MODIFICATION TO SERAQUEST EB VCA IGG

K033915 · Quest Intl., Inc. · LSE · Jan 16, 2004 · Microbiology

Device Facts

• Record ID: K033915
• Device Name: MODIFICATION TO SERAQUEST EB VCA IGG
• Applicant: Quest Intl., Inc.
• Product Code: LSE · Microbiology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The EB VCA IgG test is intended for the qualitive and semi-quantative detection of human IgG antibodies to Epstein-Barr viral capsid antigen, in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest EB VCA IgG is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against Epstein-Barr virus capsid antigen in human serum. The test uses microwells coated with inactivated EB VCA virus. Patient serum is incubated in wells; if IgG antibodies are present, they bind to the antigen. After washing, goat anti-human IgG conjugated with alkaline phosphatase is added. A substrate (p-Nitrophenyl phosphate) is added, producing a yellow end-product measured photometrically at 405 nm. The device is intended for manual use or with the HyPrep System Plus in clinical laboratory settings. Results are reported as Index values based on in-house calibrators. The assay aids clinicians in distinguishing between active/recent and past EBV infections.

Clinical Evidence

Clinical performance evaluated by comparing 113 serum samples against the Zeus EBV VCA IgG test. Results showed 61 positive and 36 negative concordant results. Excluding equivocal results, the overall agreement was 90.7% (95% CI: 85.1-96.2%).

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) in plastic microwells. Antigen: Inactivated EB VCA virus. Conjugate: Goat anti-human IgG labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Readout: Spectrophotometric at 405 nm. Manual or automated (HyPrep System Plus) operation. Room temperature incubation.

Indications for Use

Indicated for qualitative and semi-quantitative detection of human IgG antibodies to Epstein-Barr viral capsid antigen in human serum. Used as an aid in differentiating active or recent EBV infection from past infection. For in vitro diagnostic use.

Regulatory Classification

Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

Predicate Devices

• Zeus EBV VCA IgG Test System (Zeus Scientific, Inc.)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K033915

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 (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K990410, SeraQuest EB VCA IgG

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. The INDICATION/INTENDED USE and labeling have not changed from the cleared product insert. However, the sponsor did not submit any advertisements or promotional material.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for their antigen from p18 viral capsid antigen to inactivated viral capsid antigen.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, is stated (pp 17-18) of the submission.

5. A Design Control Activities Summary which includes:

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. This information has been provided.

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. The sponsor's acceptance criterion is stated that they adhere to IAO/DIS 14971, Medical Devices – Application of Risk Management to Medical Devices. The sponsor states they have their own Risk Analysis procedures in place and have concluded that modification could have and effect on the performance characteristics of their device but should have no other impact on the device. Therefore, their verification and validation activities are based on in-house established performance characteristics.

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

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.

The sponsor states in their declaration of conformity that their validation procedures consisted of comparing their device to a legally market device and their acceptance criterion consisted of an overall agreement of a 95% confidence interval of 94.8 to 98.3.

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). These have been provided and are considered acceptable.

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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, this device is determined substantially equivalent to the previously cleared (or their preamendment) device.