K Number

Device Name

ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

Manufacturer

ORTHO DIAGNOSTIC SYSTEMS, INC.

Date Cleared

1996-05-13

(460 days)

Product Code

GKZ

Regulation Number

864.5220

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Simultest CD3/CD4 (Leu-4/3a)

Reference Devices

Simultest CD3/CD4 (Leu-4/3a)

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on antibody staining and flow cytometry analysis, with no mention of AI or ML algorithms for data interpretation or classification. The statistical method used is Pearson correlation, a standard statistical technique, not an AI/ML method.

Therapeutic

No
The device is used for identification and enumeration of cells for diagnostic purposes, not for treatment.

Diagnostic

Yes

The device is intended for the "identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry," which provides information used for diagnosis or monitoring of disease.

SaMD (Software as a Medical Device)

The device description clearly states it is a "blend of the individual purified monoclonal antibodies OKT3 and OKT4A conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively," indicating it is a physical reagent, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for "identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry." This is a diagnostic purpose, providing information about a patient's immune system status.
Sample Type: It uses "whole blood," which is a biological specimen taken from the human body.
Method: It uses "flow cytometry," a common technique for analyzing cells in biological samples.
Comparison to Predicate: The device is compared to a "predicate device, Simultest CD3/CD4 (Leu-4/3a)," which is also an IVD used for similar diagnostic purposes.

These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

Not Found

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Flow cytometry

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD4-PE roKT3/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 and oo Arborake particular , 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 scalling by each marker was complex 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 mechod about on orable B for the AIDS/ARC population. OK-COMBO che normal pope 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. 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, nd were also concentrated 5-fold and diluted 5-fold to yield high range and low range cell counts. Samples were stained using Ortho-mune OX-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 The results with Ortho-mune OK-COMBO reagent analyzed moment correlation. 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.

Key results:

Normal Donors (N=202):
OKT3+ vs LEU4+: Correlation 0.88, SL 0.0001
OKT4A+ vs LEU3a+: Correlation 0.93, SL 0.0001
OKT3+T4A+ vs LEU4+3a+: Correlation 0.93, SL 0.0001

AIDS/ARC Patients (N=86):
OKT3+ vs LEU4+: Correlation 0.90, SL 0.0001
OKT4A+ vs LEU3a+: Correlation 0.96, SL 0.0001
OKT3+T4A+ vs LEU4+3a+: Correlation 0.97, SL 0.0001

Instrument Comparison (N=17 normal donors):
OKT3+ (FACScan vs Cytoron): Correlation 0.82, SL 0.0001
OKT4A+ (FACScan vs Cytoron): Correlation 0.89, SL 0.0001
OKT3+T4A+ (FACScan vs Cytoron): Correlation 0.89, SL 0.0001

Reagent Comparison on FACScan (N=17 normal donors):
Ortho-Mune OKT3+ vs BD LEU4+: Correlation 0.85, SL 0.0001
Ortho-Mune OKT4A+ vs BD LEU3a+: Correlation 0.92, SL 0.0001
Ortho-Mune OKT3+T4A+ vs BD LEU4+3a+: Correlation 0.91, SL 0.0001

Key Metrics

Pearson product moment correlation and significance level (SL).

Predicate Device(s)

Simultest™ CD3/CD4 Ortho-mune™ OK-COMBO DEVICE NAME: (Leu™-4 / 3a) CD3-FITC/CD4-PE (OKT™3 /OKT4A) Monoclonal Antibody (Murine)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
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.(b)
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.”

Summary

950568

510 (k) SUMMARY

MAY 1 3 1996

Ortho Diagnostic Systems Inc. SUBMITTER: 1001 U.S. Hwy 202 Raritan, NJ 08869-0606

CONTACT : Joanne Harris Tel.: (908) 218-8404 Fax.: (908) 218-8168

PREDICATE: Simultest™ CD3/CD4 Ortho-mune™ OK-COMBO DEVICE NAME: (Leu™-4 / 3a) CD3-FITC/CD4-PE (OKT™3 /OKT4A) Monoclonal Antibody (Murine)

DATE: February 3, 1995

DEVICE DESCRIPTION:

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 The intended use is the same as the intended use of the cytometry. 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) Sonoclonal Antibody (Murine) age 118

PERFORMANCE DATA:

For each specimen, the percentage of gated cells which showed positive staining by each marker was compared. The comparison was done by scalling by each marker was complex 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 mechod about on orable B for the AIDS/ARC population. OK-COMBO che normal pope 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

i. 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-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 |

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. (ORT' 3 / OKT. 4 ) Ortho-mune™ OK-COMBO CD3-FITC/CD4-PE Wonoclonal Antibody (Murine) age 119

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, nd were also concentrated 5-fold and diluted 5-fold to yield high range and low range cell counts. Samples were stained using Ortho-mune OX-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 The results with Ortho-mune OK-COMBO reagent analyzed moment correlation. 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.

| 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

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.

49.0

| 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 |

47.5

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.

LEU4 3a

35.0-68.0

CONCLUSIONS :

OKT3 T4A

Performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD4PE 1. (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.

0.91

33.0-62.0 |