(30 days)
Not Found
No
The summary describes a standard chemiluminescent immunoassay (CLIA) for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond basic assay result interpretation.
No.
The device is an in vitro diagnostic (IVD) intended to aid in the diagnosis of Rubella infection by detecting antibodies, not to treat or alleviate a disease.
Yes
The "Intended Use / Indications for Use" section states that the assay is "intended for use as an aid in the diagnosis of a current or recent Rubella infection".
No
The device description explicitly states it is an in vitro diagnostic device consisting of reagents provided in a plastic container (Reagent Integral) and controls in vials. This indicates a physical, hardware-based component (reagents, containers) is essential to the device's function, not just 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 LIAISON® Rubella IgM assay is "intended for use as an aid in the diagnosis of a current or recent Rubella infection in human serum samples." This clearly indicates its purpose is to provide diagnostic information from a sample taken from the human body.
- Device Description: The "Device Description" section describes the LIAISON® Rubella IgM assay as an "in vitro diagnostic device." This is a direct declaration of its classification.
- Methodology: The assay uses "chemiluminescent immunoassay (CLIA) technology," which is a common method used in in vitro diagnostics to detect specific substances in biological samples.
- Sample Type: The assay is performed on "human serum samples," which are biological specimens.
- Controls: The description of the LIAISON® Control Rubella IgM also states it is an "in vitro diagnostic device" and is used to monitor the performance of the assay, which is standard practice for IVDs.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
N/A
Intended Use / Indications for Use
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age.
The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay.
The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.
Product codes (comma separated list FDA assigned to the subject device)
LFX, JJX
Device Description
The LIAISON® Rubella IgM assay is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral. The assay configuration for the LIAISON® Rubella IgM assay allows for the performance of 100 tests.
Reagent Integral Composition:
- a. Magnetic particles mouse monoclonal antibody IgG to human IgM
- b. Calibrator 1 human serum or defibrinated plasma containing low level of Rubella IqM
- c. Calibrator 2 human serum or defibrinated plasma containing high level of Rubella laM
- d. Antigen Inactivated rubella viral particles (HPV 77 strain)
- c. Specimen diluent buffer with BSA added
- d. Conjugate -- mouse monoclonal antibodies to rubella virus conjuqated to an isoluminol derivative
The LIAISON® Control Rubella IgM is an in vitro diagnostic device consisting of 2 levels of controls to monitor the performance of the LIAISON® Rubella IgM assay
Controls (2 vials of each level):
Negative control - human serum or defibrinated plasma non-reactive for Rubella IgM Positive control - human serum or defibrinated plasma reactive for Rubella IgM
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
The prospective population consisting of 448 individuals were 89.7% Female (n=402) ranging in age from 400 AU/mL were tested. No sample misclassification was observed, indicating no hook effect.
IgM Specificity
Ten samples with Rubella IgM antibodies (from around cut-off to clearly positive) were treated with 10 mM dithiotreitol (DTT) to denature IgM, then tested in parallel with non-treated samples. Absence of IgM anti-Rubella reactivity after DTT treatment demonstrated specificity for IgM immunoglobulins.
Interference
Testing of matched sample pools containing Rubella IgM antibodies near the clinical decision point, spiked with various endogenous and exogenous substances, showed no interference at the tested concentrations. Acceptance criteria was that % change in signal not more than +10% and no change in qualitative result.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Prospective Study:
Negative Percent Agreement: 98.9% (433/438)
Positive Percent Agreement: 60.0% (6/10)
Retrospective Study:
Positive Percent Agreement: 98.9% (175/177)
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
§ 866.3510 Rubella virus serological reagents.
(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.
0
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION EXECUTIVE SUMMARY
| A. 510(k) Number: | K122397 SEP 6 2012 |
|---|---|
| B. Purpose for Submission: | New Device |
| C. Measurand: | IgM Antibody to Rubella Virus |
| D. Type of Test: | Qualitative, Chemiluminescence Immunoassay (CLIA) |
| E. Applicant: | DiaSorin Inc. |
| F. Proprietary and Established Names: | LIAISON® Rubella IgM |
| LIAISON® Control Rubella IgM | |
| G. Regulatory Information: | |
| 1. Regulation section: | 21 CFR §866.3510 Rubella Virus Serological Reagents |
| 21 CFR §862.1660 Quality control material | |
| 2. Classification: | Class II |
| 3. Product code: | LFX (Enzyme Linked Immunoabsorbent Assay, Rubella) |
| JJX (Quality control material, assayed and unassayed) |
-
- Panel: 83 Microbiology
H. Intended Use:
1. Intended use(s):
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age.
The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay.
The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.
- Indication(s) for use:
Same as Intended Use.
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
LIAISON® Analyzer family of instruments is required to perform the testing.
1
1
I. Device Description:
The LIAISON® Rubella IgM assay is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral. The assay configuration for the LIAISON® Rubella IgM assay allows for the performance of 100 tests.
Reagent Integral Composition:
- a. Magnetic particles mouse monoclonal antibody IgG to human IgM
- b. Calibrator 1 human serum or defibrinated plasma containing low level of Rubella IqM
- c. Calibrator 2 human serum or defibrinated plasma containing high level of Rubella laM
- d. Antigen Inactivated rubella viral particles (HPV 77 strain)
- c. Specimen diluent buffer with BSA added
- d. Conjugate -- mouse monoclonal antibodies to rubella virus conjuqated to an isoluminol derivative
The LIAISON® Control Rubella IgM is an in vitro diagnostic device consisting of 2 levels of controls to monitor the performance of the LIAISON® Rubella IgM assay
Controls (2 vials of each level):
Negative control - human serum or defibrinated plasma non-reactive for Rubella IgM Positive control - human serum or defibrinated plasma reactive for Rubella IgM
J. Substantial Equivalence Information:
-
- Predicate device name(s): ADVIA Centaur Rubella IgM Assay
-
- Predicate 510k number(s): K010668
-
- Comparison with predicate:
| Table 1: Table of Similarities | ||
|---|---|---|
| Characteristic | New Device | |
| LIAISON® Rubella IgM Assay | Predicate Device | |
| ADVIA Centaur Rubella IgM | ||
| (K010668) | ||
| Intended Use | The LIAISON® Rubella IgM assay uses | |
| chemiluminescent immunoassay (CLIA) | ||
| technology on the LIAISON® Analyzer for the | ||
| qualitative determination of IgM antibodies to | ||
| rubella virus in human serum samples. It is | ||
| intended for use as an aid in the diagnosis of | ||
| a current or recent Rubella infection in | ||
| individuals with signs and symptoms of | ||
| Rubella, or suspected of having rubella | ||
| infection, including women of child bearing | ||
| age. | The ADVIA Centaur Rubella IgM | |
| assay is an IgM antibody capture | ||
| microparticle direct | ||
| chemiluminometric in vitro diagnostic | ||
| assay for the qualitative detection of | ||
| IgM antibodies to the rubella virus in | ||
| serum or plasma (EDTA, heparin) as | ||
| an aid in the presumptive diagnosis of | ||
| current or recent infection with | ||
| rubella. | ||
| Assay Type | Chemiluminescent Immunoassay | Chemiluminometric immunoassay |
| Measured Analyte | IgM antibodies to rubella virus | IgM antibodies to rubella virus |
2
| Table 2 : Table of Differences | |||
|---|---|---|---|
| Characteristic | New Device | ||
| LIAISON® Rubella IgM Assay | Predicate Device | ||
| ADVIA Centaur Rubella IgM | |||
| (K010668) | |||
| Sample Matrix | Serum | Serum and plasma (EDTA, heparin) |
K. Standard/Guidance Document Referenced (if applicable):
CLSI: EP05-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline Second Edition 2004
CLSI: EP15-A2: User Verification of Performance for Precision and Trueness; Approved Guideline, 2006
CLSI: EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition 2005
L. Test Principle:
Chemiluminescence Immunoassay (CLIA) - Immunoassay technology based on the emission of light as a result of a chemical reaction.
In the 1st incubation the IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, rubella virus antigen reacts with IgM directed against rubella virus that is already bound to the solid phase. During the third incubation, the antibody conjuqate reacts with the immune complex formed during the second incubation, thus revealing that the immunological reaction has taken place. After the first and third incubations, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of rubella virus IgM concentration present in calibrators, samples or controls.
M. Performance Characteristics (if/when applicable):
- Analytical performance:
a. Precision/Reproducibility:
A twenty-day reproducibility/precision study was conducted at two external laboratories and DiaSorin Inc. The CLSI document EP5-A2 was consulted in the preparation of the testing protocol.
A coded panel was tested at all three sites, using two replicates per run in two runs per day for 20 operating days. The 20 day combined results for all 3 sites are summarized as mean AU/mL value, standard deviation, and coefficient of variation (%CV) for within run and Total across lots and across sites.
The AU/mL values for the Negative control, and 2 of the Negative precision panels gave results less than the low end of the assay range of 10 AU/mL, therefore, the RLUs were used to perform the statistical calculations for these three sample types.
3
| | | Mean | Within-Run | | Total
(Across lots and Sites) | |
|-------------------|-------|--------|------------|--------|----------------------------------|--|
| Sample ID | AU/mL | SD | %CV | SD | %CV | |
| Negative Control* | 400 AU/mL. The samples resulted in calculated concentration values above the measuring range. There was no sample misclassification indicating no hook effect was observed.
IgM Specificity
Ten samples containing Rubella IgM antibodies covering the assay range from value around cut-off level to clearly positive samples were treated with 10 mM dithiotreitol (DTT) to denature the IgM. These DTT treated samples were then tested in singlicate in parallel with the non-treated samples showed absence of IdM anti-Rubella reactivity after treatment with DTT. These data demonstrate the specificity of the LIAISON® Rubella IgM assay for IgM immunoglobulins.
| Sample ID | LIAISON® Rubella IgM assay Results (AU/mL) | |
|---|---|---|
| Before DTT treatment | After DTT treatment | |
| Sample-1 | 18.0 | 6 2012 SEP |
DiaSorin, Inc. C/O Carol DePouw 1951 Northwestern Avenue Stillwater, MN 55082
Re: K122397
Trade/Device Name: LIAISON® Rubella IgM, LIAISON® Control Rubella IgM Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: LFX, JJX Dated: August 6, 2012 Received: August 7, 2012
Dear Ms. DePouw:
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 class II (Special Controls), 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 that 1 27 deral statutes and regulations administered by other Federal agencies. You must or uny I 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form arketing your device as described in your Section 510(k) premarket
10
Page 2 – Ms Carol DePouw
notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Salgado
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
11
510(k) Number:
Device Name:
Indication For Use:
LIAISON® Rubella IgM and LIAISON® Control Rubella laM
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age.
The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay. The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Jayath
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K122 397 510(k)_