COULTER AC.T DIFF ANALYZER

K973634 · Coulter Corp. · GKZ · Oct 29, 1997 · Hematology

Device Facts

• Record ID: K973634
• Device Name: COULTER AC.T DIFF ANALYZER
• Applicant: Coulter Corp.
• Product Code: GKZ · Hematology
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The COULTER® AC-T diff™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

Device Story

Automated hematology analyzer for clinical laboratories; uses Coulter impedance measurement principle for particle counting and sizing; blood cells passing through orifice with electric current cause impedance changes proportional to cell volume; utilizes lysis to differentiate three leukocyte populations (lymphocytes, mononuclear cells, granulocytes) via WBC histogram analysis; incorporates beam photometer for hemoglobinometry; performs automated diluting and mixing; provides quantitative hematology results including three-part leukocyte differential, RDW, and MPV; includes automated calibration, quality control evaluation, patient storage, and selectable print profiles; results can be printed or transmitted; assists clinicians in hematological assessment.

Clinical Evidence

Bench testing only. Precision and accuracy studies were conducted for the additional parameters (WBC differential, RDW, and MPV). Testing met all acceptance criteria.

Technological Characteristics

Automated hematology analyzer; utilizes Coulter impedance principle for cell counting/sizing; beam photometer for hemoglobinometry; reagent system includes isotonic diluent, lytic reagent, and cleaning agent; performs automated sample dilution and mixing; provides digital output for printing/transmission.

Indications for Use

Indicated for use in clinical laboratories as a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic testing.

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

• COULTER® A C T™ Series Analyzer (K964988)
• COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (K823355)

Submission Summary (Full Text)

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K973634

| h) | 510(k) Summary |
|----|----------------|
|----|----------------|

COULTER® A^C·T diff^™ Analyzer
OCT 29 1997

| Date of Summary: | September 22, 1997 |
|----------------------------------------------|--------------------------------------------------------------------------------|
| Company/Institution name: | Coulter Corporation,<br>11800 SW 147 Ave.<br>Miami, FL. 33196, Mailcode 31-B06 |
| Contact Name: | Thomas J. English, Phone [phone] |
| Common or usual name or classification name: | Automated Differential Cell Counter |
| Product name: | COULTER® A ^C ·T diff ^™ Analyzers |
| C.F.R. Section: | 864.5220 |
| Device Class: | Class II |

510(k) numbers of Coulter devices to which substantial equivalence is claimed:
COULTER® A^C·T^™ Series Analyzer, K964988The product is a hematology Automated Differential Cell Counter which like the predicate devices, COULTER A C T Series Analyzer and COULTER COUNTER S-PLUS IV and LYSE S PLUS D, uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates the particle count, the size of the electrical pulse is proportional to cell volume.

COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D, K823355.

Under the controlled condition of lysis, a chemical reaction demonstrates three distinct populations of leukocytes: lymphocytes, mononuclear cells and granulocytes. The percentage of leukocytes that fall into each of the three categories is derived from the WBC histogram: the LY area is approximately from 35 fL to 90 fL, the MO area is approximately from 90 fL to 160 fL and the GR area is approximately from 160 fL.

The COULTER® AC T diff™ Analyzer is a quantitative, automated hematology analyzer and Intended Use: leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

The COULTER® AC T diff analyzer has the same intended use as the predicate devices. Both the A.T diff and the predicate devices utilize the Coulter principle for cell counting and sizing in combination with automatic diluting and mixing for sample processing and a beam photometer for hemoglobinometry. The same reagent system, consisting of isotonic diluent, lytic reagent, and cleaning agent, is used on the AS.T diff analyzers and the predicate devices. The ACT diff analyzers and the predicate devices have the ability to print and transmit results if the instrument has been setup to do so.

The COULTER AC T diff Analyzer is the same device as the COULTER AS T Series Analyzers except for the modifications required for the measurement of a three-part leukocyte differential, RDW, and MPV, automated calibration and quality control evaluation, patient storage and selectable print profiles.

Testing described in Section 2 of this submission focuses on attributes of precision and accuracy for the additional parameters (i. e. WBC differential, RDW and MPV). Testing met all acceptance criteria.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Thomas J. Enqlish Director, Corporate Requlatory and Clinical Affairs Coulter Corporation 11800 SW 147 Avenue Mailcode 31-B06 Miami, Florida 33196

OCT 2 9 1997

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Re: K973634 COULTER® ACT diff™ Analyzers Trade Name: Regulatory Class: II Product Code: GKZ Dated: September 23, 1997

September 24, 1997

Dear Mr. Enqlish:

Received:

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 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 requirement, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Requlations.

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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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## INDICATIONS FOR USE

510(k) Number (if known):

N/A K973634

Device Name: COULTER® AC-T diff™ Analyzer

Indications For Use:

The COULTER® AC-T diff™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

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

Prescription Use V
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Form 1-2-96)

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