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.

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

AI/ML Overview

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 (<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:

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

Summary

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JUN 21 1999

JUN 21 1999		510(k) Summary	K991454
Submitter:	DAKO Corporation6392 Via RealCarpinteria, CA 93013805-566-6655
Contact:	Gretchen M. Murray, Ph.D.
Date SummaryPrepared:	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.

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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.

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

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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 fromAspergillus niger	Succinyl histamine bovineserum albumin (SH-BSA)
Intended Use	Negative control reagents forFITC, RPE or RPE-CY5conjugated monoclonalantibodies of the IgG, heavychain isotype in preparationsof normal whole peripheralblood by flow cytometricmethods.	Negative control reagents forFITC, or RPE conjugatedmonoclonal antibodies of theIgG, heavy chain isotype inpreparations of normal wholeperipheral blood by flowcytometric methods.
Clinical Utility	Use with monoclonalantibody test reagents of theIgG, immunoglobulin isotypein flow cytometric proceduresperformed on normal donors.	Use with monoclonalantibody test reagents of theIgG, immunoglobulin isotypein flow cytometric proceduresperformed on normal donors.
Stability	Mouse IgG₁ /FITC - 3 years:Mouse IgG₁ /RPE - 2 years:Mouse IgG₁ /RPE-CY5 - 2years: from time ofmanufacture.	2 years from time ofmanufacture.
Specificity	No specific reaction tolymphocytes, monocytes,granulocytes, platelets or redblood cells.	No specific reaction tolymphocytes, monocytes,granulocytes or red bloodcells.
Storage	2-8°C, in the dark	2-8°C

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	DAK-GO1/FITC	679.1MC/FITC	DAK-GO1/RPE	679.1MC/RPE	DAK-GO1/RPE-CY5
Percent Positive Mouse IgG, LymphocytesMean(n=153 for DAKO) (n = 36 for Gentrak)	0.59%	0.16%	0.24%	0.13%	1.59%
95.0% Range Mouse IgG, PositiveLymphocytes(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

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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, LymphocytesMean(n = 36)	0.50%	0.16%
95.0% Range Mouse IgG₁ PositiveLymphocytes(n = 36)	0.1-1.4%	0-0.3%
% CV(n = 36)	95.62%	146.67%
Mean Channel FluorescenceMean(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 LymphocytesMean(n = 36)	0.16%	0.13%
95.0% Range Mouse IgG₁ PositiveLymphocytes(n = 36)	0-0.5%	0-0.4%
% CV(n = 36)	88.13%	84.93%
Mean Channel FluorescenceMean(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%

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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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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 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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Page 1 of of l

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:

(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	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)

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.”