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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)

Table 2: Specificity (Average % Positive Cells, n=5)

Table 3: Comparison of DAKO IgG1 Reagents vs. Predicate (Gentrak 679.1MC) - Overall

Key Acceptance Criteria (Implicit from provided data and intended use as negative controls):

• Reproducibility: Low variability among replicate samples for measuring non-specificity (<1% positive lymphocytes for FITC/RPE conjugates across donors and platforms). The reported %CV values (e.g., 0.12 - 0.49 for RPE, 0.31 - 0.40 for FITC) demonstrate this.
• Specificity (Lack of specific binding): No significant specific binding to various cell populations (RBCs, granulocytes, monocytes, lymphocytes, platelets). The reported average positive percentages are consistently low, generally below 1%, with the exception of RPE-CY5 binding to monocytes (3.22%) which is addressed by proper gating.
• Substantial Equivalence: Similar performance characteristics (e.g., mean % positive lymphocytes, range, %CV) as the predicate device (Gentrak Genclone mouse IgG₁, 679.1MC) when used as negative controls in flow cytometry. The document shows side-by-side comparison tables.

Study Details:

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

   • Reproducibility: Peripheral blood from 3 donors was used for 10 replicates each (total 30 replicates per fluorochrome-flow cytometer combination). Data provenance is retrospective, from DAKO Corporation (implied, as the manufacturer reports the study). The specific country is not mentioned, but DAKO Corporation is located in Carpinteria, CA, USA.
   • Specificity: 5 apparently healthy adult donors of various races were tested. Data provenance is retrospective, from DAKO Corporation.
   • Correlation/Comparison to Predicate:
     • Initial correlation: 36 apparently healthy individuals at one laboratory.
     • Normal levels of negative events: 150 apparently healthy individuals across three geographically separate laboratories (site 1: n=53, site 2: n=50, site 3: n=50 for DAKO; site 3: n=36 for Gentrak).
   • Provenance: All data appears to be retrospective and collected for the purpose of this 510(k) submission. Country of origin for the studies is implicitly USA, where DAKO Corporation is based.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The concept of "ground truth" as it applies to an AI device is not directly applicable here. This is a study of laboratory reagents. The "truth" is established by the inherent characteristics of the reagents (e.g., lack of specific binding to human antigens) as measured by standard laboratory techniques (flow cytometry). The performance metrics (e.g., % positive cells) are direct measurements, not interpretations requiring expert consensus as with image analysis. The results are based on laboratory measurements in apparently healthy individuals.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. The data being measured (e.g., % positive cells in flow cytometry) are quantitative directly obtained from instrument software, not qualitative assessments requiring adjudication by multiple readers.

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 is not an AI device or a diagnostic device where human reader performance is being evaluated. It is a reagent for laboratory testing.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm-based device. The device itself is the reagent. The "performance" is the analytical performance of the reagent.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" in this context is the biological characteristic of the reagents themselves, specifically that they are designed to be negative controls and therefore should exhibit minimal non-specific binding to human leukocyte populations. This is assessed by measuring the percentage of positive cells and the mean channel fluorescence upon exposure to normal human blood samples using established flow cytometry techniques. The "normal" range for negative events is established from a cohort of apparently healthy individuals.

7. The sample size for the training set:
   Not applicable. This is not an AI device that requires a training set. The reagents are manufactured products, and their performance is characterized through laboratory testing.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

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