# K951459: Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc Conjugate

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: Jul 14, 1997 after 837 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- 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) CD4 (Leu-3a) FITC Monoclonal Antibody (Murine) FITC Conjugate: named in the summary without a submission number

## Indications for use
Ortho-mune OKT4A (CD4) Monoclonal Antibody (Murine) FITC Conjugate is used to identify and enumerate the percentage of CD4+ human T lymphocytes in whole blood by flow cytometry. Identification and enumeration of abnormal levels of CD4 lymphocytes may be clinically significant in the prognosis of secondary immunodeficiency diseases (acquired immunodeficiency syndrome [AIDS]). AIDS is characterized by a severe reduction in T helper CD3+CD4+) lymphocytes and a decrease in the CD4:CD8 ratio. The CD4:CD8 ratio has been used as a predictor of time to the development of AIDS. CD4 counts should also be determined using a CD3/CD4 combination reagent to eliminate monocyte contamination (CD3-CD4+dim). CD4+ lymphocytes (expressed as an absolute number, a percentage of lymphocytes or as a ratio of CD4+ to CD8+ T lymphocytes) represents the best single predictor of the progression of AIDS. CD4+ lymphocyte numbers usually start to decline relatively soon after human immunodeficiency virus (HIV) infection.

Source page: https://510kreport.com/device/K951459
Methodology: https://510kreport.com/methodology