(300 days)
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No
The description details a traditional latex agglutination test, and there are no mentions of AI, ML, or related concepts.
No
Explanation: The device is a diagnostic test (rapid latex agglutination test for rubella antibodies) and not intended for treating or preventing a disease.
Yes
The device determines the presence and quantity of rubella antibodies in serum, which is used to diagnose rubella infection or immunity.
No
The device description clearly states it is a "rapid latex agglutination test," which is a laboratory assay involving physical reagents and a chemical reaction, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative determination of rubella antibodies in serum." This involves testing a sample (serum) taken from the human body in vitro (outside the body) to provide information about a person's health status (presence and level of rubella antibodies).
- Device Description: The description further clarifies that it's a "rapid latex agglutination test" using a biological sample (serum) and reagents to detect an analyte (rubella antibodies).
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hosag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected. The Latex Reagent and serum controls contain 0.1% sodium azide as a preservative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Murex Rub-ex test showed an equivalent performance in comparative studies with test kits distributed by Becton Dickinson and Orion Diagnostics. Any differences between the Murex Rub-& test and either Rubascan or Rubalex do not compromise the safety and efficacy of the product nor do they represent a potential unreasonable risk of illness or injury.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
K954920
AUG 21 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary for The Murex Rub-& Test
SAFETY AND EFFECTIVENESS
The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum. The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hosag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected. When used in accordance with the principles of Good Laboratory Practices, good standards of occupational hygiene and the instructions in the Package Insert, the reagents supplied with the test kit are not considered to present a hazard to health.
The Latex Reagent and serum controls contain 0.1% sodium azide as a preservative. Lead and copper in laboratory plumbing can react with sodium azide to produce lead and copper azide which can explode on percussion. Murex recommends that drains are flushed thoroughly with water after disposing of reagents containing sodium azide.
The Murex Rub-ex test showed an equivalent performance in comparative studies with test kits distributed by Becton Dickinson and Orion Diagnostics. Any differences between the Murex Rub-& test and either Rubascan or Rubalex do not compromise the safety and efficacy of the product nor do they represent a potential unreasonable risk of illness or injury.