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.

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

AI/ML Overview

The provided text describes the performance characteristics of the ipsogen® JAK2 RGQ PCR Kit, a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele. This is a molecular diagnostic test, not an AI/imaging device, therefore, many of the requested criteria such as expert adjudication, MRMC studies, and AI-specific ground truth methodologies are not applicable.

Here's an attempt to extract and present the information as per your request, adapting to the nature of the device:

Acceptance Criteria and Device Performance Study for ipsogen® JAK2 RGQ PCR Kit

Note: This device is a molecular diagnostic PCR kit, not an AI-based imaging device. Therefore, criteria related to image analysis, expert readers, MRMC studies, and AI-specific ground truth establishment (like pathology or outcomes data for imaging) are not directly applicable. The "acceptance criteria" here relate to the analytical accuracy of the test in detecting a specific genetic mutation compared to a reference method.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria in a table format. However, the "Performance Characteristics - Non-Clinical Studies" section describes the study's objective and results, implying that the observed accuracy demonstrates the device's acceptable performance. The primary metric presented is concordance with a reference method (Sanger Bi-directional Sequencing, BDS, and subsequently Next Generation Sequencing, NGS).

Based on the study results, we can infer the performance:

Metric	Acceptance Criteria (Implied)	Reported Device Performance (vs. BDS)	Reported Device Performance (vs. NGS for discordant samples)
Overall Agreement	High concordance with reference method	96.8% (458/473 subjects)	All 15 discordant samples from BDS agree with ipsogen JAK2 RGQ PCR Kit.
Positive Agreement (Sensitivity)	High concordance for positive samples	100% (165/165 subjects)	Not explicitly stated as a separate metric for NGS, but implying high sensitivity given agreement with NGS.
Negative Agreement (Specificity)	High concordance for negative samples	95.1% (293/308 subjects)	Not explicitly stated as a separate metric for NGS.
Accuracy at ≥1% JAK2 V617F	100% accuracy for samples with ≥1% JAK2 V617F mutation levels (implied acceptance)	100% accuracy	100% accuracy

2. Sample Size and Data Provenance

Test Set Sample Size: 473 specimens.
- 276 with suspected Polycythemia Vera (PV)
- 98 with Myelofibrosis (ET)
- 99 with Primary Myelofibrosis (PMF)
Data Provenance: Not explicitly stated, but clinical samples from subjects suspected of having myeloproliferative neoplasms. It is likely retrospective as the samples appear to be collected and then tested. No country of origin is specified.
Training Set Sample Size: Not applicable for this type of analytical validation study. The kit is a diagnostic reagent system, not a machine learning model that undergoes training.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. Ground truth was established using standard molecular diagnostic methods (Sanger Bi-directional Sequencing and Next Generation Sequencing), not by human expert consensus as would be typical for image interpretation.
Qualifications of Experts: N/A as per above. These are laboratory-based reference methods.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was established by laboratory-based objective methods (BDS and NGS). Discordances were investigated by using a more sensitive reference method (NGS).

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

MRMC Study: No. This is a molecular diagnostic kit, not an AI/imaging device requiring human reader interpretation. Therefore, an MRMC study and
assessment of human reader improvement with AI assistance are not relevant.

6. Standalone Performance (Algorithm Only)

Standalone Performance: Yes, in a way. The "algorithm" here is the chemical and enzymatic process of the PCR kit and the associated instrument's detection capabilities. The study assesses the performance of the kit itself (the "device") in detecting the mutation, independent of human interpretation beyond typical lab procedures and result reporting. The kit's results are compared directly to the reference methods.

7. Type of Ground Truth Used

Type of Ground Truth:
- Primary Ground Truth: Sanger Bi-directional Sequencing (BDS).
- Confirmatory/Higher Sensitivity Ground Truth for discordant samples: Validated Next Generation Sequencing (NGS).
- The document notes that BDS is "not as sensitive as the JAK2 assay" (which reportedly detects down to 1%), and NGS was used to confirm the 15 discordant samples. This suggests that the ground truth evolved or was refined, with NGS serving as a more robust ground truth for low-level mutations.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. As stated before, this is a diagnostic kit, not an AI model requiring a training set. The "design" of the kit is based on established molecular biology principles, not data-driven learning.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device. The kit's design and validation rely on its analytical performance against known samples or samples characterized by established, robust reference methods.

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)

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 GmbHQiagen Strasse 1Hilden, Germany D-40724
Contact Person:	Claire RyanSenior Manager, Regulatory AffairsSkelton House,Lloyd Street North,Manchester,M15 6SH,UKPhone: +44 161 204 1136Fax: +44 161 204 1200Email: 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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Device Description

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

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Intended Use

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 EDTA whole blood. The ipsogen JAK2 RGO PCR Kit is a real time PCR test performed on the QIAGEN Rotor-Gene O MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Myeloproliferative Neoplasms, in conjunction with other clinicopathological factors.

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

Comparison of the ipsogen JAK2 RGQ PCR Kit and the Predicate Device

The ipsogen JAK2 RGQ PCR Kit is substantially equivalent to the predicate device

DEN160028: ipsogen JAK2 RGQ PCR Kit ●
Similarities and differences between the insogen JAK2 RGO PCR Kit and the predicate device are shown in Table 1.

Table 1: Comparison of the ipsogen JAK2 RGQ PCR Kit with the Predicate Device

Characteristic	Device	Predicate
Similarities
Specimen Type	genomic DNA extracted fromEDTA whole blood	genomic DNA extracted fromEDTA whole blood
Assay Targets	JAK2 V617F/G1849T allele	JAK2 V617F/G1849T allele
Genomic DNAExtraction	DNA should be extracted usingthe QIAsymphony SPinstrument in combination withthe QIAsymphony DSP DNAMini Kit	DNA should be extracted usingthe QIAsymphony SPinstrument in combination withthe QIAsymphony DSP DNAMini Kit
Amplification andDetectionTechnology	Real-time PCR DNAamplification	Real-time PCR DNAamplification
Characteristic	Device	Predicate
Amplification andDetectionInstrument System	Assay uses the Rotor-Gene Q MDx	Assay uses the Rotor-Gene Q MDx
Assay Controls	Positive Control, Negative Control and Internal Control included in the kit.	Positive Control, Negative Control and Internal Control included in the kit.
Differences
Intended Use	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 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 Neoplasms, in conjunction with other clinicopathological factors.This test does not detect less common JAK2 mutations associated with Myeloproliferative Neoplasms including mutations in exon 12 and is not intended for stand-alone diagnosis of Myeloproliferative Neoplasms.	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 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 Polycythemia Vera, in conjunction with other clinicopathological factors.This test does not detect less common mutations associated with Polycythemia Vera including mutations in exon 12 and is not intended for stand-alone diagnosis of Polycythemia Vera.
Amplification andDetectionInstrument SystemSoftware	• Rotor-Gene AssayManager® software version 2.1.x• Rotor-Gene AssayManager Gamma MDx plug-in installed, version 1.0.x• JAK2 Assay Profile (from file AP_ipsogen_JAK2_blood_U S_Vx_x_xiap)( x≥0, x corresponds to the latest version available on QIAGEN Website)	• Rotor-Gene AssayManager® software version 1.0.x (where x is greater than or equal to 4)• Rotor-Gene AssayManager JAK2 plug-in installed, version 1.0.x (where x is greater than or equal to 2)• JAK2 Assay Profile (from file AP_ipsogen_JAK2_blood_U S_V1.0.0.iap)

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The differences between the ipsogen JAK2 RGQ PCR Kit and the predicate device are the broader intended use statement which has been extended to include the evaluation of patients with suspected Myeloproliferative Neoplasms in addition to Polycythemia Vera and the software following the release of the updated Rotor Gene Assay Manager (RGAM) software. This includes the update to the Rotor-Gene AssayManager software, the Rotor-Gene AssayManager Gamma MDx plug-in and the JAK2 Assay Profile. The updated software includes updates to invalidating sample flags, however there is no change to the automated data analysis and interpretation of the results for the ipsogen JAK2 RGQ PCR Kit.

These differences do not affect substantial equivalency of the ipsogen JAK2 RGQ PCR Kit and the predicate device. Both assays detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood using the QIAGEN Rotor-Gene Q MDx instrument. The differences noted above do not raise questions of safety and effectiveness because both assays use the same controls, follow the same workflow for the same purpose of DNA extraction, assay setup, and Real-time PCR DNA amplification.

Therefore, the ipsogen JAK2 RGQ PCR Kit is substantially equivalent to the legally marked predicate device listed.

Performance Characteristics - Non-Clinical Studies in this 510(k)

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.

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		Sanger bi-directionalsequencing		Total
		JAK2 V617Fpositive	JAK2 V617Fnegative
ipsogen JAK2RGQ PCR Kit	JAK2 V617Fpositive	165	15	180
	JAK2 V617Fnegative	0	293	293
	Total	165	308	473

Table 2: Concordance table between ipsogen JAK2 RGQ PCR Kit and Sanger Bidirectional Sequencing in MPN population (combined ET, PMF and PV populations)

Assessment of analytical accuracy study results in MPN cohorts

The overall concordance between results obtained for the JAK2 V617F mutation with the ipsogen JAK2 RGO PCR Kit and with Sanger sequencing (BDS) in subjects with ET, PMF and PV are provided separately:

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 .

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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%.

Conclusions

The ipsogen JAK2 RGQ PCR Kit is substantially equivalent to the legally marketed QIAGEN ipsogen JAK2 RGQ PCR Kit.

Regulation Number and Section

§ 866.6070 Mutation detection test for myeloproliferative neoplasms.

(a)
Identification. A mutation detection test for myeloproliferative neoplasms is an in vitro diagnostic device intended for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from whole blood. The test is intended for use as an adjunct to evaluation of suspected polycythemia vera in conjunction with other clinicopathological factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of all components in the test, including the following:
(A) A detailed description, including illustrations or photographs of non-standard equipment or methods, of the test components, including all required reagents, instrumentation, and equipment.
(B) Detailed documentation of the device software, including standalone software applications and hardware-based devices that incorporate software.
(C) A detailed description of methodology and assay procedures including appropriate internal and external quality controls that are recommended or provided. The description must identify those control elements that are incorporated into the testing procedure.
(D) A detailed specification for sample collection, processing, and storage.
(E) A description of the criteria for test result interpretation and reporting including result outputs, analytical sensitivity of the assay, and the values that will be reported.
(ii) Information that demonstrates the performance characteristics of the test, including:
(A) For indications for use based on a threshold established in a predicate device of this generic type, device performance data from either a method comparison study to the predicate device or through a clinical study demonstrating clinical validity using well-characterized prospectively or retrospectively obtained clinical specimens, as appropriate, representative of the intended use population.
(B) For indications for use based on a threshold not established in a predicate device of this generic type, device performance data from a clinical study demonstrating clinical validity using well-characterized prospectively or retrospectively obtained clinical specimens, as appropriate, representative of the intended use population.
(C) Device reproducibility data generated, using a minimum of three sites, of which at least two sites must be external sites, with two operators at each site. Each site must conduct a study that includes at least two operators per site, two runs per operator per day over a minimum of three non-consecutive days evaluating a sample panel that contains allelic frequencies that span the claimed measuring range, and include the clinical threshold allelic frequency. Pre-specified acceptance criteria must be provided and followed.
(D) Information on device traceability and a description of the value assignment process for calibrators and controls.
(E) Device precision data using clinical samples and controls to evaluate the within-lot, between-lot, within-run, between-run, and total variation.
(F) Device linearity data generated from samples covering the device measuring range and for any standards used in the quantitation of allelic frequencies.
(G) Device analytic sensitivity data, including limit of blank and limit of detection.
(H) Device specificity data, including interference and cross-contamination.
(I) Device and clinical specimen stability data, including real-time stability (long-term storage and in-use stability) and stability evaluating various storage times, temperatures, and freeze-thaw conditions, as appropriate.
(iii) Identification of risk mitigation elements used by the device, including a detailed description of all additional procedures, methods, and practices incorporated into the instructions for use that mitigate risks associated with testing using the device.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use statement, including an indication for use that includes the variant(s) for which the assay was designed and validated, for example, JAK2 G1849T.
(ii) A detailed description of the performance studies conducted to comply with paragraph (b)(1)(ii) of this section and a summary of the results.