ATHENA MULTI-LYTE ANA-II TEST SYSTEM

K042416 · Zeus Scientific, Inc. · LKJ · Oct 8, 2004 · Immunology

Device Facts

• Record ID: K042416
• Device Name: ATHENA MULTI-LYTE ANA-II TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LKJ · Immunology
• Decision Date: Oct 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Indications for Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ANA Test System is intended for the semiquantitative detection of IgG class antibody to 8 separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and dsDNA) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum and the qualitative detection of IgG class antibody to ANA in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders. This test is for in vitro diagnostic use.

Device Story

AtheNA Multi-Lyte ANA-II Test System is an in vitro diagnostic assay for detecting IgG antibodies in human serum. It utilizes multiplexed bead-based technology to identify antibodies against 8 specific nuclear antigens (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, dsDNA) and general ANA. The system processes serum samples to provide semiquantitative or quantitative results, aiding clinicians in diagnosing autoimmune disorders. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Method comparison between modified assay and original assay performed. Acceptance criteria: relative agreement ≥90% and comparable read times. Design control activities and risk analysis per EN 1441 conducted to verify modification impact.

Technological Characteristics

Multiplexed bead-based immunoassay system for the detection of IgG class antibodies. Designed for in vitro diagnostic use in clinical laboratory environments.

Indications for Use

Indicated for use as an in vitro diagnostic test system for the detection of antinuclear antibodies (ANA) in human serum.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

To: THE FILE

RE: DOCUMENT NUMBER

K_042416

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. AtheNA Multi-Lyte® ANA Test System (K021103).
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.
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.

The changes were 1) dilution of patient sample changed from 1:200 to 1:21 and 2) Addition of a wash step after sample incubation to remove unbound patient antibody before addition of conjugate.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, indication for use, methodology, kit component specification, packaging and analytical performance.

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 – EN 1441 guidelines (see additional information submitted in S001)
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 (Method comparison of modified assay and original assay. Acceptance criteria included relative agreement between the two assays should be greater or equal to 90% and the read time for the modified assay is comparable to the original assay)
c) A declaration of conformity with design controls (see additional information submitted in S001). 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.

6. A Truthful and Accurate Statement, a 510(k) Statement 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 device.