(217 days)
Not Found
No
The summary describes a standard real-time PCR assay and automated system for detecting viral DNA. There is no mention of AI or ML in the intended use, device description, or performance studies. The result calculation and reporting are likely based on predefined thresholds and algorithms, not learning models.
No
This device is an in vitro diagnostic (IVD) assay designed to detect and differentiate viral DNA, aiding in diagnosis, not providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster active cutaneous or mucocutaneous infections."
No
The device is an in vitro diagnostic (IVD) assay that requires specific reagents and is run on a dedicated automated hardware system (Alinity m System). It is not solely software.
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 assay is an "in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens". This describes a test performed outside of the body on a biological sample to aid in diagnosis.
- Device Description: The "Device Description" further clarifies that it is an "in vitro real-time polymerase chain reaction (PCR) assay" and is intended for use with an automated system to perform the test. It also describes the components of the assay kits, which are reagents used for in vitro testing.
- Clinical Performance Evaluation: The document details clinical performance studies using patient specimens, which is a standard requirement for demonstrating the effectiveness of an IVD.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This description perfectly aligns with the information provided about the Alinity m HSV 1 & 2 / VZV assay.
N/A
Intended Use / Indications for Use
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 2 and/or varicella-zoster infection. The Alinity m HSV 1 & 2 / VZV assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster active cutaneous or mucocutaneous infections. Negative results do not preclude herpes virus type 1, herpes simplex virus type 2 or varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions.
The Alinity m HSV 1 & 2 / VZV assay is not intended for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Alinity m HSV 1 & 2 / VZV assay is not intended for use in prenatal screening.
Product codes (comma separated list FDA assigned to the subject device)
PGI
Device Description
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. This assay is intended for use with the automated Alinity m System.
The steps of the Alinity m HSV 1 & 2 / VZV assay consist of sample preparation, PCR assembly, amplification/detection, and result calculation and reporting. The steps involved in all stages of the Alinity m HSV 1 & 2 / VZV assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random access analyzer that can perform the Alinity m HSV 1 & 2 / VZV assay in parallel with other Alinity assays on the same instrument.
The Alinity m HSV 1 & 2 / VZV assay requires two separate assay specific kits as follows:
- The Alinity m HSV 1 & 2 / VZV AMP Kit (List No. 09N61-095) is comprised of 2 types of multi-well trays:
TRAY 1: Alinity m HSV 1 & 2 / VZV AMP TRAY 1 TRAY 2: Alinity m HSV 1 & 2 / VZV ACT TRAY 2.
TRAY 1 - Alinity m HSV 1 & 2 / VZV AMP is individually packed in a foil pouch and contains 48 unit-dose liquid amplification reagent wells and 48 unitdose liquid IC wells. One well of each is used per test.
· Amplification reagent wells consist of synthetic oligonucleotides, DNA Polymerase, dNTPs, and 0.15% ProClin® 950 in a buffered solution with a reference dye. IC wells consist of plasmid DNA with unrelated IC sequences and poly dA:dT in a TE buffer containing 0.15% ProClin 950 as a preservative.
TRAY 2 - Alinity m HSV 1 & 2 / VZV ACT is individually packed in a foil pouch and contains 48 unit-dose liquid activation reagent wells. One reagent well is used per test.
· Activation reagent wells consist of magnesium chloride, potassium chloride, and tetramethylammonium chloride. Preservative: 0.15% ProClin 950.
- The Alinity m HSV 1 & 2 / VZV CTRL Kit (09N61-085) consists of negative controls and positive controls, each supplied as liquid in single-use tubes.
Alinity m HSV 1 & 2 / VZV Negative CTRL (List No. 9N61Z) consists of Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950).
Alinity m HSV 1 & 2 / VZV Positive CTRL (List No. 9N61W) consists of linearized plasmid DNA containing HSV-1, HSV-2 and VZV DNA sequences in Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950).
The Alinity m HSV 1 & 2 / VZV assay is to be run on the Alinity m System which is a fully integrated, sample to result automated system that performs real-time PCR test using the Alinity m HSV 1 & 2 / VZV AMP Kit along with the Alinity m HSV 1 & 2 / VZV CTRL Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cutaneous or mucocutaneous lesion swab specimens
Indicated Patient Age Range
all ages, including pediatric and geriatric populations
Intended User / Care Setting
Clinician-collected samples
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Prospective Study:
- Sample Size: A total of 1,258 results were included in the clinical performance analysis for each analyte (1,257 results for HSV-1, 1,257 results for HSV-2, and 1,257 results for VZV).
- Data Source: Multicenter, prospective clinical study conducted using swab specimens from lesions (including cutaneous and mucocutaneous) of symptomatic individuals suspected of HSV-1, HSV-2, and/or VZV infection at geographically diverse locations in the US. All lesion swab specimens were prospectively collected in BD UVT, COPAN UTM, or Remel M4RT collection media.
- Annotation Protocol: The Alinity m HSV 1 & 2 / VZV assay results for each analyte were directly compared to commercially available NAAT comparator method (NAAT 1). For specimens with discordant results between Alinity m and the comparator method, testing with a second commercially available RT-PCR comparator method was performed (NAAT 2).
Retrospective Study:
- Sample Size: A total of 411 specimens were included in the clinical performance analysis that had results for at least one of the analytes (410 results for HSV-1, 410 results for HSV-2, and 411 results for VZV).
- Data Source: Archived, leftover lesion swab specimens from routine clinical testing, collected from male and female individuals of all ages, including pediatric and geriatric populations. All lesion swab specimens were previously collected in BD UVT, COPAN UTM, or Remel M4RT collection media per standard of care. One lesion swab specimen was obtained from each individual.
- Annotation Protocol: The Alinity m HSV 1 & 2 / VZV assay results for each analyte were directly compared to commercially available NAAT comparator method (NAAT 1). For specimens with discordant results between Alinity m and the comparator method, testing with a second commercially available RT-PCR comparator method was performed (NAAT 2).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Studies:
- Analytical Sensitivity/Limit of Detection (LoD): The LoD for Alinity m HSV 1 & 2 / VZV assay for each analyte was determined by quantified (TCID50/mL) cultures of HSV-1 (Maclntyre), HSV-2 (MS) or VZV (Ellen) viral strains.
- HSV-1 (MacIntyre): 5.90 TCID50/mL
- HSV-2 (MS): 2.07 TCID50/mL
- VZV (Ellen): 0.055 TCID50/mL
- Inclusivity: Tested 5 HSV-1 strains/isolates, 3 HSV-2 strains/isolates, and 5 VZV strains/isolates. All strains were detected at a level of 3X LoD.
- Analytical Specificity - Cross Reactivity and Microbial Interference: Tested 55 potential cross-reacting microorganisms (viruses, bacteria, and fungi). No cross-reactivity or interference was observed.
- Interfering Substances: Evaluated 24 potentially interfering endogenous and exogenous substances. No evidence of interference (false positive or false negative results) was found.
- Competitive Interference: Evaluated three panel members with 2 analytes at 3X LoD and the third at 1000X LoD. All replicates at low concentration were detected, and high concentration targets did not interfere with low-level detection.
- Carryover Contamination: Tested 360 alternating replicates of negative and high-positive samples. Overall carryover rate was 0.0% (0/360, 95% CI: 0.0%, 1.1%).
- Within-Laboratory Precision: Evaluated using a 4-member precision panel (Moderate Positive, Low Positive, Sub-LoD, Negative) with 90 replicates per panel member. Results showed good precision. Negative panel member showed no detection.
- Reproducibility Study: Evaluated using a 4-member reproducibility panel (Positive, Low Positive, High Negative, Negative) at 3 external sites using 3 kit lots. Overall good reproducibility was demonstrated.
Clinical Performance Evaluation:
- Prospective Study:
- Study Type: Multicenter, prospective clinical study.
- Sample Size: 1,257 results for HSV-1, 1,257 results for HSV-2, and 1,257 results for VZV.
- Standalone Performance: Not explicitly stated as standalone, but compared to a commercially available NAAT comparator method (NAAT 1). Discordant samples were tested with a second comparator (NAAT 2) for information only.
- Key Results:
- HSV-1: PPA = 97.6% (123/126) (93.2, 99.2), NPA = 98.9% (1119/1131) (98.2, 99.4)
- HSV-2: PPA = 99.2% (122/123) (95.5, 99.9), NPA = 99.2% (1125/1134) (98.5, 99.6)
- VZV: PPA = 97.7% (43/44) (88.2, 99.6), NPA = 99.8% (1211/1213) (99.4, 100.0)
- Retrospective Study:
- Study Type: Retrospective study.
- Sample Size: 410 results for HSV-1, 410 results for HSV-2, and 411 results for VZV.
- Standalone Performance: Not explicitly stated as standalone, but compared to a commercially available NAAT comparator method (NAAT 1). Discordant samples were tested with a second comparator (NAAT 2) for information only.
- Key Results:
- HSV-1: PPA = 100.0% (72/72) (94.9, 100.0), NPA = 96.2% (325/338) (93.5, 97.7)
- HSV-2: PPA = 98.7% (74/75) (92.8, 99.8), NPA = 95.8% (321/335) (93.1, 97.5)
- VZV: PPA = 97.8% (44/45) (88.4, 99.6), NPA = 98.4% (360/366) (96.5, 99.2)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study:
- HSV-1: PPA = 97.6% (123/126), NPA = 98.9% (1119/1131)
- HSV-2: PPA = 99.2% (122/123), NPA = 99.2% (1125/1134)
- VZV: PPA = 97.7% (43/44), NPA = 99.8% (1211/1213)
Retrospective Study:
- HSV-1: PPA = 100.0% (72/72), NPA = 96.2% (325/338)
- HSV-2: PPA = 98.7% (74/75), NPA = 95.8% (321/335)
- VZV: PPA = 97.8% (44/45), NPA = 98.4% (360/366)
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.
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
§ 866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
(a)
Identification. A herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel is a qualitative in vitro diagnostic device intended for the simultaneous detection and differentiation of different herpes viruses in cutaneous and mucocutaneous lesion samples from symptomatic patients suspected of Herpetic infections. Negative results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use in cerebrospinal fluid samples.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed documentation for the device description, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer design and selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.
(3) Premarket notification submissions must include detailed documentation of a clinical study using lesion samples in which Herpes Simplex Virus 1, Herpes Simplex Virus 2, or Varicella Zoster Virus DNA detection was requested. The study must compare the device performance to an appropriate well established reference method.
(4) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(5) The device labeling must include a limitation statement that reads: “The device is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS).”
(6) Premarket notification submissions must include quality assurance protocols and a detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(7) The risk management activities performed as part of the manufacturer's 21 CFR 820.30 design controls must document an appropriate end user device training program that will be offered as part of efforts to mitigate the risk of failure to correctly operate the instrument.
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Image /page/0/Picture/0 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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
Abbott Molecular Inc. Stacy Ferguson Director Regulatory Affairs 1300 E Touhy Ave, Des Plaines. IL 60018.
Re: K233349
Trade/Device Name: Alinity m HSV 1 & 2 / VZV Regulation Number: 21 CFR 866.3309 Regulation Name: Herpes Virus Nucleic Acid-Based Cutaneous And Mucocutaneous Lesion Panel Regulatory Class: Class II Product Code: PGI Dated: March 26, 2024 Received: March 26, 2024
Dear Stacy Ferguson:
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/cdrb/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 (OS) 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 QS 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 (QS) 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 mediation-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).
Sincerelv.
Laura E. Ulitzky Digitally signed by Laura E. Date: 2024.05.03 13:24:17 -5 -04'00'
Laura Ulitzky, Team Lead on behalf of:
Ryan Karsner, MD Branch Chief Deputy Assistant Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological HealthEnclosure
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Indications for Use
510(k) Number (if known) K233349
Device Name Alinity m HSV 1 & 2 / VZV
Indications for Use (Describe)
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 2 and/or varicella-zoster infection. The Alinity m HSV 1 & 2 / VZV assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster active cutaneous or mucocutaneous infections. Negative results do not preclude herpes virus type 1, herpes simplex virus type 2 or varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions.
The Alinity m HSV 1 & 2 / VZV assay is not intended for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Alinity m HSV 1 & 2 / VZV assay is not intended for use in prenatal screening.
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
Submitter
| Applicants Name and Address: | Abbott Molecular Inc.
1300 E. Touhy Ave
Abbott Molecular Inc. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stacy Ferguson
Director Regulatory Affairs
Abbott Molecular, Inc.
1350 E. Touhy Avenue
Des Plaines, IL 60018
Phone: 224-206-4081 |
| Date Prepared: | May 1, 2024 |
Device Information
| Trade Name | Regulation Name | Product
Code | Regulation
Number | Class |
|---------------------------|---------------------------------------------------------------------------|-----------------|----------------------|-------|
| Alinity m HSV 1 & 2 / VZV | Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel. | PGI | 21 CFR
866.3309 | II |
Predicate Device
| Predicate Device | Product Code | 510(k) | Date Cleared |
|---|---|---|---|
| Lyra Direct HSV 1 + 2/VZV Assay | PGI | K133448 | May 13, 2014 |
Intended Use
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. The Alinity m HSV 1 & 2 / VZV assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicellazoster active cutaneous or mucocutaneous infections. Negative results do not preclude herpes simplex virus type 1, herpes simplex virus type 2 or varicella-zoster virus
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infections and should not be used as the sole basis for diagnosis, treatment or other management decisions.
The Alinity m HSV 1 & 2 / VZV assay is not intended for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Alinity m HSV 1 & 2 / VZV assay is not intended for use in prenatal screening.
Device Description
The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician--collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. This assay is intended for use with the automated Alinity m System.
The steps of the Alinity m HSV 1 & 2 / VZV assay consist of sample preparation, PCR assembly, amplification/detection, and result calculation and reporting. The steps involved in all stages of the Alinity m HSV 1 & 2 / VZV assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random access analyzer that can perform the Alinity m HSV 1 & 2 / VZV assay in parallel with other Alinity assays on the same instrument.
The Alinity m HSV 1 & 2 / VZV assay requires two separate assay specific kits as follows:
- The Alinity m HSV 1 & 2 / VZV AMP Kit (List No. 09N61-095) is comprised of 2 types of multi-well trays:
TRAY 1: Alinity m HSV 1 & 2 / VZV AMP TRAY 1 TRAY 2: Alinity m HSV 1 & 2 / VZV ACT TRAY 2.
TRAY 1 - Alinity m HSV 1 & 2 / VZV AMP is individually packed in a foil pouch and contains 48 unit-dose liquid amplification reagent wells and 48 unitdose liquid IC wells. One well of each is used per test.
· Amplification reagent wells consist of synthetic oligonucleotides, DNA Polymerase, dNTPs, and 0.15% ProClin® 950 in a buffered solution with a reference dye. IC wells consist of plasmid DNA with unrelated IC sequences and poly dA:dT in a TE buffer containing 0.15% ProClin 950 as a preservative.
TRAY 2 - Alinity m HSV 1 & 2 / VZV ACT is individually packed in a foil pouch and contains 48 unit-dose liquid activation reagent wells. One reagent well is used per test.
5
· Activation reagent wells consist of magnesium chloride, potassium chloride, and tetramethylammonium chloride. Preservative: 0.15% ProClin 950.
| Alinity m HSV 1 & 2 / VZV Assay Kit | |
|---|---|
| Alinity m HSV 1 & 2 / VZV AMP Kit | Quantity 192 Tests |
| Alinity m HSV 1 & 2 / VZV AMP TRAY 1 | 4 Trays/48 Test Each |
| Alinity m HSV 1 & 2 / VZV ACT TRAY 2 | 4 Trays/48 Test Each |
- The Alinity m HSV 1 & 2 / VZV CTRL Kit (09N61-085) consists of negative controls and positive controls, each supplied as liquid in single-use tubes.
Alinity m HSV 1 & 2 / VZV Negative CTRL (List No. 9N61Z) consists of Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950).
Alinity m HSV 1 & 2 / VZV Positive CTRL (List No. 9N61W) consists of linearized plasmid DNA containing HSV-1, HSV-2 and VZV DNA sequences in Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950).
| Alinity m HSV 1 & 2 / VZV Control Kit | |
|---|---|
| Alinity m HSV 1 & 2 / VZV Negative CTRL | 12 Tube x 0.75 mL |
| Alinity m HSV 1 & 2 / VZV Positive CTRL | 12 Tube x 0.75 mL |
The Alinity m HSV 1 & 2 / VZV assay is to be run on the Alinity m System which is a fully integrated, sample to result automated system that performs real-time PCR test using the Alinity m HSV 1 & 2 / VZV AMP Kit along with the Alinity m HSV 1 & 2 / VZV CTRL Kit.
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Similarities and Differences to Predicate Device
| Device and
Predicate | New Device
K233349 | Predicate Device
K133448 |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Number | Alinity m HSV 1 & 2 / VZV Assay | Lyra Direct HSV 1 + 2/VZV Assay |
| Similarities | | |
| Intended Use | The Alinity m HSV 1 & 2 / VZV assay is
an in vitro real-time polymerase chain
reaction (PCR) assay for the qualitative
detection and differentiation of Herpes
Simplex Virus 1 (HSV-1), Herpes Simplex
Virus 2 (HSV-2), and Varicella Zoster
Virus (VZV) DNA from clinician-
collected cutaneous or mucocutaneous
lesion swab specimens from symptomatic
patients suspected of active herpes simplex
virus 1, herpes simplex virus 2 and/or
varicella-zoster virus infection. The Alinity
m HSV 1 & 2 / VZV assay is intended to
aid in the diagnosis of herpes simplex virus
1, herpes simplex virus 2 and/or varicella-
zoster virus active cutaneous or
mucocutaneous infections. Negative
results do not preclude herpes simplex
virus type 1, herpes simplex virus type 2 or
varicella-zoster virus infections and should
not be used as the sole basis for diagnosis,
treatment or other management decisions.
The Alinity m HSV 1 & 2 / VZV assay is
not intended for use with cerebrospinal
fluid (CSF) or to aid in the diagnosis of
HSV or VZV infections of the central
nervous system (CNS). The Alinity m
HSV 1 & 2 / VZV assay is not intended for
use in prenatal screening. | The Lyra Direct HSV 1 + 2/VZV Assay is
an in vitro multiplex Real-Time PCR test
for qualitative detection and differentiation
of herpes simplex virus type 1, herpes
simplex virus type 2, and varicella-zoster
virus DNA isolated and purified from
cutaneous or mucocutaneous lesion
samples obtained from symptomatic
patients suspected of active herpes simplex
virus 1, herpes simplex virus 2 and/or
varicella-zoster infection. The Lyra Direct
HSV 1 + 2/VZV Assay is intended to aid
in the diagnosis of herpes simplex virus 1,
herpes simplex virus 2 and varicella-zoster
virus active cutaneous or mucocutaneous
infections. Negative results do not
preclude herpes simplex virus 1, herpes
simplex virus 2 and varicella-zoster virus
infections and should not be used as the
sole basis for diagnosis, treatment or other
management decisions. The Lyra Direct
HSV 1 + 2/VZV Assay is not intended for
use with cerebrospinal fluid or to aid in the
diagnosis of HSV or VZV infections of the
central nervous system (CNS). The Lyra
Direct HSV 1 + 2/VZV Assay is not
intended for use in prenatal screening. The
device is not intended for point-of-care
use. |
| Assay Type | Qualitative | Same |
| Assay Targets | Viral DNA from HSV-1, HSV-2, and VZV | Same |
| Specimen Types | Cutaneous and Mucocutaneous
(Lesion and Lesion swab specimens) | Same |
| Amplification
Technology | Real-Time Polymerase Chain Reaction
(PCR) | Same |
| Automated
Analysis | Yes | Same |
| Assay Controls | Negative Control Positive Control | Same |
| Differences | | |
| Assay Steps | All steps of the Alinity m HSV 1 & 2 /
VZV assay procedure are executed
automatically by the Alinity m System.
No intermediate processing or transfer
steps are performed by the user. | Assay processing steps are executed
manually until placed on instrument for
signal evaluation:
• Life Technologies QuantStudio Dx
• Applied Biosystems 7500 Fast Dx
• Cepheid SmartCycler II System |
| Sample
Preparation
Instrument
Components | Automated liquid handling and robotic
manipulation platform.
Automated process for sample processing
using an internal control (IC) | Mechanical lysis and addition of Process
Buffer. Manual process for sample
processing using the processing control
(PRC) |
| Reagent Kit
Storage
(Unopened) until
expiration date | -25°C to -15°C | 2°C to 8°C |
7
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Analytical Studies
Analytical Sensitivity/Limit of Detection (LoD)
The limit of detection (LoD) for Alinity m HSV 1 & 2 / VZV assay for each analyte were determined by quantified (TCID50/mL) cultures of HSV-1 (Maclntyre), HSV-2 (MS) or VZV (Ellen) viral strains diluted into pooled negative clinical swab specimens. The LoD of each analyte is presented below in Table 1.
| Table 1. Limit of Detection | ||
|---|---|---|
| Analyte | Strain | LoD (TCID50/mL) |
| HSV-1 | MacIntyre | 5.90 |
| HSV-2 | MS | 2.07 |
| VZV | Ellen | 0.055 |
8
Inclusivity
The inclusivity for the Alinity m HSV 1 & 2 / VZV assay was determined by testing 5 HSV-1 strains / isolates, 3 HSV-2 strains / isolates and 5 VZV strains / isolates. The strains whose reported units of measure were in TCID50/mL, were diluted to a concentration ≤ 3X LoD. For strains where concentration in TCID50/mL was not available, a dilution series based on copies/mL was prepared and tested. The dilution series consisted of at least one concentration that resulted in positive results 100% of the time, and at least one concentration that resulted in positive results