(56 days)
Mouse IgG1, clone DAK-GO1 Negative Control Reagents are fluorescent conjugated (fluorescein isothiocyanate isomer 1 (FITC), R-Phycoerythrin (RPE), or R-Phycoerythrin-Cyanin 5 (RPE-CY5)) monoclonal antibodies that have been developed for use as negative control reagents for FITC, RPE or RPE-CY5 conjugated monoclonal antibodies of the IgG, heavy chain isotype in preparations of normal whole peripheral blood by flow cytometric methods. Negative control reagents are one component of the suggested controls for monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.
Monoclonal Mouse IgG₁, DAK-GO1 FITC, RPE or RPE-CY5 conjugated are directed against Aspergillus niger glucose oxidase, an enzyme that is neither present nor inducible in mammalian tissues. Purified monoclonal mouse IgG1 is produced in tissue culture, dialyzed and conjugated with Fluorescein (FITC), R-phycoerythrin (RPE), or R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5). FITC CONJUGATED: One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN₃, stabilized with 1% carrier protein. RPE and RPE-Cy5 CONJUGATED: One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCI buffer, pH 7.2, 15mM NaN₃, 0.1M NaCl stabilized with 1% carrier protein
Here's an analysis of the provided text regarding the DAKO IgG1/FITC, IgG1/RPE, and IgG1/RPE-CY5 devices, focusing on acceptance criteria and supporting studies:
It's important to note that this document is a 510(k) summary submitted to the FDA in 1999 for a diagnostic device. The 'acceptance criteria' and 'device performance' are described in terms of demonstrating substantial equivalence to a predicate device, rather than a quantifiable efficacy for a clinical outcome in the way an AI algorithm might be evaluated today. The performance metrics focus on the analytical characteristics of the reagents as negative controls.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these negative control reagents are implied through comparability to the predicate device and demonstration of their intended function (non-specific binding in various cell populations and reproducibility). The tables below summarize the reported device performance, which serves as the evidence meeting these implicit acceptance criteria.
Table 1: Reproducibility (Mean % IgG1/Fluorochrome+ Lymphocytes)
| Device/Flow Cytometer | Mean % IgG1/FITC+ (Donor 1) | Mean % IgG1/FITC+ (Donor 2) | Mean % IgG1/FITC+ (Donor 3) |
|---|---|---|---|
| DAKO IgG1/FITC (FACScan) | 0.80 | 0.86 | 0.61 |
| DAKO IgG1/FITC (Profile II) | 1.30 | 1.06 | 1.14 |
| Device/Flow Cytometer | Mean % IgG1/RPE+ (Donor 1) | Mean % IgG1/RPE+ (Donor 2) | Mean % IgG1/RPE+ (Donor 3) |
| DAKO IgG1/RPE (FACScan) | 0.70 | 0.67 | 0.76 |
| DAKO IgG1/RPE (Profile II) | 0.36 | 0.33 | 0.38 |
Table 2: Specificity (Average % Positive Cells, n=5)
| Cell Population | DAKO IgG1/FITC | DAKO IgG1/RPE | DAKO IgG1/RPE-CY5 |
|---|---|---|---|
| Red Blood Cells | 0.02% | 0.00% | 0.02% |
| Granulocytes | 0.74% | 0.08% | 0.16% |
| Monocytes | 0.76% | 0.84% | 3.22% |
| Lymphocytes | 0.22% | 0.04% | 0.12% |
| Platelets | 0.04% | 0.22% | 0.10% |
Table 3: Comparison of DAKO IgG1 Reagents vs. Predicate (Gentrak 679.1MC) - Overall
| Metric | DAKO IgG1/FITC (n=153) | Gentrak IgG1/FITC (n=36) | DAKO IgG1/RPE (n=153) | Gentrak IgG1/RPE (n=36) | DAKO IgG1/RPE-CY5 (n=153) |
|---|---|---|---|---|---|
| Mean % Positive Lymphocytes | 0.59% | 0.16% | 0.24% | 0.13% | 1.59% |
| 95.0% Range % Positive Lymphocytes | 0-5.34% | 0-0.3% | 0-1.28% | 0-0.4% | 0.06-3.06% |
| % CV | 150.89% | 146.67% | 93.81% | 84.93% | 88.98% |
Key Acceptance Criteria (Implicit from provided data and intended use as negative controls):
- Reproducibility: Low variability among replicate samples for measuring non-specificity (
§ 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.”