(60 days)
F0818
Not Found
No
The device description and performance studies focus on the characteristics and performance of monoclonal antibodies used in flow cytometry for immunophenotyping. There is no mention of AI or ML algorithms for data analysis, interpretation, or any other function. The analysis of flow cytometry data is typically performed using standard gating and analysis software, not explicitly described as AI/ML in this summary.
No
Explanation: This device is for "In Vitro Diagnostic Use" for the "analysis of T-cells in peripheral blood," which is used for diagnosis, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use" and mentions that the reagents help in the "simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders" and that "Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies." These phrases directly indicate its use in diagnosing diseases.
No
The device description clearly states that the device is a conjugated antibody supplied in a buffer solution, which is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use".
- Intended Use: The intended use is for the analysis of T-cells in peripheral blood using flow cytometry, specifically for the "simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders." This is a diagnostic purpose.
- Clinical Application: The document mentions that "Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies," and these reagents are utilized for this purpose.
- Performance Studies: The document includes performance studies like Linearity, Reproducibility, Specificity, and Predicate Correlation, which are typical for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: A predicate device (K991402 DAKO Mouse anti-human T-cell, CD3/FITC, Clone UCHT1 Code No.F0818) is listed, which is a common requirement for demonstrating substantial equivalence for IVD devices seeking regulatory clearance.
- Care Setting: The intended user is in a "Clinical Laboratory," which is where IVD tests are typically performed.
All these factors strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone UCHT1 (Code No.C7067) (Anti-CD3/RPE-Cy5) and Monoclonal Mouse Anti-Human Tcell, CD3/RPE conjugated, Clone UCHT1 (Code No. R0810) (Anti-CD3/RPE) have been developed for use in flow cytometry for the analysis of T-cells in peripheral blood. These reagents allow simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. Each reagent is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.
Monoclonal Mouse Anti-Human T-cell, CD3, Clone UCHT1, RPE-Cy5 conjugated, has been developed for use in flow cytometry for the analysis of Tcells. This reagent allows simultaneous detection and quantification of CD3positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood. Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE-Cy5 is one of the reagents utilized when performing immunophenotyping of lymphocytes.
Monoclonal Mouse Anti-Human T-cell, CD3, Clone UCHT1, RPE conjugated, has been developed for use in flow cytometry for the analysis of T-cells. This reagent allows simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood. Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE is one of the reagents utilized when performing immunophenotyping of lymphocytes.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone UCHT1 (Code No. C7067) and Monoclonal Mouse Anti-Human T-cell, CD3/RPE conjugated, Clone UCHT1 (Code No. R0810) are specific for T-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD3 is produced in tissue culture, dialyzed and conjugated with either R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5) or R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN 3, 0.1M NaCl, stabilized with 1% stabilzing protein.
Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5-conjugated, C7067, and, Monoclonal Mouse Anti-Human T-cell, CD3/RPE, R0810 are specific for T-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD3 is produced in tissue culture, dialyzed and conjugated with R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5), or conjugated with R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaNg, 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Technological Characteristics - Linearity:
Binding linearity was determined over serial dilutions of a cell line known to express the antigen diluted with a cell line that has no antigenic sites. For Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 the cell line without antigenic reactivity is Raji cells, while the cell line with antigenic sites is JM cells. Five dilutions were tested, with a linear equation calculated from the results. The equation for Anti-CD3/RPE-Cy5, C7067, y = -0.02 + 1.0x, R2 = 0.999, and Anti-CD3/RPE y=2.84 + 1.0x, R2 = 0.999.
Reproducibility:
Ten replicates from peripheral blood of three donors were tested for reproducibility of Anti-CD3/RPE-Cy5 and run on two flow cytometers from different manufacturers at three concentrations of antigen. Different levels of CD3+ lymphocytes were selected from a population of normal and abnormal peripheral blood samples. Each level of CD3 was analyzed within one day on both machines.
Specificity:
Specificity of Anti-CD3/RPE-Cy5 and Anti-CD3/RPE 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 antibody binding of Anti-CD3/RPE-Cy5 and Anti-CD3/RPE are specific for lymphocytes. Lymphocytes bound to Anti-CD3/RPE-Cy5 antibodies on an average of 72%, representative of the T-cell population. Approximately 2% of monocytes bound with the Anti-CD3/RPE-Cy5. However, monocyte binding can be excluded from the lymphocyte analysis by proper gating on lymphocytes. Lymphocytes bound to Anti-CD3/RPE antibodies on an average of 70%, representative of the T-cell population. Approximately 9% of monocytes bound with the Anti-CD3/RPE.
Predicate Correlation:
Correlation of Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 to a predicate Anti-CD3/FITC, F0818 reagent, was determined by testing duplicate samples with each reagent across 153 normal, apparently healthy individuals at three geographically separate laboratories. Linear regression analysis of the data gave the following equations and Pearson correlation's:
Y(DAKO Anti-OD3/RPE-Cy5+ Lymphocytes) = 6.22 + 0.92 X(DAKO Anti-OD3/FITC + Lymphocytes); R2 = 0.9208 n = 150
y(DAKO Anti-CD3/RPE+ Lymphocytes) = 9.85 + 0.87 x(DAKO Anti-CD3/FITC + Lymphocytes). R2 = 0.8040.
In addition, samples from patients with illnesses were compared, and their data added to the results of the testing of the 150 apparently healthy individuals. Linear correlation was performed on the total database. Linear regression analysis gave the following equation and R2:
y(DAKO Anti-CD3/RPE-Cy5+ Lymphocytes) = 2.43 + 0.98 x(DAKO Anti-CD3/FITC + Lymphocytes). R2 = 0.9750 n = 177
y(DAKO Anti-CD3/RPE+ Lymphocytes) = 1.20 + 0.99 x(DAKO Anti-CD3/FITC + Lymphocytes). R2 = 0.9870 n = 176
These equations indicate that Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 reagents are comparable on 1:1 basis to the Anti-CD3/FITC, F0818 reagent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: R2 = 0.999 for Anti-CD3/RPE-Cy5, and R2 = 0.999 for Anti-CD3/RPE.
Specificity: Lymphocytes bound to Anti-CD3/RPE-Cy5 antibodies on an average of 72%. Approximately 2% of monocytes bound with Anti-CD3/RPE-Cy5. Lymphocytes bound to Anti-CD3/RPE antibodies on an average of 70%. Approximately 9% of monocytes bound with Anti-CD3/RPE.
Percentage Positive Cells for DAKO Anti-CD3/RPE-Cy5 Specificity (average n=5):
Red Blood Cells: 0.02% (range 0.0-0.1)
Granulocytes: 1.50% (range 0.9-2.2)
Monocytes: 1.82% (range 1.1-2.7)
Lymphocytes: 71.90% (range 60.3-78.6)
Platelets: 0.12% (range 0.0-0.3)
Percentage Positive Cells for DAKO Anti-CD3/RPE Specificity (average n=5):
Red Blood Cells: 0.08% (range 0.0-0.3)
Granulocytes: 0.60% (range 0.4-0.7)
Monocytes: 8.52% (range 1.6-16.3)
Lymphocytes: 69.92% (range 58.4-75.9)
Platelets: 1.08% (range 0.1-3.8)
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.
DAKO Mouse anti-human T-cell, CD3/FITC, Clone UCHT1 Code No.F0818
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
:
:
510(k) Summary
:
| Submitter: | DAKO Corporation
6392 Via Real
Carpinteria, CA 93013
805-566-6655 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gretchen M. Murray, Ph.D. |
| Date Summary
Prepared: | April, 1999 |
| Device Names: | DAKO® Mouse Anti-Human T-cell, CD3/RPE-Cy5, Clone UCHT1
(Product Code No. C7067) and
DAKO® Mouse Anti-Human T-cell, CD3/RPE, clone UCHT1
(Product Code No. R0810) |
| 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: | DAKO Mouse anti-human T-cell, CD3/FITC, Clone UCHT1 Code No.F0818 |
| Devise
Description: | Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone
UCHT1 (Code No. C7067) and Monoclonal Mouse Anti-Human T-cell, CD3/RPE
conjugated, Clone UCHT1 (Code No. R0810) are specific for T-lymphocyte
cluster determinants as evaluated by the International Workshop on Human
Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody
was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes,
BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-
Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse
anti-human CD3 is produced in tissue culture, dialyzed and conjugated with
either R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5) or R-
phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is
supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN 3 , 0.1M NaCl, stabilized
with 1% stabilzing protein. |
| Intended Use: | For In Vitro Diagnostic Use
Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, Clone UCHT1
(Code No.C7067) (Anti-CD3/RPE-Cy5) and Monoclonal Mouse Anti-Human T-
cell, CD3/RPE conjugated, Clone UCHT1 (Code No. R0810) (Anti-CD3/RPE)
have been developed for use in flow cytometry for the analysis of T-cells in
peripheral blood. These reagents allow simultaneous detection and
quantification of CD3-positive cells (T-cells) in normal and pathological
conditions such as immunodeficiency disorders. Each reagent is one
component of the suggested monoclonal antibody (MAb) combinations for
routine immunophenotyping of lymphocytes in peripheral blood. |
6
1
Comparison of Technological Characteristics:
Linearity:
Binding linearity was determined over serial dilutions of a cell line known to express the antigen diluted with a cell line that has no antigenic sites. For Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 the cell line without antigenic reactivity is Raji cells, while the cell line with antigenic sites is JM cells. Five dilutions were tested, with a linear equation calculated from the results. The equation for Anti-CD3/RPE-Cy5, C7067, y = -0.02 + 1.0x,
Image /page/1/Figure/3 description: The image contains two line graphs comparing '% Expected' to '% Recovered'. The graph on the left is titled 'CD3/RPE/Cy5, C7067 LINEARITY' and shows a linear relationship between the expected and recovered values. The graph on the right is titled 'CD3/RPE, R0810 LINEARITY' and shows two lines, one for '% Recovered' and one for '% Expected', which are very close to each other, indicating a strong correlation.
R2 = 0.999, and Anti-CD3/RPE y=2.84 + 1.0x, R2 = 0.999.
Reproducibility:
Ten replicates from peripheral blood of three donors were tested for reproducibility of Anti-CD3/RPE-Cy5 and run on two flow cytometers from different manufacturers at three concentrations of antigen. Different levels of CD3+ lymphocytes were selected from a population of normal and abnormal peripheral blood samples. Each level of CD3 was analyzed within one day on both machines.
| FACScan Anti-CD3/RPE-Cy5 | Mean % CD3+ | $\pm$ 1 SD | %CV | n |
|---|---|---|---|---|
| High Level | 71.51 | 0.53 | 0.01 | 10 |
| Medium Level | 37.54 | 0.58 | 0.02 | 10 |
| Low Level | 10.76 | 0.40 | 0.04 | 10 |
| Profile II Anti-CD3/RPE-Cy5 | Mean % CD3+ | $\pm$ 1 SD | %CV | n |
| High Level | 71.44 | 0.74 | 0.01 | 10 |
| Medium Level | 36.21 | 0.86 | 0.02 | 10 |
| Low Level | 12.35 | 0.32 | 0.03 | 10 |
| FACScan Anti-CD3/RPE | Mean % CD3 + | $\pm$ 1 SD | %CV | n |
| High Level | 72.07 | 1.11 | 0.02 | 10 |
| Medium Level | 38.50 | 0.87 | 0.02 | 10 |
| Low Level | 11.03 | 0.51 | 0.05 | 10 |
| Profile II Anti-CD3/RPE | Mean % CD3+ | $\pm$ 1 SD | %CV | n |
| High Level | 71.53 | 0.74 | 0.01 | 10 |
| Medium Level | 36.01 | 0.49 | 0.01 | 10 |
| Low Level | 10.79 | 0.53 | 0.05 | 10 |
2
Specificity:
Specificity of Anti-CD3/RPE-Cy5 and Anti-CD3/RPE 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 antibody binding of Anti-CD3/RPE-Cy5 and Anti-CD3/RPE are specific for lymphocytes. Lymphocytes bound to Anti-CD3/RPE-Cy5 antibodies on an average of 72%, representative of the T-cell population. Approximately 2% of monocytes bound with the Anti-CD3/RPE-Cy5. However, monocyte binding can be excluded from the lymphocyte analysis by proper gating on lymphocytes. Lymphocytes bound to Anti-CD3/RPE antibodies on an average of 70%, representative of the T-cell population. Approximately 9% of monocytes bound with the Anti-CD3/RPE.
| | %Positive Red
Blood Cells | % Positive
Granulocytes | % Positive
Monocytes | % Positive
Lymphocytes | % Positive
Platelets |
|---------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5) | 0.02 | 1.50 | 1.82 | 71.90 | 0.12 |
| (range) | (0.0-0.1) | (0.9-2.2) | (1.1-2.7) | (60.3-78.6) | (0.0-0.3) |
DAKO Anti-CD3/RPE-Cy5 Specificity
| | % Positive Red
Blood Cells | % Positive
Granulocytes | % Positive
Monocytes | % Positive
Lymphocytes | % Positive
Platelets |
|---------------|-------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5) | 0.08 | 0.60 | 8.52 | 69.92 | 1.08 |
| (range) | 0.0-0.3 | 0.4-0.7
(n=4) | 1.6-16.3 | 58.4-75.9 | 0.1-3.8 |
DAKO Anti-CD3/RPE Specificity
Predicate Correlation: Correlation of Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 to a predicate Anti-CD3/FITC, F0818 reagent, was determined by testing duplicate samples with each reagent across 153 normal, apparently healthy individuals at three geographically separate laboratories. Linear regression analysis of the data gave the following equations and Pearson correlation's.
Y(DAKO Anti-OD3/RPE-Cy5+ Lymphocytes) = 6.22 + 0.92 X(DAKO Anti-OD3/FITC + Lymphocytes); R2 = 0.9208 n = 150 y(DAKO Anti-CD3/RPE+ Lymphocytes) = 9.85 + 0.87 x(DAKO Anti-CD3/FITC + Lymphocytes). R2 = 0.8040.
$$\begin{array}{rcl} \stackrel{\cdot}{\bullet} &=& \stackrel{\cdot}{\bullet}\stackrel{\cdot}{\bullet} \ \end{array}$$
In addition, samples from patients with illnesses were compared, and their data added to the results of the testing of the 150 apparently healthy individuals. Linear correlation was performed on the total database. Linear regression analysis gave the following equation and R2:
y(DAKO Anti-CD3/RPE-Cy5+ Lymphocytes) = 2.43 + 0.98 x(DAKO Anti-CD3/FITC + Lymphocytes). R2 = 0.9750 n = 177 y(DAKO Anti-CD3/RPE+ Lymphocytes) = 1.20 + 0.99 x(DAKO Anti-CD3/FITC + Lymphocytes). $R^2$ = 0.9870 n = 176 These equations indicate that Anti-CD3/RPE-Cy5, C7067 and Anti-CD3/RPE, R0810 reagents are comparable on 1:1 basis to the Anti-CD3/FITC, F0818 reagent.
3
Device Description
Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5-conjugated, C7067, and, Monoclonal Mouse Anti-Human T-cell, CD3/RPE, R0810 are specific for T-lymphocyte cluster determinants as evaluated by the International Workshop on Human Leukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibody was designated B28 antibody at the Second Workshop (Reinherz, EL, Haynes, BF, Nadler, LM, Bernstein, ID, eds. Leukocyte Typing II, Vol. 2. New York-Berlin-Heidelberg-Tokyo: Springer Verlag, 1986.) Purified monoclonal mouse anti-human CD3 is produced in tissue culture, dialyzed and conjugated with R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5), or conjugated with R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaNg, 0.1M NaCl, stabilized with 1% carrier protein.
4
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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
Re: K991402
Trade Name: Monoclonal Mouse Anti-Human T-cell, CD3 Clone UCHT1 RPE-CY5 or RPE Conjugated
Regulatory Class: II Product Code: GKZ Dated: April 20, 1999 Received: April 22, 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 (QS) 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.
5
Page 2
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 Putman
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
6
K 991402
510(k) Number: Device Name: Monoclonal Mouse Anti-Human T-cell, CD3 Clone UCHT I RPE-Cy5 Conjugated
Indications For Use:
Monoclonal Mouse Anti-Human T-cell, CD3, Clone UCHT1, RPE-Cy5 conjugated, has been developed for use in flow cytometry for the analysis of Tcells. This reagent allows simultaneous detection and quantification of CD3positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.
Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE-Cy5 is one of the reagents utilized when performing immunophenotyping of lymphocytes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device)Evalu
O(k) Num
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use (Per 21 CRF 801.110)
IVD Üse (Per 21 CFR 801.119)
(Optional Format 1-2-96)
7
510(k) Number: Device Name: Monoclonal Mouse Anti-Human T-cell, CD3 Clone UCHTI, RPE Conjugated
Indications For Use:
Monoclonal Mouse Anti-Human T-cell, CD3, Clone UCHT1, RPE conjugated, has been developed for use in flow cytometry for the analysis of T-cells. This reagent allows simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood.
Immunophenotyping of lymphocytes is widely applied for diagnosis of immunodeficiencies. DAKO Anti-CD3/RPE is one of the reagents utilized when performing immunophenotyping of lymphocytes.
(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 | K991402 |
OR
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
| Over-The-Counter Use | |
|---|---|
| (Per 21 CRF 801.110) |
IVD Use
IVD USC (Per 21 CFR 801.119)
(Optional Format 1-2-96)