(71 days)
Not Found
No
The description details a standard immunometric assay technique based on chemical reactions and light detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is for in vitro diagnostic use only, intended to determine immunity to rubella virus infection by quantifying IgG antibodies, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and describes the assay's purpose as aiding "in the determination of immunity to rubella virus infection," which is a diagnostic function.
No
The device description clearly outlines a physical assay kit (reagent pack, calibrators) and a hardware system (VITROS Immunodiagnostic System) used to perform the test and read the results. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first line explicitly states "For in vitro diagnostic use only." It also describes the assay's purpose as determining IgG antibodies to rubella virus in human serum and plasma to aid in the determination of immunity, which is a classic IVD function.
- Device Description: The description details a laboratory test performed on human samples (serum and plasma) using reagents and a system to measure a biological marker (rubella IgG antibodies). This is consistent with the nature of an IVD.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only.
The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.
The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.
Product codes (comma separated list FDA assigned to the subject device)
LFX
Device Description
The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic Products Rubella IgG Reagent Pack and VITROS Immunodiagnostic Products Rubella IgG Calibrators on the VITROS Immunodiagnostic System for the qualitative and quantitative determination of rubella IgG antibodies to rubella virus in human serum and plasma. An immunometric technique is used. This involves the reaction of antirubella IgG present in the sample with rubella antigen coated onto the wells. After a wash step a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-human IgG) is added and this complexes with bound anti-rubella IgG. Unbound materials are removed by washing.
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of antirubella IgG present.
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
Clinical laboratory
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)
Comparison to Predicate Device:
Positive % Agreement/Initial Sensitivity: Study 1: 98.6%, Study 2: 97.5%
Negative % Agreement/Initial Specificity: Study 1: 91.1%, Study 2: 98.3%
CDC Panel evaluation: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive % Agreement/Initial Sensitivity: Study 1: 98.6%, Study 2: 97.5%
Negative % Agreement/Initial Specificity: Study 1: 91.1%, Study 2: 98.3%
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.
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) SUMMARY INFORMATION 2.0
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1.1 Name, Address of Applicant and Contact Person
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3730
DEC 26 2006
Contact Person: Charlotte Baker
1.2 Preparation Date
October 13, 2006
1.3 Device Trade or Proprietary Name
VITROS Immunodiagnostic Products Rubella IgG Reagent Pack VITROS Immunodiagnostic Products Rubella IgG Calibrators
Common Name: Rubella IgG Assay
1.4 Classification (Generic) Name of Device
Immunoassay Method, Rubella IgG Method Regulation 866.3510 Class: 2 Product Code: LFX
1.5 Predicate Device
ABBOTT AxSYM Rubella IgG Assay: K954045.
1.6 Device Description
The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic Products Rubella IgG Reagent Pack and VITROS Immunodiagnostic Products Rubella IgG Calibrators on the VITROS Immunodiagnostic System for the qualitative and quantitative determination of rubella IgG antibodies to rubella virus in human serum and plasma. An immunometric technique is used. This involves the reaction of antirubella IgG present in the sample with rubella antigen coated onto the wells. After a wash step a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-human IgG) is added and this complexes with bound anti-rubella IgG. Unbound materials are removed by washing.
1
The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of antirubella IgG present.
1.7 Device Intended Use
For in vitro diagnostic use only.
The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.
The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.
1.8 Comparison to Predicate Device
The VITROS Rubella IgG Reagent Pack and Calibrators are substantially equivalent to the ABBOTT AxSYM Rubella IgG Assay (predicate device) which was cleared by the FDA (K954045) for IVD use.
Table 1 (next page) presents the similarities and differences of both assays.
Ortho-Clinical Diagnostics, Inc.
2
| Similarities | ||
|---|---|---|
| Device | ||
| Characteristic | New Device-VITROS Rubella IgG | |
| assay | Predicate Device-ABBOTT | |
| AxSYM Rubella IgG assay | ||
| Intended Use | For in vitro diagnostic use only. | |
| The VITROS Immunodiagnostic | ||
| Products Rubella IgG assay is | ||
| intended for the quantitative | ||
| determination of IgG antibodies to | ||
| rubella virus in human serum and | ||
| plasma (heparin, EDTA or sodium | ||
| citrate) using the VITROS | ||
| Immunodiagnostic System. |
The VITROS Rubella IgG assay is for
use in the clinical laboratory as an aid
in the determination of immunity to
rubella virus infection. | The AxSym Rubella IgG assay is a
Microparticle Enzyme Immunoassay
(MIA) for the qualitative and
quantitative measurement of IgG
antibodies to rubella virus in serum
or plasma (EDTA, heparin or sodium
citrate) to aid in the determination of
immune status to rubella. |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Sample type | Serum and plasma (EDTA, heparin, or
sodium citrate) | Serum and plasma (EDTA, heparin,
or sodium citrate) |
| Antigen virus strain | HPV-77 | HPV-77 |
| Calibrator format | Liquid | Liquid |
| Linearity with W.H.O. 1st
International standard-
Assay range | r = 0.999 | r = 0.9999 |
| Linearity with W.H.O. 1st
International standard from
0-20 IU/mL | r = 0.9988 | Unknown |
| CDC Panel evaluation | Yes | Yes |
| Positive % Agreement/
Initial Sensitivity | Study 1: 98.6%
Study 2: 97.5% | 99.5% |
| Negative % Agreement/
Initial Specificity | Study 1: 91.1%
Study 2: 98.3% | 90.8% |
| Calibrators referenced to
W.H.O. | Yes | Yes |
| CLSI Standards Used | I/LA6, EP5, EP6, EP7, EP9 | I/LA6, EP5 |
| Differences | | |
| Antibody | Mouse monoclonal anti-human IgG | Goat anti-Human IgG |
| Sample volume | 10μL | 180μL |
| Calibrator levels | 3 | 6 |
| Reportable range | 0-350 IU/mL | 0-500 IU/mL |
| Incubation time and
temperature | 35 minutes at 37°C | 20 minutes at 37°C |
Table 1 Assay Characteristics
Ortho-Clinical Diagnostics, Inc.
,
.
3
1.9 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Rubella IgG Assay is safe and effective for the stated intended use and is substantially equivalent to the cleared predicate device.
Ortho-Clinical Diagnostics, Inc.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ortho-Clinical Diagnostics, Inc. c/o Charlotte Baker 100 Indigo Creek Dr. Rochester, NY 14626
DEC 26 2006
Re: K063143
Trade/Device Name: VITROS Immunodiagnostic Products Rubella IgG Reagent Pack VITROS Immunodiagnostic Products Rubella IgG Calibrators Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella virus serological reagents Regulatory Class: Class II Product Code: LFX Dated: December 13, 2006 Received: December 14, 2006
Dear Ms. Baker:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rained on one of begin marketing your device as described in your Section 510(k) I mo letter with a month and finding of substantial equivalence of your device to a legally promaticated predicated 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 in you attire of Compliance at (240) 276-0443. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general starters, 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,
Salyat
Sally A. Haiyat
Sally A. Hojvat Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
STATEMENT OF INTENDED USE 1.0 KOG3143
510(k) Number (if known):
Device Name:
VITROS Rubella IgG Reagent Pack VITROS Rubella IgG Calibrators
Indications for Use:
VITROS Rubella IgG Assay
For in vitro diagnostic use only.
The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.
The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.
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 In Vitro Diagnostic Devices (OIVD)
Noy an
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
KO 6 314 3 510(k)
Ortho-Clinical Diagnostics, Inc.
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