# K951632: Ortho-Mune OK-Combo Control IGG2A-Fitc/IGG2A-PE Monoclonal Antibody (Murine)

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: Mar 6, 1997 after 699 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
Longest line of descent: 1 generation back to K900078 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900078: Simultest Imk Plus (TM), Bd Becton Dickinson Vacutainer Systems Preanalytic (1990) Summary page 2.
- K950568: Ortho-Mune OK-Combo CD3-Fitc/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine), Ortho Diagnostic Systems, Inc. (1996). Cleared while this submission was under review Summary page 12.
- K950482: Ortho-Mune OK-Comvo CD3-Fitc/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine), Ortho Diagnostic Systems, Inc. (1996). Cleared while this submission was under review Summary page 12.
- K950625: Ortho-Mune OK-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine), Ortho Diagnostic Systems, Inc. (1996). Cleared while this submission was under review Summary page 12.
- K951100: Ortho-Mune OK-Combo CD3-Fitc/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine), Ortho Diagnostic Systems, Inc. (1996). Cleared while this submission was under review Summary page 12.

## Cited in the summary but kept off the family tree
- K913912: Verimed Perineometer, Verimed Holdings, Inc. (1992). Our OCR of the scanned summary read K913912, FDA’s number for Verimed Perineometer (Verimed Holdings, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Simultest CD3/CD4 (Leu-4/3a)”. Kept off the family tree. Summary page 12.

## Indications for use
Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotying of human lymphocytes in whole blood by flow cytometry using Ortho-mune OK-COMBO immunophenotyping reagents. Ortho-mune OK-COMBO immunophenotyping reagents are blends of two purified monoclonal antibodies conjugated to fluorescein isothiocyanate and phycoerythrin, respectively. The negative control is used to check for nonspecific background staining and to set the negative/positive rergions of the fluorescent cytograms.

Source page: https://510kreport.com/device/K951632
Methodology: https://510kreport.com/methodology