MOUSE IGG1 NEGATIVE CONTROLS

K991454 · Dako Corp. · GKZ · Jun 21, 1999 · Hematology

Device Facts

• Record ID: K991454
• Device Name: MOUSE IGG1 NEGATIVE CONTROLS
• Applicant: Dako Corp.
• Product Code: GKZ · Hematology
• Decision Date: Jun 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

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.

Device Story

Monoclonal mouse IgG1 (clone DAK-GO1) conjugated with FITC, RPE, or RPE-CY5; directed against Aspergillus niger glucose oxidase (non-mammalian antigen). Used as negative control reagents in flow cytometry to assess non-specific binding of IgG1 isotype antibodies in peripheral blood lymphocyte immunophenotyping. Reagents supplied in buffer with NaN3 and carrier protein. Operated by laboratory technicians in clinical settings. Output is fluorescence data measured by flow cytometer; used by clinicians to establish baseline non-specific binding levels, ensuring accuracy of specific antibody staining results. Benefits include improved diagnostic reliability by distinguishing true positive staining from background noise.

Clinical Evidence

Bench testing only. Reproducibility assessed via 10 replicates from 3 donors on 2 flow cytometers; results showed low variability. Specificity tested on 5 healthy donors across RBCs, granulocytes, monocytes, lymphocytes, and platelets; no specific binding observed for FITC/RPE conjugates. RPE-CY5 showed minor monocyte binding, manageable via gating. Correlation studies against predicate reagents performed on 36-150 samples; linear regression confirmed expected lack of 1:1 correlation typical for negative controls.

Technological Characteristics

Monoclonal mouse IgG1 (clone DAK-GO1) conjugated to FITC, RPE, or RPE-CY5. Supplied in Tris-HCl buffer, pH 7.2, 15mM NaN3, 1% carrier protein. Storage 2-8°C in dark. Analyzed via flow cytometry. No specific binding to human antigens.

Indications for Use

Indicated for use as negative control reagents in flow cytometric immunophenotyping of lymphocytes in normal whole peripheral blood. Intended for professional in vitro diagnostic use.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Gentrak Genclone mouse IgG1, 679.1MC

Submission Summary (Full Text)

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## JUN 21 1999

| JUN 21 1999 | | 510(k) Summary | K991454 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------|
| Submitter: | DAKO Corporation<br>6392 Via Real<br>Carpinteria, CA 93013<br>805-566-6655 | | |
| Contact: | Gretchen M. Murray, Ph.D. | | |
| Date Summary<br>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. | | |

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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 Red<br>Blood Cells | % Positive<br>Granulocytes | % Positive<br>Monocytes | % Positive<br>Lymphocytes | % Positive<br>Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)<br>(range) | 0.02<br>(0.0-0.1) | 0.74<br>(0.1-1.9) | 0.76<br>(0.2-1.5) | 0.22<br>(0.0-0.8) | 0.04<br>(0.0-0.1) |

#### DAKO Mouse IgG1/RPE, DAK-GO1 Specificity

| | %Positive Red<br>Blood Cells | % Positive<br>Granulocytes | % Positive<br>Monocytes | % Positive<br>Lymphocytes | % Positive<br>Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)<br>(range) | 0.00<br>(0.0-0.0) | 0.08<br>(0.0-0.01) | 0.84<br>(0.4-2.0) | 0.04<br>(0.0-0.1) | 0.22<br>(0.0-0.7) |

#### DAKO Mouse IgG1/RPE-CY5, DAK-GO1 Specificity

| | %Positive Red<br>Blood Cells | % Positive<br>Granulocytes | % Positive<br>Monocytes | % Positive<br>Lymphocytes | % Positive<br>Platelets |
|--------------------------|------------------------------|----------------------------|-------------------------|---------------------------|-------------------------|
| Average (n=5)<br>(range) | 0.02<br>(0.0-0.1) | 0.16<br>(0.0-0.3) | 3.22<br>(0.0-11.9) | 0.12<br>(0.0-0.3) | 0.10<br>(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 from<br>Aspergillus niger | Succinyl histamine bovine<br>serum albumin (SH-BSA) |
| Intended Use | Negative control reagents for<br>FITC, RPE or RPE-CY5<br>conjugated monoclonal<br>antibodies of the IgG, heavy<br>chain isotype in preparations<br>of normal whole peripheral<br>blood by flow cytometric<br>methods. | Negative control reagents for<br>FITC, or RPE conjugated<br>monoclonal antibodies of the<br>IgG, heavy chain isotype in<br>preparations of normal whole<br>peripheral blood by flow<br>cytometric methods. |
| Clinical Utility | Use with monoclonal<br>antibody test reagents of the<br>IgG, immunoglobulin isotype<br>in flow cytometric procedures<br>performed on normal donors. | Use with monoclonal<br>antibody test reagents of the<br>IgG, immunoglobulin isotype<br>in flow cytometric procedures<br>performed on normal donors. |
| Stability | Mouse IgG₁ /FITC - 3 years:<br>Mouse IgG₁ /RPE - 2 years:<br>Mouse IgG₁ /RPE-CY5 - 2<br>years: from time of<br>manufacture. | 2 years from time of<br>manufacture. |
| Specificity | No specific reaction to<br>lymphocytes, monocytes,<br>granulocytes, platelets or red<br>blood cells. | No specific reaction to<br>lymphocytes, monocytes,<br>granulocytes or red blood<br>cells. |
| Storage | 2-8°C, in the dark | 2-8°C |

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| | DAK-GO1/<br>FITC | 679.1MC/<br>FITC | DAK-GO1/<br>RPE | 679.1MC/<br>RPE | DAK-GO1/<br>RPE-CY5 |
|------------------------------------------------------------------------------------------|-------------------|------------------|-------------------|-----------------|---------------------|
| Percent Positive Mouse IgG, Lymphocytes<br>Mean<br>(n=153 for DAKO) (n = 36 for Gentrak) | 0.59% | 0.16% | 0.24% | 0.13% | 1.59% |
| 95.0% Range Mouse IgG, Positive<br>Lymphocytes<br>(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<br>(n=153 for DAKO) (n = 36 for Gentrak) | 150.89% | 146.67% | 93.81% | 84.93% | 88.98% |
| Percent Positive Mouse IgG, Lymphocytes<br>(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)<br>(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)<br>(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)<br>(n=36 for Gentrak) | 90.01% | 146.67% | 80.85% | 84.93% | 173.63% |
| Mean Channel Fluorescence<br>(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)<br>(n = 36 for Gentrak) | 1.57 | 3.07 | 1.99 | | 1.56 |
| 95.0% Range (by laboratory site) | | | | | |
| Site 1 (n = 53) | 16.23 -<br>116.63 | | 20.13 -<br>307.12 | | 28.23 -<br>205.5 |
| Site 2(n=50) | 0 - 642.69 | | 0 - 888.83 | | 49.7 -<br>2111.49 |
| Site 3(n=50 for DAKO)<br>(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)<br>(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/<br>FITC | 679.1MC/<br>FITC |
|-------------------------------------------------------------|------------------|------------------|
| Percent Positive Mouse IgG, Lymphocytes<br>Mean<br>(n = 36) | 0.50% | 0.16% |
| 95.0% Range Mouse IgG₁ Positive<br>Lymphocytes<br>(n = 36) | 0.1-1.4% | 0-0.3% |
| % CV<br>(n = 36) | 95.62% | 146.67% |
| Mean Channel Fluorescence<br>Mean<br>(n = 36) | 1.51 | 3.07 |
| 95.0% Range (by laboratory site)<br>(n = 36) | 0.87-3.12 | 0 - 16.15 |
| % CV (by laboratory site)<br>(n = 36) | 41.88% | 151.14% |

## Testing Results for DAKO Mouse IgG,/RPE, DAK-GO1 versus Gentrak Mouse igG,/RPE, 679.1MC

| | DAK-GO1/<br>RPE | 679.1MC/<br>RPE |
|-------------------------------------------------------------|-----------------|-----------------|
| Percent Positive Mouse IgG₁ Lymphocytes<br>Mean<br>(n = 36) | 0.16% | 0.13% |
| 95.0% Range Mouse IgG₁ Positive<br>Lymphocytes<br>(n = 36) | 0-0.5% | 0-0.4% |
| % CV<br>(n = 36) | 88.13% | 84.93% |
| Mean Channel Fluorescence<br>Mean<br>(n = 36) | 1.77 | 2.19 |
| 95.0% Range (by laboratory site)<br>(n = 36) | 0-6.19 | 0-12.48 |
| % CV (by laboratory site)<br>(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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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)