BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

K111072 · Bio-Rad Laboratories · OPL · Aug 23, 2011 · Microbiology

Device Facts

• Record ID: K111072
• Device Name: BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
• Applicant: Bio-Rad Laboratories
• Product Code: OPL · Microbiology
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Indications for Use

The BioPlex® 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the determination of serological status to Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in neonatal, pediatrics and immunocompromised patients, or for use at point of care facilities.

Device Story

Multiplex flow immunoassay for simultaneous detection of IgG antibodies against Measles, Mumps, Rubella, and VZV. Input: human serum or EDTA/heparinized plasma. Process: patient sample mixed with magnetic dyed beads coated with specific antigens; incubated at 37°C; washed; anti-human IgG conjugated to phycoerythrin (PE) added; incubated; washed. Output: relative fluorescence intensity (RFI) measured via flow detection. System includes Internal Standard, Serum Verification, and Reagent Blank beads for quality verification. Used in clinical laboratories by trained personnel. Output aids clinicians in determining patient serological status. Modification involves changing reagent pack QC testing frequency from per-pack/per-day to once-per-day.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design control activities, risk management, and FMEA analysis regarding the modified QC testing frequency.

Technological Characteristics

Multiplex flow immunoassay. Components include reagent pack, negative control, multi-analyte positive controls, and multiple calibrators. Designed for use with the BioPlex 2200 System. Manufacturing conforms to 21 CFR 820.30.

Indications for Use

Indicated for qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and VZV in human serum/plasma to determine serological status. Not for blood/plasma donor screening. Performance not established for neonates, pediatrics, immunocompromised patients, or point-of-care use.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• BioPlex™ 2200 MMRV IgG Kit (K091616)

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 K111072

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.

Trade Name:
BioPlex™ 2200 MMRV IgG Kit
BioPlex™ 2200 MMRV IgG Calibrator Set
BioPlex™ 2200 MMRV IgG Control Set

510(k) number: K091616

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED. There is a labeling change to alter the frequency of QC testing from once per pack and per day to once per day or per new reagent pack lot. This labeling change does not affect the intended use.

3. The modification presented in this 510(k) is a change in the frequency of the QC testing recommendations specified in the labeling. The FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

4. Comparison Information (similarities and differences)

Similarities

| Feature | Predicate device | Modified Device |
| --- | --- | --- |
| Intended Use/ Indications for Use | The BioPlex® 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma.
The BioPlex 2200 MMRV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors.
The performance of this assay has not been established for use in neonatal, pediatrics and immunocompromised patients, or for use at point of care facilities. | Same |
| Device Components | Reagent Pack, Negative control, | Same |

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| | Multi- Analyte Positive controls and Multiple Calibrators | |
| --- | --- | --- |
| Technical Specifications | Analytical and Clinical Performance Characteristics | Same |
| Fundamental Scientific Technology | Multiplex flow immunoassay | Same |

## Differences

| Feature | Predicate device | Modified Device |
| --- | --- | --- |
| Frequency of Reagent Pack QC Testing | QC once per pack and per day | QC once per day or per new reagent pack lot |

## 5. Design Control Activities Summary

a) Risk Analysis:

A Failure Modes and Effects Analysis was used to facilitate, capture and quantify potential impacts of the Low Signal Pack (LSP) phenomenon. The severity of effects for each of the assays was evaluated using 21 CFR 860 and IVDD (98/79/EC). Additionally potential misuse of the MMRV IgG product was considered during the risk analysis.

b) Verification and Validation activities:

It was determined that proteases from mold and bacteria spiked into the reagent can cause low signals during the development phase of the product. Additional verification and validation studies were conducted by spiking the BioPlex 2200 MMRV IgG kit at room temperature (25 °C) with mold and bacterial filtrates (at 1:25, 1:50, 1:100 and 1:500 levels - v/v). The percent recovery ratios of the QC controls were within the 80%-120% and the negative controls were within the specified range as per the product specifications.

The results indicated that the assays (Measles, Mumps, Rubella or VZV IgG) in the MMRV IgG Kit were not significantly affected by the microbial contaminants.

The Residual Risk acceptability criteria (RPN score) was established at < 19 for low level of concern according to the submitter's Risk Management Plan. It was determined that for each of the assays the RPN score was within 9-12, which is considered a low level of concern and hence does not require any additional mitigation activity.

c) Declaration of Conformity

Two "Declaration of Conformity" statements were submitted duly signed by the responsible individuals. The statements indicate that;

i) 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) 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.

Based on the conclusion of the risk management report, the modified QC procedure fulfills the requirements of the specifications of the design control process. Therefore, the performance of the modified QC test frequency is substantially equivalent to the current cleared kit.

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

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# 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.