MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

K092300 · Diagnostic Hybrids, Inc. · GNW · Aug 28, 2009 · Microbiology

Device Facts

• Record ID: K092300
• Device Name: MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: GNW · Microbiology
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3330
• Device Class: Class 1

Indications for Use

The Diagnostic Hybrids, Inc. D3 Ultra DFA (direct fluorescent antibody) RESPIRATORY VIRUS SCREENING & ID KIT is intended for the qualitative detection and identification of the Influenza A. Influenza B. Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance characteristics for influenza A 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 viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

Device Story

The D3 Ultra DFA Respiratory Virus Screening & ID Kit is an in vitro diagnostic assay used in clinical laboratories to detect and identify seven common respiratory viruses. The device utilizes a panel of fluorescein-labeled murine monoclonal antibodies (MAbs) that bind to specific viral antigens in respiratory specimens (e.g., nasopharyngeal aspirates, washes). The procedure involves fixing clinical specimens or cell culture monolayers onto glass slides with acetone, followed by incubation with the DFA reagents. If viral antigens are present, they are visualized as apple-green fluorescence under a fluorescence microscope, while uninfected cells are counter-stained red with Evan's Blue. The kit includes a screening reagent for initial detection and individual virus-specific reagents for identification. Results assist healthcare providers in confirming viral etiology, which informs clinical management and antibiotic stewardship. The device is intended for professional use by trained laboratory personnel.

Clinical Evidence

Clinical performance was established through prospective and retrospective studies comparing the subject device to the predicate. Studies evaluated 849 specimens across three sites. For fresh specimens (n=326), positive percent agreement (PPA) was 95.5% and negative percent agreement (NPA) was 98.3%. Frozen specimens and clinical isolates showed 100% agreement. No clinical data for 2009 H1N1 clinical specimens was established.

Technological Characteristics

The device consists of fluorescein-labeled murine monoclonal antibodies (MAbs) in aqueous solution with Evan's Blue counter-stain and 0.1% sodium azide preservative. It utilizes direct immunofluorescence (DFA) for antigen detection. The system requires a fluorescence microscope (FITC filter: 490nm excitation, 520nm emission). Components include screening and specific reagents, antigen control slides, wash solution, and mounting fluid. The assay is manual and requires acetone fixation.

Indications for Use

Indicated for respiratory virus screening and identification.

Regulatory Classification

Identification

Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

Predicate Devices

• D³ Ultra DFA Respiratory Virus Screening & ID Kit (K061101)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

To: THE FILE

RE: DOCUMENT NUMBER K092300

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or 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: D³ Ultra DFA Respiratory Virus Screening & ID Kit, K061101, cleared on November 20, 2006

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.

3. A description of the device MODIFICATION(S), including clearly product labeling in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the modification of the D³ Ultra DFA Respiratory Virus Screening & ID Kit package insert to update the analytical reactivity table to include reactivity data on the 2009 H1N1 influenza strains, Mexico/4108/2009 and California/07/2009.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which included:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity included:

i) A statement signed by the individual responsible, 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 the individual responsible, 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 or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.