(699 days)
No
The device is a negative control reagent for flow cytometry, not a software or analytical tool that would typically incorporate AI/ML. The description focuses on the biological components and their function in setting background staining levels.
No
This device is described as a "negative control" for immunophenotyping reagents used in flow cytometry. Its purpose is to check for nonspecific background staining and to set negative/positive regions, not to directly treat or diagnose a medical condition.
No
Explanation: This device is a negative control for immunophenotyping reagents. It is used to check for background staining and to set fluorescence regions, not to diagnose a condition itself.
No
The device description clearly states it is a blend of murine monoclonal antibodies conjugated to fluorochromes, which are physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "immunophenotying of human lymphocytes in whole blood by flow cytometry". This is a diagnostic procedure performed in vitro (outside the body) on a biological sample (whole blood).
- Function: The device is a negative control used to "check for nonspecific background staining and to set the negative/positive regions of the fluorescent cytograms". This is a crucial step in ensuring the accuracy and reliability of the diagnostic test being performed with the Ortho-mune OK-COMBO immunophenotyping reagents.
- Sample Type: It is used with "whole blood", a biological specimen.
- Method: It is used with "flow cytometry", a common technique for in vitro diagnostic testing of blood cells.
- Comparison to Predicate Device: The submission includes a predicate device (K900078; Simultest™ IMK Plus Reagent B-Control) which is also a control for immunophenotyping by flow cytometry, further indicating its IVD nature.
- Performance Studies: The detailed performance studies described (comparison to predicate, reproducibility, linearity) are typical for the validation of an IVD device.
Therefore, based on the provided information, the Ortho-mune OK-COMBO Control is clearly intended for use as a component in an in vitro diagnostic procedure.
N/A
Intended Use / 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 Orthomune 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.
Product codes
Not Found
Device Description
Ortho-mune OK-COMBO Control IgG2-FITC/IgG2-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
flow cytometry
Anatomical Site
human lymphocytes in whole blood
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
Performance of Ortho-mune OK-COMBO Control was compared to Simultest IMK Plus Reagent B-Control at three external, geographically distinct sites. Whole blood specimens from 203 normal donors and 84 AIDS/ARC patients were stained whole blood specamed trem 200 ties. Books on and first laser flow cytometer (Ortho Diagnostic Systems Inc.).
The percent of events that fell within the positive region were analyzed to determine the The percent or events and inn (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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Ortho-mune OK-COMBO Control to Simultest IMK Control:
- Study Design: Comparison of Ortho-mune OK-COMBO Control to Simultest IMK Plus Reagent B-Control.
- Sample Size: 203 normal donors and 84 AIDS/ARC patients.
- Data Source: Whole blood specimens.
- Methodology: Stained whole blood specimens analyzed using a laser flow cytometer (Ortho Diagnostic Systems Inc.).
- Key Results: The percent of events within the positive region and its mean (SD) and range were determined for both control reagents across normal and AIDS/ARC samples.
- Normal Donor Samples (N = 203):
- FITC: Ortho-mune Mean % in +Region = 0.32 (2SD = 0.50, Range = 0 - 1.32); Simultest Mean % in +Region = 0.25 (SD = 0.16, Range = 0 - 0.56).
- PE: Ortho-mune Mean % in +Region = 0.38 (2SD = 0.78, Range = 0 - 1.95); Simultest Mean % in +Region = 0.25 (SD = 0.29, Range = 0 - 0.84).
- AIDS/ARC Samples (N = 84):
- FITC: Ortho-mune Mean % in +Region = 0.43 (2SD = 0.34, Range = 0 - 1.10); Simultest Mean % in +Region = 0.31 (SD = 0.20, Range = 0 - 0.71).
- PE: Ortho-mune Mean % in +Region = 0.44 (2SD = 0.56, Range = 0 - 1.55); Simultest Mean % in +Region = 0.31 (SD = 0.14, Range = 0 - 0.59).
- Normal Donor Samples (N = 203):
Reproducibility Studies:
- Study Design: Within-laboratory and between-laboratory reproducibility.
- Sample Size: 11 donors for each laboratory setting.
- Data Source: Samples processed to produce CD4 depleted, CD8 depleted, CD19 depleted, and normal sample types.
- Methodology: Samples stained in replicates of ten with Ortho-mune OK-COMBO Control and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer. Percent of events within the negative region was calculated.
- Key Results:
- Within-Laboratory Reproducibility (CV):
- CD19 Depleted: 0.403 (All Sites), 0.096 (Site A), 0.085 (Site B), 0.079 (Site C).
- CD4 Depleted: 0.151 (All Sites), 0.860 (Site A), 0.079 (Site B), 0.084 (Site C).
- CD8 Depleted: 0.084 (All Sites), 0.073 (Site A), 0.080 (Site B), 0.080 (Site C).
- Normal: 0.215 (All Sites), 0.078 (Site A), 0.080 (Site B), 0.077 (Site C).
- Between-Laboratory Reproducibility (Coefficient of Variation):
- CD19 Depleted: 0.024.
- CD4 Depleted: 0.052.
- CD8 Depleted: 0.028.
- Normal: 0.023.
- Within-Laboratory Reproducibility (CV):
- Conclusion: Ortho-mune OK-COMBO Control demonstrates acceptable within and between laboratory reproducibility for all sample types.
Linearity Study:
- Study Design: Linearity of lymphocyte counts.
- Sample Size: Four normal donor samples (whole blood, EDTA).
- Methodology: Samples were concentrated by harvesting buffy coat, then diluted to produce samples with high, normal, and low numbers of lymphocyte subsets. Stained in triplicate using Ortho-mune OK-COMBO immunophenotyping reagents and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer. Least square linear regression analysis performed.
- Key Results:
- OK-COMBO CD3/CD4 (CD4 percent positive): Slope close to 1.000, R (correlation coefficient) = 1.000 for all individual donors and for 'All' data.
- OK-COMBO CD3/CD19 (CD19 percent positive): Slope close to 1.000, R (correlation coefficient) = 1.000 for all individual donors and for 'All' data.
- Conclusion: Ortho-mune OK-COMBO Control can be used to establish analysis regions over a broad range of lymphocyte counts.
Comparison of Ortho-mune OK-COMBO and Simultest Immunophenotyping Reagents:
- Study Design: Comparison of performance when Ortho-mune OK-COMBO Control is used with Ortho-mune OK-COMBO immunophenotyping reagents versus Simultest IMK Plus Reagent B-Control with Simultest immunophenotyping reagents.
- Sample Size: 191-190 normal donors, 85-83 AIDS/ARC patients.
- Methodology: Whole blood specimens stained and analyzed using the ORTHO CYTORONABSOLUTE laser flow cytometer.
- Key Results (Mean % and Range for Positive Stained Cells):
- Normal Donors - OKT3/OKB19A vs LEU4/LEU12 (N=191): Similar mean percentages and ranges.
- Normal Donors - OKT4A/OKT8 vs LEU3a/LEU2a (N=190): Similar mean percentages and ranges.
- AIDS/ARC Patients - OKT3/OKB19A vs LEU4/LEU12 (N=85): Similar mean percentages and ranges.
- AIDS/ARC Patients - OKT4A/OKT8 vs LEU3a/LEU2a (N=83): Similar mean percentages and ranges.
- Conclusion: The Ortho-mune OK-COMBO reagents and the Simultest IMK Plus reagents gave equivalent results.
Cross-Platform Comparison (FACScan and CYTORONABSOLUTE) and Reagent Comparison on FACScan:
- Study Design: Performance of Ortho-mune OK-COMBO reagents on different flow cytometers and comparison with Simultest reagents on FACScan.
- Sample Size: 29-49 normal donors.
- Methodology: Whole blood samples tested as collected, concentrated, and diluted. Stained with Ortho-mune OK-COMBO reagents and Simultest IMK Plus reagents. Analyzed on ORTHO CYTORONABSOLUTE and BD FACScan.
- Key Results:
- OKT3/OKB19A (N=29) assayed on FACScan and CYTORONABSOLUTE: Similar mean % and range.
- OKT4A/OKT8 (N=49) assayed on FACScan and CYTORONABSOLUTE: Similar mean % and range.
- OKT3/OKB19A vs LEU4/LEU12 (N=29) assayed on FACScan: Similar mean % and range.
- OKT4A/OKT8 vs LEU3a/LEU2a (N=49) assayed on FACScan: Similar mean % and range.
- Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean %, Range %, Mean % in +Region, Standard Deviation (SD), Coefficient of Variation (CV), slope, intercept, correlation coefficients (R).
Predicate Device(s)
Simultest™ IMK Plus Reagent B-Control (K900078)
Reference Device(s)
K950568, K950482, K950625, K951100
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '951633'. The characters are written in a bold, handwritten style, with varying stroke thicknesses. The overall impression is that of a quickly jotted down code or identifier.
MAR - 6 1997
ITEM 3
ATTACHMENT I
510(k) SUMMARY
FOR
ORTHO-MUNE™ OK-COMBO CONTROL IgG2-FITTC/IgG21-PE MONOCLONAL ANTIBODY (MURINE)
neetic Sys Ortho Diac ne™ OK-COMBO Centrel IgG2-FITC/IgG2-PTT C/IgG2-PE al Autibody (Murine) - Ref. No. K951632 Additional Information Subs itted December, 1996 Page 120
1
510(k) SUMMARY
SUBMITTER: Ortho Diagnostic Systems Inc. 1001 U.S. Highway 202 Raritan, NJ 08869-0606
DEVICE NAME:
CONTACT: Ms. Gail Kromer TEL: (908) 218-8179 FAX: (908) 218-8168
PREDICATE:
Ortho-mune™ OK-COMBO Control IgG22-FITC/IgG22-PE Monoclonal Antibody (Murine) :
Simultest™ IMK Plus Reagent B-Control (K900078)
DATE: December 19, 1996
DEVICE DESCRIPTION:
Ortho-mune OK-COMBO Control IgG2-FITC/IgG2-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 immunophenotying of human lymphocytes in whole blood by flow cytometry using Orthomune 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.
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 Simultest IMK Plus Reagent B-Control at three external, geographically distinct sites.
2
Whole blood specimens from 203 normal donors and 84 AIDS/ARC patients were stained whole blood specamed trem 200 ties. Books on and first laser flow cytometer (Ortho Diagnostic Systems Inc.).
The percent of events that fell within the positive region were analyzed to determine the The percent or events and inn (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 | ||||||||
| Ortho-mune OK-COMBO Control | Simultest IMK Control | Comparison | ||||||
| Fluoro- | ||||||||
| chrome | 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 | ||||||||
| Ortho-mune OK-COMBO Control | Simultest IMK Control | Comparison | ||||||
| Fluoro- | ||||||||
| chrome | 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
the Stree " OK-COMBO Control IgG2-FITC/IgG2-PIL thedy (Murine) - Ref. No. K951632 -1 As od December. 1996 I Information S Page 120
3
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 multipled 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 | |||||||
| All SITES | Site A | Site B | Site C | ||||
| Sample Type | Mean Percent in | ||||||
| Negative Region | |||||||
| with CI* | 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.
4
| TABLE D | |||||
|---|---|---|---|---|---|
| BETWEEN LABORATORY REPRODUCIBILITY | |||||
| Ortho-mune OK-COMBO Control | |||||
| Percent of Events in the Negative Region | |||||
| N = 11 donors | |||||
| 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 | |||||
| Sample Type | |||||
| 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.
5
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 Orhito-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. e™ OK-COMBO Control IgG2-FITC/IgG2--PITC/IgG2--PE Monoclonal Antibody (Murine) - Ref. No. K951632
Additional Information Submitted December, 1996 Additional Information Subu Page 125
6
Image /page/6/Figure/0 description: The image is a scatter plot titled "OK-COMBO CD3/CD4 CDS+CD4+". The x-axis is labeled "Reported CD3+CD4+ Counts" and ranges from 0 to 10000. The y-axis is labeled "Observed CD3+CD4+ Counts" and ranges from 0 to 10000. The data points are clustered along a straight line, indicating a strong positive correlation between the reported and observed counts.
日-日 0 72 ・ ◆ + 73 ・ ・ + + + 74 DONOR *** 71
CHART A
Ortho Diagnestic Systems Inc.
Ortho muse ™ OK-COMBO Control IgC2-FITC/IgGy_-PE
Memocional Antibody (Market) - Ref. No. K951632
Additional Information Submitted December, 1996 Page 126
7
Image /page/7/Figure/0 description: This image is a scatter plot titled CD19+. The x-axis is labeled "Expected CD19+ Counts" and ranges from 0 to 3000. The y-axis is labeled "Observed CD19+ Counts" and ranges from 0 to 3000. There is a dashed line going from the origin to approximately (2200, 2200), and there are data points plotted along the line.
OK-COMBO CD3/CD19
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------DONOR 71 73 ��� 73 & + + 74
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 CD4CD8 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.
8
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 Dia tic Systems Inc. Orthoe™ OK-COMBO Control IgG2-FITC/IgG2-PITC/IgG2-PE ocioual Antibody (Murine) - Ref. No. K951632 Polor Additional Information Submitted December, 1996 Page 128
9
| 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 | CYTORONABSOLUTE | ||
| Mean % | Range % | 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 e™ OK-COMBO Control IgG2-FTTC/IgG2--PE ocional Antibody (Murine) - Ref. No. K951632 Additional Information Submitted December, 1996 Page 129
10
| TABLE L | |||
|---|---|---|---|
| OKT4A/OKT8 ASSAYED ON FACSCAN AND CYTORONABSOLUTE | |||
| N=49 | |||
| Ortho-mune | |||
| Reagent | FACScan | ||
| Mean % | FACScan | ||
| 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 | BD | |||
| Reagent | FACScan | ||||
| Mean % | Range % | 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 | BD | |||
| Reagent | FACScan | ||||
| Mean % | Range % | 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 |
11
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 IgG2-FITC/IgG2-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 IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine) when used with other Ortho-mune OK-COMBO immunophenotyping reagents is substantially equivalent to various other single and two color immunophentotyping reagents when used with their respective controls.