CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY

• K Number: K963954
• Device Name: CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
• Manufacturer: CALTAG LABORATORIES, INC.
• Date Cleared: 1996-11-25 ( 54 days)
• Product Code: GKZ
• Regulation Number: 864.5220
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

CALTAG CD19 R-PE and CD19 TRI-COLOR are fluorochrome conjugated monoclonal antibody reagents that may be used to enumerate CD19+ lymphocytes in human peripheral blood by flow cytometric methods.

Device Description

The CALTAG CD19 R-PE and CD19 TRI-COLOR monoclonal antibodies bind to the surfaces of viable blood cells that express the CD19 antigen. To identify cells bearing the CD19 determinant, 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CALTAG CD19 R-PE and CD19 TRI-COLOR Mouse Monoclonal Antibodies, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit pass/fail acceptance criteria. However, we can infer some criteria from the comparisons made and the expected values presented. The "Comparison" column in the table implies the acceptance criterion of "Substantially equivalent" to the predicate devices for each item.

No.	Item	Acceptance Criteria (Inferred)	Reported Device Performance (CALTAG Antibodies)	Predicate Device Performance (Coulter Antibodies)	Comparison Result
1.	Intended Use	Substantially equivalent to predicate	Flow Cytometry	Flow Cytometry, Immunofluorescence	Substantially equivalent
2.	Specificity	Substantially equivalent to predicate	CD19	CD19	Substantially equivalent
3.	Target cell	Substantially equivalent to predicate	B lymphocyte	B lymphocyte	Substantially equivalent
4.	Chemical form	Substantially equivalent to predicate	Monoclonal antibody	Monoclonal antibody	Substantially equivalent
5.	Fluorochromes	Substantially equivalent to predicate	R-PE, TRI-COLOR	FITC, RD1	Substantially equivalent
6.	Available forms	Substantially equivalent to predicate	FITC liquid, PBS; PE liquid, PBS; TRI-COLOR liquid, PBS	lyophilized, liquid, PBS, not available	Substantially equivalent
7.	Sample prep. methods	Substantially equivalent to predicate	whole blood	whole blood	Substantially equivalent
8.	Expected values from this study (n=155)	Within or comparable to predicate device's expected range (4-21% for RD1, 3-23% for FITC)	R-PE 5-21%, TRI-COLOR 4-24%	4-21% (RD1), 3-23% (FITC)	Substantially equivalent

Reproducibility (Intra-lab and Inter-lab): While specific acceptance criteria for %CV are not explicitly stated, the data provided implies that the observed %CV values in various ranges (high, mid, low) and across different sites were considered acceptable for demonstrating reproducibility. The ranges of observed %CV were:

• CD19 R-PE (Intra-lab): 0.5% - 7.6%
• CD19 TRI-COLOR (Intra-lab): 1.0% - 6.0%

Correlation: For correlation studies, the acceptance criteria are implicitly that the R-squared (r²) value, slope, and Y-intercept indicate strong linear correlation and agreement with the predicate devices. The reported r² values are very high:

• CALTAG CD19 R-PE vs. Coulter CD19 RD1: r² = 97.7
• CALTAG CD19 R-PE vs. Coulter CD19 FITC: r² = 96.3
• CALTAG CD19 TRI-COLOR vs. Coulter CD19 RD1: r² = 96.7
• CALTAG CD19 TRI-COLOR vs. Coulter CD19 FITC: r² = 97.4
• CALTAG CD19 TRI-COLOR vs. CALTAG CD19 R-PE: r² = 97.6

The slopes are close to 1 (0.92 to 0.99) and Y-intercepts are close to 0 (-0.56 to 2.14), indicating strong agreement.

Study Information

1. Sample size used for the test set and the data provenance:

   • Expected Value Data: 155 apparently healthy normal donors.
   • Specificity Data: An unspecified number of healthy normal donors (Caucasian, Black, Hispanic and Oriental ethnic origins). The table shows data for 5 different donor samples.
   • Reproducibility Data (Intra-lab): For each antibody and each of three ranges (high, medium, low), 10 replicated determinations were performed. This involved 10 separate samples per range. The study was conducted in each of three independent laboratories.
   • Reproducibility Data (Inter-lab): Similar to intra-lab, 10 replicated determinations for each antibody in each of three ranges (high, medium, low). This involved blood samples from "the same blood donors" across three laboratories.
   • Correlation Data: 175 donors (155 normal and 20 abnormal donors).
   • Data Provenance: Geographically diverse areas of the United States, including Western, Eastern, and SouthCentral regions. The studies appear to be prospective, as blood samples were "collected" and "analyzed" for the purpose of this study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on the performance of monoclonal antibodies for flow cytometry, a lab assay. The "ground truth" is typically established by the assay itself and comparison to established methods (predicate devices), not by expert interpretation of images or other data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is a laboratory assay where results are quantifiable percentages, not subjective interpretations requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This study is about the performance of monoclonal antibodies, not an AI or human reader effectiveness study.

5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The devices are reagents for flow cytometry, which is an automated process for cell counting and phenotyping. The performance presented is of the reagents in conjunction with standard flow cytometric methods, which can be seen as an 'algorithm only' performance in terms of the reagent's interaction with the biological sample and the instrument, without human interpretation as the primary output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Expected Values and Specificity: The "ground truth" for the expected values and specificity is derived from flow cytometric analysis of samples from clearly defined populations (healthy donors, specific cell types) using the test device and comparing it to the known performance of predicate devices.
   • Reproducibility: The ground truth for reproducibility is the consistency of the assay results itself, measured by standard deviation (S.D.) and coefficient of variation (%CV).
   • Correlation: The ground truth for correlation is the established performance of the legally marketed predicate devices (Coulter CD19 RD1 and CD19 FITC monoclonal antibodies), against which the new CALTAG antibodies are compared using linear regression.

7. The sample size for the training set: Not applicable. This is a medical device study for reagents, not an AI model requiring a training set. The term "training set" is typically used in machine learning.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI model.

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.”