Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a fluorescent reagent and its use in flow cytometry for identifying cell populations based on antibody binding. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on standard flow cytometry methods and statistical analysis of cell populations.

Therapeutic

No
The device is a reagent used for laboratory testing (identifying cell types by flow cytometry) and does not directly treat or diagnose a disease.

Diagnostic

Yes

The device is a fluorescent reagent used for the "simultaneous identification of CD3+ mature T lymphocytes, CQ19+ inature Bilymphocytes, and CD45+ leukocytes... by flow cytometric methods." This identification of specific cell types, which are biological markers, facilitates the diagnosis of medical conditions.

SaMD (Software as a Medical Device)

No

The device is a fluorescent reagent containing monoclonal antibodies, which is a chemical substance used in a laboratory process (flow cytometry) to identify cells. This is a physical reagent, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the reagent is used to identify and quantify different types of leukocytes (T lymphocytes, B lymphocytes, and total leukocytes) in peripheral blood using flow cytometry. This is a diagnostic purpose, providing information about the cellular composition of a patient's blood.
Device Description: The description details how the reagent interacts with blood cells to identify specific antigens, which is a core function of an in vitro diagnostic test.
Anatomical Site: The device is used on "Blood cells," which are biological specimens taken from the human body.
Performance Studies: The document describes performance studies conducted on human blood samples (normal and abnormal donors) to determine expected values, specificity, and correlation with other diagnostic reagents. This is typical for IVD devices to demonstrate their analytical and clinical performance.
Predicate Devices: The mention of predicate devices (other monoclonal antibodies used for similar purposes) further indicates that this device falls within the category of IVDs.

The device is designed to be used in vitro (outside the body) to analyze biological specimens (blood cells) for diagnostic purposes (identifying and quantifying cell populations). This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CALTAG CD3/CD19/CD45 is a fluorescent reagent containing a combination of CD3. CD19 and CD45 monoclonal antibodies conjugated to fluorescein. phycoerythrin and the tandem fluorochrome PE-Cy5, respectively, This reagent permits the simultaneous identification of CD3+ mature T lymphocytes, CQ19+ inature Bilymphocytes, and CD45+ leukocytes including lymphocytes, monocytes and granulocytes, by flow cytometric methods.

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

21 CFR 864.5220

Device Description

The CALTAG CD3/CD19/CD45 monoclonal antibody combination binds to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood leukocytes are incubated with the monoclonal antibody, and washed to remove unbound antibody. Prior to removal of unbound antibody, lysis solution is added to lyse red blood cells. An appropriate fixative solution is added to lysed and washed cells. Stained and fixed cells 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

Blood cells / Leukocytes (T lymphocytes, B lymphocytes, lymphocytes, monocytes, granulocytes)

Indicated Patient Age Range

Expected values for pediatrics and adolescents have not been determined.

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)

NON CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

EXPECTED VALUE DATA

Blood samples were collected from a total of 155 apparently healthy normal donors in an age range of 16 to 72, with a mean age of 41, for the determination of expected values of the Caltag CD3/CD19/CD45 monoclonal antibody combination. 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 population contained members of differing ethnic origins, including adult Caucasians, Blacks, Orientals and Hispanics. Donors in geographically diverse areas of the United States, including the Eastern, SouthCentral and Western regions, participated in this study.
Results:
CD3 FITC component: 72.8% positive (mean), 7.7 S.D., Range 57-88 (+2 S.D.)
CD19 R-PE component: 13.3% positive (mean), 4.5 S.D., Range 4-22 (+2 S.D.)
CD45 TRI-COLOR component: 100.0% positive (mean), 0.1 S.D., Range 100-100 (+2 S.D.)

Comparison of CALTAG CD3 FITC, CD19 R-PE and CD45 TRI-COLOR components to the CALTAG CD3 FITC, CD19 R-PE and CD45 TRI-COLOR single antibodies. Blood samples were collected from different randomly selected populations of adult normal donors having similar age, gender and ethnic distributions for the determination of expected values for the Caltag CD3 FITC and CD45 TRI-COLOR single monoclonal antibodies, and from the same population of adult normal donors for the determination of expected values for Caltag CD19 R-PE single antibody.
Results:
CD3 FITC: 71.8% positive (mean), 6.9 S.D., Range 58-86 (±2 S.D.), n=130
CD19 R-PE: 13.0% positive (mean), 4.2 S.D., Range 5-21 (±2 S.D.), n=155
CD45 TRI-COLOR: 99.0% positive (mean), 0.9 S.D., Range 97-100 (±2 S.D.), n=40

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 CD3 FITC/CD19 R-PE/CD45 TRI-COLOR monoclonal antibody combination. 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.
Results (Mean % of Stained Cells):
CD3 FITC Component: Lymph. 78.4, Mono. 1.4, Gran. 0.8, Plt. 0.4, RBC 0.3
CD19 R-PE Component: Lymph. 13.8, Mono. 2.4, Gran. 0.8, Plt. 0.3, RBC 0.5
CD45 TRI-COLOR Component: Lymph. 100.0, Mono. 100.0, Gran. 100.0, Plt. 0.5, RBC 0.3

CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

CORRELATION DATA

The Correlation study was performed on 175 donors, including 155 normal and 20 abnormal donors.

Comparison of the CALTAG CD3 FITC conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the CALTAG CD3 FITC conjugated single monoclonal antibody:
Results: mean % positive component = 69.7, mean % positive single = 68.3, r2 value = 94.8, slope = 1.01, Y intercept = 0.33, Linear regression y = 0.33 + 1.01x

Comparison of the CALTAG CD19 R-PE conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the Caltag CD19 R-PE conjugated single monoclonal antibody:
Results: mean % positive component = 16.8, mean % positive single = 16.4, r2 value = 98.9, slope = 1.02, Y intercept = 0.08, Linear regression y = 0.08 + 1.02x

Comparison of the CALTAG CD19 R-PE conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the Coulter CD19 RD1 conjugated single monoclonal antibody:
Results: mean % positive component = 16.8, mean % positive Coulter = 16.2, r2 value = 98.1, slope = 0.95, Y intercept = 1.29, Linear regression y = 1.29 + 0.95x

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

Specificity data shows mean % of stained cells for different cell types.
Correlation data includes r2 value, slope, and Y intercept for linear regression.

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 CD3 FITC monoclonal antibody in the CD3 FITC/CD19 R-PE/CD45 TRI-COLOR combination is substantially equivalent to the Caltag CD3 FITC single monoclonal antibody for in vitro diagnostic use.

The Caltag CD19 R-PE monoclonal antibody in the CD3 FITC/CD19 R-PE/CD45 TRI-COLOR combination is substantially equivalent to the Caltag CD19 R-PE single monoclonal antibody for in vitro diagnostic use, and is substantially equivalent to the Coulter CD19 RD1 single monoclonal antibody for in vitro diagnostic use.

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. The word "CALTAG" is in large, bold, sans-serif font, with a thick line underneath it. Below the line, the word "LABORATORIES" is written in a smaller, sans-serif font. The text is black on a white background.

JAN 17 1997

K964856

510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS DATA

CD3 FITC/CD19 R-PE/CD45 TRI-COLOR™ Mouse Monoclonal Antibody Combination To Human Cell Surface Antigens by Flow Cytometry

NAME AND LOCATION OF MANUFACTURER:

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

NAME OF CONTACT PERSON:

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

DATE OF PREPARATION OF SUMMARY:

December 1, 1996

1

TRADE NAME OF THE DEVICE:

CD3 FITC/CD19 R-PE/CD45 TRI-COLOR™ Mouse Monoclonal Antibody Combination To Human Cell Surface Antigens by Flow Cytometry

COMMON NAME:

Caltag CD3 FITC/CD19 R-PE/CD45 TRI-COLOR™ Monoclonal Antibody Combination

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 CD3 FITC monoclonal antibody in the CD3 FITC/CD19 R-PE/CD45 TRI-COLOR combination is substantially equivalent to the Caltag CD3 FITC single monoclonal antibody for in vitro diagnostic use.

The Caltag CD19 R-PE monoclonal antibody in the CD3 FITC/CD19 R-PE/CD45 TRI-COLOR combination is substantially equivalent to the Caltag CD19 R-PE single monoclonal antibody for in vitro diagnostic use, and is substantially equivalent to the Coulter CD19 RD1 single monoclonal antibody for in vitro diagnostic use.

DESCRIPTION OF THE DEVICE:

The CALTAG CD3/CD19/CD45 monoclonal antibody combination binds to the surfaces of viable blood cells that express the corresponding antigens. To identify cells bearing these antigenic determinants, peripheral blood leukocytes are incubated with the monoclonal antibody, and washed to remove unbound antibody. Prior to removal of unbound antibody, lysis solution is added to lyse red blood cells. An appropriate fixative solution is added to lysed and washed cells. Stained and fixed cells are subsequently analyzed by flow cytometric methods.

INTENDED USE OF THE DEVICE:

CALTAG CD3/CD19/CD45 is a fluorescent reagent containing a combination of CD3. CD19 and CD45 monoclonal antibodies conjugated to fluorescein. phycoerythrin and the tandem fluorochrome PE-Cy5, respectively, This reagent permits the simultaneous identification of CD3+ mature T lymphocytes, CQ19+ inature Bilymphocytes, and CD45+ leukocytes including lymphocytes, monocytes and granulocytes, by flow cytometric methods.

2

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

| No. | Item | Caltag Components | Caltag Antibodies
Coulter Antibody | Comparison | |
|-----|-------------------------|-----------------------------------|-------------------------------------------------------------------|--------------------------------------------------------|-----------------------------|
| 1. | Intended Use | Flow Cytometry | Flow Cytometry
Immunofluorescence | Substantially
equivalent | |
| 2. | Specificity | CD3
CD19
CD45 | CD3 Caltag
CD19 Caltag
CD19 Coulter | Substantially
equivalent | |
| | | | | "live gating" only | |
| 3. | Target cell
for CD3 | Mature
T Lymphocyte | Mature
T Lymphocytes | Substantially
equivalent | |
| | for CD19 | B lymphocytes | B lymphocytes | Substantially
equivalent | |
| | for CD45 | All Leukocytes | All Leukocytes | "live gating" only | |
| 4. | Chemical form | Monoclonal
antibody | Monoclonal
antibody | Substantially
equivalent | |
| 5. | Fluorochromes | FITC
R-PE
R-PE
TRI-COLOR | FITC
R-PE (Caltag)
RD1 (Coulter)
not available (Coulter) | Substantially
equivalent | |
| 6. | Available forms | FITC
PE
TRI-COLOR | liquid, PBS
liquid, PBS
liquid, PBS | lyophilized
liquid, PBS
none available (Coulter) | Substantially
equivalent |
| 7. | Sample prep.
methods | whole blood | whole blood | Substantially
equivalent | |

Comparisons of Caltag Monoclonal Antibody Components to Caltag and Coulter Single Monoclonal Antibodies

NON CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

EXPECTED VALUE DATA

Blood samples were collected from a total of 155 apparently healthy normal donors in an age range of 16 to 72, with a mean age of 41, for the determination of expected values of the Caltag CD3/CD19/CD45 monoclonal antibody combination. 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.

3

The population contained members of differing ethnic origins, including adult Caucasians, Blacks, Orientals and Hispanics. Donors in geographically diverse areas of the United States, including the Eastern, SouthCentral and Western regions, participated in this study.

Summary of expected values for CALTAG CD3 FITC CD19 R-PE and CD45 TRI-COLOR components for 155 normal donors:

| procedure | S.D.
mean
% positive | | Range
+2 S.D. | |
|--------------------------|----------------------------|-----|------------------|--|
| CD3 FITC component | 72.8 | 7.7 | 57-88 | |
| CD19 R-PE component | 13.3 | 4.5 | 4-22 | |
| CD45 TRI-COLOR component | 100.0 | 0.1 | 100-100 | |

Comparison of CALTAG CD3 FITC, CD19 R-PE and CD45 TRI-COLOR components to the CALTAG CD3 FITC, CD19 R-PE and CD45 TRI-COLOR single antibodies. Blood samples were collected from different randomly selected populations of adult normal donors having similar age, gender and ethnic distributions for the determination of expected values for the Caltag CD3 FITC and CD45 TRI-COLOR single monoclonal antibodies, and from the same population of adult normal donors for the determination of expected values for Caltag CD19 R-PE single antibody.

SINGLE ANTIBODIES

| procedure | mean
% positive | S.D. | Range
±2 S.D. | n |
|----------------|--------------------|------|------------------|-----|
| CD3 FITC | 71.8 | 6.9 | 58-86 | 130 |
| CD19 R-PE | 13.0 | 4.2 | 5-21 | 155 |
| CD45 TRI-COLOR | 99.0 | 0.9 | 97-100 | 40 |

Expected values for pediatrics and adolescents have not been determined.

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 CD3 FITC/CD19 R-PE/CD45 TRI-COLOR monoclonal antibody combination. 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.

4

CD3 FITC Component
Ethnic
Origin	Lymph.	Mono.	Gran.	Plt.	RBC
Caucasian	65.2	1.7	1.5	0.6	0.3
Caucasian	81.4	1.4	0.5	0.3	0.4
Hispanic	79.2	1.9	0.6	0.3	0.4
Oriental	81.2	1.3	0.9	0.4	0.2
Black	84.9	0.9	0.6	0.4	0.4
Mean	78.4	1.4	0.8	0.4	0.3
± 1 S.D.	7.6	0.4	0.4	0.1	0.1
CD19 R-PE Component
Ethnic
Origin	Lymph.	Mono.	Gran.	Plt.	RBC
Caucasian	18.1	1.3	0.5	0.4	0.2
Caucasian	12.9	0.6	0.4	0.2	0.2
Hispanic	13.4	0.5	0.6	0.2	0.6
Oriental	12.1	0.8	0.5	0.3	0.3
Black	12.7	0.9	0.3	0.4	0.2

CD45 TRI-COLOR Component

13.8

2.4

0.8

0.3

| Ethnic

Origin	Lymph.	Mono.	Gran.	Plt.	RBC
Percent of Stained Cells
Caucasian	100.0	100.0	100.0	0.8	0.2
Caucasian	100.0	100.0	100.0	0.5	0.3
Hispanic	100.0	100.0	100.0	0.3	0.4
Oriental	100.0	100.0	100.0	0.4	0.3
Black	100.0	100.0	100.0	0.3	0.2
Mean	100.0	100.0	100.0	0.5	0.3
± 1 S.D.	0.0	0.0	0.0	0.2	0.1

0.5

0.1

0.3

0.1

0.3

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.

CLINICAL TESTS SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

CORRELATION DATA

Mean

± 1 S.D.

The Correlation study was performed on 175 donors, including 155 normal and 20 abnormal donors.

Comparison of the CALTAG CD3 FITC conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the CALTAG CD3 FITC conjugated single monoclonal antibody:

5

| procedure | mean
% positive | r2
value | slope | Y intercept |
|-----------------------------|--------------------|-------------|-------|-------------|
| CD3 FITC component | 69.7 | 94.8 | 1.01 | 0.33 |
| CD3 FITC single | 68.3 | | | |
| CD3 FITC component
Slope | + 1.01 | | | |
| y intercept | + 0.33 | | | |
| Linear regression | y = 0.33 + 1.01x | | | |

Comparison of the CALTAG CD19 R-PE conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the Caltag CD19 R-PE conjugated single monoclonal antibody:

| procedure | mean
% positive | r2
value | slope | Y
intercept |
|-------------------------------------------------------------------------------------------------|--------------------|-------------|-------|----------------|
| CD19 R-PE component | 16.8 | 98.9 | 1.02 | 0.08 |
| CD19 R-PE single | 16.4 | | | |
| CD19 R-PE component
Slope + 1.02
y intercept + 0.08
Linear regression y = 0.08 + 1.02x | | | | |

Comparison of the CALTAG CD19 R-PE conjugated monoclonal antibody component of CD3 FITC/CD19 R-PE/CD45 TRI-COLOR with the Coulter CD19 RD1 conjugated single monoclonal antibody:

| procedure | mean
% positive | r2
value | slope | Y
intercept |
|-------------------------------------------------------------------------------------------------|--------------------|-------------|-------|----------------|
| CD19 R-PE component | 16.8 | 98.1 | 0.95 | 1.29 |
| Coulter CD19 RD1 | 16.2 | | | |
| CD19 R-PE component
Slope + 0.95
y intercept + 1.29
Linear regression y = 1.29 + 0.95x | | | | |

BIBLIOGRAPHY

1. Hsu S., Cossman J., Jaffe E.; Lymphocyte subsets in normal human lymphoid tissues. Am. J. Clin. Path. 80:21-30, 1983.
1. Morimoto C., Letvin N.L., Distaso J.A., et al: The cellular basis for the induction of antigen-specific T8-suppressor cells. Eur. J. Immunol. 16:198-204, 1986.
1. Kurrle R., Cluster Report: CD3, in Fourth International Workshop And Conference On Human Leukocyte Differentiation Antigens, pp 290-293, Vienna, 1989.
Transy C., Moingeon P.E., Marshall B., et al: Most murine anti-human CD3 mAb recognize the human 4. CD3 epsilon subunit. in Fourth International Leukocyte Workshop and Conference On Human Leukocyte Differentiation Antigens. pp 293-295, Vienna, 1989.
ട. Dorken B., Moller P., Pezzutto A., Schwartz-Albiez R., Moldenhauer G., B-cell antigens:CD19, in Fourth International Workshop and Conference On Human Leucocyte Differentiation Antigens, pp 34-36, Vienna, 1989.

6

Pirruccello S.J., Johnson D.R., Reagents for flow cytometry: Monoclonal antibodies and hematopoietic 6. cell antigens, in Flow Cytometry And Clinical Diagnosis, pp 56-78, pub. American Society of Clinical Pathologists, 1994.
Shields J.G., Rigley K.P., Callard R.E., Regulation of human Bcell proliferation by the CD19 cell-surface 7. glycoprotein, in Fourth International Workshop and Conference On Human Leucocyte Differentiation Antigens, pp 40-43, Vienna, 1989.
Schwinzer R., Cluster Report CD45/CD45R, in Fourth International Workshop and Conference On 8. Human Leucocyte Differentiation Antigens, pp 628-634, Vienna, 1989.
Fifth International Workshop and Conference On Human Leucocyte Differentiation Antigens, Leucocyte 9. Typing V, White Cell Differentiation Antigens, Boston, 1993.
Reinherz E.L., Cooper M.D., Schlossman S.F., Abnormalities of T cell maturation and regulation in 10. human beings with immunodeficiency disorders. J. Clin. Invest. 68:609-705, 1981.
Schmidt R.E., Monoclonal antibodies for diagnosis of immunodeficiencies. Blut 59:200-206, 1989. 11.
Smolen J.S., Morimoto C., Steinberg A.D., et al: Systemic lupus erythematosus: delineation of 12. subpopulations by clinical serologic and Tcell marker analysis. Am. J. Med. Sci. 289:139-141, 1985.
1. Morimoto C., Steinberg A.D., Letvin A.L., et al: A defect of immunoregulatory T cell subsets in SLE patients demonstrated with anti-2H4. J. Clin. Invest. 79:762-765, 1987.
Duke O., Panayi G.S., Janossy G., et al: Analysis of T cell subsets in the peripheral blood and synovial 14. fluid of patients with rheumatoid arthritis by means of monoclonal antibodies. Ann Rheum Dis. 42:357-364, 1983.
Reinherz E.L., O'Brien C., Rosenthal P., et al: The cellular basis for viral-induced immunodeficiency: 15. Analysis by monoclonal antibodies. J. Immunol. 125:1266-1274, 1980.
Nadler L.M., in Leukocyte Typing II, Volume 2, B cell/Leukemia Panel Workshop: Summary and 16. Comments, Chapter 1:2-20, Springer Verlag, New York, 1986.
Wedgwood R.J., X-linked agammaglobulinemia, in CRC Handbook Series In Clinical Laboratory 17.. Science. CRC Press. West Palm Beach Florida, pp 41-50, 1978.
1. Pearl E.R., Vogler L.B., Okos A.J. et al, B lymphocyte precursors in bone marrow. An analysis of normal individuals and patients with antibody-deficiency states, J. Immunol. 120:1169-175, 1978.
Spickett G.P., Webster A.D., Farrant J., Cellular abnormalities in common variable immunodeficiency, 19. Immunodefic. Rev. 2:199-219, 1990.
Small T.N., Keever C., Collins N. et al, Characterization of B cells in severe combined 20. immunodeficiency disease, Hum. Immunol. 25:181-193, 1991.
Goldstein R., Izaguirre L.C., Douglas J. et al, Systemic lupus erythematosus and common variable 21. panhypogammaglobulinemia. Theoretical and practical considerations, Fed. Proc. 29:1606-1611, 1985.
1. Schwinzer R., Cluster Report CD45/CD45R, in Fourth International Workshop and Conference On Human Leucocyte Differentiation Antigens, pp 628-634, Vienna, 1989.
1. Loken M.L., Brosnan N.N., Back, B.A., Ault K.A .: Establishing optimal lymphocyte gates for immunophenotyping for flow cytometry, Cytometry 11:453-459, 1990.
1. Mandy F.F., Bergeron M., Recktenwald D., Izaguirre C.A., A simultaneous three color T cell subsets analysis with single laser flow cytometers using T cell gating protocol, J. Immunol. Methods 156:151-162, 1992.
1. Stelzer G.T., Schults K.S., Loken M.R., CD45 gating for routine flow cytometric analysis of human bone marrow specimens, in Clinical Flow Cytometry, A. Landay, K. Ault, K. Bauer, P. Rabinovitch, eds, pp 265-280, 1993.
Stewart C.C., Stewart S.J., Multiparameter analysis of leukocytes by flow cytometry, in Methods Of 26. Cell Biology, Z. Darzynkiewicz, H. Crissman eds, in press, 1994.
1. 1994 Revised Guidelines for the Performance of CD4 + T-Cell Determinations in Persons with Human Immunodeficiency Virus Infection, Morbidity And Mortality Weekly Report (MMWR), Volume 43/No. RR-3, March 4, 1994.
1. Nicholson J.K.A., Green T.A. and Collaborative Laboratories, Selection of anticoagulants for lymphocyte immunophenotyping. J. Immunol. Methods 165:31-35, 1993 .
Tennant J.R., Evaluation of the Trypan Blue technique for determination of cell viability, 29. Transplantation 2:685-694, 1964.
1. Koepke J.A., Landay A.L.: Precision and Accuracy of Absolute Lymphocyte Counts, Clin. Immunol. and Immunopath. 52:19-27, 1989.
1. Brown M.C., Hoffman R.A., Kirchanski S., Controls for flow cytometers in hematology and cellular immunology, Ann. N.Y. Acad. Sci. 468:93-103, 1986.
1. Durrand R.E., Calibration of flow cytometer detector systems, Cytometry 2:192-193, 1981.