Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a traditional immunochromatographic assay and do not mention any AI or ML components.

Therapeutic

No
The device is an in vitro diagnostic assay used for the rapid diagnosis of RSV infections, not for treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections."

SaMD (Software as a Medical Device)

No

The device is described as a qualitative immunochromatographic test that uses a Test Cartridge and fluorescent-dyed latex particles, indicating it is a physical in vitro diagnostic device, not software only.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger."

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

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

GQG

Device Description

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasal wash/aspirate, nasopharyngeal aspirate, nasopharyngeal swab samples

Indicated Patient Age Range

21 years of age and younger

Intended User / Care Setting

professional use. The RAMP RSV. Assay and QuickVue RSV Assay are for use in the central laboratory, stat-lab and point-of-care facilities

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

Not Found

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

Analytical Performance:

Analytical Sensitivity and Reactivity: Evaluated by testing 6 strains of RSV at various LoD concentrations in viral transport media (VTM) or saline solution. LoD ranged from 3.5x10² to >1.7x10⁵ TCID50/mL. Result: 90% to 100% RSV Positive.
- A-Long in Saline: LoD 6.5x10³ TCID50/mL, 100% RSV Positive
- A-Long in VTM: LoD 2.5x10³ TCID50/mL, 100% RSV Positive
- A (A-2) in Saline: LoD 1.0x10³ TCID50/mL, 100% RSV Positive
- A (A-2) in VTM: LoD 1.2x10³ TCID50/mL, 100% RSV Positive
- B CH93(18)-18 in Saline: LoD 3.5x10² TCID50/mL, 100% RSV Positive
- B CH93(18)-18 in VTM: LoD 3.5x10² TCID50/mL, 100% RSV Positive
- B Wash/18537/62 in Saline: LoD 7.0x10³ TCID50/mL, 95% RSV Positive
- B Wash/18537/62 in VTM: LoD 6.0x10³ TCID50/mL, 100% RSV Positive
- B WV/14617/85 in Saline: LoD 5.0x10³ TCID50/mL, 100% RSV Positive
- B WV/14617/85 in VTM: LoD 2.5x10³ TCID50/mL, 100% RSV Positive
- B9320 in ZMC matrix: LoD > 1.7x10⁵ TCID50/mL, 90% RSV Positive
Precision and Reproducibility: Evaluated using a panel of high negative, LoD positive, and 2x LoD positive RSV samples (RSV A (A-2)) by multiple operators at multiple sites over 5-12 days (n=396).
- Overall Agreement: 99.2% (393/396) with expected results.
- No significant differences within run, between run, operators, or sites.
- Overall RAMP Ratio %CV ranged from 13% to 16%.
Interference: Evaluated whole blood and various potentially interfering substances (medications, OTC products) at negative, LoD positive, and 2x LoD positive RSV samples (RSV A (A-2)) with n=3 replicates for each substance.
- None of the substances tested at the indicated concentrations interfered with test results based on acceptance criteria (3/3 for Negative and 2x LoD, ≥2/3 for LoD).
Analytical Specificity (Potential Cross-Reactive Organisms): Tested a panel of 16 viruses and 17 bacteria at specified concentrations.
- None of the organisms tested gave a positive result in the RAMP RSV Assay.
Transport Media Compatibility: Evaluated multiple lots of seven commercially available transport media with negative, LoD positive, and 2x LoD positive RSV samples (RSV A (A-2)).
- None of the tested transport media interfered with the performance.
- Average RAMP Ratio %CV: 12% (Negative), 16% (RSV LoD), 14% (RSV 2x LoD).
Sample Collection Swabs Compatibility: Evaluated four swab materials (Foam, Polyester, Rayon, Nylon) with negative, LoD positive, and 2x LoD positive RSV samples (RSV A (A-2)).
- Negative samples tested negative, all 2x LoD samples tested positive.
- None of the swabs tested interfered with the performance.
- Average RAMP Ratio %CV: 9% (Negative), 21% (RSV LoD), 21% (RSV 2x LoD).

Clinical Performance (Method Comparison):

Study Design: Prospective, multi-center trial during 2008-2009 RSV season, comparing RAMP RSV Assay to cell culture and DSFA.
Sample Size: 1279 fresh specimens collected from subjects 21 years of age and younger; 1140 valid results.
Data Source: 8 independent centers in the US (NY, MO(2), MD, OH(2), MA, AR), including laboratory and point-of-care settings (Emergency Department and Pediatric Testing Unit).
Clinical Sensitivity and Specificity (Overall Relative to Culture and DSFA):
- Sensitivity: 87.3%
- Specificity: 95.6%
Clinical Sensitivity and Specificity by Age (Relative to Culture and DSFA):
- NP Swab (All Ages):
  - Sensitivity: 88.2% (95% CI: 81.4 - 92.7)
  - Specificity: 97.4% (95% CI: 94.6 - 98.7)
- **NP Swab (Age

Regulation Number and Section

§ 866.3480 Respiratory syncytial virus serological reagents.

(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Summary

0

JUL 2 4 2009

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) 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: K091235

Establishment:

Response Biomedical Corporation 1781 – 75th Avenue W. Vancouver, B.C. Canada, V6P 6P2

Tel: (604) 456-6010 Fax: (604) 456-6066

Contact: Ken Pilgrim Director - Quality / Regulatory

22 July, 2009 Prepared:

Regulatory Information:

Trade Name:	RAMP® RSV Assay
Common Name:	RSV immunological test system
Classification Name:	RSV immunological test system
Regulation Number:	866.3480, Respiratory syncytial virus serological reagents.
Classification:	Class I
Product Code:	GQG
Panel:	Microbiology

Predicate Device:

Quidel QuickVue RSV Assay

Intended Use

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 vears of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

1

Description of the Device:

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.

Comparison of Technological Characteristics:

The RAMP RSV Assay and QuickVue RSV Assay are rapid immunochromatographic tests used for the detection of RSV virus antigen utilizing antibodies targeted toward the highly conserved, membrane-bound F-protein of the virus and thus do not require viable virus particles for detection. The RAMP and QuickVue RSV Assay tests provide results in approximately 15 minutes. Two methods used in the clinical laboratory are viral cell culture (culture) and Direct Specimen Fluorescence Assay (DSFA). Viral cell culture relies on the growth of cell lines and their infection with virus contained in the clinical sample. The time required to get a definitive result using these culture methods can be up to 30 days depending on the samples and methods used. DSFA relies on antigen detection and thus does not require viable virus particles in the sample to be evaluated. DSFA can be completed in several hours.

The RAMP RSV. Assay and QuickVue RSV Assay are for use in the central laboratory, stat-lab and point-of-care facilities, while viral cell culture or DSFA are for use in the central laboratories due to their requirement for specialized equipment and highly trained operators.

These methods are indicated for use in the detection of RSV in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples.

Summary of Studies:

ANALYTICAL PERFORMANCE

Analytical Sensitivity and Reactivity

The RAMP RSV Assay was evaluated for analytical sensitivity and reactivity after was determined by testing 6 strains of RSV (RSV A-Long, RSV A (A-2), RSV B CH93 (18)-18, RSV B Wash/18537/62. RSV B WV/14617/85. RSV B9320) at the LoD concentration in either viral transport media (VTM) to simulate a swab sample type or saline solution to simulate a wash sample type. Although the specific RSV strains causing infection in humans can vary year to year, all contain the conserved membrane-bound F-protein antigens targeted by the RAMP RSV Assay. Analytical sensitivity (LOD) ranged from 3.5x102 to >1.7x10° TCID26/mL.

| RSV Sample | LoD Concentration
(TCID50/mL) | RAMP Result |
|-------------------|----------------------------------|-------------------|
| A-Long in Saline | 6.5x103 | 100% RSV Positive |
| A-Long in VTM | 2.5x103 | 100% RSV Positive |
| A (A-2) in Saline | 1.0x103 | 100% RSV Positive |

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| RSV Sample | LoD Concentration
(TCID50/mL) | RAMP Result |
|---------------------------|----------------------------------|-------------------|
| A (A-2) in VTM | $1.2x10^3$ | 100% RSV Positive |
| B CH93(18)-18 in Saline | $3.5x10^2$ | 100% RSV Positive |
| B CH93(18)-18 in VTM | $3.5x10^2$ | 100% RSV Positive |
| B Wash/18537/62 in Saline | $7.0x10^3$ | 95% RSV Positive |
| B Wash/18537/62 in VTM | $6.0x10^3$ | 100% RSV Positive |
| B WV/14617/85 in Saline | $5.0x10^3$ | 100% RSV Positive |
| B WV/14617/85 in VTM | $2.5x10^3$ | 100% RSV Positive |
| B9320 in ZMC matrix | $> 1.7x10^5$ | 90% RSV Positive |

Precision and Reproducibiity

The precision and reproducibility of the RAMP RSV Assay was evaluated using a panel consisting of a high negative RSV sample, a limit of detection (LoD) RSV sample (low positive), and a 2x LoD RSV sample (moderate positive). The RSV strain used to prepare the samples was RSV A (A-2) (ATCC VR-1540) following viral titer determinations. To evaluate reproducibility, multiple operators at multiple sites tested each of the three precision samples on 5 different days. Testing at Site 2 was performed in a point-of-care (POC) setting (near patient). At one site (Site 3), to evaluate precision, operators tested each of the three precision samples an additional 7 days for a total of 12 days.

There was 99.2% agreement (393/396) with the expected test results for all specimens tested, with no significant differences within run (same operator on same day) between run, operators or sites. The RAMP RSV Assay is a qualitative assay based on numerical RAMP Ratio values. The overall RAMP Ratio %CV across all sites ranged from 13% to 16% depending on concentration tested.

| | Sample | RSV High Negative | RSV Low Positive | RSV Moderate Positive | Total Agreement
All (%) |
|--------|----------------------------|--------------------|--------------------|-----------------------|----------------------------|
| | Viral Titer
(TCID50/mL) | 200 | 1200 | 2400 | |
| Site 1 | Agreement | 30/30 | 30/30 | 30/30 | 90/90
(100%) |
| | % CV | 11% | 11% | 9% | |
| Site 2 | Agreement | 30/30 | 29/30 | 30/30 | 89/90
(98.9%) |
| | % CV | 13% | 14% | 18% | |
| Site 3 | Agreement | 71/72 | 71/72 | 72/72 | 214/216
(99.1%) |
| | % CV | 17% | 12% | 11% | |
| | Total
Agreement | 131/132
(99.2%) | 130/132
(98.5%) | 132/132
(100%) | 393/396
(99.2%) |
| | 95% CI | 95.8 - 99.9% | 94.6 - 99.6% | 97.1 - 100% | 97.8 - 99.7% |
| | Overall
% CV | 16% | 13% | 14% | |

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Interference

Whole blood and a number of other potentially interfering substances (medications and over the counter (OTC) products) that may be present naturally or artificially introduced in the nasal cavity or nasopharynx were evaluated in the RAMP RSV Assay. The substances were added to a negative sample (saline), an RSV LoD positive sample, and an RSV 2x LoD positive sample and tested in the RSV test at n=3 replicates. The RSV strain used to prepare the samples was RSV A (A-2) following titer determination. Interference was not evaluated with an RSV B strain. None of the substances tested at the concentrations indicated interfered with the test results of negative and positive RSV samples in the RAMP RSV Assay based on the RAMP Result acceptance · criteria of 3/3 (Negative and 2x LOD) and ≥2/3 (LoD). The RAMP RSV Assay is a qualitative assay based on numerical RAMP Ratio values. The Percent of Mean Control Ratio values were calculated using these RAMP Ratios.

		Negative		RSV LoD		RSV 2x LoD
Substance
Tested	Conc.
Tested	RAMP
Results	Percent of
Mean
Control
Ratio	RAMP
Results	Percent of
Mean
Control
Ratio	RAMP
Results	Percent of
Mean
Control
Ratio
Control Saline
(0.85%) only
(No interfering
substance)	N/A	Neg 3/3	100%	Pos 3/3	100%	Pos 3/3	100%
Whole Blood	2% v/v	Neg 3/3	118%	Pos 2/3	89%	Pos 3/3	86%
Mucin	1% w/v	Neg 3/3	123%	Pos 3/3	96%	Pos 3/3	94%
Scope® Mouthwash	40% v/v	Neg 3/3	117%	Pos 2/3	91%	Pos 3/3	85%
Good and Kind™
Mouthwash	40% v/v	Neg 3/3	122%	Pos 3/3	93%	Pos 3/3	83%
Cepacol® Mouth
Wash	40% v/v	Neg 3/3	128%	Pos 2/3	90%	Pos 3/3	78%
Cepacol® Lozenge
(Benzocaine)	30% w/v	Neg 3/3	115%	Pos 3/3	93%	Pos 3/3	69%
Fisherman's Friend®
Throat Drop
(Menthol)	30% w/v	Neg 3/3	107%	Pos 3/3	94%	Pos 3/3	80%
Rhinocort® Nasal
Spray (Budesonide)	15% v/v	Neg 3/3	125%	Pos 3/3	102%	Pos 3/3	76%
Nasacort® Nasal
Spray
(Triamcinolone)	15% v/v	Neg 3/3	141%	Pos 3/3	98%	Pos 3/3	85%
Flonase® Nasal
Spray (Fluticasone
Furoate)	30% v/v	Neg 3/3	145%	Pos 3/3	105%	Pos 3/3	85%
Nasonex® Nasal
Spray (Mometasone
Furoate)	15% v/v	Neg 3/3	134%	Pos 3/3	94%	Pos 3/3	79%
	Conc.
Tested	Negative		RSV LoD		RSV 2x LoD
Substance
Tested		RAMP
Results	Percent of
Mean
Control
Ratio	RAMP
Results	Percent of
Mean
Control
Ratio	RAMP
Results	Percent of
Mean
Control
Ratio
Tylenol® Tablets
(4-Acetamidophenol)	20
mg/mL	Neg 3/3	96%	Pos 3/3	90%	Pos 3/3	81%
Aspirin® Tablets
(Acetylsalicylic Acid)	30
mg/mL	Neg 3/3	127%	Pos 3/3	98%	Pos 3/3	80%
Chlor-Tripolon™
Tablets
(Chloropheniramine)	10
mg/mL	Neg 3/3	106%	Pos 3/3	110%	Pos 3/3	98%
Benadryl™ Allergy
Tablet
(Diphenhydramine)	5 mg/mL	Neg 3/3	136%	Pos 3/3	107%	Pos 3/3	91%
Delsym® DM Cough
Syrup
(Dextromethorphan)	2 mg/mL	Neg 3/3	135%	Pos 3/3	121%	Pos 3/3	105%
Robitussin® Syrup
(Guaiacol Glycerol
Ether)	40
mg/mL	Neg 3/3	140%	Pos 3/3	89%	Pos 3/3	82%
Phenylpropanol-
amine HCI (pure)	40
mg/mL	Neg 3/3	142%	Pos 3/3	105%	Pos 3/3	96%
Afrin® Nasal Spray
(Oxymetazoline HCI)	0.05% v/v	Neg 3/3	103%	Pos 3/3	86%	Pos 3/3	76%
Neo-Synephrine®
Nasal Spray
(Phenylephrine HCI)	20
mg/mL	Neg 3/3	121%	Pos 3/3	87%	Pos 3/3	84%
Otrivin® Saline
(NaCl
w/preservatives)	1.4% w/v	Neg 3/3	122%	Pos 3/3	91%	Pos 3/3	94%
Rebetol® (Ribavirin)	100
ng/mL	Neg 3/3	116%	Pos 2/3	92%	Pos 3/3	82%
Relenza®
(Zanamivir)	20
mg/mL	Neg 3/3	105%	Pos 3/3	89%	Pos 3/3	76%
Rimantadine HCI	500
ng/mL	Neg 3/3	118%	Pos 3/3	87%	Pos 3/3	85%
Tamiflu®
(Oseltamivir
Phosphate)	50
mg/mL	Neg 3/3	146%	Pos 3/3	127%	Pos 3/3	108%

র্ব

4

Analytical Specificity (Potential Cross-Reactive Organisms)

The analytical specificity of the RAMP RSV Assay was determined by testing a panel consisting of 16 viruses and 17 bacteria that may be present in the nasal cavity or nasopharynx. Bacterial and viral isolates were tested at the concentrations listed after titer determination. None of the organisms tested gave a positive result in the RAMP RSV Assay. Note: RAMP RSV Assay potential cross-reactivity with Chlamydophila pneumoniae has not been determined.

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Strain/Isolate	Concentration	RAMP result
Adenovirus, Type 1	105 TCID50/mL	Negative
Adenovirus, Type 7a	105 TCID50/mL	Negative
Human coronavirus, Strain OC43	105 TCID50/mL	Negative
Human coronavirus, Strain 229E	105 TCID50/mL	Negative
Cytomegalovirus	105 TCID50/mL	Negative
Enterovirus, Type 71	105 TCID50/mL	Negative
Epstein Barr Virus	105 TCID50/mL	Negative
Human Parainfluenza, Type 1	105 TCID50/mL	Negative
Human Parainfluenza, Type 2	105 TCID50/mL	Negative
Human Parainfluenza, Type 3	105 TCID50/mL	Negative
Influenza A, Brisbane/10/07	105 EID50/mL	Negative
Influenza B, Ohio/01/06	105 TCID50/mL	Negative
Measles	105 TCID50/mL	Negative
Human metapneumovirus	105 TCID50/mL	Negative
Mumps virus	105 TCID50/mL	Negative
Human Rhinovirus, Strain 1A	105 TCID50/mL	Negative
Bordetella pertussis	106 cfu/mL	Negative
Corynebacterium Sp.	106 cfu/mL	Negative
Escherichia coli	106 cfu/mL	Negative
Haemophilus influenzae	106 cfu/mL	Negative
Lactobacillus casei	106 cfu/mL	Negative
Legionella pneumophila	106 cfu/mL	Negative
Moraxella catarrhalis	106 cfu/mL	Negative
Mycobacterium tuberculosis, Avirulent	106 cfu/mL	Negative
Mycoplasma pneumoniae	106 cfu/mL	Negative
Neisseria meningitides	106 cfu/mL	Negative
Neisseria sicca	106 cfu/mL	Negative
Pseudomonas aeruginosa	106 cfu/mL	Negative
Staphylococcus aureus, Strain 176	106 cfu/mL	Negative
Staphylococcus epidermidis, Strain 78	106 cfu/mL	Negative
Streptococcus pneumoniae	106 cfu/mL	Negative
Streptococcus pyogenes	106 cfu/mL	Negative
Streptococcus salivarius	106 cfu/mL	Negative

Transport Media

Multiple lots of each of seven (7) commercially available transport media were evaluated for compatibility in the RAMP RSV Assay by testing a negative sample (transport media only), an RSV LoD positive sample and an RSV 2x LoD positive sample. The RSV strain used to prepare the samples was RSV A (A-2) following titer determination. The RAMP RSV Assay is a qualitative assay based on numerical RAMP Ratio values. The %CVs were calculated for the RAMP Ratios. None of the tested transport media interfered with the performance of the RAMP RSV Assay.

6

| Transport

Media Tested	RAMP Results
	Negative	RSV LoD	RSV 2x LoD
Copan
Universal
Transport Media
(UTM)	100% Neg	100% Pos	100% Pos
Remel
M4 Media	100% Neg	100% Pos	100% Pos
Remel
M4-RT Media	100% Neg	100% Pos	100% Pos
Remel
M5 Media	100% Neg	100% Pos	100% Pos
Starplex
Transport Media	100% Neg	100% Pos	100% Pos
0.85% Saline
Solution	100% Neg	93% Pos	100% Pos
Phosphate
Buffered Saline
(PBS) Solution	100% Neg	93% Pos	100% Pos
Average RAMP
Ratio
% CV	12%	16%	14%

Sample Collection Swabs

Four swab materials were evaluated for compatibility in the RAMP RSV Assay by testing a neqative sample (swab alone with no virus present), an RSV LoD positive sample and an RSV 2x LoD positive sample in the RSV test. The RSV strain used to prepare the samples was RSV A (A-2) following titer determination. Each swab was dosed with the appropriate sample and extracted into Copan Universal Transport Media prior to testing in the RAMP RSV Assay. The RAMP RSV Assay is a qualitative assay based on numerical RAMP Ratio values. The %CVs were calculated for the RAMP Ratios. The neqative sample (swab alone) tested negative and all 2x LoD samples tested positive. None of the swabs tested interfered with the performance of the RAMP RSV Assay. Note: In general, calcium alginate swabs are not recommended because they may be cytotoxic to cells and cause viral culture assay inhibition.1

| Swab
Material

Tested	RAMP Results
	Negative	RSV LoD	RSV 2x LoD
Foam	100% Neg	100% Pos	100% Pos
Polyester	100% Neg	67% Pos	100% Pos

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Rayon	100% Neg	67% Pos	100% Pos
Nylon	100% Neg	100% Pos	100% Pos
Average RAMP
Ratio
% CV	9%	21%	21%

CLINICAL PERFORMANCE

Method Comparison

The performance of the RAMP RSV Assay was compared to cell culture and DSFA in a prospective study conducted as part of a multi-center trial during the 2008-2009 RSV season. Eight (8) independent centers located in distinct geographical regions across the United States (NY, MO(2), MD, OH(2), MA, AR) evaluated the RAMP RSV Assay in parallel with cell culture and DSFA. Testing staff included both laboratory and non-laboratory personnel, and two centers (MO, AR) also performed testing in point of care settings (near patient). The sites included an Emergency Department and Pediatric Testing Unit. One thousand, two hundred and seventy nine (1279) fresh specimens were collected from subjects 21 years of age and younger. Of these specimens, valid results were obtained from 1140, with an approximately equal mix of male and female patients.

Clinical Sensitivity and Specificity

Overall Sensitivity and Specificity Relative to Culture and DSFA

	N = 1140
Sensitivity	87.3%
Specificity	95.6%

Sensitivity and Specificity by Age Relative to Culture and DSFA

NP Swab (All Ages)
Culture / DSFA		RAMP
	Positive	Negative	Total
Positive	112	15	127
Negative	7*	257	264
Total	119	272	391
			95% CI
Sensitivity	88.2%		81.4 - 92.7
Specificity		97.4%	94.6 - 98.7

1 was positive by the RAMP RSV Assay and by the Prodesse ProFlu RT-PCR analysis.

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| NP Swab (Age Trade/Device Name: RAMP RSV Assay Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: Class I Product Code: GQG Dated: April 23, 2009 Received: April 27, 2009

Dear Mr. Pilgrim:

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 either class II (Special Controls) or class III (PMA), 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.

11

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 Parts 801 and 809); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Taly Atogn

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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Statement of Indications for Use

Indications for Use

510(k) Number (if known): K091235

Device Name: RAMP® RSV Assay

Indications for Use:

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

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

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Uve Schuf

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 091235