InActiv Blue is intended for the stabilization, transportation and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.

Device Description

InActiv Blue is a virus-inactivating and lysis solution that abrogates the infectious potential of the collected material without affecting the integrity of the RNA. Two milliliters of InActiv Blue solution are provided in a polypropylene flat bottom collection tube with a high-density polyethylene (HDPE) cap (product code IB TUB). The device is non-sterile, single use. Secondary Packaging for the collection tube configuration includes racks of 50 collection tubes and cardboard boxes with either 400 or 1200 collection tubes.

Sample types intended for collection with the device include upper respiratory swab samples. Swabs are not provided with the InActiv Blue collection tubes.

The active components of the InActiv Blue solution are guanidine thiocyanate, Nlauroylsarcosine sodium salt and EDTA. These components are formulated in a sodium phosphate buffered solution containing methylene blue.

AI/ML Overview

This document describes the performance of the InActiv Blue device, a microbial nucleic acid storage and stabilization device, for stabilizing and inactivating SARS-CoV-2 in upper respiratory specimens.

Here's the breakdown of the acceptance criteria and the study results:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as "acceptance criteria" but inferred from study outcomes)	Reported Device Performance
Shelf-Life Stability:
Maintain product integrity (pH, osmolarity, appearance, evaporation) for the claimed shelf-life.	Met all stability specifications for 21 months: pH (6 +/- 0.6), osmolarity (4200 +/- 420 mOsm/kg), and visual appearance (PASS) and evaporation (PASS).
Limit of Detection (LOD):
High probability of detection at a specified viral concentration (e.g., 95% positivity).	100% positive at 45 particles/mL and 90% positive at 15 particles/mL. LOD determined as 45 particles/mL.
Sample Stability (SARS-CoV-2 RNA):
SARS-CoV-2 RNA in specimens collected and stored in InActiv Blue should be stable for 7 days at refrigerated (2-8°C) or ambient (20-25°C) temperatures, with minimal Ct value shift.	All samples remained within 3 Ct of the initial reading after 7 days at both 2-8°C and 20-25°C, across multiple product lots.
Viral Inactivation:
Significant reduction in infectivity of SARS-CoV-2.	Log infectivity reduction factor of at least 3.89 logs for three different lots of InActiv Blue after 1, 2.5, and 5 minutes of exposure. This demonstrates substantial viral inactivation.

2. Sample Size and Data Provenance

The provided document does not explicitly delineate a "test set" in the context of an algorithm or AI device as it describes a physical collection device. However, the sample sizes and data provenance for the performance studies are detailed:

Shelf-Life Stability: At least eight lots of InActiv Blue were used. Samples were stored at room temperature (15-25°C). The study appears to be retrospective in terms of analyzing existing product lots over time. The country of origin of the data is not specified, but the applicant (FertiPro NV) is based in Belgium.
Limit of Detection (LOD):
- Preliminary LOD: SARS-CoV-2 at 5 concentrations (5, 15, 45, 135, 405 particles/mL), each performed in triplicate. Total 15 preliminary tests.
- Confirmatory LOD: For each concentration (15 and 45 particles/mL), 20 replicates were evaluated. Total 40 confirmatory tests.
- The matrix used was "nasopharyngeal clinical matrix" spiked with SARS-CoV-2. The data provenance (country, retrospective/prospective) is not explicitly stated.
Sample Stability Study: Six replicate samples containing nasopharyngeal matrix were used for each of the four lots of InActiv Blue tested (newly manufactured, middle-aged, near/recently expired, and stressed). Three replicates from each lot were stored at 2-8°C and three at 20-25°C. Total of 24 replicates (4 lots x 6 replicates). The matrix was "nasopharyngeal matrix" spiked with SARS-CoV-2. Data provenance is not explicitly stated.
Viral Inactivation: Three lots of InActiv Blue (near expiration) were used. For each lot, the study involved mixing virus stock 1:1 with InActiv Blue and incubating for 1, 2.5, and 5 minutes. No specific "sample size" of individual viral samples is mentioned beyond the use of 3 lots and multiple exposure times for each. Data provenance is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the device is a physical sample collection and stabilization device, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for the performance studies (e.g., viral load, RNA integrity) is established through laboratory assays (e.g., Roche cobas SARS-CoV-2 assay) and cell culture methods.

4. Adjudication Method for Test Set

This information is not applicable. The studies described are laboratory performance studies, not clinical studies requiring adjudications of diagnoses or interpretations by experts.

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

This information is not applicable. This device is not an AI or imaging device used by human readers, so an MRMC comparative effectiveness study is not relevant.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The InActiv Blue is a physical medical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

7. Type of Ground Truth Used

The ground truth used for these studies is scientific and laboratory-based:

Shelf-Life Stability: Physical and chemical properties of the solution (pH, osmolarity, visual inspection, evaporation) against predefined specifications.
Limit of Detection: Quantification of viral particles (SARS-CoV-2) using a legally marketed molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and determining the concentration at which a specified percentage of positive results are achieved.
Sample Stability: Detection and quantification of SARS-CoV-2 RNA using a molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and monitoring the change in Ct values over time, demonstrating RNA integrity.
Viral Inactivation: Measurement of residual infectivity of SARS-CoV-2 using cell culture (Vero E6 cells) and determining the cytopathic effect and TCID50 (Tissue Culture Infectious Dose 50%) via the Reed and Muench method to quantify log reduction in infectivity.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical collection and stabilization device and does not involve AI or machine learning models that require a training set. The development of such a device relies on chemical formulation, engineering, and manufacturing process control, rather than data-driven algorithm training.

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

This information is not applicable as there is no training set for this type of device.

Summary

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June 11, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.

FertiPro NV % Gregor Kleinert Official Correspondent Ducks in a Row Compliance LLC 1447 Bentley Drive Warrington, Pennsylvania 18976

Re: K221547

Trade/Device Name: InActiv Blue Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: May 26, 2022 Received: May 27, 2022

Dear Gregor Kleinert:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K221547

Device Name InActiv Blue

Indications for Use (Describe)

InActiv Blue is intended for the stabilization and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection, transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.

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 - K221547

Applicant:	FertiPro NVIndustriepark Noord 328730 BeernemBelgium
Establishment Registration No.:	3003272500
Primary correspondent:	Gregory P. KleinertDucks in a Row Compliance LLC.1447 Bentley DriveWarrington, PA 18976Phone: 215-858-2429Email: DucksComplianceLLC@gmail.com
Summary Date:	14 March 2024
Device Proprietary Name:	InActiv Blue
Classification Name:	Microbial Nucleic Acid Storageand Stabilization Device
Regulation:Class:Panel:Product code:	866.2950Class IIMicrobiologyQBD
Predicate Device:	K202641 – DNA/RNA Shield™ CollectionTube (Manufacturer: Zymo Research)

Intended Use/Indication for Use:

Device Description:

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Sample types intended for collection with the device include upper respiratory swab samples. Swabs are not provided with the InActiv Blue collection tubes.

Principles of Operation:

InActiv Blue main active components are guanidine thiocyanate, N-lauroylsarcosine and EDTA.

Guanidine thiocyanate is a chaotropic salt acting as a denaturing agent for macromolecules leading to virus inactivation. Additionally, guanidine acts as a ribonuclease (RNase) inhibitor, therefore preventing RNA degradation in samples and so keeping the virus RNA detectable for a longer period of time.

N-lauroylsarcosine (LS) is an anionic surfactant capable of reducing viral infection by interfering with the initial binding of the virus to the cells. Inactivation of SARS-CoV-2, is accomplished by disrupting the viral envelope, making it unable for the virus to enter cells. Additionally, LS is able to inhibit RNase and so protecting RNA from degradation, keeping the virus RNA detectable for a longer period of time.

EDTA is a chelating agent and nuclease inhibitor. Due to the high affinity of EDTA to divalent cations, such as Ca2+, Mn2+ and Mg2+, which act as cofactors for nucleases it could inhibit the degradation of RNA by RNases.

Comparison to Predicate Device

InActiv Blue has similar intended use, design and technological characteristics as the predicate device, DNA/RNA Shield Collection Tube (K202641). Below is a comparison table showing similarities and differences between InActiv Blue and predicate device K202641:

Device & Predicate Device(s):	Device: K221547	Predicate: K202641
Device Trade Name	InActiv Blue	DNA/RNA Shield CollectionTube
General DeviceCharacteristic Similarities

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Intended Use/Indications ForUse	InActiv Blue is intended for thestabilization, transportation andinactivation of upper respiratoryspecimens suspected ofcontaining SARS-CoV-2. Thesedevices can be used forcollection transport and storageof specimens at refrigerated (2-8°C) or ambient temperatures(20-25°C). SARS-CoV-2 RNAin the specimens is stabilized for7 days at these specifiedtemperatures. Specimenscollected and stored in anInActiv Blue collection tube aresuitable for use with legallymarketed molecular diagnosticdevices.	The DNA/RNA Shieldcollection tube is intended forthe stabilization and inactivationof upper and lower respiratoryhuman specimens suspected ofcontaining SARS-CoV-2. Thesedevices can be used forcollection transport and storageof specimens at ambienttemperatures (20-25°C).Specimens collected and storedin a DNA/RNA Shield collectiontube are suitable for use withlegally marketed moleculardiagnostic devices.
Inactivation	RNA virus particles	Same
Analyte	RNA	Same
General DeviceCharacteristic Differences
Sample Source	Human upper respiratory	Human lower and upperrespiratory
Sample storage Temperature	7 days at refrigerated (2-8°C) orambient temperatures (20-25°C)	28 days at 20-25°C

Performance Characteristics:

Shelf-Life Stability:

Shelf-life stability of InActiv Blue was evaluated to ensure product integrity over the complete shelf-life of the product. Completed real-time stability studies included at least eight lots of InActiv Blue which have been stored at room temperature for different periods of time, with performance testing conducted at regularly spaced timepoints to support a 21-month shelf-life stability claim.

At each time points, appearance by visual inspection pH (6+/- 0.6), osmolarity (mOsm/kg 4200+/-420) and evaporation were assessed. The product met all stability specifications for the duration of the study, supporting 21 months of shelf life. The results are summarized below (Table 1).

Table 1: Shelf-life Stability of InActiv Blue when stored at 15-25°C

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InActivBlue lotsstored at15-25°C	Lotnumber	Sample age	pH ^	Osmolality(mOsm/kg)^^	Appearance *	Evaporation**
Recentlyproduced	FP23IB06	38 days	6.02	435	PASS	PASS
Intermediate aged	FP23IB03	12 months	6.03	438	PASS	PASS
	FP23IB02	12 months	6.06	449	PASS	PASS
	FP23IB01	12 months	6.07	448	PASS	PASS
	Expiredbatches	FP21IB06	> 21months	5.97	460	PASS
FP21IB04		> 21months	5.90	459	PASS	PASS
FP21IB03		> 21months	5.95	461	PASS	PASS
FP20IB06		> 21months	6.02	452	PASS	PASS

^ Mean of three determinations. At production, pH values range from 5.98 to 6.03

^^ Mean of three determinations. At production osmolarity values range from 396 to 441 mOsm/kg. Determinations were made on product diluted 1:10

Criteria: labeling does not show decreased quality and adheres well to the tube, and liquid is clear ** Criterium: >1.5 mL of InActiv Blue

Limit of Detection:

The limit of detection (LOD) of SARS-CoV-2 in InActiv Blue was established through preliminary and confirmatory LOD studies. The LOD was determined for InActiv Blue with nasopharyngeal swab samples, using the Roche cobas SARS-CoV-2 assay (EUA200009) on the cobas 6800 system.

The preliminary LOD was determined by spiking InActiv Blue with nasopharyngeal clinical matrix and SARS-CoV-2 at concentrations of 5, 15, 45, 135, and 405 particles/mL, with each determination performed in triplicate. The LOD was found to be within the range of 5-45 particles/mL.

	Table 1. Preliminary LOD Study Results
--	----------------------------------------	--	--	--

SARS-CoV-2(particles/mL)	Number ofPositiveReplicates	Number ofNegativeReplicates	% Positive
5	1	2	33%
15	3	0	100%
45	3	0	100%

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135	3	0	100%
405	3	0	100%

The confirmatory LOD was established by spiking a swab with negative clinical nasopharyngeal matrix containing either 15 or 45 SARS-CoV-2 particles/mL, into InActiv Blue media. A total of 20 replicates were evaluated for each concentration. The nasopharyngeal swabs in InActiv Blue, containing 45 particles/mL, showed that 100% of the replicates were positive, and at a concentration of 15 particles/mL 90% of the replicates were positive.

Table 2. Confirmatory LOD Study Results
-----------------------------------------	--

SARS-CoV-2(particles/mL)	NumberofPositiveSamples	NumberofNegativeSamples	% Positive
15	19	2	90%
45	21	0	100%

The LOD for nasopharyngeal swab specimen in InActiv Blue was determined to be 45 particles/mL of SARS-CoV-2.

Sample Stability Study:

Stability of SARS-CoV-2 in nasopharyngeal specimens stored InActiv Blue was evaluated using product lots of different ages to ensure that there is no decrease in the performance of the product over its claimed shelf-life. Lots of InActiv Blue from different ages (newly manufactured, middle aged and near/recently expired lots), spanning the claimed shelf-life were evaluated. Six replicate samples containing nasopharyngeal matrix were collected and stored in each of the lots of InActiv Blue. Each replicate was spiked with 135 particles/mL (= 3x LOD). Three of the replicates from each lot were stored at 2-8°C while the other 3 replicates were stored at 20-25°C for at least 7 days. Each sample was evaluated using the cobas SARS-CoV-2 assay (EUA200009) on the 6800 system at day 0, day 4 and day 7. All samples collected in the four lots and stored at both temperatures remained within 3 Ct of the initial reading, supporting the sample stability claim for InActiv Blue of 7 days at a temperature between 2-8 and 20-25°C. The following table summarizes the results obtained.

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StorageTemperature	Lotmanufacturingage	Lot #	Target 1 (ORF 1Ab)Delta Ct's		Target 2 (E gene)Delta Ct's
			Ct Day4 - CtDay 0	Ct Day7 - CtDay 0	Ct Day4 - CtDay 0	Ct Day7 - CtDay 0
4°C	new	FP23IB01	-0.12	0.00	0.74	0.80
	middle aged	FP21IB04	0.09	0.20	0.80	0.37
	after expiry date	FP21IB01	-0.36	0.05	0.13	0.12
	stressed	FP21IB01	-0.30	0.84	0.42	0.97
20°C	new	FP23IB01	-0.55	-0.22	-0.87	-0.49
	middle aged	FP21IB04	-0.23	0.47	0.33	0.45
	after expiry date	FP21IB01	0.02	-0.41	1.10	-0.42
	stressed	FP21IB01	-0.27	-0.37	0.63	-0.05

Table 3. SARS-CoV-2 RNA stability after 4 and 7 days of incubation at 2-8°C and 20-25°C

Viral Inactivation:

Inactivation was evaluated by measuring the presence of residual infective SARS-CoV-2 viral particles spiked into InActiv Blue. Inactivation studies were conducted in two phases. First a 1:1000 dilution of InActiv Blue was established to eliminate the cytotoxicity of the medium. Higher concentrations of medium were found to render the cultured cells nonviable and unusable for the viral inactivation study. The second phase of viral inactivation evaluated cvtotoxicity of SARS-COV-2 spiked into a 1:1000 dilution of the transport media for 1, 2.5 and 5 minutes after inoculation.

The second phase of the study used a high concentration of infectious viral particles (TCID50mL=10 75 or 10 739). Briefly, 100 uL of virus stock was mixed 1:1 with InActiv Blue and incubated for 1, 2.5 and 5 minutes. Negative and positive controls were prepared similarly. The virus and InActiv Blue (as well as positive and negative control samples) were then diluted 1:1000 before each replicate was added to cell culture plates containing adherent Vero E6 cells to determine the minimal incubation time required to inactivate virus. Cultures were incubated for several minutes and observed for presence or absence of cytopathic effect and TCID50 was calculated by the Reed and Muench method. Virus inactivation was evaluated using 3 lots near the expiration of InActiv Blue (approximately 21 months old). Inactivation performance of InActiv Blue after 1 minute exposure was comparable to 2.5 and 5 minutes of exposure for each of the three batches of InActiv Blue evaluated.

Since the starting viral concentration was 7.5 logs (TCIDsomL=10 7.5) for two of the lots examined and 7.39 logs (TCID50mL=10 7.39) for the third lot, the log infectivity reduction factor was calculated to be at least 3.89 logs for the virus exposed to InActiv Blue medium. Negative

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control (without virus) demonstrated minimal cellular toxicity and positive control (virus in DMEM) showed no meaningful loss of viral recovery (data not shown). The study results are summarized in Table 4 below.

Lot	exposure time	log (TCID50 control) - log(TCID50 test)	virus log reduction factor
1	1 min	7.50-3.50	4
1	2.5 min	7.50-3.50	4
1	5 min	7.50-3.50	4
2	1 min	7.50-3.50	4
2	2.5 min	7.50-3.50	4
2	5 min	7.50-3.50	4
3	1 min	7.39-3.50	3.89
3	2.5 min	7.39-3.50	3.89
3	5 min	7.39-3.50	3.89

Table 4: SARS-CoV-2 Viral Inactivation when exposed to InActiv Blue

Regulation Number and Section

§ 866.2950 Microbial nucleic acid storage and stabilization device.

(a)
Identification. A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.