MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

K082150 · Preanalytix GmbH · NTW · Feb 4, 2009 · Immunology

Device Facts

• Record ID: K082150
• Device Name: MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
• Applicant: Preanalytix GmbH
• Product Code: NTW · Immunology
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.4070
• Device Class: Class 2

Indications for Use

The PAXgene™ Blood RNA System consists of a blood collection tube (PAXgene™ Blood RNA Tube) and nucleic acid purification kit (PAXgene™ Blood RNA Kit). It is intended for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of host RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene™ Blood RNA System have only been established with "cfos and IL1B." The user is responsible for establishing appropriate PAXgene™ Blood RNA System performance characteristics for other target transcripts.

Device Story

System comprises evacuated blood collection tubes containing stabilization solution (tetradecyl trimethyl-ammonium oxalate, tartaric acid) and nucleic acid purification kit (buffers, proteinase K, DNase, spin columns). Tubes lyse cells, protect RNA from RNases, and prevent gene expression induction. Designed for collection, storage, and transport of whole blood. Purification process supports both manual and automated protocols (via QIAGEN QIAcube instrument). Output is purified intracellular RNA suitable for RT-PCR molecular diagnostic testing. Used in clinical laboratory settings by trained personnel. Benefits include stabilized RNA integrity for downstream molecular analysis.

Clinical Evidence

Bench testing only. Design control activities demonstrated that RNA obtained via the automated QIAcube protocol is compatible with molecular diagnostic applications, specifically mRNA transcript level determination by RT-PCR, and is equivalent to the manual process previously cleared in K042613.

Technological Characteristics

System utilizes chemical stabilization reagents and physical extraction protocols. Modification includes integration with QIAgen QIAcube automated instrument. Elution buffer volume increased from 5 mL to 6 mL. Fundamental scientific technology (RNA stabilization and purification) remains unchanged. Design controls and risk analysis performed per ISO 14971:2004.

Indications for Use

Indicated for the purification of intracellular RNA from whole blood collected in PAXgene Blood RNA Tubes for use in RT-PCR molecular diagnostic testing. Performance established only for FOS and IL1B gene transcripts; users must validate other targets.

Regulatory Classification

Identification

RNA Preanalytical Systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification System for RT-PCR Used in Molecular Diagnostic Testing).” See § 866.1(e) for the availability of this guidance document.

Predicate Devices

• PAXgene™ Blood RNA System (k042613)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k082150

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. PAXgene™ Blood RNA System (k042613)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the package labeling.
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 modifications include:

- addition of an automated RNA extraction device (QIAgen QIAcube®) in addition to a manual extraction method
- Increase in volume of the elution buffer from 5 mL to 6 mL
- Modification to the package insert/user's manual to include changing the BR5 buffer volume in the "Kit Contents" table (pg. 5) and amending of the following sections to include the automated protocols in addition to the manual protocols:

- "Principle and procedure" section (pg. 9)
- "RNA concentration and purification" section (pg. 12)
- Additional flowchart added (pg. 13) to show flow of automated protocol
- "Equipment and Reagents to be supplied by User" (pg. 26)
- "important Notes" (pg. 27-33)
- "Automated protocol" section (pg. 40).

- Summaries of comparisons between the manual and automated methods, kit contents

4. Comparison Information (similarities and differences): The differences to the applicant's legally marketed predicate device are listed in #3. The similarities to the applicant's legally marketed predicate device include intend use, sample type, sample volume, overall scientific principle, and RNA extraction reagents.
5. A Design Control Activities Summary which includes:

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

The risk analysis method used to assess the impact of the modifications was identified as ISO 14971:2004 (pg. 21). A summary of Design Control activities was included to demonstrate a comparison between the manual and automated methods and any potential affect on RNA yield, purity, integrity, genomic DNA (gDNA) contamination, repeatability, reproducibility, reliability, hands-on time, and total preparation time.

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 (Repeatability and Reproducibility Test matrix and Verification and Validation tests, pg. 21-32).
c) A declaration of conformity with design controls. The declaration of conformity should include:

{1}

2

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 (Attachment 6), 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 (Attachment 6).

6. A Truthful and Accurate Statement, a 510(k) Summary 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 (or their preamendment) device.