(89 days)
Not Found
No
The document describes a standard automated immunoassay using chemiluminescent detection technology. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and light detection, not algorithmic learning.
No
This device is an in-vitro diagnostic (IVD) intended for the detection of Zika virus IgM antibodies, not for treatment or therapy.
Yes
This device is intended for the "presumptive qualitative detection of Zika virus IgM antibodies in human sera," and its results are to be "used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences" to aid in the diagnosis of Zika virus infection. This clearly indicates its role in the diagnostic process.
No
The device is an immunoassay kit with various chemical reagents and magnetic particles, intended to be used with a specific hardware analyzer (LIAISON® XL Analyzer). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "presumptive qualitative detection of Zika virus IgM antibodies in human sera". This indicates that the test is performed on a biological specimen (human sera) in vitro (outside of the body) to provide diagnostic information about a disease (Zika virus infection).
- Device Description: The description details the components of the assay, which are reagents designed to interact with components in the patient's serum to produce a measurable signal. This is characteristic of an in vitro test.
- Performance Studies: The performance studies describe testing the device with human serum samples to evaluate its ability to detect Zika virus IgM antibodies. This further confirms its use as an in vitro diagnostic tool.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively. Positive results must be confirmed by following the latest CDC quidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IqM levels over the course of illness are not well characterized. IqM levels are variable, may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
This LIAISON® XL Zika Capture IgM II assay is not indicated for testing blood or plasma donors.
The test has to be performed on the LIAISON® XL Analyzer.
LIAISON® XL Zika Capture IgM II Control Set
The DiaSorin LIAISON® XL Zika Capture IgM II Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL Zika Capture IgM II assay. The performance characteristics of the LIAISON® XL Zika Capture IgM II controls have not been established for any other assay or instrument platforms different from the LIAISON® XL.
Product codes
QFO, QCH
Device Description
The LIAISON® XL Zika Capture IqM II assay is an automated immunoassay utilizing chemiluminescent (CLIA) detection technology for the detection of human IgM antibodies against Zika Virus in patient sera.
The LIAISON® XL Zika Capture IgM II assay consists of the components described in the following tables.
Magnetic Particles (2.4 mL) - Magnetic particles coated with a mouse monoclonal antibody to human IgM diluted in phosphate buffer containing BSA, surfactant, and 29 Index.
- ZIKV-C: 0.01 to 35 Index value. Values below 0.01 Index reported as 35 Index.
Analytical Sensitivity/Assay Cut-offs:
- Evaluated using WHO 1st International Standard for anti-Asian lineage Zika virus antibody (human) (NIBSC 16/352).
- Undiluted standard (1000 IU/mL) returned a positive result just above cutoffs (1 for ZIKV-M, 4 for ZIKV-C).
- 1:3 dilution returned a negative result.
Analytical Specificity/Cross-Reactivity and Interference:
- Cross-reactivity study: Evaluated potential interference from antibodies against related viruses and organisms with similar symptoms.
- One Dengue IgM sample (1/43 tested) was reactive, but also reactive with comparator method.
- One Parvovirus B19 IgM sample (1/14 tested) was reactive.
- One rheumatoid factor sample (1/16 tested) was reactive.
- Noted possibility of cross-reactivity to Chikungunya IgM based on previous assay version (sample not available for re-testing).
- No reactivity with Anti-Chikungunya virus (IgM and IgG), Anti-Cytomegalovirus (IgM and IgG), Anti-Dengue virus (IgG), Anti-Epstein Barr Virus (IgM and IgG), Anti-Parvovirus B19 (IgG), Anti-Varicella zoster virus (IgM and IgG), Yellow fever virus post-immunization, Anti-West Nile Virus (IgM and IgG), Anti- Malaria/anti-plasmodium falciparum, Adenovirus, Enterovirus, Anti-Hepatitis (C) virus (Total IgG), Anti-Hepatitis (B) virus (IgM and Total Antibodies), Anti-Herpes simplex virus 1 (IgM and IgG), Anti-Herpes simplex virus 2 (IgM and IgG), Anti-Rubella virus (IgM and IgG), Anti-Borrelia sp.(Lyme Disease) (IgM and Total Ig), Anti-Treponema pallidum.(Syphilis) (Total Antibodies), Human Anti-mouse Antibody (HAMA), Anti-nuclear antibodies (ANA).
- Interference study: Performed on 3 negative and 3 positive serum samples near clinical decision points for various endogenous substances.
- Hemoglobin at 10 mg/mL showed significant positive interference. At 2 mg/mL, interference was minimal with no change in final call.
- No interference observed for Bilirubin (conjugated and unconjugated), Triglycerides, Cholesterol, Albumin, HAMA, Rheumatoid Factor.
Class Specificity:
- Evaluated for ZIKV-M (anti-IgM) and ZIKV-C (anti-IgG) reagent packs using 6 specimens with various levels of Zika virus IgM and high levels of IgG. DTT treatment used to inactivate IgM.
- All IgM positive samples dropped below assay cut-off after DTT treatment.
- IgG positive samples demonstrated ≤ 10% change in Index value.
Carry-Over:
- Performed for ZIKV-M and ZIKV-C reagent packs on LIAISON® XL.
- Carry-over was not observed; average of negative samples following high sample showed ≤ 10% difference from negatives before high sample. 100% negative results for negative samples following high sample.
Stability:
- Kit Shelf-Life: 9 months at 2-8 °C.
- Reagent Integral Shelf-Life: ZIKV-M at 2-8 °C for 9 months; ZIKV-C at 2-8 °C for 18 months.
- Calibration Curve: 14 days.
- Reagent Integrals Open Use Storage: On-board Analyzer at 11-15 °C for 14 days; at 2-8 °C for 14 days.
- Reconstituted Conjugates Open Use Storage: At 2-8 °C for 14 days.
- ZIKV-M Reconstituted Calibrator Open Use: Room Temperature (18-25°C) for 6 hours; at 2-8 °C for 24 hours.
- ZIKV-C Calibrator Open Use: At 2-8 °C for 14 days.
- Control Shelf-Life: ZIKV-M Controls at 2-8 °C for 10 months; ZIKV-C Controls at 2-8 °C for 10 months.
- Control Open Use Storage: On-board Analyzer at 18-25 °C for 24 hours; at 2-8°C for 56 days.
- Specimen Stability: Human serum samples stable for 7 days at 2-8 °C and 24 hours at 18-25 °C. Stable through 3 freeze/thaw cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA) for Day 8-84: 95.6% (95%CI 91.6-97.8%)
Negative Percent Agreement (NPA) - Non-endemic (U.S): 99.6% (97.8 - 99.9%)
Negative Percent Agreement (NPA) - Endemic (Dominican Republic): 97.6% (94.9 - 98.9%)
Total Negative Percent Agreement: 98.6% (97.1% - 99.3%)
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.
InBios ZIKV Detect™ 2.0 IgM Capture ELISA (DEN180069)
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
§ 866.3935 Zika virus serological reagents.
(a)
Identification. Zika virus serological reagents arein vitro diagnostic devices that consist of antigens or antibodies for the detection of Zika virus or Zika antibodies in human specimens from individuals who have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The detection aids in the diagnosis of current or recent Zika virus infection or serological status. Negative results obtained with this test do not preclude the possibility of Zika virus infection, past or present. Positive results should be interpreted with consideration of other clinical information and laboratory findings and should not be used as the sole basis for treatment or other patient management decisions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include:
(i) An intended use with a detailed description of what the device detects (Zika IgM antibodies, other Zika antibodies, or Zika antigens), the type of results provided to the user, the specimen type for which testing is indicated (
e.g., serum, whole blood), the clinical indications appropriate for test use, and the specific population(s) for which the test is intended.(ii) Performance characteristics from analytical and clinical studies required under paragraphs (b)(2)(ii) and (iii) of this section.
(iii) A detailed explanation of the interpretation of results and criteria for validity of results (
e.g., criteria that internal or external quality controls must meet in order for a test/test run to be valid, minimum signal strength that the sample has to yield to be interpretable as a valid result).(iv) Limiting statements indicating that:
(A) Results are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. The test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence.
(B) Device results are intended to be followed up according to the latest professional guidelines (
e.g., recommendations from the Centers for Disease Control and Prevention) for the diagnosis of Zika virus infection.(C) Negative test results do not preclude the possibility of Zika virus infection, past or present.
(D) Specimens can result in false negative results on the device if collected outside of the appropriate response window for specific Zika virus antigens or antibodies, as determined by scientific evidence (
e.g., for IgM
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
October 28, 2019
DiaSorin Inc. Sandra Zimniewicz Senior Regulatory Affairs Specialist 1951 Northwestern Avenue Stillwater, Minnesota 55082-0285
Re: K192046
Trade/Device Name: LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set Regulation Number: 21 CFR 866.3935 Regulation Name: Zika Virus Serological Reagent Regulatory Class: Class II Product Code: QFO, QCH Dated: July 30, 2019 Received: July 31, 2019
Dear Sandra Zimniewicz:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; 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 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).
Sincerely,
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) SUMMARY
| 1. DATE PREPARED: | July 30, 2019 |
|---|---|
| 2. APPLICANT INFORMATION: | Sandra Zimniewicz |
| Senior Regulatory Affairs Specialist | |
| DiaSorin Inc. | |
| 1951 Northwestern Ave. | |
| P.O. Box 285 | |
| Stillwater, MN 55082-0285 | |
| Phone (651) 351-5711 | |
| Fax (651) 351-5711 | |
| Email: sandra.zimniewicz@diasorin.com | |
| 3. REGULATORY INFORMATION: | |
| Trade Name: | LIAISON® XL Zika Capture IgM II |
| Common Names/Descriptions: | Zika virus assay |
| Classification Names: | Zika Virus Serological Reagents: |
| Class II, 21 CFR 866.3935; Microbiology (83) | |
| Assayed quality control material for clinical | |
| microbiology assays: Class II, 21CFR 866.3920; | |
| Microbiology (83) | |
| Product Code: | QFO - Zika Virus Serological Reagents |
| QCH - Assayed quality control material for | |
| clinical microbiology assays | |
| 4. PREDICATE DEVICE: | InBios ZIKV Detect™ 2.0 IgM Capture ELISA |
| (DEN180069) |
5. INTENDED USE / INDICATIONS FOR USE
LIAISON® XL Zika Capture IqM II
The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers
3
from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively. Positive results must be confirmed by following the latest CDC quidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IqM levels over the course of illness are not well characterized. IqM levels are variable, may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
This LIAISON® XL Zika Capture IgM II assay is not indicated for testing blood or plasma donors.
The test has to be performed on the LIAISON® XL Analyzer.
LIAISON® XL Zika Capture IgM II Control Set
The DiaSorin LIAISON® XL Zika Capture IgM II Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL Zika Capture IgM II assay. The performance characteristics of the LIAISON® XL Zika Capture IgM II controls have not been established for any other assay or instrument platforms different from the LIAISON® XL.
6. DEVICE DESCRIPTION
The LIAISON® XL Zika Capture IqM II assay is an automated immunoassay utilizing chemiluminescent (CLIA) detection technology for the detection of human IgM antibodies against Zika Virus in patient sera.
The LIAISON® XL Zika Capture IgM II assay consists of the components described in the following tables.
| Magnetic Particles
(2.4 mL) | Magnetic particles coated with a mouse monoclonal
antibody to human IgM diluted in phosphate buffer
containing BSA, surfactant, and 29 Index.
The ZIKV-C reagent pack measures between 0.01 and 35 Index value. The lowest reportable value is 0.01 Index. Values below 0.01 Index should be reported as 35 Index.
10.4 DETECTION LIMITS
Detection Limits (Limit of Blank, Limit of Detection, Limit of Quantitation) are not applicable to the LIAISON® XL Zika Capture IgM II assay.
10.5 ANALYTICAL SENSITIVITY/ ASSAY CUT-OFFs
Analytical sensitivity was evaluated using the WHO 1st International Standard for anti-Asian lineage Zika virus antibody (human) (NIBSC 16/352). This preparation is composed of pooled serum obtained from six individuals who tested positive for Zika infection. The undiluted standard (1000 IU/mL) returned a positive result in the LIAISON® XL Zika Capture IgM II assay with Index values just above the ZIKV-M and ZIKV-C cutoff values of 1 and 4, respectively. The standard tested at a 1:3 dilution returned a negative result in the assay.
10.6 ANALYTICAL SPECIFICITY/CROSS-REACTIVITY and INTERFERENCE
The cross reactivity study for the LIAISON® XL Zika Capture IgM II assay was designed to evaluate potential interference from antibodies against other closely related viruses as well as organisms whose infection produces symptoms similar to those observed during Zika virus infection. Samples containing IgM and IgG antibodies against other flavivirus specimens and disease state specimens were used to test for potentially cross-reactive antibodies.
One Dengue IgM sample (1/43) was reactive in the LIAISON® XL Zika Capture IgM II assay although this sample was also reactive with the comparator method. Additionally, one Parvovirus B19 IgM (1/14) and one rheumatoid factor (1/16) samples were reactive in the LIAISON® XL Zika Capture IgM II assay. There is a possibility of cross-reactivity to Chikungunya IgM in the assay as a sample cross-reactive in the first version of the assay was not available for repeat measurements with the LIAISON® XL Zika Capture IqM II assay.
| Organism/Condition | Samples
tested | Number Reactive
with LIAISON® XL
Zika Capture IgM
II Assay | % Reactive |
|------------------------------|-------------------|---------------------------------------------------------------------|------------|
| Anti-Chikungunya virus (IgM) | 17 | 0 | 0 |
| Anti-Chikungunya virus (IgG) | 14 | 0 | 0 |
| Anti-Cytomegalovirus (IgM) | 11 | 0 | 0 |
| Anti-Cytomegalovirus (IgG) | 11 | 0 | 0 |
11
| Anti-Dengue virus (IgM) | 43 | 1^ | 2.33% |
|---|---|---|---|
| Anti-Dengue virus (IgG) | 53 | 0 | 0 |
| Anti-Epstein Barr Virus (IgM) | 11 | 0 | 0 |
| Anti-Epstein Barr Virus (IgG) | 10 | 0 | 0 |
| Anti-Parvovirus B19 (IgM) | 14 | 1& | 7.14% |
| Anti-Parvovirus B19 (IgG) | 13 | 0 | 0 |
| Anti-Varicella zoster virus (IgM) | 11 | 0 | 0 |
| Anti-Varicella zoster virus (IgG) | 14 | 0 | 0 |
| Yellow fever virus post-immunization | 17 | 0 | 0 |
| Anti-West Nile Virus (IgM) | 15 | 0 | 0 |
| Anti-West Nile Virus (IgG) | 19 | 0 | 0 |
| Anti- Malaria/anti-plasmodium falciparum* | 10 | 0 | 0 |
| Adenovirus** | 10 | 0 | 0 |
| Enterovirus*** | 10 | 0 | 0 |
| Anti-Hepatitis (C) virus (Total IgG) | 10 | 0 | 0 |
| Anti-Hepatitis (B) virus (IgM) | 10 | 0 | 0 |
| Anti-Hepatitis (B) virus (Total Antibodies) | 10 | 0 | 0 |
| Anti-Herpes simplex virus 1 (HSV-1) (IgM) | 10 | 0 | 0 |
| Anti-Herpes simplex virus 1 (HSV-1) (IgG) | 10 | 0 | 0 |
| Anti-Herpes simplex virus 2 (HSV-2) (IgM) | 10 | 0 | 0 |
| Anti-Herpes simplex virus 2 (HSV-2) (IgG) | 10 | 0 | 0 |
| Anti-Rubella virus (IgM) | 10 | 0 | 0 |
| Anti-Rubella virus (IgG) | 10 | 0 | 0 |
| Anti-Borrelia sp.(Lyme Disease) (IgM) | 10 | 0 | 0 |
| Anti-Borrelia sp.(Lyme Disease) (Total Ig) | 12 | 0 | 0 |
| Anti-Treponema pallidum.(Syphilis) | |||
| (Total Antibodies) | 20 | 0 | 0 |
| Human Anti-mouse Antibody (HAMA) | 11 | 0 | 0 |
| Anti-nuclear antibodies (ANA) | 29 | 0 | 0 |
| Rheumatoid Factor | 16 | 1& | 6.25% |
*Specimens were confirmed positive for Malaria infection, but serological status is not known.
**Presence of antibodies was assumed from the results of culture and complement fixation in 3/10 samples; 4/10 showed IgA and IgG presence by ELISA; 3/10 were not characterized.
***Presence of antibodies was assumed from the results of culture and complement fixation.
^This sample was Zika IgM positive by a comparator assay.
&This sample was Zika IgM negative by a comparator assay.
Controlled studies of potentially interfering substances performed on 3 negative and 3 positive serum samples near the clinical decision points showed only interference in the LIAISON® XL Zika Capture IgM II assay for hemoglobin. The positive interference for hemoglobin at 10 mg/mL was significant while at 2 mg/mL interference was minimal with no change in the final call. The testing was based on CLSI-EP7-A2.
| Endogenous Substance | Concentration Tested |
|---|---|
| Hemoglobin | 10 mg/mL and 2 mg/mL |
| Bilirubin (conjugated) | 0.4 mg/mL |
12
| Bilirubin (unconjugated) | 0.4 mg/mL |
|---|---|
| Triglycerides | 30 mg/mL |
| Cholesterol | 5 mg/mL |
| Albumin | 60 mg/mL |
| HAMA | 800-1380 ng/mL |
| Rheumatoid Factor | 3500-17800 IU/mL |
10.7 CLASS SPECIFICITY
Antibody class specificity was evaluated on each of the ZIKV-M (anti-IgM antibody) and ZIKC-C (anti-IgG antibody) reagent packs. Six (6) specimens containing various levels of Zika virus IgM antibodies and high levels of Zika virus IgG antibodies were used for this testing. DTT was used to specifically inactivate IgM antibodies without affecting IgG antibodies.
Class specificity for the LIAISON® XL Zika Capture IgM II assay was demostrated as all IgM positive samples dropped below the assay cut-off value after treatment with DTT while the IgG positive samples demonstrated ≤ 10% change in Index value.
10.8 CARRY-OVER
Sample carry-over testing was performed independently for the ZIKV-M and ZIKV-C reagent packs on the LIAISON® XL to determine if there is potential instrument carryover. The study was designed to demonstrate that a sample containing a high level of analyte which preceded a sample containing no analyte will not cause an inappropriate elevation of the subsequent negative sample signal. Carry-over was not observed in either the ZIKV-M or the ZIKV-C reagent pack under the specific testing conditions. For each run, the average of the negative sample replicates following the high sample showed ≤ 10% difference from the average of the negative sample replicates which were tested prior to the high sample. Additionally, the percent of negative results of the negative sample following the high sample was 100% for each reagent pack.
| LIAISON® XL Zika Capture IgM II Reagents | |
|---|---|
| Study | Stability |
| Kit Shelf-Life at 2-8 °C | 9 months |
| ZIKV-M Reagent Integral Shelf-Life at 2-8 °C | 9 months |
| ZIKV-C Reagent Integral Shelf-Life at 2-8 °C | 18 months |
| Calibration Curve | 14 days |
| Reagent Integrals Open Use Storage On-board Analyzer | |
| at 11-15 °C | 14 days |
| Reagent Integrals Open Use Storage at 2-8 °C | 14 days |
| Reconstituted Conjugates Open Use Storage at 2-8 °C | 14 days |
| ZIKV-M Reconstituted Calibrator Open Use at Room | |
| Temperature (18-25°C) | 6 hours |
| ZIKV-M Reconstituted Calibrator Open Use at 2-8 °C | 24 hours |
| ZIKV-C Calibrator Open Use at 2-8 °C | 14 days |
11.0 STABILITY
13
| LIAISON® XL Zika Capture IgM II Control Set | |
|---|---|
| Study | Stability |
| ZIKV-M Controls Shelf-Life at 2-8 °C | 10 months |
| ZIKV-C Controls Shelf-Life at 2-8 °C | 10 months |
| Control Open Use Storage On-board Analyzer at 18-25 °C | 24 hours |
| Control Open Use Storage at 2-8°C | 56 days |
SPECIMEN STABILITY
Studies were performed to determine the stability of human serum samples at storage temperatures of 2-8°C, and 18-25°C. A multiple freeze/thaw (F/T) study was also performed. Testing was performed with both the ZIKV-M and ZIKV-C reagent packs using a minimum of five (5) serum samples having index values below, near and above the respective reagent pack cut-off values. Stability of human serum samples was determined to be 7 days at 2- 8 °C and 24 hours at room temperature (18 – 25 °C). Serum samples are stable through 3 freeze/thaw cycles.
12. CONCLUSION:
The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labelling is sufficient and it satisfies the requirements of 21CFR 809.10.