BD DIRECTIGEN EZ RSV

K101514 · Becton, Dickinson & CO · GQG · Jul 9, 2010 · Microbiology

Device Facts

• Record ID: K101514
• Device Name: BD DIRECTIGEN EZ RSV
• Applicant: Becton, Dickinson & CO
• Product Code: GQG · Microbiology
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3480
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.

Device Story

Rapid membrane enzyme immunoassay for qualitative detection of RSV antigen; utilizes nasopharyngeal wash, aspirate, or swab specimens. Modification involves transition from liquid control reagents to dry swab controls. Device used in clinical settings to aid diagnosis of RSV infections in pediatric populations. Healthcare providers perform assay; visual interpretation of membrane results. Modification does not alter fundamental scientific technology or clinical performance.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design control activities, risk analysis, and verification/validation demonstrating that predetermined acceptance criteria for the modified control reagents were met.

Technological Characteristics

Rapid membrane enzyme immunoassay. Modification: dry swab control formulation replacing liquid controls. No change to fundamental scientific technology, sensing principle, or assay format.

Indications for Use

Indicated for symptomatic infants and young children to aid in the diagnosis of RSV infections using nasopharyngeal wash, aspirate, or swab specimens.

Regulatory Classification

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.

Predicate Devices

• BD Directigen™ EZ RSV assay (K022133)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K101514

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:
BD Directigen EZ™ RSV assay, K022133

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. The modification of the device consisted in the change from liquid control reagents to dry swabs controls. This modification has not had any effect or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

4. Comparison Information (similarities and differences). Clinical and analytical performance/functionality remain unchanged from the previous device. The positive and negative liquid controls from the legally marketed device have been changed to a dry swab control formulation.

5. A Design Control Activities Summary which includes:

a) Risk Analysis conducted to identify expected hazards and risks associated with the planned modifications to the BD Directigen™ EZ RSV assay. Each hazard/risk identified in this analysis was evaluated according to the Risk Management procedure, and assigned a Risk Index level to indicate the severity of the hazard/risk and the probability of occurrence. Corrective Action(s) were then determined, if necessary, for each identified hazard/risk to mitigate the hazard/risk.

b) A declaration of conformity with design controls. The declaration of conformity includes:

i) A statement signed by Mr. Gregory P Payne, stating that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by Mr. Gregory P Payne, stating that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.