(189 days)
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No
The summary describes a system for collecting, stabilizing, and purifying RNA from blood for RT-PCR. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical and physical processes for RNA isolation.
No.
The device is intended for the collection, storage, and transport of blood for the stabilization, isolation, and purification of host RNA for RT-PCR used in molecular diagnostic testing, not for direct therapeutic treatment.
No
The device is intended for the collection, storage, transport, stabilization, and purification of RNA from blood for use in molecular diagnostic testing, not for directly performing the diagnosis itself. It is a sample preparation system that supports diagnostic testing.
No
The device description clearly states it consists of physical components: blood collection tubes, a purification kit with various buffers, enzymes, tubes, and columns. It is a system for collecting, storing, and purifying RNA from blood, not a software-only device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is used for "isolation and purification of host RNA from whole blood for RT-PCR used in molecular diagnostic testing." This directly aligns with the definition of an IVD, which are used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device is a system for collecting, storing, and processing blood samples to obtain RNA for downstream analysis. This is a typical function of IVD sample preparation devices.
- Performance Studies: The summary of performance studies mentions compatibility with "molecular diagnostic applications such as mRNA transcript level determination by RT-PCR." This further reinforces its use in a diagnostic context.
- Predicate Device: The predicate device listed is also the "PAXgene™ Blood RNA System," which is likely already classified as an IVD.
The fact that performance characteristics are established for specific targets (cfos and IL1B) and the user is responsible for validating others for "molecular diagnostic testing" confirms its intended use in a diagnostic workflow.
N/A
Intended Use / 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.
PAXgene Blood RNA Kit is for the purification of intracellular RNA from whole blood collected in the PAXgene Blood RNA Tube. When the kit is used in conjunction with the PAXgene Blood RNA Tube, the system provides purified intracellular 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 FOS and IL1B gene transcripts. The user is responsible for establishing appropriate PAXgene Blood RNA System performance characteristics for other target transcripts.
Product codes (comma separated list FDA assigned to the subject device)
NTW
Device Description
The PAXgene™ Blood RNA System consists of:
- PAXgene™ Blood RNA tubes
- · PAXgene™ Blood RNA kit.
The PAXgene™ Blood RNA tube is of a sterile, plastic, evacuated blood collection tube containing stabilization solution (tetradecyl trimethyl-ammonium oxalate and tartaric acid. These components serve to lyse cells, protect RNA molecules from degradation by ribonucleases (RNases) and prevent induction of gene expression. The kit consists of 5 aqueous buffer solutions for resuspending, binding, washing, and eluting RNA, RNase-free water, proteinase K. an RNase-Free DNase set, spin columns, microcentrifuge tubes, processing tubes, and secondary blood collection tube closures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Design Control activities performed demonstrated the RNA obtained from the QIAcube is compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR. Therefore the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.4070 RNA Preanalytical Systems.
(a)
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.(b)
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.
0
Ro 82150
510(k) Summary Of Safety and Effectiveness
FEB ~ 4 2009
This Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA of 1990 and 21 § 807.92
| Establishment: | PreAnalytiX GMBH
Feldbachstrasse,
Hombrechtikon Switzerland CH-8634 |
|------------------------|-----------------------------------------------------------------------------------------------------------|
| Registration Number: | 3005202328 |
| Contact Person: | M. Wendy Ballesteros
Regulatory Affairs Manager
Telephone no.: 201-847-6280
Fax No. 201-847-4858 |
| Date of Summary: | August 1, 2008 |
| Device: | |
| Trade Name: | PAXgene™ Blood RNA System |
| Classification Name: | RNA Preanalytical Systems |
| Classification: | Class II |
| Regulation: | 21 CFR 866.4070 |
| Product Code: | NTW |
| Panel | Immunology |
| Performance Standards: | None Established under 514 of the Food, Drug and
Cosmetic Act |
Intended 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.
1
Device Description:
The PAXgene™ Blood RNA System consists of:
- PAXgene™ Blood RNA tubes
- · PAXgene™ Blood RNA kit.
The PAXgene™ Blood RNA tube is of a sterile, plastic, evacuated blood collection tube containing stabilization solution (tetradecyl trimethyl-ammonium oxalate and tartaric acid. These components serve to lyse cells, protect RNA molecules from degradation by ribonucleases (RNases) and prevent induction of gene expression. The kit consists of 5 aqueous buffer solutions for resuspending, binding, washing, and eluting RNA, RNase-free water, proteinase K. an RNase-Free DNase set, spin columns, microcentrifuge tubes, processing tubes, and secondary blood collection tube closures.
Substantial Equivalence:
Based on comparison of the device features, materials, intended use and performance, the PAXgene™ Blood RNA System is shown to be substantially equivalent to the commercially available PAXqene™ Blood RNA System as described in K042613, cleared on April 14, 2005.
The PAXgene™ Blood RNA System described in this submission differs from the predicate device as described in K042613 as follows:
- Change in operating principal to allow automation of the PAXgene™ Blood RNA System sample purification process on QIAGEN's QIAcube instrument.
| Operating Principal of
Principal Device | Operating Principal of
Predicate Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The PAXgene™ Blood RNA System
that enables the collection, stabilization,
storage, and transportation of whole
blood specimens, together with rapid
and efficient manual and automated
protocols for purification of intracellular
RNA. The system requires the use of
PAXgene Blood RNA Tubes for blood
collection and RNA stabilization,
followed by RNA purification using the
PAXgene Blood RNA Kit. | The PAXgene™ Blood RNA System
that enables the collection, stabilization,
storage, and transportation of whole
blood specimens, together with a rapid
and efficient protocol for purification of
intracellular RNA. The system requires
the use of PAXgene Blood RNA Tubes
for blood collection and RNA
stabilization, followed by RNA
purification using the PAXgene Blood
RNA Kit. |
- Change in Buffer BR5 (Elution Buffer) volume from 5 mL to 6 mL.
| Principal Device | Predicate Device |
|---|---|
| Buffer BR5 | |
| (Elution Buffer) | |
| 6 ml | |
| Ammonium sulfate | Buffer BR5 |
| (Elution Buffer) | |
| 5 ml | |
| Ammonium sulfate |
2
Summary of Design Control Activities:
The Design Control activities performed demonstrated the RNA obtained from the QIAcube is compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR. Therefore the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613.
IM-2611176
M. Wendy Ballesteros Regulatory Affairs Manager BD Diagnostics - Preanalytical Systems Becton Dickinson and Company
Kyler Estes
Date
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.
FEB = 4 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
PreAnalytiX GmbH c/o Becton Dickinson and Co. Ms. Wendy Ballesteros Regulatory Affairs Manager 1 Becton Drive, MC 312 Franklin Lakes, NJ 07417
Re: K082150
Trade/Device Name: PAXgene™ Blood RNA System Regulation Number: 21 CFR 866.4070 Regulation Name: RNA Preanalytical Systems Regulatory Class: Class II Product Code: NTW Dated: December 05, 2008 Received: January 15, 2009
Dear Ms. Ballesteros:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see aboye) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding
4
Page 2 -- Ms. Wendy Ballesteros
of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ie mchan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
CONFIDENTIAL
Indication for Use
510(k) Number (if known):
Device Name: PAXgene™ Blood RNA System
Indication For Use:
PAXgene Blood RNA Kit is for the purification of intracellular RNA from whole blood collected in the PAXgene Blood RNA Tube. When the kit is used in conjunction with the PAXgene Blood RNA Tube, the system provides purified intracellular 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 FOS and IL1B gene transcripts. The user is responsible for establishing appropriate PAXgene Blood RNA System performance characteristics for other target transcripts.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off/
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082150