# K952791: Directigen Meningitis Combo Test

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 30, 1996 after 346 days
- Product code: GTJ (Antisera, All Groups, N. Meningitidis)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Phadebact® S.pneumoniae and H.influenzae co-agglutination tests: named in the summary without a submission number
- (no number) Phadebact® Streptccoccus Test (A,B,C,G): named in the summary without a submission number
- (no number) Strep A Test: named in the summary without a submission number
- (no number) Strep B Test: named in the summary without a submission number
- (no number) Strep D Test: named in the summary without a submission number
- (no number) Strep F Test: named in the summary without a submission number
- (no number) Bacto Antisera for N.meningitidis groups A,B.C,D,X,Y,Z,Z', and W135: named in the summary without a submission number

## 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. pneurnoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and £. co/i 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.

Source page: https://510kreport.com/device/K952791
Methodology: https://510kreport.com/methodology