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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the PAXgene™ Blood RNA System, focusing on the acceptance criteria and the study proving it, as per your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K082150) does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K042613) by showing that the RNA obtained using the updated system (with QIAcube automation) is "compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR."

The core assertion is: "Therefore the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613."

Implicit Acceptance Criteria (derived from the justification of equivalence):

Acceptance Criteria Category	Specific Criteria (Implicit from Equivalence Claim)	Reported Device Performance
RNA Compatibility	RNA obtained using the automated protocol on QIAGEN's QIAcube must be compatible with molecular diagnostic applications.	"The RNA obtained from the QIAcube is compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR."
Equivalence to Predicate	The automated RNA purification process must be equivalent to the manual process of the predicate device (K042613) for RNA quality and quantity.	"the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613."
Target Transcripts	Performance characteristics for "cfos and IL1B" must be maintained. (This is an existing statement from the predicate's intended use and not a new criterion for this submission).	Performance for cfos and IL1B is implicitly maintained due to demonstrated equivalence to the predicate, which had established performance for these.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information provided is very high-level, stating only that "Design Control activities performed demonstrated the RNA obtained from the QIAcube is compatible..." This suggests an internal validation study, but no details on the participants or samples are given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The study described is a technical validation of RNA compatibility, not a diagnostic study requiring expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the study did not involve human interpretation or a "test set" in the sense of comparing human reads or diagnostic outcomes. It was an analytical performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or interpretation where different readers evaluate cases. The PAXgene™ Blood RNA System is a pre-analytical device for RNA purification.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The study described could be considered a form of "standalone" evaluation in that it evaluates the automated RNA purification process (the "algorithm" or automated protocol) on QIAGEN's QIAcube in isolation, without involving human interpretation of the purification process itself. However, "standalone" usually refers to the performance of a diagnostic algorithm independent of human input in the diagnostic decision. Here, the "performance" is the quality and yield of the RNA. The document focuses on demonstrating that the RNA produced by the automated system is equivalent to that produced by the manual system of the predicate device, for subsequent molecular diagnostic testing.

7. Type of Ground Truth Used

The "ground truth" in this context is the quality and quantity of RNA deemed acceptable for downstream molecular diagnostic applications, specifically RT-PCR, as well as the equivalence to the RNA produced by the predicate manual method. This is established through the "Design Control activities" and presumably involved analytical measurements (e.g., RNA yield, purity, integrity, and successful amplification of target transcripts like cfos and IL1B). It is an analytical validation against established laboratory standards and the performance of the predicate.

8. Sample Size for the Training Set

This information is not applicable/not provided. The PAXgene™ Blood RNA System is a chemical and mechanical system for RNA purification; it does not involve machine learning or AI models that require a "training set" in the conventional sense. The "training" here would be the development and optimization of the automated protocol itself.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for developing the automated protocol would have been achieving optimal RNA quality and yield comparable to the manual method, established through iterative testing and analytical measurements.

Summary

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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 GMBHFeldbachstrasse,Hombrechtikon Switzerland CH-8634
Registration Number:	3005202328
Contact Person:	M. Wendy BallesterosRegulatory Affairs ManagerTelephone no.: 201-847-6280Fax 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 andCosmetic Act

Intended Use

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Device Description:

The PAXgene™ Blood RNA System consists of:

PAXgene™ Blood RNA tubes
· PAXgene™ Blood RNA kit.

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 ofPrincipal Device	Operating Principal ofPredicate Device
The PAXgene™ Blood RNA Systemthat enables the collection, stabilization,storage, and transportation of wholeblood specimens, together with rapidand efficient manual and automatedprotocols for purification of intracellularRNA. The system requires the use ofPAXgene Blood RNA Tubes for bloodcollection and RNA stabilization,followed by RNA purification using thePAXgene Blood RNA Kit.	The PAXgene™ Blood RNA Systemthat enables the collection, stabilization,storage, and transportation of wholeblood specimens, together with a rapidand efficient protocol for purification ofintracellular RNA. The system requiresthe use of PAXgene Blood RNA Tubesfor blood collection and RNAstabilization, followed by RNApurification using the PAXgene BloodRNA Kit.

Change in Buffer BR5 (Elution Buffer) volume from 5 mL to 6 mL.

Principal Device	Predicate Device
Buffer BR5(Elution Buffer)6 mlAmmonium sulfate	Buffer BR5(Elution Buffer)5 mlAmmonium sulfate

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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

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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

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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

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CONFIDENTIAL

Indication for Use

510(k) Number (if known):

Device Name: PAXgene™ Blood RNA System

Indication For Use:

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

Regulation Number and Section

§ 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.