← Product Code [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) · K950568 # ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (K950568) _Ortho Diagnostic Systems, Inc. · GKZ · May 13, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K950568 ## Device Facts - **Applicant:** Ortho Diagnostic Systems, Inc. - **Product Code:** [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ.md) - **Decision Date:** May 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. ## Device Story Ortho-mune OK-COMBO is a blend of purified murine monoclonal antibodies (OKT3 and OKT4A) conjugated to fluorochromes (FITC and PE). It is used in clinical laboratories to stain whole blood specimens for analysis via flow cytometry. The device identifies and enumerates CD3+ (T cells) and CD4+ (helper/inducer T cells) lymphocytes. By providing quantitative data on these cell populations, the device assists clinicians in assessing immune status, particularly in patients with conditions like AIDS/ARC. The output is presented as a percentage of positive stained cells, which healthcare providers use to monitor disease progression or immune function. ## Clinical Evidence Clinical performance was evaluated by comparing the subject device to the predicate using whole blood specimens from 202 normal donors and 86 AIDS/ARC patients. Additional validation included 50 samples analyzed on both CytoronAbsolute and FACScan flow cytometers. Primary endpoints were the percentage of positive stained cells for CD3, CD4, and double-positive populations. Results showed high correlation (Pearson r range 0.82-0.97, p < 0.0001) between the subject device and the predicate, and between different flow cytometry platforms, demonstrating equivalent performance. ## Technological Characteristics Murine monoclonal antibodies (OKT3 and OKT4A) conjugated to fluorescein isothiocyanate (FITC) and phycoerythrin (PE). The device functions as a reagent for flow cytometry-based cell identification. No specific materials standards or software algorithms are described; the device is a chemical reagent. ## Regulatory Identification An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.” ## Predicate Devices - Simultest™ CD3/CD4 (Leu™-4/3a) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K950568 510(k) SUMMARY MAY 13 1995 SUBMITTER: Ortho Diagnostic Systems Inc. 1001 U.S. Hwy 202 Raritan, NJ 08869-0606 CONTACT: Joanne Harris Tel.: (908) 218-8404 Fax.: (908) 218-8168 DEVICE NAME: Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE (OKT™3/OKT4A) Monoclonal Antibody (Murine) PREDICATE: Simultest™ CD3/CD4 (Leu™-4/3a) DATE: February 3, 1995 ## DEVICE DESCRIPTION: Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT4A conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively. ## INTENDED USE: Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The intended use is the same as the intended use of the predicate device, Simultest CD3/CD4 (Leu-4/3a) commercially distributed by Becton Dickinson Immunocytometry Systems. ## TECHNOLOGICAL CHARACTERISTICS: Both Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) and Simultest CD3/CD4 (Leu-4/3a) utilize monoclonal antibodies specific for human T cells (OKT3/Leu-4) and human helper/inducer T cells (OKT4A/Leu-3a) respectively, conjugated to the same fluorochromes, fluorescein isothiocyanate and phycoerythrin. Ortho Diagnostic Systems Inc. Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE (OKT™3/OKT4) Monoclonal Antibody (Murine) Page 118 {1} # PERFORMANCE DATA: Performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) was compared with that of Simultest CD3/CD4 (Leu-4/3a). Whole blood specimens from 202 normal donors, and 86 AIDS/ARC patients were stained and analyzed using the CytoronAbsolute™ flow cytometer, Ortho Diagnostic Systems Inc. For each specimen, the percentage of gated cells which showed positive staining by each marker was compared. The comparison was done by calculating the mean and range of the percent of positive stained cells for each marker. The Pearson product moment correlation was the statistical method used to compare the reagents. These data are shown in Table A for the normal population and in Table B for the AIDS/ARC population. OK-COMBO CD3-FITC/CD4-PE and Simultest CD3/CD4 reagents gave equivalent results for the CD3 and CD4 markers when used to stain whole blood from normal donors and AIDS/ARC patients. | TABLE A: N=202 PEARSON PRODUCT MOMENT CORRELATION PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTED BY OKT3/OKT4A AND LEU4/3a ASSAYED ON THE CYTORONABSOLUTE | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Ortho-Mune Reagent | Mean% | Range% | BD Reagent | Mean% | Range% | Correlation | SL¹ | | OKT3⁻ | 75.8 | 58.3-89.1 | LEU4⁻ | 74.2 | 57.0-87.7 | 0.88 | 0.0001 | | OKT4A⁻ | 46.2 | 13.5-69.0 | LEU3a⁻ | 45.3 | 14.5-64.1 | 0.93 | 0.0001 | | OKT3⁻T4A⁻ | 45.6 | 13.3-69.0 | LEU4⁻3a⁻ | 44.9 | 14.3-63.7 | 0.93 | 0.0001 | ¹. SL Is The Significance Level, e.g., An SL Of 0.0500 Would Mean That There Is A 95% Probability That The Ortho-Mune And The BD Reagent Are Significantly Correlated. | TABLE B: N=86 PEARSON PRODUCT MOMENT CORRELATION PERCENT POSITIVE STAINED CELLS IN AIDS/ARC DONORS DETECTED BY OKT3/OKT4A AND LEU4/3a ASSAYED ON THE CYTORONABSOLUTE | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Ortho-Mune Reagent | Mean% | Range% | BD Reagent | Mean% | Range% | Correlation | SL¹ | | OKT3⁻ | 76.7 | 26.0-94.0 | LEU4⁻ | 76.5 | 39.8-95.3 | 0.90 | 0.0001 | | OKT4A⁻ | 16.7 | 0.5-47.7 | LEU3a⁻ | 16.6 | 0.6-51.5 | 0.96 | 0.0001 | | OKT3⁻T4A⁻ | 16.2 | 0.4-47.5 | LEU4⁻3a⁻ | 16.3 | 0.5-51.3 | 0.97 | 0.0001 | ¹. SL Is The Significance Level, e.g., An SL Of 0.0500 Would Mean That There Is A 95% Probability That The Ortho-Mune And The BD Reagent Are Significantly Correlated. Ortho Diagnostic Systems Inc. Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE (OKT™3/OKT4) Monoclonal Antibody (Murine) Page 119 {2} Studies were also performed using the Becton Dickinson FACScan™ flow cytometer. Whole blood samples were collected from 17 normal donors. These samples were tested as collected to provide normal range cell counts, and were also concentrated 5-fold and diluted 5-fold to yield high range and low range cell counts. Samples were stained using Ortho-mune OK-COMBO CD3-FITC/CD4 PE and Simultest CD3/CD4 (Lev-4/3A) reagent. The samples stained with the OK-COMBO reagent were analyzed on both the CytoronAbsolute flow cytometer and the FACScan flow cytometer. The same samples stained with Simultest reagent were analyzed on the FACScan flow cytometer. The mean percentage and range of positive stained cells for each marker and for the double positive stained cells were correlated using Pearson product moment correlation. The results with Ortho-mune OK-COMBO reagent analyzed on both the CytoronAbsolute flow cytometer and the FACScan flow cytometer are provided in Table F. The results comparing the OK-COMBO reagent with the Simultest reagent analyzed on the FACScan flow cytometer are provided in Table G. The data demonstrate equivalent performance of Ortho-mune OK-COMBO CD3-FITC/CD4-PE reagent using both the CytoronAbsolute and FACScan flow cytometers, and equivalent performance of Ortho-mune OK-COMBO CD3-FITC/CD4-PE reagent to the Simultest CD3/CD4 (Leu-4/3a) reagent when analyzed on the FACScan flow cytometer. | TABLE F: N=50 OKT3/OKT4A ASSAYED ON FACSCAN AND CYTORON | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Ortho-Mune Reagent | FACScan | | Cytoron | | FACScan Vs Cytoron | | | | Mean% | Range | Mean% | Range | Correlation | SL¹ | | OKT3* | 72.7 | 53.0-92.0 | 72.3 | 51.9-84.9 | 0.82 | 0.0001 | | OKT4A* | 52.6 | 39.0-65.0 | 49.2 | 34.7-62.7 | 0.89 | 0.0001 | | OKT3*T4A* | 49.0 | 35.0-68.0 | 48.4 | 34.0-62.4 | 0.89 | 0.0001 | 1. SL Is The Significance Level, e.g. SL Of 0.0500 Would Mean That There Is A 95% Probability That The Ortho-Mune Reagent, Assayed On Both Instruments, Are significantly Correlated. Ortho Diagnostic Systems Inc. Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE (OKT™3/OKT4) Monoclonal Antibody (Murine) Page 120 {3} | TABLE G: N=50 OKT3/OKT4A VS LEU4/3a ASSAYED ON THE FACSCAN | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Ortho-Mune Reagent | FACScan | | BD Reagent | FACScan | | Ortho Vs BD Reagent | | | | Mean% | Range | | Mean% | Range | Correlation | SL¹ | | OKT3* | 72.7 | 53.0-92.0 | LEU4* | 71.8 | 52.0-88.0 | 0.85 | 0.0001 | | OKT4A* | 52.6 | 39.0-65.0 | LEU3a* | 51.8 | 36.0-65.0 | 0.92 | 0.0001 | | OKT3*T4A* | 49.0 | 35.0-68.0 | LEU4*3a* | 47.5 | 33.0-62.0 | 0.91 | 0.0001 | 1. SL Is The Significance Level, e.g. SL Of 0.0500 Would Mean That There Is A 95% Probability That The Ortho-Mune And BD Reagents, Assayed On The FACScan, Are Significantly Correlated. ## CONCLUSIONS: 1. Performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD4PE (OKT3/OKT4A) Monoclonal Antibody (Murine) is substantially equivalent to Simultest CD3/CD4 (Leu-4/3a) reagent in identification and enumeration of CD3+ and CD4+ human lymphocytes in whole blood by flow cytometry. Ortho Diagnostic Systems Inc. Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE (OKT™3/OKT4) Monoclonal Antibody (Murine) Page 121 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K950568](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K950568) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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