(56 days)
Not Found
Not Found
No
The device is a negative control reagent for flow cytometry, which is a chemical substance used for calibration and quality control, not a software or hardware device that would typically incorporate AI/ML. The description focuses on the chemical composition and performance characteristics of the reagent.
No
The device is described as a "negative control reagent" used for "routine immunophenotyping of lymphocytes in peripheral blood," which are diagnostic rather than therapeutic purposes.
No
Explanation: This device is described as a "negative control reagent," used to establish baselines and validate other diagnostic assays (monoclonal antibody combinations for immunophenotyping). It does not directly provide diagnostic information about a patient's condition but rather ensures the reliability of the diagnostic test it accompanies.
No
The device description clearly indicates that the device is a physical reagent (monoclonal antibodies conjugated with fluorescent dyes) supplied in a buffer solution. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagents are for use in "preparations of normal whole peripheral blood by flow cytometric methods" for "routine immunophenotyping of lymphocytes in peripheral blood." This indicates the device is intended for use on biological specimens (blood) to provide information about a person's health status (immunophenotyping).
- Device Description: The description details the composition of the reagents, which are antibodies designed to interact with components of a biological sample.
- Performance Studies: The document includes detailed performance studies (reproducibility, specificity, correlations, normal levels) conducted on human peripheral blood samples. This is characteristic of an IVD device that requires validation for its intended use on biological specimens.
- Predicate Device: The mention of a predicate device (Gentrak Genclone mouse IgG₁, 679.1MC) further supports its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for IVDs.
The device is a reagent used in vitro (outside the body) to analyze components of a biological sample (peripheral blood) to provide information relevant to diagnosis or health status (immunophenotyping). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Monoclonal Mouse IgG₁, DAK-GO1 FITC, RPE or RPE-CY5 conjugated have been developed for use in flow cytometry for the peripheral blood. These reagents are intended to be used 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 in routine immunophenotyping of lymphocytes.
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.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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
Reproducibility:
Sample size: 10 replicates from peripheral blood of three donors.
Data source: Peripheral blood of three donors.
Annotation protocol: Not specified, but involved running on two flow cytometers from different manufacturers.
Specificity:
Sample size: 5 apparently healthy adult donors of various races.
Data source: DAKO Corporation, apparently healthy adult donors.
Annotation protocol: Not specified, but included testing cell populations (RBC's, granulocytes, monocytes, lymphocytes and platelets).
Correlation to predicate reagents:
Sample size: 36 apparently healthy individuals.
Data source: Peripheral blood lymphocytes from normal, apparently healthy individuals at one laboratory.
Annotation protocol: Duplicate samples tested with each reagent (DAKO and Gentrak), with linear regression analysis.
Normal levels of negative events:
Sample size: 150 apparently healthy individuals.
Data source: Three geographically separate laboratories.
Annotation protocol: Normal means and ranges for each reagent were measured.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility:
Study type: Reproducibility
Sample size: 10 replicates from peripheral blood of three donors.
Key results: Little variability among replicate samples for the measurement of non-specificity of percent positive lymphocytes. Variability between flow cytometers observed. RPE-CY5 reproducibility expected to be consistent with FITC and RPE conjugates.
Specificity:
Study type: Specificity
Sample size: 5 apparently healthy adult donors.
Key results: No specific antibody binding of Monoclonal Mouse IgG, DAK-GO1 FITC and RPE conjugated with any of the cell populations (RBC's, granulocytes, monocytes, lymphocytes and platelets). The RPE-CY5 conjugate showed significant binding with monocytes (3.22%), which can be excluded from lymphocyte analysis with proper gating.
Correlations to predicate reagents:
Study type: Correlation
Sample size: 36 apparently healthy individuals for DAKO IgG1/FITC and RPE compared to Gentrak predicate.
Key results: Linear regression analysis showed Y(DAKO IgG1/FITC+ Lymphocytes) = . 28 + 1.39X(Gentrak IgG1/FITC + Lymphocytes)-R-= .4581 and Y(DAKO IgG1/RPE+ Lymphocytes) = . 05 + . 87X(Gentrak IgG1/RPE+ Lymphocytes); R = . 4429. No 1:1 linear correlation observed, which is expected for negative control reagents due to high variability and values less than one. This produced R-values more indicative of a random sample rather than a linear model.
Normal levels of negative events:
Study type: Normal levels
Sample size: 150 apparently healthy individuals.
Key results: Normal means and ranges measured for each reagent as x, y, and z respectively (values not provided in this section but in the Table).
Comparison of DAKO Mouse IgG₁ DAK-GO1 to Gentrak Genclone Mouse IgG₁ 679.1MC:
Study Type: Substantial Equivalence Comparison (Comparative data)
Sample Size: n=153 for DAKO, n=36 for Gentrak (Overall and by site)
Key Results:
- Mean Percent Positive Mouse IgG₁ Lymphocytes:
- DAK-GO1/FITC: 0.59% (Overall), 0.79% (Site 1), 0.47% (Site 2), 0.49% (Site 3)
- 679.1MC/FITC: 0.16% (Overall), 0.16% (Site 3)
- DAK-GO1/RPE: 0.24% (Overall), 0.35% (Site 1), 0.20% (Site 2), 0.16% (Site 3)
- 679.1MC/RPE: 0.13% (Overall), 0.13% (Site 3)
- DAK-GO1/RPE-CY5: 1.59% (Overall), 3.6% (Site 1), 0.53% (Site 2), 0.64% (Site 3)
- 95.0% Range Mouse IgG₁ Positive Lymphocytes: Varied by product and site, typically low percentages, with some ranges extending to 5.34% (DAK-GO1/FITC Site 1) and 3.06% (DAK-GO1/RPE-CY5 Site 1).
- % CV: High variability, especially for DAKO products, ranging from 74.59% to 174.15%.
- Mean Channel Fluorescence: Varied by product and site.
- For n=36 comparison:
- DAK-GO1/FITC vs 679.1MC/FITC: Mean Percent Positive Lymphocytes DAK-GO1/FITC 0.50% vs 679.1MC/FITC 0.16%. Mean Channel Fluorescence DAK-GO1/FITC 1.51 vs 679.1MC/FITC 3.07.
- DAK-GO1/RPE vs 679.1MC/RPE: Mean Percent Positive Lymphocytes DAK-GO1/RPE 0.16% vs 679.1MC/RPE 0.13%. Mean Channel Fluorescence DAK-GO1/RPE 1.77 vs 679.1MC/RPE 2.19.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reproducibility:
%CV values (for percent IgG₁/FITC+ and IgG₁/RPE+ lymphocytes):
FACScan: 0.31 to 0.40 (FITC), 0.38 to 0.45 (RPE)
Profile II: 0.12 to 0.49 (FITC), 0.18 to 0.52 (RPE)
Specificity:
DAKO Mouse IgG₁/FITC, DAK-GO1 Specificity (Average (n=5) and range):
%Positive Red Blood Cells: 0.02 (0.0-0.1)
% Positive Granulocytes: 0.74 (0.1-1.9)
% Positive Monocytes: 0.76 (0.2-1.5)
% Positive Lymphocytes: 0.22 (0.0-0.8)
% Positive Platelets: 0.04 (0.0-0.1)
DAKO Mouse IgG₁/RPE, DAK-GO1 Specificity (Average (n=5) and range):
%Positive Red Blood Cells: 0.00 (0.0-0.0)
% Positive Granulocytes: 0.08 (0.0-0.01)
% Positive Monocytes: 0.84 (0.4-2.0)
% Positive Lymphocytes: 0.04 (0.0-0.1)
% Positive Platelets: 0.22 (0.0-0.7)
DAKO Mouse IgG₁/RPE-CY5, DAK-GO1 Specificity (Average (n=5) and range):
%Positive Red Blood Cells: 0.02 (0.0-0.1)
% Positive Granulocytes: 0.16 (0.0-0.3)
% Positive Monocytes: 3.22 (0.0-11.9)
% Positive Lymphocytes: 0.12 (0.0-0.3)
% Positive Platelets: 0.10 (0.0-0.4)
Correlations of Mouse IgG₁, DAK-GO1 and Mouse IgG₁, DAK-GO1 to predicate reagents:
Y(DAKO IgG1/FITC+ Lymphocytes) = . 28 + 1.39X(Gentrak IgG1/FITC + Lymphocytes)-R-= .4581 n = 36
Y(DAKO IgG1/RPE+ Lymphocytes) = . 05 + . 87X(Gentrak IgG1/RPE+ Lymphocytes); R = . 4429 n = 36
Testing Results for DAKO Mouse IgG₁, DAK-GO1 and 679, 1MC:
Percent Positive Mouse IgG, Lymphocytes:
DAK-GO1/FITC: Mean 0.59%, 95.0% Range 0-5.34%, % CV 150.89% (n=153)
679.1MC/FITC: Mean 0.16%, 95.0% Range 0-0.3%, % CV 146.67% (n=36)
DAK-GO1/RPE: Mean 0.24%, 95.0% Range 0-1.28%, % CV 93.81% (n=153)
679.1MC/RPE: Mean 0.13%, 95.0% Range 0-0.4%, % CV 84.93% (n=36)
DAK-GO1/RPE-CY5: Mean 1.59%, 95.0% Range 0.06-3.06%, % CV 88.98% (n=153)
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.
Gentrak Genclone mouse IgG₁, 679.1MC
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
§ 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.”
0
JUN 21 1999
| JUN 21 1999 | 510(k) Summary | K991454 | |
|---|---|---|---|
| Submitter: | DAKO Corporation | ||
| 6392 Via Real | |||
| Carpinteria, CA 93013 | |||
| 805-566-6655 | |||
| Contact: | Gretchen M. Murray, Ph.D. | ||
| Date Summary | |||
| Prepared: | April 19, 1999 | ||
| Device Name: | DAKO® IgG1/FITC, Clone DAK-G01, Code No. X0927; IgG1/RPE, Clone DAK-GO1 Code No. X0928; IgG1/RPE-CY5, Clone DAK-G01, Code No. X0955 | ||
| Device Classification: | Class II according to 21 CFR 864.5220, on the basis that monoclonal antibodies are accessories for automated differential cell counters. | ||
| Panel: | The device classification is under the Hematology and Pathology Devices panel, Division of Clinical Laboratory Devices. | ||
| Predicate Device: | Gentrak Genclone mouse IgG₁, 679.1MC | ||
| Device | 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 | ||
| Intended Use: | For In Vitro Diagnostic Use | ||
| Monoclonal Mouse IgG₁, DAK-GO1 FITC, RPE or RPE-CY5 conjugated have been developed for use in flow cytometry for the peripheral blood. These reagents are intended to be used 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 in routine immunophenotyping of lymphocytes. |
1
Comparison of
Technological Characteristics
Reproducibility of ten replicates from peripheral blood of three donors were run on two flow cytometers from different manufacturers. Normal peripheral blood samples were used for measuring lymphocytes for levels of nonspecificity with Mouse IgG1, DAK-GO1 negative control reagents. Values are expressed as a percent of the total lymphocyte count.
| FACScan | Mean % IgG₁/FITC+ | ±1 SD | %CV | n |
|---|---|---|---|---|
| Donor 1 | 0.80 | 0.25 | 0.31 | 10 |
| Donor 2 | 0.86 | 0.35 | 0.40 | 10 |
| Donor 3 | 0.61 | 0.23 | 0.37 | 10 |
| Profile II | Mean % IgG₁/FITC+ | ±1 SD | %CV | n |
| Donor 1 | 1.30 | 0.62 | 0.49 | 10 |
| Donor 2 | 1.06 | 0.32 | 0.30 | 10 |
| Donor 3 | 1.14 | 0.13 | 0.12 | 10 |
| FACScan | Mean % IgG₁/RPE+ | ±1 SD | %CV | n |
| Donor 1 | 0.70 | 0.27 | 0.38 | 10 |
| Donor 2 | 0.67 | 0.30 | 0.45 | 10 |
| Donor 3 | 0.76 | 0.27 | 0.36 | 10 |
| Profile II | Mean % IgG₁/RPE+ | ±1 SD | %CV | n |
| Donor 1 | 0.36 | 0.12 | 0.35 | 10 |
| Donor 2 | 0.33 | 0.17 | 0.52 | 10 |
| Donor 3 | 0.38 | 0.07 | 0.18 | 10 |
The reproducibility results indicate that there is little variability among replicate samples for the measurement of non-specificity of percent positive lymphocytes. There is some variability between flow cytometers as indicated by the differences in percentages of lymphocytes detected. No reproducibility testing was performed for IgG1/RPE-CY5. However, since the reagent is the same IgG1 antibody as the FITC conjugate and the RPE conjugate except for being conjugated with a different fluorochrome, it is expected that IgG,/RPE-Cy5, Code No. X0955 has the same consistent reproducibility as IgG,/FITC, Code No. X0927 and IgG,/RPE, Code No. X0928 when tested on lymphocytes.
2
Specificity of Monoclonal Mouse IgGy, DAK-GO1 FITC, RPE and RPE-CY5 conjugated has been verified by tests performed on five apparently healthy adult donors of various races at DAKO Corporation. Cell populations tested were RBC's, granulocytes, monocytes, lymphocytes and platelets. The results indicate that there is no specific antibody binding of Monoclonal Mouse IgG, DAK-GO1 FITC and RPE conjugated with any of the cell populations. However, the RPE-CY5 conjugate did have a significant amount of binding with monocytes (3.22%). This nonspecific binding can be excluded from the lymphocyte analysis region with proper gating on the lymphocytes.
DAKO Mouse IgGi/FITC, DAK-GO1 Specificity
| | %Positive Red
Blood Cells | % Positive
Granulocytes | % Positive
Monocytes | % Positive
Lymphocytes | % Positive
Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)
(range) | 0.02
(0.0-0.1) | 0.74
(0.1-1.9) | 0.76
(0.2-1.5) | 0.22
(0.0-0.8) | 0.04
(0.0-0.1) |
DAKO Mouse IgG1/RPE, DAK-GO1 Specificity
| | %Positive Red
Blood Cells | % Positive
Granulocytes | % Positive
Monocytes | % Positive
Lymphocytes | % Positive
Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)
(range) | 0.00
(0.0-0.0) | 0.08
(0.0-0.01) | 0.84
(0.4-2.0) | 0.04
(0.0-0.1) | 0.22
(0.0-0.7) |
DAKO Mouse IgG1/RPE-CY5, DAK-GO1 Specificity
| | %Positive Red
Blood Cells | % Positive
Granulocytes | % Positive
Monocytes | % Positive
Lymphocytes | % Positive
Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)
(range) | 0.02
(0.0-0.1) | 0.16
(0.0-0.3) | 3.22
(0.0-11.9) | 0.12
(0.0-0.3) | 0.10
(0.0-0.4) |
Correlations of Mouse IgG,/FITC, DAK-GO1 and Mouse IgG,/RPE, DAK-GO1 to predicate reagents, Mouse IgG, /FITC, 679.1MC and Mouse IgG, /RPE, 679.1MC were determined by testing duplicate samples with each reagent on peripheral blood lymphocytes on normal, apparently healthy individuals at one laboratory. Linear regression analysis of the data gave the following equations and Pearson correlations.
Y(DAKO IgG1/FITC+ Lymphocytes) = . 28 + 1.39X(Gentrak IgG1/FITC + Lymphocytes)-R-= .4581 n = 36 Y(DAKO IgG1/RPE+ Lymphocytes) = . 05 + . 87X(Gentrak IgG1/RPE+ Lymphocytes); R = . 4429 n = 36
Normal levels of negative events were measured for each reagent at three geographically separate laboratories. The sample size(s) was 150 apparently healthy individuals. Normal means and ranges for each reagent were x, y, and z respectively. The regression analysis indicated that there was not a 1:1 linear correlation of the Mouse IgG,/FITC, DAK-GO1 reagent and Mouse IgG, /FITC, 679.1MC nor of Mouse IgG,/RPE, DAK-GO1 reagent and Mouse IgG, /RPE, 679.1MC. As expected with negative control reagents, the values are highly variable and less than one. This produced R-values that are more indicative of a random sample rather than a linear model. Linear regression analysis of a data set measuring negative events would be expected to show no correlation.
Linearity testing using human cell lines was not performed. There would be no specificity or sensitivity detected as the antibody is not directed against a human antigen.
3
Substantial Equivalence Comparison of DAKO's Substantial Equivalence Companson of Driko o
Mouse IgG,, DAK-GO1 to Gentrak Genclone Mouse IgG,, 679.1MC
CONFIDENTIAL
| Attribute | DAKO | Gentrak Genclone |
|---|---|---|
| Clone: | Mouse IgG₁, DAK-GO1 | Mouse IgG₁, 679.1MC |
| Epitope | Glucose oxidase from | |
| Aspergillus niger | Succinyl histamine bovine | |
| serum albumin (SH-BSA) | ||
| Intended Use | 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 for | |
| FITC, or RPE conjugated | ||
| monoclonal antibodies of the | ||
| IgG, heavy chain isotype in | ||
| preparations of normal whole | ||
| peripheral blood by flow | ||
| cytometric methods. | ||
| Clinical Utility | Use with monoclonal | |
| antibody test reagents of the | ||
| IgG, immunoglobulin isotype | ||
| in flow cytometric procedures | ||
| performed on normal donors. | Use with monoclonal | |
| antibody test reagents of the | ||
| IgG, immunoglobulin isotype | ||
| in flow cytometric procedures | ||
| performed on normal donors. | ||
| Stability | Mouse IgG₁ /FITC - 3 years: | |
| Mouse IgG₁ /RPE - 2 years: | ||
| Mouse IgG₁ /RPE-CY5 - 2 | ||
| years: from time of | ||
| manufacture. | 2 years from time of | |
| manufacture. | ||
| Specificity | No specific reaction to | |
| lymphocytes, monocytes, | ||
| granulocytes, platelets or red | ||
| blood cells. | No specific reaction to | |
| lymphocytes, monocytes, | ||
| granulocytes or red blood | ||
| cells. | ||
| Storage | 2-8°C, in the dark | 2-8°C |
4
| | DAK-GO1/
FITC | 679.1MC/
FITC | DAK-GO1/
RPE | 679.1MC/
RPE | DAK-GO1/
RPE-CY5 |
|------------------------------------------------------------------------------------------|-------------------|------------------|-------------------|-----------------|---------------------|
| Percent Positive Mouse IgG, Lymphocytes
Mean
(n=153 for DAKO) (n = 36 for Gentrak) | 0.59% | 0.16% | 0.24% | 0.13% | 1.59% |
| 95.0% Range Mouse IgG, Positive
Lymphocytes
(n=153 for DAKO) (n = 36 for Gentrak) | 0-5.34% | 0-0.3% | 0-1.28% | 0-0.4% | 0.06-3.06% |
| % CV
(n=153 for DAKO) (n = 36 for Gentrak) | 150.89% | 146.67% | 93.81% | 84.93% | 88.98% |
| Percent Positive Mouse IgG, Lymphocytes
(by laboratory site) | | | | | |
| Site 1(n=53) | 0.79% | | 0.35% | | 3.6% |
| Site 2(n=50) | 0.47% | | 0.20% | | 0.53% |
| Site 3(n=50 for DAKO)
(n=36 for Gentrak) | 0.49% | 0.16% | 0.16% | 0.13% | 0.64% |
| 95.0% Range (by laboratory site) | | | | | |
| Site 1(n=53) | 0.06-5.34% | | 0.08-1.28% | | 0.34-3.06% |
| Site 2(n=50) | 0-1.65% | | 0-0.65% | | 0.06-1.87% |
| Site 3(n=50 for DAKO)
(n=36 for Gentrak) | 0.1-1.5% | 0-0.3% | 0-0.5% | 0-0.4% | 0.1-2.6% |
| % CV (by laboratory site) | | | | | |
| Site 1(n=53) | 174.15% | | 79.80% | | 74.59% |
| Site 2(n=50) | 86.50% | | 94.74% | | 85.13% |
| Site 3(n=50 for DAKO)
(n=36 for Gentrak) | 90.01% | 146.67% | 80.85% | 84.93% | 173.63% |
| Mean Channel Fluorescence
(by laboratory site) | | | | | |
| Mean | | | | | |
| Site 1(n=53) | 30.52 | | 81.23 | | 82.15 |
| Site 2(n = 50) | 172.79 | | 169.00 | 2.19 | 398.90 |
| Site 3(n=50 for DAKO)
(n = 36 for Gentrak) | 1.57 | 3.07 | 1.99 | | 1.56 |
| 95.0% Range (by laboratory site) | | | | | |
| Site 1 (n = 53) | 16.23 -
116.63 | | 20.13 -
307.12 | | 28.23 -
205.5 |
| Site 2(n=50) | 0 - 642.69 | | 0 - 888.83 | | 49.7 -
2111.49 |
| Site 3(n=50 for DAKO)
(n = 36 for Gentrak) | 0.87 - 3.22 | 0 - 16.15 | 0 - 7.146 | 0 - 12.48 | 0.72 - 3.70 |
| % CV (by laboratory site) | | | | | |
| Site 1 (n = 53) | 71.94% | | 114.43% | | 79.82% |
| Site 2(n = 50) | 119.30% | | 150.28% | 153.47% | 154.56% |
| Site 3(n=50 for DAKO)
(n = 36 for Gentrak) | 46.46% | 151.14% | 102.09% | | 54.25% |
Testing Results for DAKO Mouse IgG,/FITC/RE/CY5, DAK-G01 and
esting Results for DAKO Mouse IgG,/FITC/RPE/CY5, C79, 1MC ts for DARO Mouse IgG,/FITC/RPE, 679.1MC
प
5
Testing Results for DAKO Mouse IgG,/FITC, DAK-GO1 versus Gentrak Mouse IgG,/FITC, 679.1MC
·
| | DAK-GO1/
FITC | 679.1MC/
FITC |
|-------------------------------------------------------------|------------------|------------------|
| Percent Positive Mouse IgG, Lymphocytes
Mean
(n = 36) | 0.50% | 0.16% |
| 95.0% Range Mouse IgG₁ Positive
Lymphocytes
(n = 36) | 0.1-1.4% | 0-0.3% |
| % CV
(n = 36) | 95.62% | 146.67% |
| Mean Channel Fluorescence
Mean
(n = 36) | 1.51 | 3.07 |
| 95.0% Range (by laboratory site)
(n = 36) | 0.87-3.12 | 0 - 16.15 |
| % CV (by laboratory site)
(n = 36) | 41.88% | 151.14% |
Testing Results for DAKO Mouse IgG,/RPE, DAK-GO1 versus Gentrak Mouse igG,/RPE, 679.1MC
| | DAK-GO1/
RPE | 679.1MC/
RPE |
|-------------------------------------------------------------|-----------------|-----------------|
| Percent Positive Mouse IgG₁ Lymphocytes
Mean
(n = 36) | 0.16% | 0.13% |
| 95.0% Range Mouse IgG₁ Positive
Lymphocytes
(n = 36) | 0-0.5% | 0-0.4% |
| % CV
(n = 36) | 88.13% | 84.93% |
| Mean Channel Fluorescence
Mean
(n = 36) | 1.77 | 2.19 |
| 95.0% Range (by laboratory site)
(n = 36) | 0-6.19 | 0-12.48 |
| % CV (by laboratory site)
(n = 36) | 98.97% | 153.47% |
6
Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is smaller than the eagle symbol.
JUN 21 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gretchen M. Murray, Ph.D. Regulatory Affairs Manager DAKO Corporation 6392 Via Real Carpinteria, California 93013
K991454 Re:
Trade Name: Monoclonal Mouse IgG, Clone DAK-GO1, FITC, RPE or RPE-CY5 Conjugated Regulatory Class: II Product Code: GKZ Dated: April 22, 1999 Received: April 26, 1999
Dear Dr. Murray:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K991454
Device Name: Monoclonal Mouse IgG; Clone DAK-GO1, FITC Conjugated Monoclonal Mouse IgG1 Clone DAK-GO1, RPE Conjugated Monoclonal Mouse IgG1 Clone DAK-GO1, RPE-CY5 Conjugated
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991454 |
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use (Per 21 CRF 801.110)
IVD Use (Per 21 CFR 801.119)
(Optional Format 1-2-96)