← Product Code [NHX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NHX) · K112810

# MULTI-ANALYTE DETECTION SYSTEMS (K112810)

_Bio-Rad Laboratories · NHX · Oct 26, 2011 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NHX/K112810

## Device Facts

- **Applicant:** Bio-Rad Laboratories
- **Product Code:** [NHX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NHX.md)
- **Decision Date:** Oct 26, 2011
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.5775
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results. The BioPlex® 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex® 2200 System. The BioPlex 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack. The BioPlex 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.

## Device Story

Multiplex flow immunoassay system for detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP). Input: human serum or plasma samples. Process: patient sample, diluent, and antigen-coated fluorescent beads incubated in reaction vessel; wash cycle removes unbound antibody; anti-human IgG phycoerythrin conjugate added; second wash cycle; bead mixture passes through detector. Output: relative fluorescence intensity (RFI) used to identify assay/control beads and quantify immobilized antibody. Includes Internal Standard Bead (ISB), Serum Verification Bead (SVB), and Reagent Blank Bead (RBB) for system verification. Used in clinical laboratory settings by trained personnel. Results aid physicians in diagnosing rheumatoid arthritis in conjunction with other clinical findings.

## Clinical Evidence

No clinical data provided. Substantial equivalence based on design control activities, risk management (FMEA), and verification of the modified QC procedure.

## Technological Characteristics

Multiplex flow immunoassay; fluorescent bead-based detection; anti-human IgG phycoerythrin reporter conjugate. System includes Internal Standard Bead (ISB), Serum Verification Bead (SVB), and Reagent Blank Bead (RBB). Calibrated using six-vial set. Operates on BioPlex 2200 System.

## Regulatory Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

## Predicate Devices

- BioPlex®2200 Anti-CCP Kit (k093954)

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k112810

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

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.) BioPlex®2200 Anti-CCP Kit, k093954.
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). There are no changes in the intended use or in the Indications for use.
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: Change in the frequency of Quality Control (QC) testing from QC on each reagent pack to QC once per day or per new reagent pack lot.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and frequency of QC testing. On the predicate, QC testing was on each reagent pack. On the modified device, QC testing is once per day or per new reagent pack lot.
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. Bio-Rad Laboratories used Failure Mode and Effect Analysis (FMEA). This was included in pages 1-10 of the Risk Management Report Addendum (RMPA).
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 (See RMPA).
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 (see file)
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 (see statement in file).

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (See statement in file)

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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NHX/K112810](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NHX/K112810)

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