Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a flow cytometry reagent for identifying and enumerating B lymphocytes. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation.

Therapeutic

No
This device is for diagnosis (identification and enumeration) and not for treatment or prevention of disease.

Diagnostic

Yes
The device is intended for identification and enumeration of CD19+ human B lymphocytes in whole blood, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Monoclonal Antibody (Murine) Phycoerythrin (PE) Conjugate," which is a biological reagent, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for "identification and enumeration of CD19+ human B lymphocytes in whole blood by flow cytometry." This is a diagnostic purpose, analyzing a biological sample (whole blood) outside of the body to provide information about a patient's health status (specifically, their B cell population).
Device Description: It's a reagent (monoclonal antibody conjugate) used to stain cells in a biological sample for analysis.
Input Imaging Modality: Flow cytometry is a technique used to analyze characteristics of cells in a fluid sample, which is a common method in IVD testing.
Anatomical Site: Whole blood is a biological specimen.
Performance Studies: The document describes performance studies comparing the device to a predicate device using human blood specimens from normal donors and patients with AIDS/ARC. This is typical for demonstrating the performance of an IVD.
Predicate Device: The mention of a predicate device ("Monoclonal Antibody Test for B Cells") further indicates that this device is intended to perform a similar diagnostic function as an existing IVD.

The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description by providing information about a specific cell population in blood, which can be used in the diagnosis or monitoring of various conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ortho-mune OKB19A PE Conjugate is intended for use in identification and enumeration of CD19+ human B lymphocytes in whole blood by flow cytometry.

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

Not Found

Device Description

Ortho-mune OKB19A Monoclonal Antibody (Murine) Phycoerythrin (PE) Conjugate contains the purified monoclonal antibody OKB19A conjugated to the fluorochrome phycoerythrin.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

flow cytometry

Anatomical Site

whole blood

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 was compared with a predicate device at three external sites. 205 normal donors and 87 AIDS/ARC patients. Linear regression analysis of total percent CD19+ cells from the combined normal and AIDS/ARC populations showed a regression equation of Y = 0.711 + 0.88(X) and an R-value of 0.909, demonstrating equivalent performance.

Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative percent CD19+ cells.
Within laboratory reproducibility: For low concentration (1.134% positive), CVs were 24.182% (Site A), 20.793% (Site B), 22.106% (Site C).
For normal concentration (15.330% positive), CVs were 5.082% (Site A), 4.635% (Site B), 4.545% (Site C).
For high concentration (26.760% positive), CVs were 3.438% (Site A), 3.401% (Site B), 3.447% (Site C).
Between laboratory reproducibility: For low concentration (mean 1.132%), coefficient of variation was 1.466%.
For normal concentration (mean 15.395%), coefficient of variation was 0.976%.
For high concentration (mean 26.518%), coefficient of variation was 0.782%.
The reagent showed acceptable within and between laboratory reproducibility.

A linearity study was performed using an automated hematology analyzer to determine total lymphocyte count, and the CYTORONABSOLUTE flow cytometer to determine the percent positive CDx cells. The reagent demonstrated linear performance for total CD19+ lymphocyte subsets across a lymphocyte count range of 20 cells/uL to 9000 cells/uL with slopes indistinguishable from 1 and R values of 1.000 for all donors.

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

Not Found

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.

Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE Phycoerythrin)

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

JAN 2 2 1997

K964754

REVISED 510(k) SUMMARY

SUBMITTER:

Ortho Diagnostic Systems 1001 U.S. Hwy 202 Raritan, NJ 08869-0606

CONTACT:

Joanne Harris Tel: (908) 218-8404 Fax: (908) 218-8168

DEVICE NAME:

Ortho-mune™ OKB™19A (CD19) Monoclonal Antibody (Murine) Phycoerythrin Conjugate

PREDICATE:

Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE Phycoerythrin)

DATE:

May 14, 1996

DEVICE DESCRIPTION

Ortho-mune OKB19A Monoclonal Antibody (Murine) Phycoerythrin (PE) Conjugate contains the purified monoclonal antibody OKB19A conjugated to the fluorochrome phycoerythrin.

INTENDED USE

Ortho-mune OKB19A PE Conjugate is intended for use in identification and enumeration of CD19+ human B lymphocytes in whole blood by flow cytometry. The intended use is the same as the intended use of the predicate device, Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE (Phycoerythrin)] commercially distributed by Becton Dickinson Immunocytometry Systems.

TECHNOLOGICAL CHARACTERISTICS

Both Ortho-mune OKB19A Monoclonal Antibody (Murine) PE Conjugate and Monoclonal Antibody Test for B Cells utilize monoclonal antibodies specific for human B cells (OKB19A/Leu-12) respectively, conjugated to the same fluorochrome, phycoerythrin.

1

PERFORMANCE CHARACTERISTICS

Performance of Ortho-mune OKB19A Monocional Antibody (Murine) PE Conjugate was compared with that of Monoclonal Antibody Test For B Cells at three external, geographically distinct sites. Whole blood specimens from 205 normal donors, and 87 AIDS/ARC patients were stained and analyzed using the ORTHO CYTORONABSOLUTE™ flow cytometer, Ortho Diagnostic Systems Inc.

For each specimen, the percentage of gated cells which showed positive by each marker was calculated. The mean and range of the percent CD19+ cells for the normal donor and AIDS/ARC population are shown in Table 1 and Table 2 respectively.

TABLE 1

| PERCENT POSITIVE STAINED CELLS IN NORMAL DONORS DETECTED BY
OKB19A AND LEU-12 ASSAYED ON THE CYTORONABSOLUTE

N=205
Ortho-mune
Reagent	Mean %	Range %	BD
Reagent	Mean %	Range %
OKB19A
(CD19)+	13.3	1.3 - 31.1	LEU-12
(CD19)+	14.1	0.1 - 31.3

TABLE 2

| PERCENT POSITIVE STAINED CELLS IN AIDS/ARC PATIENTS DETECTED BY
OKB19A AND LEU-12 ASSAYED ON THE CYTORONABSOLUTE

N=87
Ortho-mune
Reagent	Mean %	Range %	BD
Reagent	Mean %	Range %
OKB19A
(CD19)+	10.2	0.4 - 41.9	LEU-12
(CD19)+	11.1	0.8 - 38.7

2

Linear regression analysis of total percent CD19+ cells from the combined normal and AIDS/ARC populations is found in Chart 1.

Image /page/2/Figure/2 description: The image is a scatter plot titled "Ortho-mune OKB19A(PE)". The x-axis is labeled "Predicate Reagent", and the y-axis is labeled "Ortho-mune Reagent". The plot shows a positive correlation between the two reagents. The equation of the line of best fit is Y = 0.711 + 0.88(X), and the R-value is 0.909.

Ortho-mune OKB19A (CD19) PE vs Monocloual Autibody Test for B Cells (Leu-12)

This study demonstrates that the performance of Ortho-mune OKB19A (CD19) Monoclonal Antibody (Murine) PE Conjugate is equivalent to Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE (Phycoerythrin)] reagent in identification and enumeration CD19+ human lymphocytes in whole blood by flow cytometry.

3

Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative percent CD19+ cells.

Specimens from each of ten normal donors (whole blood, EDTA) were processed using monoclonal antibodies bound to microbeads to produce samples of low, normal, and high relative percent CD19+ cells. The samples were separated into aliquots for each laboratory. Samples were stained in replicates of 10 with Ortho-mune OKB19A. (CD19) PE Conjugate reagent and analyzed using the ORTHO CYTORONABSOLUTE flow cytometer.

For within laboratory reproducibility, the variance for the replicate results was calculated within site, concentration and donor. The variance was averaged across site, concentration and donor. The square root replicate variance (SD) was divided by the appropriate mean percent positive result (by site and concentration) and multiplied by 100 to obtain the CV. Within laboratory reproducibility results for determination of total percent CD19+ cells are presented in Table 3.

TABLE 3

| Concerner Color Color N=10 donors N=10 donors - N=10 donors - 10 donors - 10 done | HHUN LAH
a martin min 2018 12:22 2 : 9 : 9 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 : 2 | | | OF A FOR VIREPRODUCIBILITY | | | |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------|-----------------|------------|
| ortho-mune OKB19A(PF) | ALESTICSS
Mean
Percent
Positive | Site A
CV | A # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # #
Rens I | Site Rite Rite Real | | CV Rens CV Ren | |
| TOTAL CD19 Low Career
TOTAL CD19' Normal | 1.134
15.330 | 24.182
5.082 | 100
100 | 20.793
4.635 | 100
98 | 22.106
4.545 | 100
100 |
| TOTAL CD19 High | 26.760 | 3.438 | ਰੇਰੇ | 3.401 | 100 | 3.447 | 100 |

4

The between laboratory CV was computed as follows. The mean percent positive for The between faboratory of This computed. The SD was computed on the three site means within concentration was on the CV was obtained by dividing the SD by the overall means within concentration and multiplying by 100. Between laboratory reproducibility mean within consembly of total percent CD19+ cells are presented in Table 4.

	6.4		•••
C	and the	C

BETWEEN LABORATORY REPRODUCIBILITY
Ortho-mune OKB19A(PE)
N=10 donors
	SITE A	SITE B	SITE C	ACROSS SITE
Ortho-mune OKB19A(PE)	Mean Percent Positive (All Donors)	Mean Percent Positive (All Donors)	Mean Percent Positive (All Donors)	Coefficient of Variation	# Reps
TOTAL CD19+ Low	1.132	1.152	1.119	1.466	300
TOTAL CD19+ Normal	15.395	15.410	15.144	0.976	298
TOTAL CD19+ High	26.518	26.787	26.930	0.782	299

Ortho-mune OKB19A (CD19) Monoclonal Antibody (Murine) PE Conjugate immunophenotyping reagent shows acceptable within and between laboratory reproducibility for determination of CD19+ lymphocyte percentages

5

A linearity study was performed using an automated hematology analyzer to determine total lymphocyte count, and the CYTORONABSOLUTE flow cytometer to determine the percent positive CDx cells.

Specimens from four normal donors (whole blood, EDTA) were processed to produce samples with low, normal and high numbers of lymphocyte subsets. Each whole blood specimen was concentrated by harvesting the buffy coat to obtain a white blood cell count between 20,000 and 40,000 cells/uL and then diluting to produce samples of high, normal and low numbers of lymphocyte subsets. A portion of each sample was stained in triplicate using Ortho-mune OKB19A (CD19) PE Conjugate immunophenotyping reagent and analyzed using the CYTORONABSOLUTE flow cytometer. The total lymphocyte count of the concentrated sample for each donor was obtained using an automated hematology analyzer.

Linear regression analyses were performed as follows. The expected (X axis ) values were calculated by multiplying the corresponding serial dilutions by the hematology analyzer derived buffy coat lymphocyte count and by the CYTORONABSOLUTE derived Jymphocyte subset percent positive. The observed (Y axis) values were determined as the total lymphocyte count calculated from the hematology derived value of the concentrated sample times the CYTORONABSOLUTE derived lymphocyte subset percent positive at each dilution.

The Ortho-mune OKB19A (CD19) PE Conjugate reagent demonstrated linear performance for total CD19+ lymphocyte subsets across a lymphocyte count range of 20 cells/uL to 9000 cells/uL as demonstrated with slopes indistinguishable from 1 and R values of 1.000.

Linear regression analyses of observed versus expected values for total percent CD19+ cells for each donor specimen are shown in. Regression analysis statistics are provided in Table 5.

6

CHART 2

Image /page/6/Figure/1 description: The image is a scatter plot with the x-axis labeled "Expected CD18+ Counts" and the y-axis labeled "Observed CD18+ Counts". The plot shows a strong positive correlation between the expected and observed counts, with data points clustered tightly around a diagonal line. The x and y axis range from 0 to 1400. There are several data points plotted on the graph.

Ortho'-mune OKB19A(PE)

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LINEARITY
Ortho-mune OKB19A(PE)
N=4
Ortho-mune
OKB19A(PE)	Donor	SLOPE	CI	INTERCEPT	CI	R
TOTAL CD19+	1	1.003	0.01	-6.012	5.33	1.000
TOTAL CD19+	2	1.004	0.00	-4.017	2.59	1.000
TOTAL CD19+	3	1.003	0.00	-4.126	2.20	1.000
TOTAL CD19+	4	1.001	0.00	0.311	1.36	1.000
TOTAL CD19+	All	1.002	0.00	-3.308	1.50	1.000

CONCLUSION

Performance of Ortho-mune OKB19A (CD19) Monoclonal Antibody (Murine) Phycoerythrin Conjugate is substantially equivalent to Monoclonal Antibody Test for B Cells [Anti-Leu-12 (CD19) PE (Phycoerythrin)] in the identification and enumeration of CD19+ human T lymphocytes in whole blood by flow cytometry.

8

Reproducibility studies were performed at three independent laboratories using samples with low, normal, and high relative percent CD19+ cells.

Specimens from each of ten normal donors (whole blood, EDTA) were processed using monoclonal antibodies bound to microbeads to produce samples of low, normal, and high relative percent CD19+ cells. The samples were separated into aliquots for each laboratory. Samples were stained in replicates of 10 with Ortho-mune OKB19A (CD19) PE Coniugate reagent and analyzed using the ORTHO CYTORONABSOLUTE flow cytometer.

For within laboratory reproducibility, the variance for the replicate results was calculated within site, concentration and donor. The variance was averaged across site, concentration and donor. The square root replicate variance (SD) was divided by the appropriate mean percent positive result (by site and concentration) and multiplied by 100 to obtain the CV. Within laboratory reproducibility results for determination of total percent CD19+ cells are presented in Table 3.

TABLE 3

WITHIN LABORATORY REPRODUCIBILITY
Ortho-mune OKB19A(PE)
N = 10 donors
Ortho-mune OKB19A(PE)	All SITES
Mean
Percent
Positive	Site A		Site B		Site C
TOTAL CD19+ Low	1.134	24.182	100	20.793	100	22.106	100
TOTAL CD19+ Normal	15.330	5.082	100	4.635	98	4.545	100
TOTAL CD19+ High	26.760	3.438	99	3.401	100	3.447	100