(346 days)
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No
The device description and performance studies focus on a latex agglutination test based on antibody-antigen reactions, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a diagnostic test kit used to detect bacterial antigens, not to treat a condition.
Yes
The device is a presumptive latex agglutination test used for the direct qualitative detection of antigens to various bacteria in bodily fluids (CSF, serum, urine, or blood culture media), which is a diagnostic function.
No
The device is a latex agglutination test kit, which is a physical diagnostic test involving chemical reactions and visual observation of agglutination. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "presumptive latex agglutination test for the direct qualitative detection of antigens" in biological samples (CSF, serum, urine, blood culture media). This is a classic description of an in vitro diagnostic test.
- Device Description: The description details how the test works by reacting antibodies with antigens in a sample to produce a visible result (agglutination). This process is performed outside of the body, which is the definition of "in vitro."
- Anatomical Site: The samples tested (CSF, serum, urine, blood culture media) are all biological specimens taken from the body, not the body itself.
- Performance Studies: The performance studies involve testing the device's ability to identify pathogens from culture plates, which is an in vitro process.
The information provided clearly indicates that this device is designed to be used in vitro (outside the body) to diagnose or detect specific conditions or substances in biological samples.
N/A
Intended Use / Indications for Use
The Directigen® Meningitis Test Kits are a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1 in cerebrospinal fluid (CSF), serum, urine, or blood culture media. Visible agglutination occurs when a sample containing any of these bacterial antigens is reacted with its respective antibody-coated latex beads. This 510(k) was submitted to add colony confirmation and serotyping claims to the Intended Use Statement.
Product codes
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Device Description
Specific antibodies are bound to the surface of latex beads. In the presence of specific antigens, latex particle aggregation becomes large enough to allow visualization of positive agglutination These specific soluble polysaccharide antigens accumulate in CSF, serum, urine or blood as a result of infection by H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1.
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
Clinical Correlation: Two external studies were conducted to enable the addition of a claim for the Directigen® Meningitis Test Kits by providing colony confirmation and serogrouping capabilities from suspected colony growth for S.pneumoniae, H. influenzae type b, group B Streptococcus, N. meningitidis groups A, B, C, Y, or W135.
Key Metrics
| Suspected Organism | # Tested | Relative Sensitivity (95% Confidence Interval) | Relative Specificity (95% Confidence Interval) | % Uninterpretable Initial Testing |
|---|---|---|---|---|
| H. influenzae type b | 112 | 100% (92-100) | 98.5% (92-100)2 | 3.6% |
| S. pneumoniae | 124 | 93% (84-98) | 79% (66-88)1 | 0% |
| Group B Streptococcus | 129 | 100% (95-100) | 90.5% (80-96)1 | 0% |
| Neisseria meningitidis Group A/Y | 106 | 100% (83-100) | 100% (96-100)2 | 10.4% |
| Neisseria meningitidis Group C/W135 | 94 | 96% (82-100) | 98.5% (92-100)2 | 11.7% |
| Neisseria meningitidis Group B | 106 | 85% (55-98) | 100% (96-100)2 | 4.7% |
1 - Refor to Limitations of the Procedure
2 - Reaulta after repear testing with 1:10 dilution
Predicate Device(s)
Phadebact ® S.pneumoniae and H.influenzae co-agglutination tests; Phadebact ® Streptococcus Test (A,B,C,G) and Strep A Test, Strep B Test, Strep D Test, and Strep F Test; Bacto Antisera for N.meningitidis groups A,B,C,D,X,Y,Z,Z', and W135.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3390
Neisseria spp. direct serological test reagents.(a)
Identification. Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identifyNeisseria spp. from cultured isolates. Additionally, some of these reagents consist ofNeisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence ofNeisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.(b)
Classification. Class II (performance standards).
0
- . C/ =
MAY 3 0 1996 May 29, 1996
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: | Directigen ® Meningitis Combo Test Directigen ® Neisseria meningitidis Test |
|---|---|
| Common Name/Description: | Latex agglutination antigen detection kit |
| Classification Name: | Antisera, All groups; N.meningitidis |
| PREDICATE DEVICE: | Phadebact ® S.pneumoniae and H.influenzae co-agglutination tests; Phadebact ® Streptococcus Test (A,B,C,G) and Strep A Test, Strep B Test, Strep D Test, and Strep F Test; Bacto Antisera for N.meningitidis groups A,B,C,D,X,Y,Z,Z', and W135. |
DEVICE DESCRIPTION:
INTENDED USE: The Directigen® Meningitis Test Kits are a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1 in cerebrospinal fluid (CSF), serum, urine, or blood culture media. Visible agglutination occurs when a sample containing any of these bacterial antigens is reacted with its respective antibody-coated latex beads. This 510(k) was submitted to add colony confirmation and serotyping claims to the Intended Use Statement.
KIT DESCRIPTION: Specific antibodies are bound to the surface of latex beads. In the presence of specific antigens, latex particle aggregation becomes large enough to allow visualization of positive agglutination These specific soluble polysaccharide antigens accumulate in CSF, serum, urine or blood as a result of infection by H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1.
1
PERFORMANCE DATA:
Clinical Correlation: Two external studies were conducted to enable the addition of a claim for the Directigen® Meningitis Test Kits by providing colony confirmation and serogrouping capabilities from suspected colony growth for S.pneumoniae, H. influenzae type b, group B Streptococcus, N. meningitidis groups A, B, C, Y, or W135.
Conclusion: The Directigen® Meningitis Test Kits demonstrated acceptable performance for all latex reagents for serologic identification of each respective pathogen from culture plates.
| Suspected
Organism | #
Tested | Relative Sensitivity
(95% Confidence Interval) | Relative Specificity
(95% Confidence Interval) | % Uninterpretable
Initial Testing |
|---------------------------------------------------------|-------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------|
| H. influenzae
type b | 112 | 100% (92-100) | 98.5% (92-100)2 | 3.6% |
| S. pneumoniae | 124 | 93% (84-98) | 79% (66-88)1 | 0% |
| Group B
Streptococcus | 129 | 100% (95-100) | 90.5% (80-96)1 | 0% |
| Neisseria
meningitidis
Group A/Y | 106 | 100% (83-100) | 100% (96-100)2 | 10.4% |
| Neisseria
meningitidis
Group C/W135 | 94 | 96% (82-100) | 98.5% (92-100)2 | 11.7% |
| Neisseria
meningitidis
Group B | 106 | 85% (55-98) | 100% (96-100)2 | 4.7% |
1 - Refor to Limitations of the Procedure
2 - Reaulta after repear testing with 1:10 dilution
Based on the clinical trial data, a footnote has been added to the data summary table referring the user to the Limitations of the Procedure regarding the possibility of cross-reactivity with some strains of S. viridans group with the S. pneumoniae latex reagent. Additional tests may be needed to differentiate S. viridans from S. pneumoniae. In addition, certain bacterial isolates obtained from blood culture plates which are morphologically similar to, but gram stain inconsistent with the suspect colony, may exhibit non-specific agglutination and/or false positive reactions (ie. beta-hemolytic nonpathogenic Neisseria species with the Group B Strep latex). Therefore, a gram stain result should be performed prior to use with the colony confirmation procedure.