(243 days)
No
The description details a standard chemiluminescence immunoassay (CLIA) process performed by an automated analyzer. There is no mention of AI, ML, or any algorithms beyond basic signal processing and comparison to thresholds for qualitative results.
No
This device is an immunoassay for the qualitative detection of specific IgG antibodies to varicella-zoster virus, used as an aid in the determination of previous infection. It is a diagnostic tool, not a device intended for treating or preventing a medical condition.
Yes
The device is described as an "aid in the determination of previous infection of varicella-zoster virus," which directly supports its use in diagnosing a past medical condition.
No
The device description clearly outlines a chemiluminescence immunoassay (CLIA) technology performed on a LIAISON® Analyzer, involving physical components like magnetic particles, antibodies, and reagents. This is a hardware-based in vitro diagnostic device, not a software-only device.
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 for the "qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum." This involves testing a biological sample (human serum) in vitro (outside the body) to provide information about a person's health status (previous infection with VZV).
- Device Description: The description details a laboratory-based assay using chemiluminescence immunoassay (CLIA) technology to analyze components of a biological sample (antibodies in serum). This is a hallmark of IVD devices.
- Performance Studies: The document describes clinical trials and reproducibility studies conducted on human serum samples to evaluate the performance of the assay. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicellazoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.
Product codes
LFY
Device Description
The method for the qualitative determination of specific IgG to varicella- zoster virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer.
Varicella-zoster virus antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgG is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-VZV IgG antibodies, present in calibrators, samples or controls, bind to the solid phase. After each incubation, the unbound material is removed with a wash cycle. During the second incubation, the antibody conjugate reacts with anti-VZV IgG already bound to the solid phase. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is induced. The light signal, directly related to the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-VZV IgG in calibrators, samples or controls.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external U.S. laboratories and at DiaSorin. Testing was performed on prospectively-collected U.S. samples as defined below. The samples were tested by LIAISON® VZV IgG and a comparison assay, at the trial sites per the manufacturers' instructions for use.
Specimens that were equivocal by both assays were not included in the percent agreement calculation. Positive or negative results from the LIAISON® VZV IgG assay were considered as non-agreements in the calculation of percent positive agreement and percent negative agreement when the corresponding reference assay result was equivocal,
Sample Sizes:
745 total samples were used in the primary comparison table.
689 total samples from "Prospective Samples: Pregnant Women"
Data Source: Prospectively-collected U.S. samples.
Annotation Protocol: Not explicitly detailed, but implied by the comparison to a reference assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Comparative Clinical Trials.
Sample Size: 745 total samples for the initial comparison, 689 samples for prospective pregnant women.
AUC: Not found.
MRMC: Not found.
Standalone Performance: Not found.
Key Results:
Comparison of DiaSorin LIAISON® VZV IgG to VZV IgG ELISA:
For 745 total samples:
Positive Agreement: 98.8% (659/667), Exact 95% confidence interval: 97.7 - 99.5%
Negative Agreement: 84.4% (65/77), Exact 95% confidence interval: 74.4 - 91.7%
Prospective Samples: Pregnant Women (689 total samples):
Positive Agreement: 99.2% (645/650), (98.2 - 99.7%)
Negative Agreement: 64.1% (25/39), (47.6 - 78.8%)
Reproducibility Study:
Performed at 3 sites over five days (EP15-A2 protocol). Used 3 different kit lots and a coded panel of 9 frozen repository samples (negative levels, low positive, moderate to high positive), plus various controls.
Results expressed as an Index value, summarizing within-run, between-run, between-site, and overall sd and %CV for various controls and samples. For instance, Overall %CV ranged from 8.24% to 19.0% for the tested samples and controls.
Assay Precision Performance:
Established at DiaSorin following EP5-A2 protocol. Same serum samples and controls as reproducibility study, tested in quadruplicate over 20 working days on one LIAISON® instrument and one kit lot.
Results expressed as an Index value, summarizing within-run, between-run, and overall sd and %CV. For instance, Overall %CV for samples and controls ranged from 12.62% to 23.02%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent Positive Agreement
Percent Negative Agreement
Predicate Device(s)
Diamedix Is-VZV IgG Test System, K981867
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).
0
FEB 2 6 2007
SUBMITTED BY:
5.0 510(k) SUMMARY
Mari Meyer Requlatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5635 Fax (651) 351-5669 E-mail: mari meyer@diasorin.com
NAME OF DEVICE:
Trade Name:
Common Names/Descriptions:
DiaSorin LIAISON® VZV IgG
Immunoassay for the detection of specific IgG antibodies to varicella-zoster virus (VZV IgG).
Classification Names:
Product Code:
PREDICATE DEVICE:
Varicella-zoster virus Serological Reagents
LFY
Diamedix Is-VZV IgG Test System, K981867
DEVICE DESCRIPTION:
INTENDED USE: The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicellazoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.
KIT DESCRIPTION: The method for the qualitative determination of specific IgG to varicella- zoster virus is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer.
Varicella-zoster virus antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to human IgG is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-VZV IgG antibodies, present in calibrators, samples or controls, bind to the solid phase. After each incubation, the unbound material is removed with a wash cycle. During the second incubation, the antibody conjugate reacts with anti-VZV IgG already bound to the solid phase. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is induced. The light signal, directly related to the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of anti-VZV IgG in calibrators, samples or controls.
PERFORMANCE DATA:
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external U.S. laboratories and at DiaSorin. Testing was performed on prospectively-collected U.S. samples as defined below. The samples were tested by LIAISON® VZV IgG and a comparison assay, at the trial sites per the manufacturers' instructions for use.
Specimens that were equivocal by both assays were not included in the percent agreement calculation. Positive or negative results from the LIAISON® VZV IgG assay were considered as non-agreements in the calculation of percent positive agreement and percent negative agreement when the corresponding reference assay result was equivocal,
Section 5
Page 5 - 1
1
DiaSorin LIAISON® VZV IgG Premarket Notification
Compares number of samples positive on both assays to sum of all positive samples on the reference assay + samples equivocal on the reference assay and negative on the LIAISON® VZV IgG. Compared number of samples negative on both assay to sum of all negative samples on the reference assay + samples equivocal on the reference assay and positive on the LIAISON® VZV IgG
| | DiaSorin
LIAISON® VZV IgG | VZV IgG ELISA | | | |
|----------|------------------------------|--------------------|-------------------------------|----------|-------|
| | | Positive | Equivocal | Negative | Total |
| | Positive | 659 | 7 | 4 | 670 |
| | Equivocal | 1 | 1 | 1 | 3 |
| | Negative | 3 | 4 | 65 | 72 |
| | Total | 663 | 12 | 70 | 745 |
| | | Percent Agreement | Exact 95% confidence interval | | |
| Positive | | 98.8%
(659/667) | 97.7 - 99.5% | | |
| Negative | | 84.4%
(65/77) | 74.4 - 91.7% | | |
Prospective samples: Subjects Sent to the Laboratory for varicella-zoster virus testing
Prospective Samples: Pregnant Women
LIAISON® VZV IgG Results | VZV IgG ELISA Results | |||
---|---|---|---|---|
Positive | Equivocal | Negative | Total | |
Positive | 645 | 11 | 3 | 659 |
Equivocal | 3 | 0 | 0 | 3 |
Negative | 2 | 0 | 25 | 27 |
Total | 650 | 11 | 28 | 689 |
Percent Agreement | ||||
Positive | 99.2% | (645/650) | 98.2 - 99.7% | |
Negative | 64.1% | (25/39) | 47.6 - 78.8% |
REPRODUCIBILITY: Reproducibility studies were performed at 3 sites in a five-day protocol outlined in CLSI document, EP15-A2. The study included 3 different LIAISON® VZV IgG kit lots. Each site used a different lot of the LIAISON® VZV IgG Assay for the study. A coded panel comprised of 9 frozen repository samples, prepared representing negative levels, low positive analyte levels, and moderate to high positive levels, was used in this study. The study also included the U.A.ISON® VZV IgG controls (Neg Ctl and Pos Ctl) which are marketed in Europe, an internal serum borderline control (011006) and a commercially marketed serum ToRCH Negative and Positive Control (BR Neg Ctl and BR Pos Ctl). Results expressed as an Index value are summarized in the following table.
ﮨﯿﮟ
2
DiaSorin LIAISON® VZV IgG Premarket Notification
. . .
| | | Mean | Within-
run | Within-
run | Between-
run | Between-
run | Between-
site | Between-
site | Overall | Overall |
|----------------------------|----|-------|----------------|----------------|-----------------|-----------------|------------------|------------------|---------|---------|
| ID# | N | Index | sd | %CV | sd | %CV | sd | %CV | sd | %CV |
| DiaSorin Neg Ctl | 60 | 30.3 | 2.97 | 9.0 | 4.52 | 7.87 | 3.88 | 12.8 | 5.64 | 18.6 |
| DiaSorin Pos Ctl | 60 | 434 | 42.6 | 9.81 | 48.9 | 9.21 | 40.3 | 9.29 | 62.4 | 14.4 |
| 011006 (Cutoff Ctl) | 60 | 246 | 22.8 | 9.44 | 26.4 | 10.2 | 13.6 | 5.54 | 33.9 | 13.8 |
| BR Neg Ctl
(100% serum) | 60 | Trade/Device Name: LIAISON® VZV IgG Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-Zoster virus Serological Reagents Regulatory Class: Class II Product Code: LFY Dated: February 13, 2007 Received: February 16, 2007
Dear Ms. Meyer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, anton
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
4.0 INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
LIAISON® VZV IgG
Indications For Use:
The LIAISON® VZV IgG Assay uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soyland
Division Sign-Off
Page 4 - 1
Office of In Vitro Diagnostic Device Evaluation and Safety
700(k) K061820