COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES

K993356 · Coulter Corp. · GKZ · Apr 20, 2000 · Hematology

Device Facts

• Record ID: K993356
• Device Name: COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
• Applicant: Coulter Corp.
• Product Code: GKZ · Hematology
• Decision Date: Apr 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The COULTER hematology analyzers with IRF and MRV parameters are quantitative, automated hematology analyzers and leukocyte differential counters intended For In Vitro Diagnostic Use in clinical laboratories. These systems also provide automated Reticulocyte analysis.

Device Story

COULTER hematology analyzers perform automated blood analysis in clinical laboratory settings. Input consists of blood samples; device utilizes VCS Technology (laser light scatter and nucleic acid dye) to measure reticulocyte parameters, including Immature Reticulocyte Fraction (IRF) and Mean Reticulocyte Volume (MRV). Impedance technology is used for counting and sizing RBCs and platelets. System provides automated CBC, 5-part leukocyte differential, and reticulocyte analysis. Output is quantitative data used by laboratory professionals to assist in clinical hematological assessment. Device benefits include automated, high-throughput processing of multiple blood parameters compared to manual methods.

Clinical Evidence

Bench testing only. Accuracy and imprecision experiments compared the subject device to predicate methods. Accuracy analysis (N=332) showed a slope of 0.835 and R=0.757 for IRF. Imprecision studies (N=90) for IRF and MRV demonstrated mean differences of 0 and 0.04 fL respectively, with SD of difference at 0.04 for IRF and 2.33 for MRV.

Technological Characteristics

Automated hematology analyzer utilizing VCS Technology (laser light scatter and nucleic acid dye) for reticulocyte parameters and impedance for RBC/platelet counting. Measures CBC, 5-part differential, and reticulocyte parameters. System is intended for clinical laboratory use.

Indications for Use

Indicated for use in clinical laboratories as a quantitative, automated hematology analyzer and leukocyte differential counter for the identification and classification of formed elements of blood, including automated reticulocyte analysis.

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

• Sysmex™ w/IRF Parameter (K971736/S1)
• COULTER® GEN-S™ System (K962988)
• COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344)

Submission Summary (Full Text)

{0}------------------------------------------------

K993356

## Summary of Safety & Effectiveness COULTER® Hematology Analyzers with IRF & MRV Parameters

#### Submitted By 1.0

Stan Sugrue, Ph.D. Senior Requlatory Affairs Specialist Coulter Corporation 11800 SW 147 Avenue MC 31-B06 Miami. FL 33196 Telephone: [phone] FAX: [phone]

APR 2, 0 2000

#### 2.0 Date Submitted

March 28, 2000

#### 3.0 Device Name(s)

## 3.1 Proprietary Names

COULTER® Hematology Analyzers with IRF & MRV Parameters

## 3.2 Classification Names

The product is classified as a Class III device as found in 21CFR 864.5220.

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood. (CFR 864.5220) . The Classification Number is 81GKZ.

#### 4.0 Predicate Device(s)

Sysmex™ w/IRF Parameter (K971736/S1), COULTER® GEN-S™ System (K962988), COULTER® New Methylene Blue Prep Retic MAXM/AL Analyzers (K925344)

#### 5.0 Description

The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL).This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.

#### 6.0 Intended Use

The COULTER hematology analyzers with IRF and MRV parameters are quantitative, automated hematology analyzers and leukocyte differential counters intended For In Vitro Diagnostic Use in clinical laboratories. These systems also provide automated Reticulocyte analysis.

#### 7.0 Comparison to Predicate(s):

The following table show the basic similarities and differences between the COULTER® GEN-S and predicate device(s).

{1}------------------------------------------------

### SIMILARITIES TO THE PREDICATE

| COULTER hematology analyzers with IRF and MRV parameters | Sysmex SE & R Series |
|----------------------------------------------------------|----------------------|
| Systems provide automated reticulocyte analysis | Same |
| Report IRF parameter | Same* |

*Reported as sum of MFR (Middle Fluorescence Ratio) and HFR (High Fluorescence Ratio)

### DIFFERENCES FROM THE PREDICATE:

| COULTER hematology analyzers with IRF and MRV<br>parameters | Sysmex R Series |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Quantitative, automated hematology analyzers and leukocyte<br>differential counters | Measures reticulocyte parameters only |
| Report MRV parameters | No MRV analysis |
| Measure CBC, 5-part differential and reticulocyte parameters | Measures reticulocyte parameters only |
| Use impedance for counting and sizing RBCs and platelets | No RBC or platelet analysis |
| Reticulocyte parameters derived from laser light scatter and<br>nucleic acid dye (New Methylene Blue) | Reticulocyte parameters are measured by<br>fluorescence and light scatter utilizing a<br>fluorescent dye (Auramine-O) |

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to hematology analyzers already in commercial distribution. Equivalence is demonstrated through compared sample accuracy and imprecision experiments.

| PARAMETER | IRF |
|--------------------------------------|----------------|
| UNITS | Not Applicable |
| POPULATION MEAN<br>Predicate Method | 0.199 |
| POPULATION MEAN<br>Comparator Method | 0.391 |
| MEAN DIFFERENCE | -0.192 |
| SD OF DIFFERENCE | 0.07953 |
| SLOPE | 0.835 |
| Y-INTERCEPT | 0.225 |
| R | 0.757 |
| N | 332 |

1RF Accuracy Analysis : GEN•S vs Sysmex SE9500

## IRF and MRV Paired Imprecision results: GEN.S

| | IRF | MRV |
|--------------------|----------------|------------------|
| Units | Not Applicable | Femtoliters (fL) |
| N | 90 | 90 |
| Population Minimum | 0.127 | 93.6 |
| Population Maximum | 0.372 | 123.2 |
| Mean difference | 0 | 0.04 |
| S.D. of Difference | 0.04 | 2.33 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its wings and body.

# APR 2 0 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Coulter Corporation 11800 SW 147 Avenue MC 31-B06 Miami, Florida 33196

Re: K993356

Trade Name: COULTER® Hematology Analyzers with IRF & MRV Parameters Regulatory Class: III Product Code: GKZ Dated: March 28, 2000 Received: March 29, 2000

# Dear Dr. Sugrue:

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.

{3}------------------------------------------------

## Page 2

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" (21CFR 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 Sutman

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

{4}------------------------------------------------

# INDICATIONS FOR USE

993356 510(k) Number (if known):

#### COULTER Hematology Analyzers with IRF and MRV Parameters Device:

# Indications For Use:

The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis.

# 21 CFR 864.5220 Automated differential cell counter

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Retu E. Maún

(Division Sign-Off)
Division of Clinical Laboratory Devices K993356
510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Form 1-2-96)