(458 days)
Simultest™ CD4/CD8 (Leu™-3a/2a)
Not Found
No
The summary describes a flow cytometry reagent for identifying and enumerating cell populations. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis focuses on antibody binding and flow cytometry measurements, not algorithmic interpretation of data using AI/ML.
No.
The device is used to identify and enumerate specific human T lymphocytes for diagnostic purposes, not to treat a condition or disease.
Yes
The device is intended for "identification and enumeration of CD4+ and CD8+ human T lymphocytes in whole blood by flow cytometry," which is a process used to gather information about a patient's health status, making it a diagnostic device.
No
The device description clearly states it is a "Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT4A and OKT8 conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively," indicating it is a biological reagent, not software.
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 CD4+ and CD8+ human T lymphocytes in whole blood by flow cytometry." This is a diagnostic purpose, providing information about a patient's health status (specifically, their immune system).
- Sample Type: The device is used with "whole blood," which is a biological specimen taken from the human body.
- Method: It utilizes "flow cytometry," a laboratory technique used to analyze characteristics of cells in a fluid.
- Comparison to Predicate: The intended use is stated to be the same as a predicate device, Simultest CD4/CD8, which is also an IVD used for similar diagnostic purposes.
These factors clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Ortho-mune OK-COMBO CD4-FITC/CD8-PE is intended for use in identification and enumeration of CD4+ and CD8+ human T lymphocytes in whole blood by flow cvtometry. The intended use is the same as the intended use of the predicate device. Simultest CD4/CD8 (Leu-3a/2a) commercially distributed by Becton Dickinson Immunocytometry Systems.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT4A and OKT8 conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) was compared with that of Simultest CD4/CD8 (Leu-3a/2a) at three external, geographically distinct sites. Whole blood specimens from 190 normal donors, and 83 AIDS/ARC patients were stained and analyzed using the ORTHO CYTORONABSOLUTE flow cytometer, Ortho Diagnostic Systems Inc.
For each specimen, the percentage of gated cells which showed positive by each marker was calculated. The mean and range of the percent CD4+ and percent CD8+ cells for the normal donor and AIDS/ARC population are shown in Table 1 and Table 2 respectively.
Linear regression analysis of total percent CD4+ cells from the combined normal and AIDS/ARC populations is found in Chart 1. Likewise, linear regression analysis of percent CD8+ cells from the combined normal and AIDS/ARC populations is found in Chart 2.
These studies demonstrate that the performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) is equivalent to Simultest CD4/CD8 (Leu-3a/2a) reagent in identification and enumeration of CD4+ and CD8+ human lymphocytes in whole blood by flow cytometry.
Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative vercent CD4+ and CD8+ cells.
Specimens from each of eleven normal donors (whole blood, EDT A) were processed using monoclonal antibodies bound to microbeads to produce samples of low, normal, and high relative percent CD4+ and CD8+ cells. The samples were separated into aliquots for each laboratory. Samples were stained in replicates of 10 with Ortho-mone OK-COMBO CD4/CD8 reagent and analyzed using the ORTHO CYTORONABSOLUTE flow cvtometer.
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 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 for determination of total percent CD4+ and percent CD8+ cells are presented in Table 3.
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 reproductifity results for deternination of total percent CDA+ and percent CD8+ cells are presented in Table 4.
Ortho-mune OK-COMBO CD4/CD8 immunophenotyping reagent shows acceptable within and between laboratory reproducibility for determination of total CD4+ and CD8+ lymphocyte percentages.
A linearity study was performed using an automated hematology analyzer to determine total lymphocyte count, and the CYTORONABSOLUTE flow cytometer to determine the percent positive CDx cells.
Specimens from four normal donors (whole blood, EDTA) were processed to produce samples with low, normal and high numbers of lymphocyte subsets. Each whole blood specimen was concentrated by harvesting the buffy cost to obtain a white blood cell count between 20,000 and 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-muse OK-COMBO CD4/CDS immunophenotyping reagent and analyzed using the CYTORONABSOLUTE flow cytometer. The total lymphocyte count of the concentrated sample for each donor was obtained using an automated hematology analyzer.
Linear regression analyses were performed as follows. 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 CYTORONABSOLUTE derived lymphocyte subset percent positive. The observed (Y axis) values were determined as the total lymphocyte count calculated from the hematology derived value of the concentrated sample times the CYTORONABSOLUTE derived lymphocyte subset percent positive at each dilution.
The OK-COMBO CD4/CD8 reagent demonstrated linear performance for both total CD4+ and CD8+ lymphocvte subsets across a lymphocyte count range of 20 celle/ul to 18,676 cells/ul as demonstrated with slopes indistinguishable from 1 and R values of 1.000.
Linear regression analyses of observed versus expected values for total percent CD4+ and percent CD8+ cells for each donor specimen are shown in Chart 3 and Chart 4 respectively. Regression analysis statistics are provided in Table 5.
Conclusion: Performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CDS-PE (OKT4A/OKTB) Monoclonal Antibody (Murine) is equivalent to Becton Dickinson (CA.14AOK To) Monocrolar at novement for idemification and desembination of percent CD4+ and CD8+ tymphocytes in whole blood by Bow wyssenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Simultest™ CD4/CD8 (Leu™-3a/2a)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
REVISED 510(k) SUMMARY
| SUBMITTER: | Ortho Diagnostic Systems
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
CD4-FITC/CD8-PE
(OKT™4A/OKT8)
Monoclonal Antibody (Murine) | PREDICATE: | Simultest™ CD4/CD8
(Leu™-3a/2a) |
| DATE: | February 16, 1996 | | |
DEVICE DESCRIPTION
Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT4A and OKT8 conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.
INTENDED USE
Ortho-mune OK-COMBO CD4-FITC/CD8-PE is intended for use in identification and enumeration of CD4+ and CD8+ human T lymphocytes in whole blood by flow cvtometry. The intended use is the same as the intended use of the predicate device. Simultest CD4/CD8 (Leu-3a/2a) commercially distributed by Becton Dickinson Immunocytometry Systems.
TECHNOLOGICAL CHARACTERISTICS
Both Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) and Simultest CD4/CD8(Leu-30/2a) utilize monoclonal antibodies specific for human helper/inducer T cells (OKT4A/Leu 3a) and human suppressor/cytotoxic T cells (OKT8/Leu-2a) respectively, conjugated to the same fluorochromes, fluorescein isothiocvanate and phycoerythrin.
1
PERFORMANCE CHARACTERISTICS
Performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) was compared with that of Simultest CD4/CD8 (Leu-3a/2a) at three external, geographically distinct sites. Whole blood specimens from 190 normal donors, and 83 AIDS/ARC patients were stained and analyzed using the ORTHO CYTORONABSOLUTE™ flow cytometer, Ortho Diagnostic Systems Inc.
For each specimen, the percentage of gated cells which showed positive by each marker was calculated. The mean and range of the percent CD4+ and percent CD8+ cells for the normal donor and AIDS/ARC population are shown in Table 1 and Table 2 respectively.
| PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTED
BY OKT4A/OKT8 AND LEU-3a/2a ASSAYED ON THE CYTORONABSOLUTE
| N=190 | |||||
|---|---|---|---|---|---|
| Ortho-mune | |||||
| Reagent | Mean % | Range % | BD | ||
| Reagent | Mean % | Range % | |||
| CD4+ | |||||
| (OKT4A) | 47.5 | 11.6-70.8 | CD4+ | ||
| (LEU3a) | 44.1 | 13.1-61.2 | |||
| CD8+ | |||||
| (OKT8) | 27.8 | 10.9-72.8 | CD8+ | ||
| (LEU2a) | 29.5 | 12.5-69.1 |
TABLE 1
2
| TABLE | 1 |
|---|---|
| ra A | ાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા |
| PERCENT POSITIVE STAINED CELLS IN AIDS/ARC PATIENTS DETECTED
BY OKT4A/OKT8 AND LEU-3a/2a ASSAYED ON THE CYTORONABSOLUTE
| N=83 | |||||
|---|---|---|---|---|---|
| Ortho-mune | |||||
| Reagent | Mean % | Range % | BD | ||
| Reagent | Mean % | Range % | |||
| CD4+ | |||||
| (OKT4A) | 18.2 | 0.1-60.4 | CD4+ | ||
| (LEU3a) | 15.8 | 0.2-50.4 | |||
| CD8+ | |||||
| (OKT8) | 56.1 | 12.6-81.9 | CD8+ | ||
| (LEU2a) | 58.9 | 22.5-88.4 |
Linear regression analysis of total percent CD4+ cells from the combined normal and AIDS/ARC populations is found in Chart 1. Likewise, linear regression analysis of percent CD8+ cells from the combined normal and AIDS/ARC populations is found in Chart 2.
3
CHART 1
OK-COMBO CD4/CD8 vs Simultest Leu-3a/2a
TOTAL CD4+ PERCENT
Image /page/3/Figure/2 description: This image is a scatter plot that compares the OK-COMBO Reagent to the Predicate Reagent. The x-axis represents the Predicate Reagent, and the y-axis represents the OK-COMBO Reagent. The plot shows a strong positive correlation between the two reagents. The equation of the line of best fit is Y = 1.886 + 1.08500, and the correlation coefficient R is 0.971.
4
CHART 2
OK-COMBO CD4/CD8 vs Simultest Leu-32/2a
Image /page/4/Figure/2 description: This image is a scatter plot that compares the OK-COMBO Reagent and Predicate Reagent. The x-axis represents the Predicate Reagent, and the y-axis represents the OK-COMBO Reagent. The data points are clustered around a line, which indicates a positive correlation between the two reagents. The equation of the line is Y = 0.112 + 0.84400, and the R-value is 0.955.
TOTAL CD8+ PERCENT
These studies demonstrate that the performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine) is equivalent to Simultest CD4/CD8 (Leu-3a/2a) reagent in identification and enumeration of CD4+ and CD8+ human lymphocytes in whole blood by flow cytometry.
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD4-FITC/CD8-PE Ref. No. K95-0625 Additional Information Submitted February, 1996 Page 132
5
Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative vercent CD4+ and CD8+ cells
Specimens from each of eleven normal donors (whole blood, EDT A) were processed using monoclonal antibodies bound to microbeads to produce samples of low, normal, and high relative percent CD4+ and CD8+ cells. The samples were separated into aliquots for each laboratory. Samples were stained in replicates of 10 with Ortho-mone OK-COMBO CD4/CD8 reagent and analyzed using the ORTHO CYTORONABSOLUTE flow cvtometer.
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 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 for determination of total percent CD4+ and percent CD8+ cells are presented in Table 3
| WITHIN LABORATORY REPRODUCIBILITY | |||||||
|---|---|---|---|---|---|---|---|
| OK-COMBO CD4/CD8 | |||||||
| N = 11 donors | |||||||
| All SITES | |||||||
| Mean | |||||||
| Percent | |||||||
| Positive | Site A | Site B | Site C | ||||
| OK-COMBO | |||||||
| CD4/CD8 | CV | # | |||||
| Reps | CV | # | |||||
| Reps | CV | # | |||||
| Reps | |||||||
| TOTAL CD4+ Low | 11.232 | 8.268 | 98 | 7.358 | 109 | 6.701 | 109 |
| TOTAL CD4+ Normal | 49.455 | 3.118 | 110 | 2.443 | 110 | 2.736 | 109 |
| TOTAL CD4+ High | 67.528 | 3.049 | 110 | 2.093 | 110 | 3.360 | 104 |
| TOTAL CD8+ Low | 7.521 | 15.735 | 110 | 7.186 | 110 | 7.972 | 104 |
| TOTAL CD8+ Normal | 32.782 | 4.244 | 110 | 3.102 | 110 | 3.442 | 109 |
| TOTAL CD8+ High | 56.234 | 3.392 | 98 | 2.462 | 109 | 2.740 | 109 |
TABLE 3
6
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 reproductifity results for deternination of total percent CDA+ and percent CD8+ cells are presented in Table 4.
TABLE 4
| BETWEEN LABORATORY REPRODUCIBILITY | |||||
|---|---|---|---|---|---|
| OK-COMBO CD4/CD8 | |||||
| N= 11 donors | |||||
| OK-COMBO | |||||
| CD4/CD8 | SITE A | ||||
| Mean Percent Positive | |||||
| (All Donors) | SITE B | ||||
| Mean Percent Positive | |||||
| (All Donors) | SITE C | ||||
| Mean Percent Positive | |||||
| (All Donors) | ACROSS SITE | ||||
| Coefficient | |||||
| of | |||||
| Variation | # | ||||
| Reps | |||||
| TOTAL CD4+ Low | 10.744 | 11.994 | 11.389 | 5.496 | 316 |
| TOTAL CD4+ Normal | 50.103 | 49.392 | 48.937 | 1.189 | 329 |
| TOTAL CD4+ High | 67.934 | 68.473 | 66.235 | 1.729 | 324 |
| TOTAL CD8+ Low | 7.908 | 7.623 | 7.097 | 5.453 | 324 |
| TOTAL CD8+ Normal | 32.636 | 32.913 | 32.741 | 0.427 | 329 |
| TOTAL CD8+ High | 55.979 | 56.787 | 55.271 | 1.354 | 316 |
Ortho-mune OK-COMBO CD4/CD8 immunophenotyping reagent shows acceptable within and between laboratory reproducibility for determination of total CD4+ and CD8+ lymphocyte percentages
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD4-FTTC/CD8-PE Ref. No. K95-062.5 Additional Information Submitted February, 1996 Page 134
159
7
A linearity study was performed using an automated hematology analyzer to determine total lymphocyte count, and the CYTORONABSOLUTE flow cytometer to determine the percent positive CDx cells.
Specimens from four normal donors (whole blood, EDTA) were processed to produce samples with low, normal and high numbers of lymphocyte subsets. Each whole blood specimen was concentrated by harvesting the buffy cost to obtain a white blood cell count between 20,000 and 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-muse OK-COMBO CD4/CDS immunophenotyping reagent and analyzed using the CYTORONABSOLUTE flow cytometer. The total lymphocyte count of the concentrated sample for each donor was obtained using an automated hematology analyzer.
Linear regression analyses were performed as follows. 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 CYTORONABSOLUTE derived lymphocyte subset percent positive. The observed (Y axis) values were determined as the total lymphocyte count calculated from the hematology derived value of the concentrated sample times the CYTORONABSOLUTE derived lymphocyte subset percent positive at each dilution.
The OK-COMBO CD4/CD8 reagent demonstrated linear performance for both total CD4+ and CD8+ lymphocvte subsets across a lymphocyte count range of 20 celle/ul to 18,676 cells/ul as demonstrated with slopes indistinguishable from 1 and R values of 1.000.
Linear regression analyses of observed versus expected values for total percent CD4+ and percent CD8+ cells for each donor specimen are shown in Chart 3 and Chart 4 respectively. Regression analysis statistics are provided in Table 5.
8
Image /page/8/Figure/0 description: The image is a graph titled "OK-COMBO CD4/CD8 CD4+". The x-axis is labeled "Expected CD4+ Counts" and ranges from 0 to 10000. The y-axis is labeled "Observed CD4+ Counts" and ranges from 0 to 10000. The graph shows a linear relationship between the expected and observed CD4+ counts.
CHART 3
DONOR *** 71 8-3 ପ 72 *** 73 合 ★ ★ 74
CHART 4 OK - COMBO CO4CD8 CD8+
Image /page/8/Figure/3 description: This image is a graph with two axes labeled "Expected CD3+ Counts" and "Observed CD3+ Counts". The x-axis, "Expected CD3+ Counts", ranges from 0 to 8000, while the y-axis, "Observed CD3+ Counts", ranges from 0 to 9000. A dashed line runs through the graph, starting at the origin and ending at approximately (6000, 6000). There are several points plotted on the graph, which appear to follow the trend of the dashed line.
士士 ★ 74 DONOR *** 71 8-0 - 72 ++ 73
Ortho Diagnostic Systems Inc.
Ortho-muse OK-COMBO CD4-FITC/CD8-PE Ref. No. K95-0625 Additional Information Submitted February, 1996 Page 136
161
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9
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CONCLUSION
2017
19 1
Performance of the two color reagent Ortho-mune OK-COMBO CD4-FITC/CDS-PE (OKT4A/OKTB) Monoclonal Antibody (Murine) is equivalent to Becton Dickinson (CA.14AOK To) Monocrolar at novement for idemification and desembination of percent CD4+ and CD8+ tymphocytes in whole blood by Bow wyssenses .
Ortho Diagnonnie Sjonamic Itar Cortho-mune ON «CCMMBO CD4-FITC/CD8-PE Ref. You W205-0625 Additional Internantine Submitted February, 1996 Page 137
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