(280 days)
Not Found
No
The description details a standard immunoassay technology (ELFA) with automated steps and calculation based on a stored calibration curve. There is no mention of AI, ML, or any learning algorithms.
No.
The device is an in vitro diagnostic (IVD) assay intended to measure IgG antibodies for rubella virus and aid in determining immune status, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the assay is "intended as an aid in the determination of immune status to rubella," which is a diagnostic purpose.
No
The device description clearly outlines a physical assay using reagents, a Solid Phase Receptacle (SPR), and an automated instrument to perform the assay steps and measure fluorescence. This involves significant hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum." The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the living body.
- Device Description: The description details how the assay works using human serum samples and reagents in a laboratory setting, which is characteristic of an IVD.
- Clinical Performance: The section on clinical performance describes testing the device with human serum samples from different populations (pregnant women, general) and comparing the results to a comparator, which is standard practice for evaluating the performance of an IVD.
- Predicate Device(s): The mention of a predicate device (Abbott's AxSYM Rubella IgG Antibody Assay) with a K number (K954045) indicates that this device is being compared to a previously cleared IVD.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
Product codes
LFX
Device Description
The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the Rubella antigen fixed onto the interior wall of the SPR to capture the Rubella antibodies present in the sample. After dilution, the sample is incubated with the SPR. Rubella IgG antibodies present in the specimen bind to the Rubella antigen coating the interior of the SPR. Unbound components are eliminated during the preliminary wash step.
A second incubation step is then performed using alkaline phosphatase labeled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step.
During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm.
The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
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 performance of this device has not been established for screening of cord blood, or for neonatal samples.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision
Four serum samples were tested in duplicate twice a day (2 runs per day over 10 days) on each of the 2 reagent lots using a single instrument at each of three sites (N = 240). The repeatability (intra-run precision, between-site precision and total precision were calculated according to the CLS10 EP5-A2 document.
Clinical Performance
Prospective populations
Prospective Pregnant Women:
Positive Agreement: 96.9% (309/319), 95% CI: 94.3 – 98.5
Negative Agreement: 66.7% (2/3), 95% CI: 9.4 – 99.2
Sample size: 325
Prospective General:
Positive Agreement: 97.1% (170/175), 95% CI: 93.5 – 99.1
Negative Agreement: 66.7% (2/3), 95% CI: 9.4 – 99.2
Sample size: 179 (One sample was defined as QNS and excluded from the analysis)
Retrospective populations
Retrospective Pregnant Women:
Positive Agreement: 92.7% (179/193), 95% CI: 88.1 – 96.0
Negative Agreement: 100% (3/3), 95% CI: 29.2 – 100.0
Sample size: 200
Retrospective General:
Positive Agreement: 92.3% (169/183), 95% CI: 87.5 – 95.8
Negative Agreement: 100% (104/104), 95% CI: 96.5 – 100.0
Sample size: 291 (Five samples were defined as QNS and excluded from the analysis)
Pre-selected Pregnant Women Population
Positive Agreement: 92.0% (23/25), 95% CI: 74.0 - 99.0
Negative Agreement: 100% (102/102), 95% CI: 96.4 - 100.0
Sample size: 127 (Two samples were defined as QNS and excluded from the analysis)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
K080766 510(k) SUMMARY
VIDAS® RUB IgG Assay
DEC 2 3 2008
A. Submitter Information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Sandra Perreand |
| Sr. Director, North American Regulatory Affairs | |
| Phone Number: | 314-731-8594 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 2008 |
| B. Device Name | |
| Trade Name: | VIDAS® RUB IgG Assay |
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
|---|---|
| Common Name: | Rubella IqG Antibody |
| Classification Name: | Enzyme Linked Immunoabsorbent Assay, Rubella |
C. Predicate Device Name Trade Name:
AxSYM Rubella IgG Antibody Assay
D. Device Description
The assay principle combines a 2-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. It is coated with Rubella antigen. The other reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips. The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the Rubella antigen fixed onto the interior wall of the SPR to capture the Rubella antibodies present in the sample. After dilution, the sample is incubated with the SPR. Rubella IgG antibodies present in the specimen bind to the Rubella antigen coating the interior of the SPR. Unbound components are eliminated during the preliminary wash step.
A second incubation step is then performed using alkaline phosphatase labeled monoclonal anti-human IgG antibodies (mouse), followed by a second wash step.
During the final detection step, the substrate (4-Methyl-umbellifery) phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm.
The intensity of the fluorescence is proportional to the concentration of antibodies present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
E. Intended Use
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
1
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the VIDAS RUB IgG assay to the predicate
device is presented in the table below.
| Item | VIDAS® RUB IgG Assay | Abbott's
AxSYM Rubella IgG Antibody Assay
(K954045) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Intended Use | The VIDAS® RUB IgG (RBG) assay uses
Enzyme Linked Fluorescent Assay
(ELFA) technology on the VIDAS®
automated instruments for the in vitro
quantitative and qualitative measurement
of IgG antibodies to rubella virus in
human serum. The VIDAS® RUB IgG
assay is intended as an aid in the
determination of immune status to rubella.
The performance of this device has not
been established for screening of cord
blood, or for neonatal samples. Likewise,
performance characteristics of the assay
have not been established for
immunocompromised or
immunosuppressed individuals. | The AxSYM Rubella IgG assay is a
Microparticle Enzyme Immunoassay
(MEIA) for the quantitative and
qualitative measurement of IgG
antibodies to rubella virus in human
serum or plasma (EDTA, heparin or
sodium citrate) to aid in the
determination of immune status to
rubella. |
| Specimen | Serum | Serum or plasma (EDTA, heparin or
sodium citrate) |
| Analyte | Rubella IgG | Rubella IgG |
| Antibody | Mouse monoclonal anti-human IgG | Goat anti-human IgG |
| Assay Principle | Two step antibody binding of Rubella
antibodies. An antigen is bound to a solid
phase and anti-human IgG is in liquid
form and is labeled with fluorescent
compound | Twostep antibody binding of Rubella
antibodies. An antigen is bound to a
solid phase and anti-human IgG is in
liquid form and is labeled with
fluorescent compound |
| Automated | Yes | Yes |
| Assay Technique | Enzyme-linked fluorescent assay (ELFA) | Microparticle enzyme immunoassay
(MEIA) |
| Sample Volume | 100 μL | 180 μL |
| Traceability/
Standardization | Master curve for each kit lot and each
calibrator lot are traceable to the 2nd
preparation of the World Health
Organization (WHO) 1st International
Rubella Reference Standard | Each calibrator lot is traceable to the
World Health Organization (W.H.O.)
2nd International Standard for Anti-
Rubella Immunoglobulin |
| Measurement range | 0 - 400 IU/mL | 0 - 500.0 IU/mL |
2
G. Performance Data
Precision
Four serum samples were tested in duplicate twice a day (2 runs per day over 10 days) on each of the 2 reagent lots using a single instrument at each of three sites (N = 240). The repeatability (intra-run precision, between-site precision and total precision were calculated according to the CLS10 EP5-A2 document.
| | | Repeatability | | Inter-run
precision | | Between site
precision | | Total precision | |
|----------|-----------------------------------|-----------------------|-----------|------------------------|-----------|---------------------------|-----------|-----------------------|-----------|
| Sample | Mean
concentration
on IU/mL | Standard
deviation | CV
(%) | Standard
deviation | CV
(%) | Standard
deviation | CV
(%) | Standard
deviation | CV
(%) |
| Sample 1 | 7.8 | 0.58 | 7.4 | 0.58 | 7.4 | 0.20 | 2.5 | 0.84 | 10.8 |
| Sample 2 | 8.8 | 0.57 | 6.4 | 0.66 | 7.4 | 0.22 | 2.5 | 0.89 | 10.2 |
| Sample 3 | 29.8 | 1.46 | 4.9 | 2.62 | 8.8 | 0.95 | 3.2 | 3.14 | 10.6 |
| Sample 4 | 154.6 | 10.58 | 6.8 | 18.49 | 12.0 | 0.00 | 0.0 | 21.30 | 13.8 |
Clinical Performance
The following tables compare the results of the V!DAS® RUB !gG assay to the consensus comparator
Prospective populations
| | Prospective Pregnant Women
2/3 Consensus | | | | Prospective General
2/3 Consensus | | | |
|--------|---------------------------------------------|-------|-----|-------|--------------------------------------|-------|-----|-------|
| VIDAS® | Pos | Equiv | Neg | Total | Pos | Equiv | Neg | Total |
| Pos | 309 | 1 | 0 | 310 | 170 | 1 | 0 | 171 |
| Equiv | 10 | 3 | 0 | 13 | 3 | 1 | 0 | 4 |
| Neg | 0 | 0 | 2 | 2 | 0 | 2 | 2 | 4 |
| Total | 319 | 4 | 2 | 325 | 173 | 4 | 2 | 179* |
| % Agreement | 95% CI | % Agreement | 95% CI | |
|---|---|---|---|---|
| Positive | 96.9% (309/319) | 94.3 – 98.5 | 97.1% (170/175) | 93.5 – 99.1 |
| Negative | 66.7% (2/3) | 9.4 – 99.2 | 66.7% (2/3) | 9.4 – 99.2 |
*One sample was defined as QNS (quantity not sufficient) and excluded from the analysis.
3
Retrospective populations
| | Retrospective Pregnant Women
2/3 Consensus | | | | | Retrospective General
2/3 Consensus | | | |
|--------|-----------------------------------------------|-------|-----|-------|-----|----------------------------------------|-----|-------|--|
| VIDAS® | Pos | Equiv | Neg | Total | Pos | Equiv | Neg | Total | |
| Pos | 179 | 0 | 0 | 179 | 169 | 0 | 0 | 169 | |
| Equiv | 9 | 4 | 0 | 13 | 7 | 4 | 0 | 11 | |
| Neg | 0 | 5 | 3 | 8 | 1 | 6 | 104 | 111 | |
| Total | 188 | 9 | 3 | 200 | 177 | 10 | 104 | 291* | |
| % Agreement | 95% CI | % Agreement | 95% CI | |
|---|---|---|---|---|
| Positive | 92.7% (179/193) | 88.1 – | ||
| 96.0 | 92.3% (169/183) | 87.5 – 95.8 | ||
| Negative | 100% (3/3) | 29.2 – | ||
| 100.0 | 100% (104/104) | 96.5 – | ||
| 100.0 |
*Five samples were defined as QNS (quantity not sufficient) and excluded from the analysis
Pre-selected Pregnant Women Population
| Pre-selected Pregnant Women
| 2/3 Consensus Method | ||||
|---|---|---|---|---|
| VIDAS® | Pos | Equiv | Neg | Total |
| Pos | 23 | 0 | 0 | 23 |
| Equiv | 0 | 0 | 0 | 0 |
| Neg | 0 | 2 | 102 | 104 |
| Total | 23 | 2 | 102 | 127* |
| % Agreement | 95% CI | |
|---|---|---|
| Positive | 92.0% (23/25) | 74.0 - 99.0 |
| Negative | 100% (102/102) | 96.4 - 100.0 |
*Two samples were defined as QNS (quantity not sufficient) and excluded from the analysis.
H. Conclusion
The VIDAS® RUB IgG Assay is substantially equivalent to Abbott Laboratories AxSYM Rubella lgG Antibody Assay.
The 510(k) summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sandra Perreand Sr. Director, N.A. Regulatory Affairs bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042
DEC 2 3 2008
Re: K080766
Regulation Number: 21CFR §866.3510 Regulation Name: Regulatory Class: Product Code: Dated: Received:
Trade/Device Name: VIDAS® RUB IgG Assay Rubella virus serological reagents Class II LFX December 19, 2008 December 22, 2008
Dear Ms. Perreand:
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, morket the device, subject to the general controls provisions of the Act. The general controls, ontrols. 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 ruality our uns (QS) regulation (21 CFR Part 820).
5
Page 2 -
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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attayma
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
Indications for Use
510(k) Number (if known): K080766
Device Name: VIDAS® RUB IgG
Indications For Use:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the VIDAS® automated instruments for the in vitro quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS® RUB IgG assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
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 (OIVD)
Une Schaf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080766