ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)

K951632 · Ortho Diagnostic Systems, Inc. · GKZ · Mar 6, 1997 · Hematology

Device Facts

• Record ID: K951632
• Device Name: ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
• Applicant: Ortho Diagnostic Systems, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotyping 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 regions of the fluorescent cytograms.

Device Story

Ortho-mune OK-COMBO Control consists of murine monoclonal antibodies (IgG2a) conjugated to FITC and PE fluorochromes; antibodies are not specific for human cellular antigens. Used in clinical laboratories by technicians/operators performing flow cytometry. Device serves as negative control for immunophenotyping assays; added to whole blood samples to assess nonspecific background staining and establish negative/positive fluorescence gates. Output is a fluorescent signal profile used to calibrate flow cytometer analysis regions. Enables accurate identification of lymphocyte subsets (e.g., CD3, CD4, CD8, CD19) by ensuring proper gating; supports clinical decision-making by providing quality control for immunophenotyping results in patients with immune-related conditions.

Clinical Evidence

Bench testing and comparative clinical performance study. Evaluated 203 normal donors and 84 AIDS/ARC patients. Compared Ortho-mune OK-COMBO Control against predicate using Ortho CytoronAbsolute and BD FACScan flow cytometers. Metrics included mean percent positive events, SD, and CVs for within-lab and between-lab reproducibility. Linearity studies (R=1.000) confirmed performance across broad lymphocyte count ranges. Results demonstrated equivalent performance to predicate for CD3, CD4, CD8, and CD19 markers.

Technological Characteristics

Murine monoclonal antibodies (IgG2a) conjugated to FITC and PE fluorochromes. Non-specific for human cellular antigens. Designed for use with flow cytometry systems (e.g., Ortho CytoronAbsolute, BD FACScan).

Indications for Use

Indicated for use as a negative control in the immunophenotyping of human lymphocytes in whole blood samples from patients, including normal donors and those with disease states such as AIDS/ARC, when analyzed by flow cytometry.

Regulatory Classification

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™ IMK Plus Reagent B-Control (K900078)

Reference Devices

• Simultest CD3/CD4 (Leu-4/3a) (K913912)
• Ortho-mune OK-COMBO CD3-FITC/CD4-PE (K950568)
• Ortho-mune OK-COMBO CD3-FITC/CD8-PE (K950482)
• Ortho-mune OK-COMBO CD4-FITC/CD8-PE (K950625)
• Ortho-mune OK-COMBO CD3-FITC/CD19-PE (K951100)

Submission Summary (Full Text)

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K 9516a32
MAR - 6 1997

# ITEM 3

## ATTACHMENT I

### 510(k) SUMMARY

FOR

### ORTHO-MUNE™ OK-COMBO CONTROL IgG₂₆-FITC/IgG₂₆-PE MONOCLONAL ANTIBODY (MURINE)

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂₆-FITC/IgG₂₆-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 120

{1}

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂a-FITC/IgG₂a-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 121

# 510(k) SUMMARY

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

**CONTACT:** Ms. Gail Kromer
**TEL:** [phone]
**FAX:** [phone]

## DEVICE NAME:

Ortho-mune™ OK-COMBO Control
IgG₂a-FITC/IgG₂a-PE
Monoclonal Antibody (Murine)

## PREDICATE:

Simultest™ IMK Plus
Reagent B-Control
(K900078)

**DATE:** December 19, 1996

## DEVICE DESCRIPTION:

Ortho-mune OK-COMBO Control IgG₂a-FITC/IgG₂a-PE Monoclonal Antibody (Murine) is a blend of murine monoclonal antibodies, not specific for human cellular antigens, conjugated to the fluorochromes, fluorescein isothiocyanate (FITC) and phycoerythrin (PE), respectively.

## INTENDED USE:

Ortho-mune OK-COMBO Control is intended for use as negative control for immunophenotyping 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 regions of the fluorescent cytograms.

## TECHNOLOGICAL CHARACTERISTICS:

Both Ortho-mune OK-COMBO Control and Simultset IMK Plus Reagent B-Control use monoclonal antibodies which are not specific for human cellular antigens, purified and conjugated to fluorescein isothiocyanate and phycoerythrin.

## PERFORMANCE DATA:

Performance of Ortho-mune OK-COMBO Control was compared to Simultset IMK Plus Reagent B-Control at three external, geographically distinct sites.

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Whole blood specimens from 203 normal donors and 84 AIDS/ARC patients were stained and analyzed using the ORTHO CYTORONABSOLUTE™ laser flow cytometer (Ortho Diagnostic Systems Inc.).

The percent of events that fell within the positive region were analyzed to determine the expected mean, standard deviation (SD) and range for Ortho-mune OK-COMBO Control and Simultest IMK Control. These data are shown in Table A (Normal Donor Samples) and Table B (AIDS/ARC Samples).

| TABLE A | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| PERCENT OF EVENTS WITHIN THE POSITIVE REGION EXPECTED VALUES | | | | | | | | |
| NORMAL DONOR SAMPLES N = 203 | | | | | | | | |
| Fluoro-chrome | Ortho-mune OK-COMBO Control | | | Simultest IMK Control | | | Comparison | |
| | Mean % in +Region | 2SD | Range* | Mean % in +Region | SD | Range* | ΔMean | CI |
| FITC | 0.32 | 0.50 | 0 - 1.32 | 0.25 | 0.16 | 0 - 0.56 | 0.07 | 0.07 |
| PE | 0.38 | 0.78 | 0 - 1.95 | 0.25 | 0.29 | 0 - 0.84 | 0.13 | 0.12 |
| TABLE B | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| PERCENT OF EVENTS WITHIN THE POSITIVE REGION EXPECTED VALUES | | | | | | | | |
| AIDS/ARC SAMPLES N = 84 | | | | | | | | |
| Fluoro-chrome | Ortho-mune OK-COMBO Control | | | Simultest IMK Control | | | Comparison | |
| | Mean % in +Region | 2SD | Range* | Mean % in +Region | SD | Range* | ΔMean | CI |
| FITC | 0.43 | 0.34 | 0 - 1.10 | 0.31 | 0.20 | 0 - 0.71 | 0.11 | 0.08 |
| PE | 0.44 | 0.56 | 0 - 1.55 | 0.31 | 0.14 | 0 - 0.59 | 0.13 | 0.12 |

*Calculated

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂a-FITC/IgG₂a-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 122

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Reproducibility studies were performed at three independent laboratories using samples with low, normal and high percent positive lymphocyte subsets. The samples were processed to produce CD4 depleted, CD8 depleted, CD19 depleted and normal sample types. A portion of each sample was stained in replicates of ten with Ortho-mune OK-COMBO Control and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer.

The percent of events within the negative region was calculated on all four sample types. For within laboratory reproducibility, the variance for the replicate results was calculated within site, concentration and donor. The variance was averaged across site, concentration and donor. The square root of the average replicate variance (SD) was divided by the appropriate mean percent positive result (by site and concentration) and multiplied by 100 to obtain the CV. Within laboratory reproducibility results are provided in Table C.

| TABLE C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| WITHIN LABORATORY REPRODUCIBILITY
Ortho-mune OK-COMBO Control
Percent of Events in the Negative Region | | | | | | | |
| N = 11 donors | | | | | | | |
| Sample Type | All SITES
Mean Percent in
Negative Region
with CI* | Site A | | Site B | | Site C | |
| | | CV | # Reps | CV | # Reps | CV | # Reps |
| CD19 Depleted | 99.318 +/- 0.027 | 0.403 | 110 | 0.096 | 110 | 0.085 | 110 |
| CD4 Depleted | 99.314 +/- 0.057 | 0.151 | 99 | 0.860 | 110 | 0.079 | 109 |
| CD8 Depleted | 99.332 +/- 0.009 | 0.084 | 110 | 0.073 | 110 | 0.080 | 106 |
| Normal | 99.306 +/- 0.015 | 0.215 | 110 | 0.078 | 110 | 0.080 | 110 |

*Confidence Interval (CI) is at 95%.

The between laboratory CV was computed as follows. The mean percent positive for each site within concentration was calculated. The SD was computed on the three site means within concentration and the CV was obtained by dividing the SD by the overall mean within concentration and multiplying by 100. Between laboratory reproducibility results are provided in Table D.

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂-FITC/IgG₂-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 123

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| TABLE D | | | | | |
| --- | --- | --- | --- | --- | --- |
| BETWEEN LABORATORY REPRODUCIBILITY
Ortho-mune OK-COMBO Control
Percent of Events in the Negative Region | | | | | |
| N = 11 donors | | | | | |
| Sample Type | SITE A | SITE B | SITE C | ACROSS SITE | |
| | Mean Percent in Negative Region with CI*
(All Donors) | Mean Percent in Negative Region with CI*
(All Donors) | Mean Percent in Negative Region with CI*
(All Donors) | Coefficient of Variation | # Rep |
| CD19 Depleted | 99.304 +/- 0.403 | 99.345 +/- 0.096 | 99.305 +/- 0.085 | 0.024 | 330 |
| CD4 Depleted | 99.324 +/- 0.151 | 99.262 +/- 0.860 | 99.363 +/- 0.079 | 0.052 | 318 |
| CD8 Depleted | 99.358 +/- 0.084 | 99.334 +/- 0.073 | 99.303 +/- 0.080 | 0.028 | 326 |
| Normal | 99.311 +/- 0.215 | 99.326 +/- 0.077 | 99.281 +/- 0.080 | 0.023 | 330 |

*Confidence Interval (CI) is at 95%.

Ortho-mune OK-COMBO Control demonstrates acceptable within and between laboratory reproducibility for all sample types (CD4 depleted, CD8 depleted, CD19 depleted and normal).

A linearity study was performed using automated hematology analyzers and the ORTHO CYTORONABSOLUTE laser flow cytometer to determine the while blood cell count and percent lymphocytes of the normal donor samples being used in this study.

Four normal donor samples (whole blood, EDTA) were processed to produce samples with low, normal and high numbers of lymphocyte subsets. Each whole blood sample was concentrated by harvesting the buffy coat to obtain a white blood cell (WBC) count between 20,000 to 40,000 cells/uL, and then diluting to produce samples of high, normal and low numbers of lymphocyte subsets. A portion of each sample was stained in triplicate using Ortho-mune OK-COMBO immunophenotyping reagents and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer.

Least square linear regression analyses were performed as follows. The lymphocyte count for the buffy coat was derived by multiplying the WBC results from the hematology analyzer times the percent lymphocyte from the hematology analyzer. The expected (X axis) values were calculated by multiplying the corresponding serial dilutions by the hematology analyzer derived buffy coat lymphocyte count and by the ORTHO CYTORONABSOLUTE derived lymphocyte subset percent positive at each dilution.

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂a-FITC/IgG₂a-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 124

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Linearity results for two specificities of clinical significant, CD4 and CD19, are provided in Tables E and F, and Charts A and B to illustrate that Ortho-mune OK-COMBO Control can be used to establish analysis regions over a broad range of lymphocyte counts. Linearity graphs for each donor (donor #71 - donor #74) are presented for OK-COMBO CD3/CD4 (CD4 percent positive) in Chart A and for OK-COMBO CD3/CD19 (CD19 percent positive) in Chart B. The slope with confidence interval, intercept with confidence interval, and correlation coefficients are provided for OK-COMBO CD3/CD4 (CD4 percent positive) and OK-COMBO CD3/CD19 (CD19 percent positive) in Tables E and F.

| TABLE E | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| LINEARITY
OK-COMBO CD3/CD4 | | | | | | |
| N = 4 | | | | | | |
| OK-COMBO
CD3/CD4 | Donor | SLOPE | CI | INTERCEPT | CI | R |
| CD3^{+}CD4^{+} | 71 | 0.999 | 0.003 | 7.735 | 5.402 | 1.000 |
| CD3^{+}CD4^{+} | 72 | 1.000 | 0.003 | 1.512 | 2.233 | 1.000 |
| CD3^{+}CD4^{+} | 73 | 0.999 | 0.004 | 4.855 | 7.155 | 1.000 |
| CD3^{+}CD4^{+} | 74 | 0.999 | 0.003 | 13.555 | 10.706 | 1.000 |
| CD3^{+}CD4^{+} | All | 0.999 | 0.002 | 6.516 | 3.118 | 1.000 |
| TABLE F | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| LINEARITY
OK-COMBO CD3/CD19 | | | | | | |
| N = 4 | | | | | | |
| OK-COMBO
CD3/CD19 | Donor | SLOPE | CI | INTERCEPT | CI | R |
| TOTAL CD19^{+} | 71 | 1.004 | 0.009 | -2.895 | 3.922 | 1.000 |
| TOTAL CD19^{+} | 72 | 1.003 | 0.013 | -1.702 | 4.146 | 1.000 |
| TOTAL CD19^{+} | 73 | 1.002 | 0.004 | -2.003 | 1.730 | 1.000 |
| TOTAL CD19^{+} | 74 | 1.007 | 0.018 | -18.749 | 14.665 | 1.000 |
| TOTAL CD19^{+} | All | 1.003 | 0.008 | -5.916 | 4.016 | 1.000 |

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₄-FITC/IgG₄-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 125

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OK-COMBO CD3/CD4
CD3+CD4+


DONOR 71 72 73 74

# CHART A

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₁₆-FITC/IgG₁₆-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 126

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OK-COMBO CD3/CD19

CD19+


# CHART B

Performance of Ortho-mune OK-COMBO Control when used with Ortho-mune OK-COMBO immunophenotyping reagents was compared with that of the Becton Dickinson (BD) Simultest IMK Plus Reagent B-Control when used with Simultest immunophenotyping reagents. Data from studies comparing CD3/CD19 and CD4/CD8 reagents are presented below.

Performance of the two color reagents Ortho-mune OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A) Monoclonal Antibody (Murine) and Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) using Ortho-mune OK-COMBO Control was compared with that of Simultest IMK Plus Reagent C-Anti-Leu-4/Anti-Leu-12 (CD3/CD19) and Simultest IMK Plus Reagent-D-Anti-Leu3a/Anti-Leu-2a (CD4/CD8) using Simultest IMK Plus Reagent B-Control. Whole blood specimens from normal donors and AIDS/ARC patients were stained and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer.

Ortho Diagnostic Systems Inc.

Ortho-mune™ OK-COMBO Control IgG₂α-FITC/IgG₂α-PE

Monoclonal Antibody (Murine) - Ref. No. K951632

Additional Information Submitted December, 1996

Page 127

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For each specimen, the percentage of gated cells which showed positive stating by each marker was calculated. The mean and range of the percent of positive stained cells for the normal donor population are shown in Tables G and H, and for the AIDS/ARC population in Tables I and J. The Ortho-mune OK-COMBO reagents and the Simultest IMK Plus reagents gave equivalent results for the CD3, CD19, CD4, and CD8 markers when used to stain whole blood from normal donors and AIDS/ARC patients.

| TABLE G | | | | | |
| --- | --- | --- | --- | --- | --- |
| PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTED BY OKT3/OKB19A AND LEU4/LEU12 | | | | | |
| N = 191 | | | | | |
| Ortho-mune Reagent | Mean % | Range % | BD Reagent | Mean % | Range % |
| OKT3 | 75.0 | 56.4-88.6 | LEU4 | 73.9 | 53.6-88.5 |
| OKB19A | 14.0 | 1.4-32.1 | LEU12 | 13.7 | 2.2-30.9 |
| TABLE H | | | | | |
| --- | --- | --- | --- | --- | --- |
| PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTED BY OKT4A/OKT8 AND LEU3a/LEU2a | | | | | |
| N = 190 | | | | | |
| Ortho-mune Reagent | Mean % | Range % | BD Reagent | Mean % | Range % |
| OKT4A | 47.5 | 11.6-70.8 | LEU3a | 44.1 | 13.1-61.2 |
| OKT8 | 27.8 | 10.9-72.8 | LEU2a | 29.5 | 12.5-69.1 |
| TABLE I | | | | | |
| --- | --- | --- | --- | --- | --- |
| PERCENT POSITIVE STAINED CELLS IN AIDS/ARC PATIENTS DETECTED BY OKT3/OKB19A AND LEU4/LEU12 | | | | | |
| N = 85 | | | | | |
| Ortho-Mune Reagent | Mean % | Range % | BD Reagent | Mean % | Range % |
| OKT3 | 76.9 | 39.4-93.6 | LEU4 | 76.1 | 40.8-92.2 |
| OKB19A | 8.9 | 0.5-41.8 | LEU12 | 9.9 | 0.3-41.1 |

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₄-FITC/IgG₂₄-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 128

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| TABLE J | | | | | |
| --- | --- | --- | --- | --- | --- |
| PERCENT POSITIVE STAINED CELLS IN AIDS/ARC PATIENTS DETECTED BY OKT4A/OKT8 AND LEU3a/LEU2a | | | | | |
| N = 83 | | | | | |
| Ortho-mune Reagent | Mean % | Range % | BD Reagent | Mean % | Range % |
| OKT4A | 18.2 | 0.1-60.4 | LEU3a | 15.8 | 0.2-50.4 |
| OKT8 | 56.1 | 12.6-81.9 | LEU2a | 58.9 | 22.5-88.4 |

Studies were also performed using the Becton Dickinson FACScan™ flow cytometer. Whole blood samples were collected from 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 with Ortho-mune OK-COMBO reagents and with the Simultest IMK Plus reagents of comparable specificity. Ortho-mune OK-COMBO Control and Simultest IMK Plus Reagent B-Control were used with their respective OK-COMBO and Simultest reagents. The samples stained with the OK-COMBO reagents were analyzed on both the ORTHO CYTORONABSOLUTE and FACScan flow cytometers. The same samples stained with Simultest reagents were analyzed on the FACScan flow cytometer.

The mean percentage and range of positive stained cells for each marker were calculated. The results with Ortho-mune OK-COMBO reagents analyzed on both the ORTHO CYTORONABSOLUTE and BD FACScan flow cytometers are provided in Table K and Table L. The results comparing the OK-COMBO reagents with the Simultest reagents analyzed on the FACScan flow cytometer are provided in Table M and Table N.

These data demonstrate equivalent performance of the Ortho-mune OK-COMBO reagents using OK-COMBO Control when analyzed on both the ORTHO CYTORONABSOLUTE and BD FACScan flow cytometers, and equivalent performance of the OK-COMBO reagents using OK-COMBO Control to the Simultest IMK Plus reagents using Simultest IMK Plus Reagent B-Control when analyzed on the FACScan flow cytometer.

| TABLE K | | | | |
| --- | --- | --- | --- | --- |
| OKT3/OKB19A ASSAYED ON FACSCAN AND CYTORONABSOLUTE | | | | |
| N = 29 | | | | |
| Ortho-mune Reagent | FACScan
Mean % Range % | | CYTORONABSOLUTE
Mean % Range % | |
| OKT3 | 68.9 | 52.0-90.0 | 68.8 | 51.1-83.5 |
| OKB19A | 12.1 | 4.0-26.0 | 11.7 | 4.2-25.4 |

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂-FITC/IgG₂-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996

{10}

| TABLE L | | | | |
| --- | --- | --- | --- | --- |
| OKT4A/OKT8 ASSAYED ON FACSCAN AND CYTORONABSOLUTE | | | | |
| N=49 | | | | |
| Ortho-mune Reagent | FACScan Mean % Range % | | CYTORONABSOLUTE Mean % Range % | |
| OKT4A | 51.5 | 35.0-68.0 | 48.9 | 32.3-63.7 |
| OKT8 | 26.7 | 18.0-39.0 | 24.8 | 14.0-39.3 |
| TABLE M | | | | | |
| --- | --- | --- | --- | --- | --- |
| OKT3/OKB19A Vs. LEU4/LEU12 ASSAYED ON THE FACSCAN | | | | | |
| N = 29 | | | | | |
| Ortho-mune Reagent | FACScan Mean % Range % | | BD Reagent | FACScan Mean % Range % | |
| OKT3 | 68.9 | 52.0-90.0 | LEU4 | 69.9 | 50.0-85.0 |
| OKB19A | 12.1 | 4.0-26.0 | LEU12 | 14.0 | 6.0-29.0 |
| TABLE N | | | | | |
| --- | --- | --- | --- | --- | --- |
| OKT4A/OKT8 Vs. LEU3a/LEU2a ASSAYED ON THE FACSCAN | | | | | |
| N = 49 | | | | | |
| Ortho-mune Reagent | FACScan Mean % Range % | | BD Reagent | FACScan Mean % Range % | |
| OKT4A | 51.5 | 35.0-68.0 | LEU3a | 49.2 | 36.0-62.0 |
| OKT8 | 26.7 | 18.0-39.0 | LEU2a | 29.1 | 20.0-40.0 |

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂, FITC/IgG₁, PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 130

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In addition, the performance of the following Ortho-mune OK-COMBO immunophenotyping reagents when used with Ortho-mune OK-COMBO Control has been compared to the performance of various other single color and two color reagents and Simultest CD3/CD4 (Leu-4/3a [K913912] in the following 510(k) Premarket Notifications.

| Reagent | K# | Date Cleared |
| --- | --- | --- |
| Ortho-mune OK - COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) | K950568 | May 13, 1996 |
| Ortho-mune OK - COMBO CD3-FITC/CD8-PE (OKT3/OKT8) | K950482 | May 10, 1996 |
| Ortho-mune OK - COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) | K950625 | May 13, 1996 |
| Ortho-mune OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A) | K951100 | May 13, 1996 |

## CONCLUSION:

Performance of Ortho-mune OK-COMBO Control IgG₂ₐ-FITC/IgG₂ₐ-PE Monoclonal Antibody (Murine) is substantially equivalent to Simultest IMK Plus Reagent B-Control when used with Ortho-mune OK-COMBO and Simultest immunophenotyping reagents, respectively.

Ortho-mune OK-COMBO Control IgG₂ₐ-FITC/IgG₂ₐ-PE Monoclonal Antibody (Murine) when used with other Ortho-mune OK-COMBO immunophenotyping reagents is substantially equivalent to various other single and two color immunophenotyping reagents when used with their respective controls.

Ortho Diagnostic Systems Inc.
Ortho-mune™ OK-COMBO Control IgG₂ₐ-FITC/IgG₂ₐ-PE
Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996
Page 131