(699 days)
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.
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.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Ortho-mune™ OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine):
Device: Ortho-mune™ OK-COMBO Control IgG2-FITC/IgG2-PE Monoclonal Antibody (Murine)
Intended Use: Negative control for immunophenotyping of human lymphocytes in whole blood by flow cytometry using Ortho-mune OK-COMBO immunophenotyping reagents. Used to check for non-specific background staining and to set negative/positive regions of fluorescent cytograms.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Simultest™ IMK Plus Reagent B-Control) and acceptable reproducibility and linearity. Therefore, the "acceptance criteria" are implied by the comparative performance and good internal consistency.
| Performance Metric | Acceptance Criteria (Implied by Equivalence/Acceptability) | Reported Device Performance (Ortho-mune OK-COMBO Control) |
|---|---|---|
| Equivalence to Predicate Device | ||
| Mean % Events in Positive Region (Normal Donors) | Similar mean % and range as the predicate (Simultest IMK Control), with small ΔMean and CI. (e.g., ΔMean approaching 0, CI covering 0). | FITC: Mean 0.32% (SD 0.50, Range 0-1.32). ΔMean vs. predicate: 0.07 (CI 0.07). |
| PE: Mean 0.38% (SD 0.78, Range 0-1.95). ΔMean vs. predicate: 0.13 (CI 0.12). | ||
| Mean % Events in Positive Region (AIDS/ARC Patients) | Similar mean % and range as the predicate (Simultest IMK Control), with small ΔMean and CI. | FITC: Mean 0.43% (SD 0.34, Range 0-1.10). ΔMean vs. predicate: 0.11 (CI 0.08). |
| PE: Mean 0.44% (SD 0.56, Range 0-1.55). ΔMean vs. predicate: 0.13 (CI 0.12). | ||
| Reproducibility | ||
| Within Laboratory Reproducibility (CV) | Low coefficient of variation (CV) across different sample types, suggesting consistent results within a laboratory. (No specific threshold given, but values generally below ~1% are good in flow cytometry). | CD19 Depleted: 0.403%. CD4 Depleted: 0.151%. CD8 Depleted: 0.084%. Normal: 0.215%. (These are "All Sites" CVs based on aggregated variance; individual site CVs are lower). |
| Between Laboratory Reproducibility (CV) | Low coefficient of variation (CV) across different laboratories, suggesting consistent results between labs. (No specific threshold given, but generally <5% is considered good for inter-lab variability). | CD19 Depleted: 0.024%. CD4 Depleted: 0.052%. CD8 Depleted: 0.028%. Normal: 0.023%. |
| Linearity (Ortho-mune OK-COMBO Control with OK-COMBO Reagents) | Slope close to 1, intercept close to 0, and high correlation coefficient (R close to 1) for various lymphocyte subsets (CD3+CD4+, Total CD19+), indicating accurate measurement across a broad range. | CD3+CD4+: Slope = 0.999 (CI 0.002), Intercept = 6.516 (CI 3.118), R = 1.000 (All Donors). Individual donor slopes range from 0.999-1.000, R=1.000. |
| TOTAL CD19+: Slope = 1.003 (CI 0.008), Intercept = -5.916 (CI 4.016), R = 1.000 (All Donors). Individual donor slopes range from 1.002-1.007, R=1.000. | ||
| Concomitant use with Ortho-mune Reagents vs. Predicate Reagents | Ortho-mune reagents with OK-COMBO Control should yield equivalent mean % and range of positive stained cells compared to Simultest reagents with their control. | The tables G-J (Normal Donors, AIDS/ARC Patients) and M-N (FACScan Comparison) generally show very similar mean percentages and overlapping ranges for comparable markers (e.g., OKT3 vs. LEU4, OKB19A vs. LEU12, OKT4A vs. LEU3a, OKT8 vs. LEU2a) between the OK-COMBO system and the Simultest system. The document concludes "These data demonstrate equivalent performance." |
| Performance across different Flow Cytometers | Ortho-mune OK-COMBO reagents with OK-COMBO Control should yield equivalent mean % and range of positive stained cells when run on ORTHO CYTORONABSOLUTE and FACScan. | Tables K and L show comparable mean percentages and overlapping ranges for OKT3, OKB19A, OKT4A, and OKT8 when analyzed on both ORTHO CYTORONABSOLUTE and FACScan. |
2. Sample Size Used for the Test Set and Data Provenance
- Equivalence to Predicate Device (Percent of Events in Positive Region):
- Normal Donors: N = 203 whole blood specimens.
- AIDS/ARC Patients: N = 84 whole blood specimens.
- Provenance: "three external, geographically distinct sites." Implies prospective collection, but not explicitly stated. Country of origin not specified.
- Reproducibility Studies:
- N = 11 donors (processed to produce CD4 depleted, CD8 depleted, CD19 depleted, and normal sample types).
- Number of Replicates: 10 replicates per sample type per site for within-laboratory, aggregated results for between-laboratory.
- Provenance: "three independent laboratories." Implies prospective collection. Country of origin not specified.
- Linearity Study:
- N = 4 normal donor samples (whole blood, EDTA) processed to generate low, normal, and high numbers of lymphocyte subsets.
- Number of Replicates: Triplicate staining for each sample.
- Provenance: Normal donor samples; not explicitly stated if from external sites or internal. Country of origin not specified.
- Comparison of Ortho-Mune Reagents + Control vs. Predicate Reagents + Control:
- Normal Donors (Tables G, H): N = 191 (CD3/CD19), N = 190 (CD4/CD8) whole blood specimens.
- AIDS/ARC Patients (Tables I, J): N = 85 (CD3/CD19), N = 83 (CD4/CD8) whole blood specimens.
- FACScan Comparison (Tables K, L, M, N): N = 29 (OKT3/OKB19A), N = 49 (OKT4A/OKT8) normal donor whole blood samples.
- Provenance: Not explicitly stated for all these specific comparisons, but generally "Whole blood specimens from normal donors and AIDS/ARC patients" were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This study does not involve "experts" establishing a disease diagnosis or image ground truth for the test set. Instead, it involves laboratory measurements using flow cytometry. The accuracy of the measurements relies on the instrument (ORTHO CYTORONABSOLUTE laser flow cytometer) and established laboratory protocols for staining and analysis. The "ground truth" for the test samples in the linearity study, for example, was derived from automated hematology analyzers and further calculations based on dilutions and flow cytometry results (expected X-axis values).
4. Adjudication Method for the Test Set
Not applicable. This is a technical performance study of a control reagent in a laboratory setting, not a clinical study requiring expert adjudication of diagnoses.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this is not an MRMC study. It is a technical performance study of a laboratory reagent demonstrating equivalence to a predicate and acceptable performance characteristics. It does not involve human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study primarily evaluates the standalone performance of the Ortho-mune OK-COMBO Control reagent in conjunction with flow cytometers. The primary data presented (mean percentages, ranges, reproducibility CVs, linearity slopes/intercepts/R-values) are objective measurements generated by the instruments and the reagents, not subject to human interpretation in the sense of a diagnostic decision. The device itself is a "negative control" reagent, used for instrument calibration and assessment of non-specific staining, rather than a diagnostic algorithm that produces an output for human interpretation.
7. The Type of Ground Truth Used
The ground truth is based on:
- Comparative Performance: The established performance data of the legally marketed predicate device, Simultest™ IMK Plus Reagent B-Control. The goal is to show the new device produces equivalent results.
- Internal Consistency: For reproducibility and linearity, the "ground truth" is derived from consistency across replicates, laboratories, and expected values based on known dilutions or physiological ranges (e.g., in normal vs. AIDS/ARC patient samples).
- Instrument Measurements: The quantitative outputs from the ORTHO CYTORONABSOLUTE laser flow cytometer and automated hematology analyzers.
8. The Sample Size for the Training Set
Not applicable. This is a performance study for a laboratory reagent. There is no "training set" in the context of machine learning or AI algorithms; the reagents are chemical/biological products whose performance characteristics are intrinsically determined by their composition and manufacturing process.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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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
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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 REGIONEXPECTED 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 REGIONEXPECTED 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 REPRODUCIBILITYOrtho-mune OK-COMBO ControlPercent of Events in the Negative Region | |||||||
| N = 11 donors | |||||||
| All SITES | Site A | Site B | Site C | ||||
| Sample Type | Mean Percent inNegative Regionwith 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 REPRODUCIBILITYOrtho-mune OK-COMBO ControlPercent of Events in the Negative Region | |||||
| N = 11 donors | |||||
| SITE A | SITE B | SITE C | ACROSS SITE | ||
| Mean Percent inNegative Regionwith CI*(All Donors) | Mean Percent inNegative Regionwith CI*(All Donors) | Mean Percent inNegative Regionwith CI*(All Donors) | CoefficientofVariation | #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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| LINEARITYOK-COMBO CD3/CD4 | |||||||||
| N = 4 | |||||||||
| OK-COMBOCD3/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 | ||||||
|---|---|---|---|---|---|---|
| LINEARITYOK-COMBO CD3/CD19 | ||||||
| N = 4 | ||||||
| OK-COMBOCD3/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
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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
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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-muneReagent | Mean % | Range % | BDReagent | 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 DONORSDETECTED 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-MuneReagent | Mean % | Range % | BDReagent | 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-muneReagent | Mean % | Range % | BDReagent | 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-muneReagent | 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
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| TABLE L | |||
|---|---|---|---|
| OKT4A/OKT8 ASSAYED ON FACSCAN AND CYTORONABSOLUTE | |||
| N=49 | |||
| Ortho-muneReagent | FACScanMean % | FACScanRange % | CYTORONABSOLUTEMean %Range % |
| OKT4A | 51.5 | 35.0-68.0 | 48.932.3-63.7 |
| OKT8 | 26.7 | 18.0-39.0 | 24.814.0-39.3 |
| TABLE M | |||||
|---|---|---|---|---|---|
| OKT3/OKB19A Vs. LEU4/LEU12 ASSAYED ON THE FACSCAN | |||||
| N = 29 | |||||
| Ortho-muneReagent | FACScan | BDReagent | 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 NOKT4A/OKT8 Vs. LEU3a/LEU2a ASSAYED ON THE FACSCAN | |||||
|---|---|---|---|---|---|
| N = 49 | |||||
| Ortho-muneReagent | FACScan | BDReagent | 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.
§ 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.”