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.

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.

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 NaN3, 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

Device: DAKO® Mouse Anti-Human T-cell, CD3/RPE-Cy5, Clone UCHT1 (C7067) and DAKO® Mouse Anti-Human T-cell, CD3/RPE, clone UCHT1 (R0810)

Intended Use: For In Vitro Diagnostic Use in flow cytometry for the analysis of T-cells in peripheral blood, allowing simultaneous detection and quantification of CD3-positive cells (T-cells) in normal and pathological conditions. It is a component of suggested monoclonal antibody combinations for routine immunophenotyping of lymphocytes in peripheral blood.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (C7067)	Device Performance (R0810)
Linearity: Demonstrate a linear relationship between expected and recovered antigen concentrations.	y = -0.02 + 1.0x, R² = 0.999 (excellent linearity)	y = 2.84 + 1.0x, R² = 0.999 (excellent linearity)
Reproducibility: Consistent measurement of CD3+ cells across different antigen levels, instruments, and within a single day. (No explicit quantitative acceptance criteria for %CV or SD were stated, but low values are generally expected for good reproducibility.)	High Level: Mean % CD3+ 71.51 (SD 0.53, CV 0.01) on FACScan; 71.44 (SD 0.74, CV 0.01) on Profile II	High Level: Mean % CD3+ 72.07 (SD 1.11, CV 0.02) on FACScan; 71.53 (SD 0.74, CV 0.01) on Profile II
	Medium Level: Mean % CD3+ 37.54 (SD 0.58, CV 0.02) on FACScan; 36.21 (SD 0.86, CV 0.02) on Profile II	Medium Level: Mean % CD3+ 38.50 (SD 0.87, CV 0.02) on FACScan; 36.01 (SD 0.49, CV 0.01) on Profile II
	Low Level: Mean % CD3+ 10.76 (SD 0.40, CV 0.04) on FACScan; 12.35 (SD 0.32, CV 0.03) on Profile II	Low Level: Mean % CD3+ 11.03 (SD 0.51, CV 0.05) on FACScan; 10.79 (SD 0.53, CV 0.05) on Profile II
Specificity: Antibodies should specifically bind to lymphocytes (T-cells) with minimal binding to other cell types (RBCs, granulocytes, monocytes, platelets).	Average 71.90% positive Lymphocytes (range 60.3-78.6). Low binding to other cell types (e.g., 1.82% monocytes, 0.02% RBCs).	Average 69.92% positive Lymphocytes (range 58.4-75.9). Low binding to other cell types (e.g., 8.52% monocytes, 0.08% RBCs).
Predicate Correlation: High correlation and comparable performance to the predicate device (DAKO Anti-CD3/FITC, F0818) in peripheral blood samples from healthy individuals and patients with illnesses. (Implicitly, a high R² value close to 1 and a slope close to 1 with a small intercept are desired).	Healthy (n=150): Y = 6.22 + 0.92X, R² = 0.9208Total (n=177): Y = 2.43 + 0.98X, R² = 0.9750	Healthy (n=150): Y = 9.85 + 0.87X, R² = 0.8040Total (n=176): Y = 1.20 + 0.99X, R² = 0.9870

2. Sample Sizes Used for Test Set and Data Provenance

Linearity Test Set: 5 serial dilutions of a cell line expressing the antigen (JM cells) diluted with a cell line without antigenic sites (Raji cells). Data provenance not specified (likely in-house lab, prospective).
Reproducibility Test Set: 10 replicates from peripheral blood of "three donors" at three concentrations (high, medium, low). Data provenance not specified (likely in-house lab, prospective).
Specificity Test Set: 5 apparently healthy adult donors of various races. Data provenance: DAKO Corporation (in-house lab, prospective).
Predicate Correlation Test Set:
- Healthy Individuals: 153 normal, apparently healthy individuals.
- Patient Samples: An unspecified number of samples from "patients with illnesses" were added to the healthy individual data.
- Total for C7067: 177 samples (150 healthy + 27 patient samples).
- Total for R0810: 176 samples (150 healthy + 26 patient samples).
- Data Provenance: Three geographically separate laboratories (likely prospective, multi-site study).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The studies described are for the performance characteristics of an in vitro diagnostic reagent (antibody). The "ground truth" in this context is based on the inherent molecular specificity of the antibody and its performance in flow cytometry, rather than expert interpretation of complex images or clinical cases.

No "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth were used.
The ground truth for antigen expression was established by using known cell lines (JM cells for expression, Raji cells for no expression) in the linearity study, and by the established methodology of flow cytometry for reproducibility and specificity.
The predicate correlation study compares the new reagents to a previously validated predicate, implicitly using the predicate's results as a reference.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations (e.g., of images or clinical reports) by human readers. The measurements are quantitative outputs from flow cytometry.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a reagent for flow cytometry, not an algorithm or system that directly aids human readers in interpretation or diagnosis. The study assessed the reagent's performance against established laboratory standards and a predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies conducted (linearity, reproducibility, specificity, predicate correlation) assess the standalone performance of the reagents themselves in a laboratory setting when used in flow cytometry. While flow cytometry involves human operation, the performance metrics reported are for the reagent's ability to bind to target cells and be quantified, not for human interpretation aided by an algorithm.

7. The Type of Ground Truth Used

Linearity: Known concentrations of antigen-expressing cells (JM cells) mixed with non-expressing cells (Raji cells).
Reproducibility: Target population of CD3+ lymphocytes within peripheral blood samples, as measured by flow cytometry. The reference values are the means of the repeated measurements.
Specificity: Known cell populations (RBCs, granulocytes, monocytes, lymphocytes, platelets) obtained from healthy donors. The expected "ground truth" is that the antibody should primarily bind to lymphocytes (T-cells).
Predicate Correlation: The results obtained using the legally marketed predicate device (DAKO Mouse anti-human T-cell, CD3/FITC, Clone UCHT1 Code No. F0818) serve as the reference standard.

8. The Sample Size for the Training Set

The provided text does not explicitly mention a "training set" in the context of machine learning or algorithm development. The device is a diagnostic reagent (antibody) for flow cytometry, and its development typically involves laboratory characterization rather than iterative training on large datasets like an AI algorithm. If "training" refers to the development and initial characterization of the antibody itself:

The antibody (UCHT1) was designated at the "Second Workshop" (International Workshop on Human Leukocyte Differentiation Antigens), implying a historical development and characterization process that predates this submission.
The production of purified monoclonal mouse anti-human CD3 is described, but the "training set" size for its initial development or characterization is not specified in this document.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" in the machine learning sense is not directly applicable here. The "ground truth" for the antibody's properties (specificity to CD3, binding characteristics) would have been established through:

Immunological assays: Early characterization during antibody development to confirm its binding to the CD3 antigen on T-cells.
International Workshops: The antibody's designation (B28 antibody at the Second Workshop) indicates that its specificity and reactivity were validated and recognized by the scientific community, likely through extensive testing against various cell types and patient samples, establishing its utility as a marker for CD3. This historical validation forms the basis of its "ground truth" for specificity.

Summary

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JUN 21 1999

K991402

510(k) Summary

Submitter:	DAKO Corporation6392 Via RealCarpinteria, CA 93013805-566-6655
Contact:	Gretchen M. Murray, Ph.D.
Date SummaryPrepared:	April, 1999
Device Names:	DAKO® Mouse Anti-Human T-cell, CD3/RPE-Cy5, Clone UCHT1(Product Code No. C7067) andDAKO® Mouse Anti-Human T-cell, CD3/RPE, clone UCHT1(Product Code No. R0810)
DeviceClassification:	Class II according to 21 CFR 864.5220, on the basis that monoclonalantibodies 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
DeviseDescription:	Monoclonal Mouse Anti-Human T-cell, CD3/RPE-Cy5 conjugated, CloneUCHT1 (Code No. C7067) and Monoclonal Mouse Anti-Human T-cell, CD3/RPEconjugated, Clone UCHT1 (Code No. R0810) are specific for T-lymphocytecluster determinants as evaluated by the International Workshop on HumanLeukocyte Differentiation Antigens. UCHT1 CD3-specific monoclonal antibodywas 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 mouseanti-human CD3 is produced in tissue culture, dialyzed and conjugated witheither R-phycoerythrin (RPE) covalently coupled to cyanin 5 (Cy5) or R-phycoerythrin (RPE). One ml (1.0 ml) containing the conjugated antibody issupplied in 0.05M Tris-HCl buffer, pH 7.2, 15mM NaN 3 , 0.1M NaCl, stabilizedwith 1% stabilzing protein.
Intended Use:	For In Vitro Diagnostic UseMonoclonal 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 inperipheral blood. These reagents allow simultaneous detection andquantification of CD3-positive cells (T-cells) in normal and pathologicalconditions such as immunodeficiency disorders. Each reagent is onecomponent of the suggested monoclonal antibody (MAb) combinations forroutine immunophenotyping of lymphocytes in peripheral blood.

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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

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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 RedBlood Cells	% PositiveGranulocytes	% PositiveMonocytes	% PositiveLymphocytes	% PositivePlatelets
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 RedBlood Cells	% PositiveGranulocytes	% PositiveMonocytes	% PositiveLymphocytes	% PositivePlatelets
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.

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Device Description

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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.

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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

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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)

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510(k) Number: Device Name: Monoclonal Mouse Anti-Human T-cell, CD3 Clone UCHTI, RPE Conjugated

Indications For Use:

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)
--	--------------------------------------------------------	--

Signature

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K991402

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)

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.”