(891 days)
No
The description focuses on physical calibration beads and flow rate measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is a calibration and verification kit for a flow cytometry system, designed to ensure accurate measurement of absolute lymphocyte counts, not to treat or diagnose patients.
No.
The Ortho-Count Calibration Kit is intended to calibrate and verify the calibration of a laser flow cytometry system, not to directly diagnose a disease or condition in a patient. It is a quality control tool for an analytical instrument.
No
The device description clearly states that the device contains "Calibrator Bead Suspension" and "Verifier Bead Suspensions," which are physical components (microparticle beads suspended in a buffer). This indicates it is a hardware/reagent-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is used to "calibrate and verify calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE Laser Flow Cytometry System." This system is used to count lymphocytes, which are components of blood.
- Device Description: The description details how the kit is used to calibrate the flow cytometer for absolute cell counting. It mentions using "known 'events'/unit volume" and verifying accuracy with "Verifier Bead Suspensions" that approximate values expected from patients with different white blood cell counts. This directly relates to analyzing biological samples (blood) for diagnostic purposes.
- Performance Studies: The performance studies compare the calibration method using this kit to other methods for determining absolute lymphocyte counts, including comparison to a Coulter JT2 calibrated with an S-CAL Kit. This demonstrates its use in a clinical or laboratory setting for obtaining results relevant to patient samples.
- Predicate Device: The predicate device listed is the "S-CAL® Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System Coulter Diagnostics" (K813375). Predicate devices are typically other IVD products that the current device is being compared to for regulatory purposes.
While the text doesn't explicitly state "for diagnostic use," the context of calibrating a flow cytometer used for absolute lymphocyte counting, the comparison to other methods for obtaining these counts, and the use of verifiers that mimic patient sample ranges strongly indicate that this kit is intended for use in a laboratory setting to support diagnostic testing of patient samples.
N/A
Intended Use / Indications for Use
Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System is intended to be used to calibrate and verify calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE. This intended use is substantially equivalent to the intended use of S-CAL Kit, the predicate device, for lymphocyte counting. The intended use is different than that for S-CAL Kit in that Ortho-Count Calibration Kit may not be used to calibrate the ORTHO CYTORONABSOLUTE for parameters other than lymphocyte counting. This difference does not affect the safety or effectiveness of Ortho-Count Calibration Kit for its intended use since the ORTHO CYTORONABSOLUTE is not intended for all of the same uses as the Coulter Systems with which S-CAL Kit is intended to be used.
Product codes
Not Found
Device Description
Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System, contains a Calibrator Bead Suspension for absolute lymphocyte count calibration and Verifier Bead Suspensions (I, II and III) to verify accuracy of absolute count calibration.
The Calibrator Bead Suspension is manufactured as known "events"/unit volume (i.e. the Calibration Number) in the form of microparticle beads suspended in a proprietary buffer. The size of the microparticles has been selected to emulate the range of size of leukocytes detected by the ORTHO CYTORONABSOLUTE under specified gating conditions.
The Verifier Bead Suspensions (I, II and III), are composed of materials identical to the Calibrator Bead Suspension and collectively provide a range of particle bead concentrations. The target values chosen approximate values expected from patients with low (Verifier I), normal (Verifier II) and high (Verifier III) white blood cell counts, The Verifiers are used to verify accuracy of the absolute respectively. lymphocyte count calibration immediately following calibration and are also used as daily quality control verification that the ORTHO CYTORONABSOLUTE is in calibration. A properly calibrated instrument will provide absolute counts within + 10% of the labeled events/uL for each Verifier supsension.
In the context of immune status monitoring, absolute cell count is defined as the number of cells per unit volume. The ORTHO CYTORONABSOLUTE uses precision stepper motors to deliver diluted sample to the instrument's flow cell at a constant rate. Since constant flow rate means movement of a fixed volume per unit time, analysis time determines the volume of sample analyzed. Calibration of the ORTHO CYTORONABSOLUTE consists of setting analysis time such that a volume corresponding to 1 uL of undiluted sample is examined.
Ortho-Count Calibrator Bead Suspension, representing a known number of particles per unit volume (i.e. events/uL) at the same dilution as used for testing samples, is counted until its "Calibration Number" is reached; the instrument is set to this analysis time. In subsequent analyses events are to passage of the equivalent of 1 uL of undiluted sample the instrument flowcell. As a result of this calibration, sample results can be read in absolute count, i.e. "events"/uL.
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 an ORTHO CYTORONABSOLUTE calibrated using Ortho-Count Calibration Kit (Meth 2) was compared to performance of the same instrument calibrated using whole blood whose total lymphocyte count was determined with a Coulter JT2 calibrated using S-CAL Kit (Meth 1), and to performance of the Coulter JT2 calibrated with S-CAL Kit (JT2). There were no significant differences in absolute lymphocyte counts that could be attributed to either the instrument or the method of calibration.
Four ORTHO CYTORONABSOLUTE instruments located in different regions of the United States, were calibrated using Ortho-Count Calibration Kit to assess inter-laboratory reproducibility os evidenced by Ortho-Count Calibration Kit Verifier Bead Suspensions. Overall precision of the absolute counts between laboratories was equivalent to the within laboratory precision.
Consistency of calibration of ORTHO CYTORONABSOLUTE instruments was demonstrated in a study comparing absolute lymphocyte counts obtained on a panel of donors at each of the four study sites.
Figure 1. Absolute lymphocyte counts were determined using cross-calibrated ORTHO CYTORONABSOLUTE instruments for a whole blood panel kept overnight at room temperature or shipped for next day delivery to each site. The average lymphocyte count obtained at each site is plotted versus the mean lymphocyte count across sites for each of 41 samples.
A study was performed to demonstrate that when calibrated using Ortho-Count Calibration Kit it is possible to obtain equivalent absolute lymphocyte subset counts directly from the ORTHO CYTORONABSOLUTE. Figure 2 shows strong correlation between absolute count values determined directly on the ORTHO CYTORONABSOLUTE and those calculated from combined hematology and other flow cytometer/reagent results. Regression analysis of the data yields a slope of 0.89, a y-intercept of -31 t 13 and a correlation coefficient (r) = 0.96.
The utility of the Ortho-Count Calibrator Kit Verifier Bead Suspensions as quality control indicators of proper calibration of the ORTHO CYTORONABSOLUTE was demonstrated in a study in which counts/volume (absolute counts) were measured on the three verifier suspensions twice per week over a period of 60 days. Figure 3 shows the absolute counts obtained at each laboratory over the two months. The tight agreement in measurements made using each of the Verifier Bead Suspensions confirms the suitability of Ortho-Count Calibration Kit as an accurate quality control measure of the status of calibration of the ORTHO CYTORONABSOLUTE.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
S-CAL® Kit for ORTHO CYTORONABSOLUTE [K813375] Laser Flow Cytometry System Coulter Diagnostics
Reference Device(s)
Not Found
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
ITEM 7.
807.87 (h) . A 510(k) SUMMARY AS DESCRIBED IN 807.92 OR A 510(k) STATEMENT AS DESCRIBED IN 807.93.
MAY - 9 1996
Ortho Diagnostic Systems Inc. Ortho CrionomaBSOLUTE " Laser Flow Cytometry System Page 56
1
510 (k) SUMMARY
SUBMITTER : Ortho Diagnostic Systems Inc. CONTACT : Ms. Joanne Harris Tel.: (908) 218-8404 1001 U.S. Hwy 202 Raritan, NJ 08869-0606 Fax.: (908) 218-8168 DEVICE NAME: Ortho-Count Calibration Kit PREDICATE: S-CAL® Kit for ORTHO CYTORONABSOLUTE [K813375] Laser Flow Cytometry System Coulter Diagnostics
[864.8185 Calibrator for red cell and white cell counting}
DATE: November 29, 1993
DEVICE DESCRIPTION:
Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System, contains a Calibrator Bead Suspension for absolute lymphocyte count calibration and Verifier Bead Suspensions (I, II and III) to verify accuracy of absolute count calibration.
The Calibrator Bead Suspension is manufactured as known "events"/unit volume (i.e. the Calibration Number) in the form of microparticle beads suspended in a proprietary buffer. The size of the microparticles has been selected to emulate the range of size of leukocytes detected by the ORTHO CYTORONABSOLUTE under specified gating conditions.
The Verifier Bead Suspensions (I, II and III), are composed of materials
identical to the Calibrator Bead Suspension and collectively provide a range of particle bead concentrations. The target values chosen approximate values expected from patients with low (Verifier I), normal (Verifier II) and high (Verifier III) white blood cell counts, The Verifiers are used to verify accuracy of the absolute respectively. lymphocyte count calibration immediately following calibration and are also used as daily quality control verification that the ORTHO CYTORONABSOLUTE is in calibration. A properly calibrated instrument will provide absolute counts within + 10% of the labeled events/uL for each Verifier supsension.
In the context of immune status monitoring, absolute cell count is defined as the number of cells per unit volume. The ORTHO CYTORONABSOLUTE uses precision stepper motors to deliver diluted sample to the instrument's flow cell at a constant rate. Since constant flow rate means movement of a fixed volume per unit time, analysis time determines the volume of sample analyzed. Calibration of the ORTHO CYTORONABSOLUTE consists of setting analysis time such that a volume corresponding to 1 uL of undiluted sample is examined.
Ortho Diagnostic Systems Inc. Ortho-Count Calibration Kit for
ORTHO CYTORONABSOLUTE™ Laser Flow Cytometry System Page 57
2
Ortho-Count Calibrator Bead Suspension, representing a known number of particles per unit volume (i.e. events/uL) at the same dilution as used for testing samples, is counted until its "Calibration Number" is reached; the instrument is set to this analysis time. In subsequent analyses events are to passage of the equivalent of 1 uL of undiluted sample the instrument flowcell. As a result of this calibration, sample results can be read in absolute count, i.e. "events"/uL.
INTENDED USE:
Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System is intended to be used to calibrate and verify calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE. This intended use is substantially equivalent to the intended use of S-CAL Kit, the predicate device, for lymphocyte counting. The intended use is different than that for S-CAL Kit in that Ortho-Count Calibration Kit may not be used to calibrate the ORTHO CYTORONABSOLUTE for parameters other than lymphocyte counting. This difference does not affect the safety or effectiveness of Ortho-Count Calibration Kit for its intended use since the ORTHO CYTORONABSOLUTE is not intended for all of the same uses as the Coulter Systems with which S-CAL Kit is intended to be used.
TECHNOLOGICAL CHARACTERISTICS:
Ortho-Count Calibration Kit and S-CAL Kit both contain components which are recognized by cell counters as leukocytes and are used to convert the electronic signal obtained from such instruments into accurate leukocyte count results expressed in clinical terms. Both kits consist of suspensions of particles, whose size, shape, concentration and other
characteristics have been accurately determined. Ortho-Count Calibration Kit employees microparticle beads, while S-CAL Kit uses fixed erythrocytes in suspension, to simulate leukocytes.
PERFORMANCE DATA:
Performance of an ORTHO CYTORONABSOLUTE calibrated using Ortho-Count Calibration Kit (Meth 2) was compared to performance of the same instrument calibrated using whole blood whose total lymphocyte count was determined with a Coulter JT2 calibrated using S-CAL Kit (Meth 1), and to performance of the Coulter JT2 calibrated with S-CAL Kit (JT2). As shown in Tabla.1. there were no significant differences in absolute lymphocyte counts that could be attributed to either the instrument or the method of calibration.
3
TABLE 1
LYMPHOCYTE COUNTS FRON A HENATOLOGY ANALYZER VERSUS
LYMPHOCYTE COUNTS FRON ORTHO CYTORONABSOLUTE CALIBRATED BY
DIFFERENT METHODS
| Donor
Number | Mean
JT2 | Std.
Dev. | Mean
Method 1 | Std.
Dev | Mean
Method 2 | Std.
Dev | Ratio
Meth1
JT2 | Ratio
Meth2
JT2 | Ratio
Meth2
Meth1 |
|----------------------------|-------------|--------------|------------------|-------------|------------------|-------------|-----------------------|-----------------------|-------------------------|
| 1 | 1983 | 75 | 1776 | 23 | 1940 | 90 | 0.90 | 0.98 | 1.09 |
| 2 | 2383 | 41 | 2189 | 94 | 2147 | 88 | 0.92 | 0.90 | 0.98 |
| 3 | 1767 | 137 | 1736 | 71 | 1668 | 93 | 0.98 | 0.94 | 0.96 |
| 4 | 2217 | 75 | 2076 | 81 | 2129 | 90 | 0.94 | 0.96 | 1.03 |
| 5 | 1800 | 47 | 1805 | 52 | 1807 | 110 | 1.00 | 1.00 | 1.00 |
| 6 | 2250 | 55 | 2265 | 29 | 2132 | 56 | 1.01 | 0.95 | 0.94 |
| 7 | 1600 | 122 | 1557 | 25 | 1476 | 98 | 0.97 | 0.92 | 0.95 |
| 8 | 2300 | 71 | 2323 | 138 | 2271 | 61 | 1.01 | 0.99 | 0.98 |
| 9 | 3820 | 164 | 3730 | 81 | 3855 | 94 | 0.98 | 1.01 | 1.03 |
| 10 | 2517 | 117 | 2481 | 73 | 2413 | 141 | 0.99 | 0.96 | 0.97 |
| Mean
Standard Deviation | | | | | | | 0.97
0.04 | 0.96
0.04 | 0.99
0.05 |
Four ORTHO CYTORONABSOLUTE instruments located in different regions of the United States, were calibrated using Ortho-Count Calibration Kit to assess inter-laboratory reproducibility os evidenced by Ortho-Count Calibration Kit Verifier Bead Suspensions. Table 2 shows the accuracy and precision of the absolute counts at each site. Overall precision of the absolute counts between laboratories was equivalent to the within laboratory precision.
Table 2. Across Site Accuracy and Precision of Absolute Counts on Four Microparticle Calibrated CytoronAbsolutes
| Location | Site
One | Site
Two | Site
Three | Site
Four | Overall
Inter-Lab |
|--------------|-------------|-------------|---------------|--------------|----------------------|
| Verifier I | | | | | |
| Mean | 1736 | 1699 | 1669 | 1670 | 1693 |
| Std. Dev. | 61 | 43 | 43 | 44 | 55 |
| % CV | 3.5 | 2.5 | 2.6 | 2.6 | 3.2 |
| Verifier II | | | | | |
| Mean | 7851 | 7726 | 7805 | 7614 | 7748 |
| Std. Dev. | 174 | 225 | 101 | 173 | 193 |
| % CV | 2.2 | 2.9 | 1.3 | 2.3 | 2.5 |
| Verifier III | | | | | |
| Mean | 15434 | 15169 | 15209 | 14755 | 15140 |
| Std. Dev. | 257 | 492 | 225 | 288 | 409 |
| % CV | 1.7 | 3.2 | 1.5 | 2.0 | 2.7 |
Consistency of calibration of ORTHO CYTORONABSOLUTE instruments was demonstrated in a study comparing absolute lymphocyte counts obtained on a panel of donors at each of the four study sites.
4
Mean absolute lymphocyte counts from eight determinations on each donor per site were plotted against the overall mean lymphocyte count for each donor across sites (Figure 1).
Image /page/4/Figure/1 description: Figure 1 shows the absolute lymphocyte counts measured on cross-calibrated ORTHO CYTORONABSOLUTE Instruments. The figure is a title for a scientific paper or presentation. The title is written in a clear and concise manner.
Image /page/4/Figure/2 description: This image is a scatter plot comparing the lymphocyte count at different sites with the mean lymphocyte count. The x-axis represents the mean lymphocyte count, ranging from 0 to 3500, while the y-axis represents the lymphocyte count at sites, ranging from 0 to 4000. The plot includes data points from four different sources: ODSI, Rush, UCLA, and USC, each represented by a different symbol. The data points generally show a positive correlation between the mean lymphocyte count and the lymphocyte count at sites.
Figure 1. Absolute lymphocyte counts were determined using cross-calibrated ORTHO CYTORONABSOLUTE instruments for a whole blood panel kept overnight at room temperature or shipped for next day delivery to each site. The average lymphocyte count obtained at each site is plotted versus the mean lymphocyte count across sites for each of 41 samples.
The determination of an absolute lymphocyte subset count requires both a lymphocyte count and the percentage of lymphocytes positive for the marker. By convention, these measurements have required separate flow cytometry and hematology instruments. A study was performed to demonstrate that when calibrated using Ortho-Count Calibration Kit it is possible to obtain equivalent absolute lymphocyte subset counts directly from the ORTHO CYTORONABSOLUTE. Figure 2 shows strong correlation between absolute count values determined directly on the ORTHO CYTORONABSOLUTE and those calculated from combined hematology and other flow cytometer/reagent results. Regression analysis of the data yields a slope of 0.89, a y-intercept of -31 t 13 and a correlation coefficient (r) = 0.96.
Ortho Diagnostic Systems Inc. Ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System Page 60
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Direct Determination of Absolute Lymphocyte Counts on the ORTHO Figure 2. CYTORONABSOLUTIE Versus Hematology Plus Other Flow Cytometer Calculations
Image /page/5/Figure/1 description: The image is a scatter plot comparing lymphocyte counts. The x-axis represents lymphocyte counts measured by hematology plus alternate flow cytometers, ranging from 0 to 3000. The y-axis represents lymphocyte counts measured on Cyloron Absolute, also ranging from 0 to 3000. The plot displays data points for CD19, CD3+CD8+, CD3+CD4+, and Total CD3+.
Absolute lymphocyte subset values were determined directly using a Figure 2. single ORTHO CYTORONABSOLUTE. These data are plotted versus absolute lymphocyte counts determined using separate flow cytometers and automated hematology analyzers. Absolute lymphocyte subsets plotted are: CD19, CD8+ cells that are also CD3+, CD4+ cells that are also CD3+ and total CD3+ cells
The utility of the Ortho-Count Calibrator Kit Verifier Bead Suspensions as quality control indicators of proper calibration of the ORTHO CYTORONABSOLUTE was demonstrated in a study in which counts/volume (absolute counts) were measured on the three verifier suspensions twice per week over a period of 60 days. Figure 3 shows the absolute counts obtained at each laboratory over the two months. The tight agreement in measurements made using each of the Verifier Bead Suspensions confirms the suitability of Ortho-Count Calibration Kit as an accurate quality control measure of the status of calibration of the ORTHO CYTORONABSOLUTE.
Ortho Diagnostic Systems Inc. Ortho-Count Calibration Kit for
ORTHO CYTORONABSOLUTE™ Laser Flow Cytometry System Page 61
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Ortho-Count Calibration Kit Verifier Bead Suspensions as Figure 3. Quality Control Indicators of Status of Calibration of the ORTHO CYTORONABSOLUTE
Image /page/6/Figure/1 description: The figure shows a scatter plot of verifier counts versus days post calibration. The y-axis shows the verifier counts in events per microliter, ranging from 0 to 16000. The x-axis shows the days post calibration, ranging from 0 to 60. There are three distinct clusters of data points, one around 14000, one around 8000, and one around 1000.
Four ORTHO CYTORONABSOLUTE instruments were calibrated using Ortho-Pigure 3. Count Calibration Kit. The absolute count of each Verifier Bead Suspension is plotted for each laboratory on each day throughout the study.
CONCLUBIONS :
-
- Ortho-Count Calibration Kit is substantially equivalent to S-CAL Kit used to calibrate Coulter hematology instruments, for the intended use of calibration and verification of the calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE.
-
- Ortho-Count Calibration Kit functions as a suitable crosscalibration standard to ensure inter-laboratory reproducibility.
- Ortho-Count Calibration Kit provides accurate calibration 3. and verification of calibration of the ORTHO CYTORONABSOLUTE, permitting direct determination of absolute lymphyocyte subset values equivalent to those obtained using values calculated from separatte flow cytometers and hematology analyzers.
- Ortho-Count Calibration Kit provides reliable quality 4 . control of the calibration status of the ORTHO CYTORONABSOLUTE.