Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a lysis solution and monoclonal antibodies used in flow cytometry, with no mention of AI or ML in the description or performance studies.

Therapeutic

No.
The device is a lysis solution intended to aid in the enumeration of leukocytes for analysis by flow cytometric methods, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

No

Caltag Cal-Lyse is a lysis solution used to prepare human peripheral blood samples for analysis by flow cytometry. It aids in the enumeration of leukocytes by lysing red blood cells, which is a sample preparation step, not a diagnostic step itself. The diagnosis is made based on the subsequent analysis using flow cytometric methods and monoclonal antibodies.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a "lysis solution," which is a chemical reagent, not software. The summary describes the use of this solution in conjunction with monoclonal antibodies and flow cytometry, all of which are hardware and chemical components.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that Caltag Cal-Lyse is a lysis solution used to prepare samples of anticoagulated human peripheral blood for analysis by flow cytometry. This analysis is intended as an aid in the enumeration of leukocytes. This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
Device Description: The description details how the lysis solution is used in conjunction with monoclonal antibodies to prepare blood samples for flow cytometric analysis of leukocytes. This process is performed outside of the human body using biological specimens.
Anatomical Site: The samples are derived from "peripheral blood," which is a human specimen.
Performance Studies: The document describes performance studies conducted on human blood samples (normal and abnormal donors) to evaluate the device's performance in terms of leukocyte recovery, red blood cell lysis, and correlation with predicate devices. This is typical for IVD devices demonstrating their analytical performance.
Key Metrics: The metrics reported (specificity, leukocyte recovery, red blood cell lysis, correlation) are all relevant to the analytical performance of a device used to prepare samples for diagnostic testing.
Predicate and Reference Devices: The mention of predicate and reference devices (other antibodies and lysing reagents) further indicates that this device is intended for use in a laboratory setting for diagnostic purposes, as it is being compared to other commercially available IVDs.

The device is used in vitro (outside the body) to prepare a human specimen (peripheral blood) for analysis that provides information about the composition of the blood (enumeration of leukocytes), which is used in diagnostic processes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Caltag Cal-Lyse is a lysis solution to enable the lysis of erythrocytes in samples of anticoagulated human peripheral blood. Cal-Lyse lysing solution is intended as an aid in the enumeration of leukocytes that have been stained with Caltag monoclonal antibodies for analysis by flow cytometric methods.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

Caltag monoclonal antibodies bind to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood samples are incubated with fluorochrome-conjugated monoclonal antibodies. Cells are subsequently washed to remove unbound antibody. Prior to the removal of unbound antibody. Cal-Lyse lysing solution is added to lyse red blood cells. Cells may subsequently be washed. resulting in the elimination of red cell debris as well as unbound antibody. Cal-Lyse lysing solution contains paraformaldehyde as fixative, and no additional fixation is required. Antibody-stained and fixed leukocytes are subsequently analyzed by flow cytometric methods.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Flow Cytometry

Anatomical Site

Not Found

Indicated Patient Age Range

Expected values for pediatrics and adolescents have not been established. (The study included adult normal donors in an age range of 16 to 72, with a mean age of 41.)

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

Expected Value Data:
Blood samples collected from 155 apparently healthy adult normal donors (age 16-72, mean 41). Samples were stained with Caltag monoclonal antibodies and red blood cells lysed with Caltag Cal-Lyse lysing solution. Samples collected and analyzed in three independent laboratories. Approximately equal numbers of males and females. Donors from differing ethnic origins (Caucasian, Black, Oriental, Hispanic) and geographically diverse areas of the United States (Western, Eastern, SouthCentral regions).

Specificity Data:
Blood samples obtained from healthy normal donors of Caucasian, Black, Hispanic and Oriental ethnic origins. Samples stained with Caltag monoclonal antibodies and red blood cells lysed with Caltag Cal-Lyse lysing solution. Cells in lymphocyte, monocyte, and granulocyte regions selected for analysis. Separate samples from same donors prepared for analysis of red blood cells and platelets and stained with each Caltag monoclonal antibody.

Leukocyte Recovery Data:
Blood samples obtained from 5 normal donors (Caucasian, Black, Hispanic, Oriental ethnic origins). Leukocyte counts enumerated prior to and immediately following lysis with Caltag Cal-Lyse lysing solution and Ortho-mune™ Lysing Reagent using an appropriate hematology analyzer.

Red Blood Cell Lysis Data:
Blood samples obtained from 5 normal donors. Red cells lysed with Caltag Cal-Lyse lysis solution. Red blood cells enumerated prior to and immediately following lysis using an appropriate hematology analyzer.

Correlation Data:
Normal and abnormal donors. A total of 155 normal donor samples collected and analyzed in each of three independent laboratories, analyzed on either FACscan or Profile flow cytometers. Normal donor population included members of differing ethnic origins (adult Caucasian, Black, Oriental, Hispanic). Donors from geographically diverse areas of the United States (Western, Eastern, SouthCentral regions). Males and females represented in approximately equal numbers. A total of 20 abnormal donors analyzed on both FACscan and Profile flow cytometers at a single site.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical tests supporting substantial equivalence (Expected Value Data, Specificity Data, Leukocyte Recovery Data, Red Blood Cell Lysis Data) and Clinical tests supporting substantial equivalence (Correlation Data).

Expected Value Data:

Sample Size: 155 normal donors.
Key Results:
- CD3 FITC: Mean % positive = 71.0, S.D. = 7.4, Range (±2 S.D.) = 58-86.
- CD19 R-PE: Mean % positive = 13.0, S.D. = 4.2, Range (±2 S.D.) = 5-21.

Specificity Data:

Key Results (CD3 FITC): Mean % Stained Cells in Lymph. = 78.4, Mono. = 1.4, Gran. = 0.8, Pht. = 0.3, RBC = 0.4.
Key Results (CD19 R-PE): Mean % Stained Cells in Lymph. = 13.9, Mono. = 0.8, Gran. = 0.9, Pit. = 0.4, RBC = 0.7.

Leukocyte Recovery Data:

Sample Size: 5 normal donors.
Key Results: Mean % Recovered = 90.8 (S.D. = 6.0). Leukocyte recovery was comparable between Cal-Lyse and Ortho-mune lysing reagents.

Red Blood Cell Lysis Data:

Sample Size: 5 normal donors.
Key Results: Mean % Lysis = 91.8 (S.D. = 1.9).

Correlation Data:

Sample Size: 175 (155 normal donors + 20 abnormal donors).
Key Results (r2 value, slope, Y intercept presented for each comparison):
- Caltag CD19 R-PE vs. Coulter CD19 RD1: r2 = 97.7, slope = 0.92, Y intercept = 1.30.
- Caltag CD19 R-PE vs. Coulter CD19 FITC: r2 = 96.3, slope = 0.93, Y intercept = 0.69.
- Caltag CD19 TRI-COLOR vs. Coulter CD19 RD1: r2 = 96.7, slope = 0.92, Y intercept = 2.14.
- Caltag CD19 TRI-COLOR vs. Coulter CD19 FITC: r2 = 97.4, slope = 0.94, Y intercept = 1.36.
- Caltag CD19 TRI-COLOR vs. Caltag CD19 R-PE: r2 = 97.6, slope = 0.99, Y intercept = -0.56.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Expected Value Data: Mean % positive, S.D., Range (±2 S.D.)
Specificity Data: Percent of Stained Cells
Leukocyte Recovery Data: Percent Recovered
Red Blood Cell Lysis Data: Percent Lysed
Correlation Data: mean % positive, r2 value, slope, Y intercept

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.

The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Coulter CD19 RD1 monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.
The Caltag CD19 TRI-COLOR monoclonal antibody is substantially equivalent to the Coulter CD19 FITC monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.
The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Coulter CD19 FITC monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.
The Caltag CD19 TRI-COLOR monoclonal antibody is substantially equivalent to the Coulter CD19 RD1 monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.
The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Caltag CD19 TRI-COLOR monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

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

Regulation Number and Section

§ 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.”

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for Caltag Laboratories. Below the logo is a signature that appears to be "Ka65232". To the right of the signature is the date "May 14 1997".

510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Caltag Cal-Lyse™ Lysing Solution For Use With Caltag Monoclonal Antibodies In Flow Cytometric Procedures

NAME AND LOCATION OF MANUFACTURER:

Caltag Laboratories, Inc. 1849 Old Bayshore Highway Suite 200 Burlingame, CA 94010 (800) 874-4007

NAME OF CONTACT PERSON:

1

Robert C. Johnson Executive Vice President Caltag Laboratories, Inc.

DATE OF PREPARATION OF SUMMARY:

December 24, 1996

1

TRADE NAME OF THE DEVICE:

Caltag Cal-Lyse Lysing Solution For Use With Caltag Monoclonal Antibodies In Flow Cytometric Procedures

集

COMMON NAME:

Caltag Cal-Lyse Lysing Solution

CLASSIFICATION NAME:

Automated Differential Cell Coulter (21 CFR 864.5220)

LEGALLY MARKETED DEVICE (PREDICATE DEVICE) TO WHICH THE MANUFACTURER IS CLAIMING SUBSTANTIAL EQUIVALENCE:

The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Coulter CD19 RD1 monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

The Caltag CD19 TRI-COLOR monoclonal antibody is substantially equivalent to the Coulter CD19 FITC monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Coulter CD19 FITC monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

The Caltag CD19 TRI-COLOR monoclonal antibody is substantially equivalent to the Coulter CD19 RD1 monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

The Caltag CD19 R-PE monoclonal antibody is substantially equivalent to the Caltag CD19 TRI-COLOR monoclonal antibody when red blood are lysed with the Cal-Lyse lysing solution in flow cytometric procedures.

DESCRIPTION OF THE DEVICE:

Caltag monoclonal antibodies bind to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood samples are incubated with fluorochromeconjugated monoclonal antibodies. Cells are subsequently washed to remove unbound antibody. Prior to the removal of unbound antibody. Cal-Lyse lysing solution is added to lyse red blood cells. Cells may subsequently be washed. resulting in the elimination of red cell debris as well as unbound antibody.

2

Cal-Lyse lysing solution contains paraformaldehyde as fixative, and no additional fixation is required. Antibody-stained and fixed leukocytes are subsequently analyzed by flow cytometric methods.

ﺍﻟﻤﺴﺘﻘﻠﺔ

INTENDED USE OF THE DEVICE:

Caltag Cal-Lyse is a lysis solution to enable the lysis of erythrocytes in samples of anticoagulated human peripheral blood. Cal-Lyse lysing solution is intended as an aid in the enumeration of leukocytes that have been stained with Caltag monoclonal antibodies for analysis by flow cytometric methods.

SUMMARY OF THE TECHNICAL CHARACTERISTICS OF THE MANUFACTURER'S DEVICE COMPARED TO THE PREDICATE DEVICE:

Comparisons of Caltag CD19 and Coulter CD19 Monoclonal Antibodies In Samples In Which Red Blood Cells Are Lysed With Caltag Cal-Lyse Lysing Solution

No.	Item	Caltag Antibodies	Coulter Antibodies	Comparison
1.	Intended Use	Flow Cytometry	Flow Cytometry
Immunofluorescence	Substantially
equivalent
2.	Specificity	CD19	CD19	Substantially
equivalent
3.	Target cell	B lymphocyte	B lymphocyte	Substantially
equivalent
4.	Chemical form	Monoclonal
antibody	Monoclonal
antibody	Substantially
equivalent
5.	Fluorochromes	R-PE,
TRI-COLOR	FITC,
RD1	Substantially
equivalent
6.	Available forms
FITC
PE
TRI-COLOR	liquid, PBS
liquid, PBS
liquid, PBS	lyophilized
liquid, PBS
not available	Substantially
equivalent
7.	Sample prep.
methods	whole blood	whole blood	Substantially
equivalent
8.	Expected values
from this study (n=155)
R-PE
TRI-COLOR	5-21%
4-24%	4-21% (RD1)
3-23% (FITC)	Substantially
equivalent

3

NON CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

EXPECTED VALUE DATA

Blood samples were collected from a total of 155 apparently healthy adult normal donors in an age range of 16 to 72, and a mean age of 41.

Samples were stained with Caltag monoclonal antibodies and red blood cells were lysed with Caltag Cal-Lyse lysing solution. Samples were collected and analyzed in each of three independent laboratories. An approximately equal number of males and females were collected and analyzed in each laboratory.

The normal donor population included members of differing ethnic origins, including adult Caucasian, Black, Oriental and Hispanic. Donors in geographically diverse areas of the United States, including the Western, Eastern and SouthCentral regions, participated in this study.

Summary of expected values for the CALTAG T and B cell monoclonal antibodies, CD3 FITC and CD19 R-PE, for all normal donors:

| procedure | mean
% positive | S.D. | Range
±2 S.D. | n |
|-----------|--------------------|------|------------------|-----|
| CD3 FITC | 71.0 | 7.4 | 58-86 | 155 |
| CD19 R-PE | 13.0 | 4.2 | 5-21 | 155 |

Expected values for pediatrics and adolescents have not been established. The values obtained from normal individuals may vary from laboratory to laboratory; therefore, it is recommended that each laboratory establish its own normal range.

SPECIFICITY DATA

Blood samples were obtained from healthy normal donors of Caucasian, Black, Hispanic and Oriental ethnic origins. Samples of each donor were stained with Caltag monoclonal antibodies and red blood cells were lysed with Caltag Cal-Lyse lysing solution. Cells contained in the lymphocyte, monocyte and granulocyte regions were selected for analysis. Separate samples from the same donors were prepared for analysis of red blood cells and platelets and stained with each of the Caltag monoclonal antibodies.

The following specificity data were obtained with the Caltag T and B cell monoclonal antibodies, CD3 FITC and CD19 R-PE, following the lysis of red blood cells with Caltag Cal-Lyse lysing solution:

| CD3 PITC

Bthnic	Percent of Stained Cells
Origin	Lymph.	Mono.	Gran.	Pht.	RBC
Caucasian	65.2	1.7	1.5	0.3	0.6
Caucasian	81.4	1.4	0.5	0.4	0.3
Hispanic	79.2	1.9	0.6	0.3	0.4
Oriental	81.2	1.3	0.9	0.2	0.4
Black	84.9	0.9	0.6	0.4	0.4
Mean	78.4	1.4	0.8	0.3	0.4
+1 S.D.	7.6	0.4	0.4	0.1	0.1

4

| CD19 H-PE

Ethnic	Percent of Stained Cells
Origin	Lymph. Mono.		Gran.	Pit.	RBC
Caucasian	18.0	0.6	0.9	0.5	0.5
Caucasian	13.3	1.1	0.8	0.3	0.7
Hispanic	12.2	0.7	0.8	0.4	1.0
Oriental	11.2	1.6	1.3	0.4	0.5
Black	14.6	0.0	0.5	0.6	0.9
Mean	13.9	0.8	0.9	0.4	0.7
+1 S.D.	2.6	0.6	0.3	0.1	0.2

Specific and/or nonspecific antibody Fc binding to monocytes in a patient sample can be excluded by proper gating on lymphocytes on the flow cytometer.

LEUKOCYTE RECOVERY DATA

This study was conducted on blood samples obtained from 5 normal donors consisting of representatives from Caucasian, Black, Hispanic and Oriental ethnic origins. An appropriate hematology analyzer was used enumerate leukocytes prior to, and immediately following the lysis of red blood cells with Caltag Cal-Lyse lysing solution and with the Ortho-mune™ Lysing Reagent. Leukocyte recovery from members of differing ethnic origins was comparable. Leukocyte recovery following lysis with Cal-Lyse and Ortho-mune lysing reagents was comparable.

It should be noted that washing of cells alone, in the absence of a lysis procedure may result in a modest loss of cells.

In the following table describing leukocyte recovery, leukocyte counts are expressed as cells per cu. mm.

| Donor
No. | Race | Leukocyte Count
Prior
to Lysis | Leukocyte Count
Following
Lysis | Percent
Recovered |
|--------------|-----------|--------------------------------------|---------------------------------------|----------------------|
| 1 | Caucasian | 8300 | 7200 | 86.7 |
| 2 | Caucasian | 8100 | 7200 | 88.9 |
| 3 | Black | 5700 | 4800 | 84.2 |
| 4 | Hispanic | 6200 | 6000 | 96.8 |
| 5 | Oriental | 7400 | 7200 | 97.3 |
| Mean | | 7140 | 6480 | 90.8 |
| ± 1 SD | | 1150 | 1073 | 6.0 |

RED BLOOD CELL LYSIS DATA

This study was conducted on blood samples obtained from 5 normal donors, to determine whether essentially all red cells were lysed by the lysing solution. Red cells were lysed in a sample of blood from each donor with Caltag Cal-Lyse lysis solution. An appropriate hematology analyzer was used to enumerate red blood cells prior to and immediately following lysis. The differing orders of magnitude of red cells counted prior to and following lysis should be noted in the following table.

5

Red Blood Cell Count

| Donor
No. | Prior to Lysis
cells/cu.mm. x 106 | Following Lysis
cells/cu.mm x 105 | Percent
Lysed |
|--------------|--------------------------------------|--------------------------------------|------------------|
| 1 | 5.1 | 3.0 | 94.1 |
| 2 | 5.1 | 5.0 | 90.2 |
| 3 | 4.3 | 3.0 | 93.0 |
| 4 | 3.7 | 3.0 | 91.8 |
| 5 | 4.9 | 5.0 | 89.7 |
| Mean | 4.6 | 3.8 | 91.8 |
| ±1 S.D. | 0.6 | 1.1 | 1.9 |

CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

CORRELATION DATA

The correlation for the Cal-Lyse lysing solution was based on the performance of the Caltag B cell monoclonal antibodies CD19 R-PE and CD19 TRI-COLOR. The percent, as well as the mean fluorescence, of B lymphocytes is substantially lower than is observed for T lymphocytes in normal peripheral blood. The resulting analysis of B lymphocytes by flow cytometric methods may be more susceptible to uncontrolled variations in the staining and lysis methods employed.

Samples obtained from normal and abnormal donors were stained with Caltag and comparable Coulter B cell monoclonal antibodies. Red blood cells were lysed with Caltag Cal-Lyse lysing solution in samples that had been stained with both Caltag and Coulter monoclonal antibodies.

A total of 155 normal donor samples were collected and analyzed in each of three independent laboratories, and analyzed on either the FACscan or Profile flow cytometers.

The normal donor population included members of differing ethnic origins, including adult Caucasian, Black, Oriental and Hispanic. Donors in geographically diverse areas of the United States, including the Western, Eastern and SouthCentral regions, participated in this study. Males and females were represented in approximately equal numbers.

A total of 20 abnormal donors were analyzed on both the FACscan and Profile flow cytometers at a single site. Correlations were obtained for the Caltag and Coulter B cell monoclonal antibodies for all normal and abnormal donors (n = 175). Red blood cells from all samples were lysed with Cal-Lyse lysing solution.

Comparison of the Caltag CD19 R-PE conjugated monoclonal antibody with the Coulter CD19 RD1 conjugated monoclonal antibody:

| procedure | mean %
positive | r2
value | slope | Y
intercept | n |
|-----------|--------------------|-------------|-------|----------------|-----|
| CD19 R-PE | 16.4 | 97.7 | 0.92 | 1.30 | 175 |
| CD19 RD1 | 16.2 | | | | |

6

CD19 R-PE

y = 1.30 + 0.92x Linear regression

Comparison of the CALTAG CD19 R-PE conjugated monoclonal antibody with the Coulter CD19 FITC conjugated monoclonal antibody:

| procedure | mean %
positive | r2
value | slope | Y
intercept | n |
|-----------|--------------------|-------------|-------|----------------|-----|
| CD19 R-PE | 16.4 | 96.3 | 0.93 | 0.69 | 175 |
| CD19 FITC | 16.7 | | | | |

CD19 R-PE y = 0.69 + 0.93x Linear regression

Comparison of the CALTAG CD19 TRI-COLOR conjugated monoclonal antibody with the Coulter CD19 RD1 conjugated monoclonal antibody:

| procedure | mean %
positive | value | slope | y
intercept n | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|------------------|-----|
| CD19 TRI-COLOR 17.1 | and the figure would be the count of the count of the count of the comments of the comments of the comments of the comments of the comments of the comments of the comments of | 96.7 | 0.92 | Comments
2.14 | 175 |
| CD19 RD1 | 16.2 | | | | |

CD19 TRI-COLOR Linear regression y =2.14 + 0.92x

Comparison of the CALTAG CD19 TRI-COLOR conjugated monoclonal antibody with the Coulter CD19 FITC conjugated monoclonal antibody:

| procedure | mean %
positive | $r^2$
value | slope | Y
intercept | n |
|----------------|--------------------|----------------|-------|----------------|-----|
| CD19 TRI-COLOR | 17.1 | 97.4 | 0.94 | 1.36 | 175 |
| CD19 FITC | 16.7 | | | | |

CD19 TRI-COLOR Linear regression y = 1.36 + 0.94x

Comparison of the CALTAG CD19 TRI-COLOR conjugated monoclonal antibody with the CALTAG CD19 R-PE conjugated monoclonal antibody:

| procedure | mean %
positive | r2
value | slope | Y
intercept | n |
|-------------------------------------|---------------------|-------------|-------|----------------|-----|
| CD19 TRI-COLOR | 17.1 | 97.6 | 0.99 | -0.56 | 175 |
| CD19 R-PE | 16.4 | | | | |
| CD19 TRI-COLOR
Linear regression | $y = -0.56 + 0.99x$ | | | | |

BIBLIOGRAPHY

Mishell B.B., Shilgi A.M., Selected methods in collular immunology, W.H. Freeman and Company, 1980. 1.
1. Transport and diffusion of red blood cells, Whittern R. editor, Williams and Williams, 1964.
1. Gorgi, J.V., Cheng H., Margolick J. et al, Quality control in the flow cytometric measurement of Tlymphocyte subsets: the multicenter AIDS cohort study experience, Clin. Immunol. Immunopathol. 55:173, 1990.
NCCLS Document H42-T, Clinical applications of flow cytometry: Quality Assurance and 4. immunophenotyping of peripheral blood lymphocytes, Tentative Guideline, May, 1992.