade/Device Name: Simplexa™Flu A/B & RSV Direct Simplexa "Flu A/B & RSV Positive Control Pack Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel nucleic acid assay system Regulatory Class: Class II Product Code: OCC, OOI Dated: May 18, 2012 Received: May 21, 2012

Dear Ms. Viviani:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any is with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jóááym.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K120413

Simplexa™ Flu A/B & RSV Direct Device Name: Simplexa™ Flu A/B & RSV Positive Control Pack

Indications for Use:

Simplexa™ Flu A/B & RSV Direct (REF MOL2650)

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

Performance characteristics for influenza A were established with clinical specimens collected during the 2010/2011 influenza season when 2009 HINI influenza and H3N2 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

Simplexa™ Flu A/B & RSV Positive Control Pack (REF) MOL2660)

X And/Or Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Tamara Feldhuhn

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K 120413

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.