PAXgene® Blood DNA Tube

K231469 · Preanalytix GmbH · PJE · Jun 21, 2023 · Clinical Chemistry

Device Facts

• Record ID: K231469
• Device Name: PAXgene® Blood DNA Tube
• Applicant: Preanalytix GmbH
• Product Code: PJE · Clinical Chemistry
• Decision Date: Jun 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Indications for Use

The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

Device Story

PAXgene® Blood DNA Tube; vacuum-filled blood collection tube; contains additive for stabilization of genomic DNA in whole blood; used for collection, transport, and storage of blood samples; modification involves change to nominal 2.5 mL draw volume range; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Clinical testing was conducted to validate performance following the draw volume specification change. Results demonstrated acceptable performance. No further specific metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

Vacuum-filled blood collection tube; contains chemical additive for genomic DNA stabilization; nominal draw volume 2.5 mL; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for collection, anticoagulation, stabilization, transport, and storage of venous whole blood for human DNA preparation for molecular diagnostic testing. No specific patient population, age, or gender restrictions provided; contraindications not specified.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• PAXgene® Blood DNA Tube (K142821)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K231469

B Applicant

PreAnalytiX GmbH

C Proprietary and Established Names

PAXgene® Blood DNA Tube

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PJE | Class II | 21 CFR 862.1675 - Blood Specimen Collection Device | CH - Clinical Chemistry |

## II Review Summary:

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: K142821, PAXgene® Blood DNA Tube.
2. Submitter's statement that the INDICATIONS FOR USE/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).
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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. The device modification is a change to the PAXgene® Blood DNA Tube’s nominal (2.5 mL) draw volume range.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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.

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.

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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