(462 days)
Ortho-mune OK-COMBO CD3-FITC/CD8-PE is intended for use in identification and enumeration of CD3+ 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(s), Ortho-mune OKT3 Monoclonal Antibody (Murine) FITC Conjugate, and Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin conjugate.
Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT8 conjugated to the fluorochromes fluorescein isothiccyanate and phycoerythrin respectively.
This document describes the performance characteristics of the Ortho-mune™ OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) and its equivalence to predicate single-color reagents. Note: This document is from 1996 and uses terminology and study designs common for that era. There are no explicitly stated "acceptance criteria" in the format of pass/fail thresholds in this summary. Instead, the study aims to demonstrate "equivalence" through statistical comparisons and reproducibility. The document also does not describe an AI/algorithm-based device but rather a new diagnostic reagent. Therefore, sections related to AI-specific criteria (e.g., human-in-the-loop, AI vs. without AI assistance, training data) are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative acceptance criteria with pass/fail thresholds are not stated. Instead, the studies aimed to demonstrate equivalence to predicate devices and acceptable reproducibility and linearity. The reported device performance is presented as statistical comparisons and descriptive statistics.
| Study Type | Performance Metric | Stated Goal (Implicit Acceptance Criteria) | Reported Device Performance and Conclusion |
|---|---|---|---|
| Equivalence to Predicate Dual-color vs. Single-color Reagents | Mean % & Range % for CD3+ and CD8+ cells | Equivalence in percentage detection to predicate single-color reagents. | Normal Donors (N=199): - CD3+: Dual Color Mean % = 74.5 (Range 45.9-87.4) vs. Single Color Mean % = 75.9 (Range 58.4-90.1) - CD8+: Dual Color Mean % = 31.2 (Range 15.0-74.9) vs. Single Color Mean % = 29.2 (Range 13.2-75.5) AIDS/ARC Patients (N=77): - CD3+: Dual Color Mean % = 73.5 (Range 27.5-90.7) vs. Single Color Mean % = 77.7 (Range 35.6-96.4) - CD8+: Dual Color Mean % = 59.1 (Range 25.6-89.8) vs. Single Color Mean % = 60.3 (Range 18.1-92.1) Combined Population (Normal & AIDS/ARC): - CD3+: Linear regression: Y = -0.359 + 0.976(X), R = 0.928 - CD8+: Linear regression: Y = 5.547 + 0.882(X), R = 0.969 Conclusion: Performance is "equivalent" to single-color reagents. |
| Equivalence to Other Flow Cytometers | Linear regression (Correlation R-value) | Equivalence of ORTHO CYTORONABSOLUTE with recognized flow cytometers (FACScan and EPICS). | CYTORONABSOLUTE vs. FACScan (CD3+CD8+): Y = -0.3519 + 1.03999(x), R = 0.9955 CYTORONABSOLUTE vs. COULTER EPICS (CD3+CD8+): Y = 2.707 + 0.981(X), R = 0.983 Conclusion: Demonstrates "equivalent performance" of the ORTHO CYTORONABSOLUTE flow cytometer to Becton Dickinson FACScan and COULTER EPICS. |
| Within-Laboratory Reproducibility | Coefficient of Variation (CV) | Acceptable within-laboratory reproducibility for various cell percentages (low, normal, high). | TOTAL CD3+ Low/Normal/High: CVs from 1.539% to 3.488% across 3 sites. CD3+CD8+ Low/Normal/High: CVs from 2.904% to 11.214% across 3 sites. Conclusion: Acceptable within-laboratory reproducibility. |
| Between-Laboratory Reproducibility | Coefficient of Variation (CV) | Acceptable between-laboratory reproducibility for various cell percentages. | TOTAL CD3+ Low/Normal/High: Across Site CVs from 1.139% to 2.899%. CD3+CD8+ Low/Normal/High: Across Site CVs from 1.837% to 12.309%. Conclusion: Acceptable between-laboratory reproducibility. |
| Linearity Study | Slope and R-value of linear regression (Observed vs. Expected) | Linear performance across a wide range of lymphocyte counts. | TOTAL CD3+ (All donors): Slope = 0.999 (CI 0.001), R = 1.000 CD3+CD8+ (All donors): Slope = 1.000 (CI 0.002), R = 1.000 Conclusion: Demonstrated linear performance for both subsets across 20 to 18,676 cells/ul with slopes "indistinguishable from 1" and R values of 1.000. (Note: An R-value of exactly 1.000 is highly unusual in biological systems and may suggest data smoothing or specific analytical methods). |
2. Sample sizes used for the test set and the data provenance
Equivalence to Predicate Reagents Study:
- Sample Size: 199 normal donors and 77 AIDS/ARC patients. Total N=276.
- Data Provenance: Not explicitly stated, but likely from a US-based clinical setting as it's a 510(k) submission to the FDA. The data is prospective, collected for the purpose of this study.
Equivalence to Other Flow Cytometers Study:
- Sample Size: Ten normal donors (whole blood, EDTA).
- Data Provenance: Not explicitly stated, but likely from a US-based clinical setting, prospective.
Reproducibility Studies:
- Sample Size: Eleven normal donors (whole blood, EDTA).
- Data Provenance: Not explicitly stated, but likely from a US-based clinical setting, prospective. Conducted at three independent laboratories.
Linearity Study:
- Sample Size: Four normal donors (whole blood, EDTA).
- Data Provenance: Not explicitly stated, but likely from a US-based clinical setting, prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is a reagent for flow cytometry, which directly identifies and enumerates cell populations. The "ground truth" for the test set is established by the measurements from the predicate devices (single-color reagents) which are considered the established method. There are no human experts "establishing ground truth" in the sense of image interpretation or diagnostic classification. The measurements are quantitative outputs from flow cytometers.
4. Adjudication method for the test set
Not applicable. This device provides quantitative measurements from a flow cytometer. The "ground truth" is derived from a comparative measurement against established methods (predicate reagents) or from internal consistency (reproducibility, linearity). There is no subjective human assessment requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/algorithm-based diagnostic device where human readers interact with AI. It is a laboratory reagent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is evaluated in a standalone manner against predicate reagents and for its intrinsic measurement characteristics (reproducibility, linearity) when used with a flow cytometer.
7. The type of ground truth used
The ground truth used for assessing the new dual-color reagent (Ortho-mune OK-COMBO CD3-FITC/CD8-PE) was primarily:
- Comparative Measurements: Measurements obtained from the predicate single-color reagents (Ortho-mune OKT3 Monoclonal Antibody FITC Conjugate and Ortho-mune OKT8 Monoclonal Antibody Phycoerythrin conjugate) for CD3+ and CD8+ cell percentages.
- Internal Consistency: For reproducibility and linearity studies, the ground truth is the expected statistical behavior (e.g., low coefficient of variation for reproducibility, R-value near 1 and slope near 1 for linearity with serially diluted samples or known concentrations).
- Comparison to other established flow cytometers: For the instrument comparison part of the study, the measurements from the Becton Dickinson FACScan and COULTER EPICS flow cytometers were used as a comparative benchmark for the ORTHO CYTORONABSOLUTE.
There is no pathology, expert consensus on subjective findings, or outcomes data used as ground truth in this submission for this specific device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning algorithm. There is no concept of a "training set" for this type of diagnostic reagent.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/machine learning algorithm, there is no training set or ground truth established for it in that context.
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REVISED 510(k) SUMMARY
MAY 10 1996
Joanne Harris CONTACT: SUBMITTER: Ortho Diagnostic Systems 1001 U.S. Hwy 202 Tel: (908) 218-8404 Fax: (908) 218-8168 Raritan, NJ 08869-0606
Ortho-mune™ OK-COMBO DEVICE NAME: CD3-FITC/CD8-PE (OKTTM3/OKT8) Monoclonal Antibody (Murine)
Ortho-mune™ OKT™3 PREDICATE: Monoclonal Antibody (Murine) FITC Conjugate
Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin Conjugate
DATE:
February 29, 1996
DEVICE DESCRIPTION
Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT8 conjugated to the fluorochromes fluorescein isothiccyanate and phycoerythrin respectively .
INTENDED USE
Ortho-mune OK-COMBO CD3-FITC/CD8-PE is intended for use in identification and enumeration of CD3+ 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(s), Ortho-mune OKT3 Monoclonal Antibody (Murine) FITC Conjugate, and Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin conjugate.
TECHNOLOGICAL CHARACTERISTICS
Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine), Ortho-mune OKT3 Monoclonal Antibody (Murine) FITC Conjugate, and Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin Conjugate all utilize
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monoclonal antibodies specific for human T cells (OKT3) and human suppresser/cytotoxic T cells (OKT8) respectively. The purified monoclonal antibodies are conjugated to the same fluorochromes, fluorescein isothiocyanate and phycoerythrin respectively.
PERFORMANCE CHARACTERISTICS
Performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) was compared with that of single color reagents Ortho-mune OKT3 Monoclonal Antibody (Murine) FITC Conjugate and Orthomune OKT8 Monoclonal Antibody (Murine) Phycoerythrin Conjugate. Whole blood specimens from 199 normal donors, and 77 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 total percent CD3+ and total percent CD8+ for the normal population and the AIDS/ARC population are shown in Table 1 and Table 2, respectively.
| PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTEDBY OKT3/OKT8 AND OKT3 FITC AND OKT8 PEASSAYED ON THE CYTORONABSOLUTEN=199 | |||||||
|---|---|---|---|---|---|---|---|
| Dual ColorReagent | Mean % | Range % | Single ColorReagent | Mean % | Range % | ||
| CD3+(OKT3) | 74.5 | 45.9-87.4 | CD3+(OKT3) | 75.9 | 58.4-90.1 | ||
| CD8+(OKT8) | 31.2 | 15.0-74.9 | CD8+(OKT8) | 29.2 | 13.2-75.5 |
TABLE 1
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. No. K95-0482 Additional Information Submitted February, 1996 Page 187
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TABLE 2
PERCENT POSITIVE STAINED CELLS IN AIDS/ARC PATIENTS DETECTED BY OKT3/OKT8 AND OKT3 FITC AND OKT8 PE ASSAYED ON THE CYTORONABSOLUTE N=77
| Dual ColorReagent | Mean % | Range % | Single ColorReagent | Mean % | Range % |
|---|---|---|---|---|---|
| CD3+(OKT3) | 73.5 | 27.5-90.7 | CD3+(OKT3) | 77.7 | 35.6-96.4 |
| CD8+(OKT8) | 59.1 | 25.6-89.8 | CD8+(OKT8) | 60.3 | 18.1-92.1 |
Linear regression analysis of total percent CD3+ cells from the combined normal and AIDS/ARC populations is found in Chart 1. Likewise, linear regression analysis of total percent CD8+ cells from the combined normal and AIDS/ARC populations is found in Chart 2.
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CHART i
Image /page/3/Figure/1 description: The image shows the text "OK-COMBO CD3/CD8 vs Ortho-mune OKT3 FITC". The text is in bold and is centered in the image. The text appears to be a title or heading.
Image /page/3/Figure/2 description: This image is a scatter plot comparing "OK-COMBO Reagent" and "Predicate Reagent". The x-axis represents "Predicate Reagent", while the y-axis represents "OK-COMBO Reagent". The data points are scattered around a line, and the equation of the line is given as Y = -0.359 + 0.976(X), with an R-value of 0.928.
TOTAL CD3+ PERCENT
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. No. K95-0482 Additional Information Submitted February, 1996 Page 189
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CHART 2
OK-COMBO CD3/CD8 vs Ortho-mune OKT8 PE
Image /page/4/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 positive correlation between the two reagents, with the equation of the line of best fit being Y = 5.547 + 0.882(X) and an R-value of 0.969.
TOTAL CD8+ PERCENT
These studies demonstrate that the performance of the two color reagent Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT3) Monoclonal Antibody (Murine) is equivalent to the single color reagents Ortho-mune OKT3 FITC Conjugate and OKT8 PE equiration to the single single of total percent CD3+ and total percent CD8+ cells in whole blood by flow cytometry.
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. Nc. K95-0482 Additional Information Submitted February, 1996 Page 190
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For the CD3+CD8+ cell population the mean percent and range of results for the normal and AIDS/ARC population obtained using Ortho-mune OK-COMBO CD3-FITC/CD8-PE are shown in Table 3. Cells positive for both markers could not be determined with the single color reagents.
TABLE 3
| PERCENT MEAN AND RANGE OF CD3+CD8+ CELLS IN NORMAL ANDAIDS/ARC DONORS DETECTED BY OKT3/OKT8ASSAYED ON THE CYTORONABSOLUTE | |||||
|---|---|---|---|---|---|
| Normal Donors | Mean % | Range % | AIDS/ARCDonors | Mean % | Range % |
| CD3+CD8+(OKT3/OKT8) | 25.8 | 12.3-67.5 | CD3+CD8+(OKT3/OKT8) | 53.3 | 5.1-86 |
ORTHO CYTORONABSOLUTE™ Laser Flow Cytometer was used in the clinical studies comparing the performance of Ortho-mune OK-COMBO CD3-FITC/CD8-PE immunophenotyping reagent to Ortho-mune OKT3 FITC conjugate and OKT8 Phycoerythrin conjugate
A study was done comparing the performance of the ORTHO CYTORONABSOLUTE flow cytometer to recognized flow cytometers, Becton Dickinson FACScan™ and COULTER EPICS™ flow cytometers.
Specimens from ten normal donors (whole blood, EDTA) were processed using monoclonal antibodies bound to magnetic microbeads to product samples with low, normal, and high relative percent positive CD8 cells. A portion of each sample was stained in triplicate using immunophenotyping reagents from each manufacturer. Specimens stained with Ortho-mune OK-COMBO reagents were analyzed using the ORTHO CYTORONABSOLUTE flow cytometer. Likewise, samples stained with Simultest reagents were analyzed using the FACScan flow cytometer, and samples stained with Cyto-Stat®/ COULTER CLONE® were analyzed using the COULTER EPICS flow cytometer.
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For each sample the mean of the triplicate results were calculated for the Becton Dickinson FACScan, COULTER EPICS, and CYTOTONABSOLUTE within concentration and donor. Least square regression analyses were performed on these mean results for the FACScan (X axis) versus the CYTORONABSOLUTE (Y axis), and for the COULTER EPICS (X axis) versus the CYTORONABSOLUTE (Y axis). Results for percent CD3+CD8+ cells using Ortho-mune OK-COMBO CD3-FITC/CD8-PE and the CYTORONABSOLUTE versus Simultest CD3/CD8 (Leu-4/2a) using the FACScan are presented in Chart 3.
CHART 3
Image /page/6/Figure/2 description: This image is a scatter plot comparing CYTORONABSOLUTE and FACScan measurements. The plot includes data points, a trendline, and an equation describing the relationship between the two variables. The equation is Y = -0.3519 + 1.03999(x), with an R-value of 0.9955, indicating a strong positive correlation. The plot is labeled as 'Site B' and measures 'Percent CD3+CD8+'.
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Results for percent CD3+CD8+ cells using Ortho-mune OK-COMBO CD3+CD8+ cells and the CYTORONABSOLUTE flow cytometer versus Cyto-Stat/ COULTER CLONE CD3(IgG1)-FITC/T8-RD1 and the COULTER EPICS flow cytometer are presented in Chart 4.
Image /page/7/Figure/1 description: The image is a scatter plot comparing CYTORONABSOLUTE and COULTER EPICS at Site A, measuring Percent CD3+CD8+. The x-axis represents COULTER EPICS, and the y-axis represents CYTORONABSOLUTE, with values ranging from 0 to 80. A regression line is plotted through the data points, with the equation Y = 2.707 + 0.981(X) and a correlation coefficient R = 0.983.
CHART 4
These studies demonstrate the equivalent performance of the ORTHO CYTORONABSOLUTE flow cytometer to both the Becton Dickinson FACScan and the COULTER EPICS flow cytometer for determination of percent positive cells when used with appropriate immunophenotyping reagents.
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. No. K95-0482 Additional Information Submitted February, 1996 Page 193
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Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative percent CD3+ and CD8+ cells.
Specimens from each of eleven normal donors (whole blood, EDTA) were processed using monoclonal antibodies bound to microbeads to produce samples of low, normal, and high relative percent CD3+ and CD8+ cells. The samples were separated into aliquots for each laboratory. Samples were stained in replicates of 10 with Ortho-mune OK-COMBO CD3/CD8 reagent and analyzed using the ORTHO CYTORONABSOLUTE flow cytometer.
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 CD3+ and percent CD3+CD8+ cells are presented in Table 4.
| WITHIN LABORATORY REPRODUCIBILITY | |||||||
|---|---|---|---|---|---|---|---|
| OK-COMBO CD3/CD8 | |||||||
| N = 11 donors | |||||||
| OK-COMBOCD3/CD8 | All SITESMeanPercentPositive | Site A | Site B | Site C | |||
| CV | #Reps | CV | #Reps | CV | #Reps | ||
| TOTAL CD3+ Low | 56.525 | 3.400 | 98 | 2.486 | 110 | 3.488 | 109 |
| TOTAL CD3+ Normal | 76.676 | 2.130 | 110 | 1.569 | 110 | 2.307 | 109 |
| TOTAL CD3+ High | 87.146 | 2.407 | 109 | 1.539 | 110 | 2.424 | 110 |
| CD3+ CD8+ Low | 4.010 | 11.214 | 108 | 9.430 | 110 | 11.151 | 104 |
| CD3+ CD8+ Normal | 28.053 | 4.793 | 110 | 3.610 | 110 | 5.250 | 109 |
| CD3+ CD8+ High | 44.311 | 4.359 | 98 | 2.904 | 110 | 4.147 | 109 |
TABLE 4
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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 for determination of total percent CD3+ and percent CD3+CD8+ cells are presented in Table 5.
TABLE 5
| BETWEEN LABORATORY REPRODUCIBILITY | |||||
|---|---|---|---|---|---|
| OK-COMBO CD3/CD8 | |||||
| N = 11 donors | |||||
| OK-COMBOCD3/CD8 | SITE AMean PercentPositive(All Donors) | SITE BMean PercentPositive(All Donors) | SITE CMean PercentPositive(All Donors) | ACROSS SITECoefficientofVariation | #Reps |
| TOTAL CD3+ Low | 56.707 | 58.151 | 54.879 | 2.899 | 317 |
| TOTAL CD3+ Normal | 77.261 | 77.105 | 75.676 | 1.139 | 329 |
| TOTAL CD3+ High | 87.964 | 87.987 | 85.491 | 1.646 | 329 |
| CD3+ CD8+ Low | 4.088 | 3.467 | 4.439 | 12.309 | 322 |
| CD3+ CD8+ Normal | 28.451 | 27.058 | 28.614 | 3.051 | 329 |
| CD3+ CD8+ High | 45.009 | 44.386 | 43.396 | 1.837 | 317 |
Ortho-mune OK-COMBO CD3/CD8 immunophenotyping reagent shows acceptable within and between laboratory reproducibility for determination of total CD3+ and CD3+CD8+ lymphocyte percentages.
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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 coat 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-mune OK-COMBO CD3/CD8 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 CD3/CD8 reagent demonstrated linear performance for both total CD3+ and CD3+CD8+ lymphocyte subsets across a lymphocyte count range of 20 cells/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 CD3+ and percent CD3+CD8+ cells for each donor specimen are shown in Chart 5 and Chart 6 respectively. Regression analysis statistics are provided in Table 6.
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Image /page/11/Figure/1 description: This image is a scatter plot titled "OK - COMBO CD3/CD3 CD3+". The x-axis is labeled "Expected CDS+ Counts" and ranges from 0 to 14000. The y-axis is labeled "Observed CDS+ Counts" and ranges from 0 to 14000. A line of best fit is plotted through the data points.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------DONOR *** 71 0-0-0 73 & & △ 74
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. No. K4/5-0482 Additional Information Submitted February, 1996 Page 197
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CHART 6
OK - COMBO CD3/CD8 CD3+CD8+
Image /page/12/Figure/1 description: This image is a scatter plot with a line through the data. The x-axis is labeled "Expected CDS+CD8+ Counts" and ranges from 0 to 4000. The y-axis is labeled "Observed CDS+CD8+ Counts" and ranges from 0 to 4000. The data points are clustered around the line, indicating a strong correlation between the expected and observed counts.
DONOR *** 71 0-3 0 72 �-� 73 & & & 74
Ortho Diagnostic Systems Inc. Ortho-mune OK-COMBO CD3-FITC/CD8-PE Ref. No. K.95-0482 Additional Information Submitted February, 1996 Page 198
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TABLE 6
| OK-COMBO CD3/CD8 | ||||||
|---|---|---|---|---|---|---|
| N = 4 | ||||||
| OK-COMBOCD3/CD8 | Donor | SLOPE | CI | INTERCEPT | CI | R |
| TOTAL CD3+ | 1 | 0.999 | 0.003 | 10.907 | 6.694 | 1.000 |
| TOTAL CD3+ | 2 | 0.999 | 0.003 | 4.833 | 4.327 | 1.000 |
| TOTAL CD3+ | 3 | 0.999 | 0.003 | 5.103 | 9.583 | 1.000 |
| TOTAL CD3+ | 4 | 0.999 | 0.003 | 12.567 | 12.589 | 1.000 |
| TOTAL CD3+ | All | 0.999 | 0.001 | 7.870 | 3.552 | 1.000 |
| CD3+CD8+ | 1 | 1.000 | 0.003 | -0.889 | 2.414 | 1.000 |
| CD3+CD8+ | 2 | 0.999 | 0.005 | -0.144 | 3.352 | 1.000 |
| CD3+CD8+ | 3 | 0.999 | 0.005 | -0.657 | 5.106 | 1.000 |
| CD3+CD8+ | 4 | 1.001 | 0.005 | -5.762 | 6.280 | 1.000 |
| CD3+CD8+ | All | 1.000 | 0.002 | -1.868 | 1.935 | 1.000 |
CONCLUSION
Based upon the linear regression analysis of the clinical study data, and the supplemental studies performed demonstrating equivalence of the CYTORONABSOLUTE flow cytometer to the recognized flow cytometers, Becton Dickinson FACScan, and COULTER EPICS, Ortho-mune OK-COMBO CD3-FITC/CD8-PE (OKT3/OKT8) Monoclonal Antibody (Murine) is equivalent to the single color immunophenotyping reagents OKT3 Monoclonal Antibody (Murine) FITC Conjugate and Ortho-mune OKT8 Monoclonal Antibody (Murine) Phycoerythrin Conjugate for identification and determination of percent CD3+ and CD8+ lymphocytes in whole blood by flow cytometry.
§ 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.”