(554 days)
Not Found
No
The device description and performance studies describe a manual latex agglutination test with visual interpretation, not an AI/ML-based system.
No.
This device is designed for the detection and quantitation of rubella antibodies in human serum, which is a diagnostic function, not a therapeutic one. It provides information about a patient's immune status or potential infection, but it does not treat or alleviate any condition.
Yes
The device is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies, which is used to determine immune status or recent/active infection, fitting the definition of a diagnostic device.
No
The device description clearly states it is a "passive latex agglutination test" and describes the use of "latex reagent" and "card surface," indicating it is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "detection and/or quantitation of rubella antibodies in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence and level of rubella antibodies).
- Device Description: The description details a test that uses a reagent (sensitized latex) mixed with a human specimen (serum) on a card surface to observe a reaction (agglutination). This is a classic description of an in vitro diagnostic test.
- Target Specimen: The test uses "human serum," which is a biological specimen taken from the human body.
- Purpose: The purpose is to determine the presence and level of rubella antibodies, which is information used for diagnosis, monitoring, or screening related to rubella infection and immune status.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RUBAscan ® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection. The RUBAscan ® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.
Product codes
Not Found
Device Description
The RUBAscan ® Card Test is based upon the well established principles of passive latex agglutination. Latex is sensitized according to a patented process using solubilized rubella virus antigens from disrupted virions. This latex reagent, when mixed with serum containing rubella antibodies on a card surface, will agglutinate, forming visible clumps. In the absence of antibody, or if the concentration is insufficient to react, the latex will remain smooth and evenly dispersed.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Correlation: The following studies were conducted to enable the addition of a quantitative sensitivity claim of 10 IU/mL at the 1:10 screening dilution. The NCCLS guideline I/LA6-T was used as a guideline for performing the testing.
-
Internal testing was conducted to validate that the RUBAscan® Card Test dilution of 1:10 is equivalent to the 10 IU/mL cut-off.
Conclusion: The RUBAscan® Card Test met the acceptance criteria (≥ 95% as suggested by the NCCLS guidelines) for sensitivity and specificity of the in-house testing at the dilution of 1:10 when a commercially available ElA was used as the reference and a commercially available latex assay was used to resolve nonconcordant results. -
Two external studies were conducted to validate that the screening dilution of the RUBAscan® Card Test in clinical laboratorians' hands was equivalent to the 10 IU/mL immune status cut-off as defined by the commercially available EIA.
Conclusion: The RUBAscan® Card Test resolved sensitivity and specificity met the 95% confidence intervals for the observed sensitivity and specificity including 95% at the two sites. -
A CDC evaluation panel was tested internally using a 1:10 dilution.
Conclusion: The RUBAscan® Card Test identified all 100 samples correctly.
Reproducibility:
- Two external studies were conducted to validate dilution reproducibility at the 10 IU/mL cut-off.
Conclusion: Reproducibility of the RUBAscan® Card Test was acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity
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
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with a capital letter 'K', followed by the numbers '952721'. The characters are written in a dark ink, and the background is white. The handwriting appears to be somewhat stylized.
June 14, 1995
SUMMARY OF SAFETY AND EFFECTIVENESS
SUBMITTED BY:
Judith J. Smith Becton Dickinson Microbiology Systems P O Box 243 Cockeysville, MD 21030-0243
NAME OF DEVICE:
Trade Name: Common Name/Description:
Classification Name:
DEC 2 0 1996
RUBAscan® Card Test Latex agglutination for Rubella antibodies Latex agglutination assay, Rubella
PREDICATE DEVICE:
K832228; RUBAscan® Card Test
DEVICE DESCRIPTION:
INTENDED USE: The RUBAscan ® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection.
The RUBAscan ® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.
KIT DESCRIPTION: The RUBAscan ® Card Test is based upon the well established principles of passive latex agglutination. Latex is sensitized according to a patented process using solubilized rubella virus antigens from disrupted virions. This latex reagent, when mixed with serum containing rubella antibodies on a card surface, will agglutinate, forming visible clumps. In the absence of antibody, or if the concentration is insufficient to react, the latex will remain smooth and evenly dispersed.
1
A single specimen can be used to obtain a qualitative judgment about its antibody content. Analysis of dilutions of the specimen can give quantitative results.
PERFORMANCE DATA:
Clinical Correlation: The following studies were conducted to enable the addition of a quantitative sensitivity claim of 10 IU/mL at the 1:10 screening dilution. The NCCLS guideline I/LA6-T was used as a guideline for performing the testing.
-
. Internal testing was conducted to validate that the RUBAscan® Card Test dilution of 1:10 is equivalent to the 10 IU/mL cut-off.
Conclusion: The RUBAscan® Card Test met the acceptance criteria (≥ 95% as suggested by the NCCLS guidelines) for sensitivity and specificity of the in-house testing at the dilution of 1:10 when a commercially available ElA was used as the reference and a commercially available latex assay was used to resolve nonconcordant results. -
. Two external studies were conducted to validate that the screening dilution of the RUBAscan® Card Test in clinical laboratorians' hands was equivalent to the 10 IU/mL immune status cut-off as defined by the commercially available EIA.
Conclusion: The RUBAscan® Card Test resolved sensitivity and specificity met the 95% confidence intervals for the observed sensitivity and specificity including 95% at the two sites. -
. A CDC evaluation panel was tested internally using a 1:10 dilution.
Conclusion: The RUBAscan® Card Test identified all 100 samples correctly.
Beproducibility:
- . Two external studies were conducted to validate dilution reproducibility at the 10 IU/mL cut-off.
Reproducibility of the RUBAscan® Card Test was Conclusion: acceptable.