Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard PCR and ARMS technology, and the analysis is based on fluorescent signal detection and cycle threshold, which are typical for real-time PCR and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The device is described as a qualitative in vitro diagnostic test for the JAK2 V617F/G1849T allele, intended for use as an adjunct to evaluation of suspected Myeloproliferative Neoplasm. It is a diagnostic tool, not one that treats or prevents disease.

Diagnostic

Yes

This device is described as an "in vitro diagnostic test" for detecting a specific genetic allele. Its intended use is "as an adjunct to evaluation of suspected Myeloproliferative Neoplasm," indicating its role in assisting with a medical diagnosis, rather than being a standalone treatment or direct intervention.

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic kit that includes reagents and is used in conjunction with specific hardware instruments (QIAsymphony SP instrument and Rotor-Gene Q MDx instrument) for sample preparation, amplification, and detection. While it uses software (Rotor-Gene AssayManager), it is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ipsogen JAK2 RGQ PCR Kit is a "qualitative in vitro diagnostic test".
Device Description: The "Device Description" also refers to the kit as a "qualitative in vitro diagnostic test".
Sample Type: The test is performed on genomic DNA extracted from EDTA whole blood, which is a biological sample taken from the body.
Purpose: The test is intended for use as an adjunct to the evaluation of suspected Myeloproliferative Neoplasm, which is a medical condition.
Method: The test uses real-time PCR, a common technique used in in vitro diagnostics to detect specific genetic sequences.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The ipsogen JAK2 RGQ PCR Kit is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Myeloproliferative Neoplasm in conjunction with other clinicopathological factors.

This test does not detect less common JAK2 mutations associated with Myeloproliferative Neoplasm including mutations in exon 12 and is not intended for stand-alone diagnosis of Myeloproliferative Neoplasm.

Product codes (comma separated list FDA assigned to the subject device)

PSU

Device Description

The ipsogen® JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from whole blood. The ipsogen JAK2 RGQ PCR Kit uses polymerase chain reaction (PCR), and ARMS (amplification refractory mutation system) technology on the Rotor-Gene O MDx instrument.

Samples are extracted and prepared using the QIAsymphony SP instrument (QSSP) with the QIAsymphony® DSP DNA Mini Kit, followed by assay setup amplification and detection are carried out using the ipsogen JAK2 RGQ PCR Kit with the Rotor-Gene Q MDx and Rotor-Gene AssayManager software version 2.1.x**. Rotor-Gene AssayManager Gamma MDx plug-in installed, version 1.0.x** and an associated JAK2 Assay profile (from file AP ipsogen JAK2 blood US Vx x x**.iap).

The extraction step on the OIAsymphony instrument (OSSP) ensures that enough gDNA (of adequate quality) is purified during each run (no repeated extraction for the same sample is expected unless the instrument states that the step failed).

The ipsogen JAK2 RGQ PCR Kit is designed to be used with the Rotor-Gene Q MDx (RGO) instrument which is a real-time PCR analyzer designed for rapid thermal cvcling and real-time detection of PCR assays. The Rotor-Gene AssayManager (RGAM) controls and monitors PCR reactions and allows the determination of the mutation status based upon PCR results.

The presence of the JAK2 mutation is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the RGO MDx is inversely proportional to the DNA target concentration present in the original specimen.

The ipsogen JAK2 RGQ PCR Kit contains reagents for two separate PCR reactions: one mutation-specific reaction and one wild-type specific reaction mix uses a mutant-specific or wild-type specific primer (Reverse primer), together with a common Forward primer and a labeled probe, to amplify and detect the G1849T mutation or the wild-type sequence in the JAK2 gene.

In addition, each Reaction Mix contains reagents (unlabeled primers, probe and oligonucleotide template) for an internal control reaction. The internal control is designed to be a reaction that does not compete significantly with the mutation-specific or wildtype specific, reaction mixes. and serve to demonstrate that the entire assay process has proceeded correctly for each specimen.

Note: ** x≥ 0, x corresponds to the latest version available on OIAGEN Website

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

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)

Analytical Accuracy
The purpose of this study was to validate the analytical accuracy of the ipsogen JAK2 RGO PCR Kit under condition of normal use on clinical samples from subjects suspected of having myeloproliferative neoplasms. This study was performed on gDNA samples extracted from a total of 473 specimens: 276 with suspected PV, 98 with ET and 99 with PMF. The JAK2 V617F status of the patient samples obtained with the ipsogen JAK2 RGQ PCR kit were compared with the JAK2 V617F status obtained with the reference method for JAK2 status determination, i.e. an independently validated bi-directional sequencing (BDS). Of the 473 specimens 15 specimens were JAK2 positive by the ipsogen JAK2 RGQ PCR kit while negative by BDS.

The overall agreement is 96.8% (458/473 subjects; 95% CI: [94.8%; 98.2%]). The positive agreement was 100% (165/165 subjects: 95%Cl: [97.8%; 100%] and the negative agreement was 95.1 % (293/308 subjects; 95% CI: [92.1%; 97.2 %]). The results are shown in Table 2.

Assessment of analytical accuracy study results in MPN cohorts
For ET, the overall agreement is 90.8% (89/98 subjects; 95% CI: [83.3% - 95.7%]), the positive agreement is 100% (43/43 subjects; 95% CI: [91.8% - 100%]), and the negative agreement is 83.6% (46/55 subjects; 95% CI: [71.2% - 92.2%]).

For PMF. the overall agreement is 94.9% (94/99 subjects: 95% CI: [88.6% - 98.3%]), the positive agreement is 100% (51/51 subjects: 95% CI: [93.0% - 100%]), and the negative agreement is 89.6% (43/48 subjects; 95% CI: [77.3% – 96.5%]).

For PV, the overall agreement is 99.6% (275/276 subjects: 95% CI: [98.0% - 100%]), the positive agreement is 100% (71/71 subjects: 95% CI: [94.9% - 100%]), and the negative agreement is 99.5% (204/205 subjects; 95% CI: [97.3% - 100%]).

The specimens yielding discordant results appeared to have mutation levels below the BDS detection capability (around 10%). Because Sanger sequencing is not as sensitive as the JAK2 assay, and the JAK2 assay reporting ≥ 1%, a separate study was conducted using a validated next generation sequencing (NGS) method to detect JAK2 V617F allele in the 15 discordant samples (9 ET, 5 PMF, and 1 PV), as well as a randomly selected set of 22 JAK2 V617F positive and negative concordant specimens. All 15 discordants tested positive by NGS, agreeing with the ipsogen JAK2 RGQ PCR Kit. All concordant samples tested the same with NGS and in agreement with the ipsogen JAK2 RGO PCR Kit and BDS.

Conclusion of the analytical accuracy study
The ipsogen JAK2 RGQ PCR Kit was 100% accurate for the detection of JAK2 V617F allele in specimens from subjects with JAK2 V617F levels ≥1%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Overall agreement: 96.8% (458/473 subjects; 95% CI: [94.8%; 98.2%])
Positive agreement: 100% (165/165 subjects: 95%Cl: [97.8%; 100%])
Negative agreement: 95.1 % (293/308 subjects; 95% CI: [92.1%; 97.2 %])

For ET:
Overall agreement: 90.8% (89/98 subjects; 95% CI: [83.3% - 95.7%])
Positive agreement: 100% (43/43 subjects; 95% CI: [91.8% - 100%])
Negative agreement: 83.6% (46/55 subjects; 95% CI: [71.2% - 92.2%])

For PMF:
Overall agreement: 94.9% (94/99 subjects: 95% CI: [88.6% - 98.3%])
Positive agreement: 100% (51/51 subjects: 95% CI: [93.0% - 100%])
Negative agreement: 89.6% (43/48 subjects; 95% CI: [77.3% – 96.5%])

For PV:
Overall agreement: 99.6% (275/276 subjects: 95% CI: [98.0% - 100%])
Positive agreement: 100% (71/71 subjects; 95% CI: [94.9% - 100%])
Negative agreement: 99.5% (204/205 subjects; 95% CI: [97.3% - 100%])

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.

DEN160028

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.

Not Found

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

Regulation Number and Section

N/A

Summary

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January 12, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

QIAGEN, GmbH c/o Claire Ryan Senior Manager, Regulatory Affairs OIAGEN Manchester, LTD Skelton House, Lloyd Street North Manchester, M15 6SH UK

Re: K172287

Trade/Device Name: ipsogen® JAK2 RGQ PCR Kit Regulation Number: 21 CFR 866.6070 Regulation Name: Mutation detection test for myeloproliferative neoplasms Regulatory Class: Class II Product Code: PSU Dated: December 14, 2017 Received: December 14, 2017

Dear Claire Ryan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yun-fu Hu -S

for Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172287

Device Name ipsogen JAK2 RGQ PCR Kit

Indications for Use (Describe)

The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The ipsogen JAK2 RGQ PCR Kit is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Myeloproliferative Neoplasm in conjunction with other clinicopathological factors.

This test does not detect less common JAK2 mutations associated with Myeloproliferative Neoplasm including mutations in exon 12 and is not intended for stand-alone diagnosis of Myeloproliferative Neoplasm.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

General Information

| Submitted by: | QIAGEN GmbH
Qiagen Strasse 1
Hilden, Germany D-40724 | | |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| Contact Person: | Claire Ryan
Senior Manager, Regulatory Affairs
Skelton House,
Lloyd Street North,
Manchester,
M15 6SH,
UK
Phone: +44 161 204 1136
Fax: +44 161 204 1200
Email: claire.ryan@qiagen.com | | |
| Date Prepared: | July 28, 2017 | | |
| Device Name: | ipsogen® JAK2 RGQ PCR Kit | | |
| Trade Name: | ipsogen® JAK2 RGQ PCR Kit | | |
| Common Name: | Mutation detection test for myeloproliferative neoplasms | | |
| Classification: | Class II | | |
| Product Code: | PSU | | |
| Predicate Device | | | |
| Manufacturer | Product Name | 510(k) No. | |
| QIAGEN GmbH | ipsogen® JAK2 RGQ PCR Kit | DEN160028 | |

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