K Number

Device Name

COULTER Z2 ANALYZER

Manufacturer

COULTER CORP.

Date Cleared

1999-05-11

(41 days)

Product Code

GKL

Regulation Number

864.5200

Intended Use

The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

Device Description

The COULTER Z2 is a general purpose dual threshold particle counter and sizer designed to count and size particles, suspended in an aqueous electrolyte solution, within the range of 1 to 120 um equivalent spherical diameter. The instrument is designed for both biological and industrial use. As with the predicate devices, the COULTER Z2 utilizes the Coulter principle for the enumeration and sizing of blood cells. The same reagent system, composed of an isotonic diluent, lytic reagent to lyse red blood cells for WBC measurement and instrument cleaner, is used on COULTER STKS, Z1, and Z2 instruments. The COULTER STKS, Z1, and Z2 instruments are capable of determining the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, like the COULTER STKS, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV). Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

COULTER-Z1, COULTER-STKS

Reference Devices

COULTER® Z1 Analyzer, COULTER® STKS Analyzer

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a particle counter utilizing the Coulter principle, a well-established electrical impedance method for cell counting and sizing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The device relies on physical principles and basic data processing for its measurements.

Therapeutic

No.
It is an in vitro diagnostic device used to count and size particles in blood for diagnostic purposes, not for directly treating a medical condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Blood Cell or WBC) and thrombocyte concentration (Platelet Count or Plt)." This indicates its role in diagnosing or monitoring medical conditions by providing specific measurements of these blood components.

SaMD (Software as a Medical Device)

The device description clearly describes a physical instrument ("general purpose dual threshold particle counter and sizer") that utilizes the Coulter principle, a hardware-based method for counting and sizing particles. It also mentions a "hydraulic metering station built into the electronics main unit" and "operator-adjustable controls are accessible by means of a keyboard data terminal," all indicative of a hardware device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt)."

This statement directly identifies the device's purpose as being used outside of the body (in vitro) for diagnostic purposes, which is the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GKL

Device Description

As with the predicate devices, the COULTER Z2 utilizes the Coulter principle for the enumeration and sizing of blood cells. The same reagent system, composed of an isotonic diluent, lytic reagent to lyse red blood cells for WBC measurement and instrument cleaner, is used on COULTER STKS, Z1, and Z2 instruments.

The COULTER STKS, Z1, and Z2 instruments are capable of determining the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, like the COULTER STKS, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 results.

COULTER Z2 Analyzer Imprecision Analysis by Reproducibility:

PARAMETER	UNITS	MEAN	SD	CV%
RBC	X 10^6 cells/µL	4.77	.0981	2.06
PLT	x 10^3 cells/µL	153.8	4.54	2.95
MPV	fL	7.99	0.12	1.48
MCV	fL	83.14	0.73	0.87

COULTER Z2 Analyzer ACCURACY ANALYSIS: COMPARED SAMPLES:

PARAMETER	UNITS	N	POP. MIN	POP. MAX	MEAN DIFF.	SD	MEAN % DIFF	CORR COEFF
RBC	x 10^6 cells/µL	31	3.50	6.02	0.16	0.24	3.51	0.90
MCV	fL	31	78.00	97.46	0.54	2.7	0.65	0.82
PLT	x 10^3 cells/µL	31	134	483	56.23	50.09	23.13	0.82
MPV	FL	31	7.15	11.27	0.55	0.43	6.52	0.89

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

COULTER® Z1 Analyzer, COULTER® STKS Analyzer

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 864.5200 Automated cell counter.

(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).

Summary

Summary of Safety and Effectiveness

COULTER® Z2 Analyzer

Submitted By: 1.0

Tom English Manager, Premarket Product Regulatory Compliance Coulter Corporation 11800 SW 147 Avenue, MC 31-B06 Miami, FL 33196 Telephone: (305) 380-4331 FAX: (305) 380-3618

2.0 Date Submitted:

March 30, 1999

3.0 Device Names:

3.1 Proprietary Name(s):
COULTER® Z2 Analyzer
3.2. Classification Name(s):
Automated cell counter (21 CFR §864.5200)

Predicate Device(s): 4.0

COULTER® Z1 Analyzer COULTER® STKS Analyzer

5.0 Description

COULTER Z2 has the same technological characteristics and is substantially equivalent to the COULTER® STKS analyzer that was cleared by 510(k) K885093 cleared on Dec. 28, 1988.

The COULTER Z2 is the same device as the COULTER® Z1, cleared by 510(k) K952308 on October 6, 1995 except for the measurement of two additional parameters, Mean Cell Volume (MCV) and Mean Platelet Volume (MPV) and the ability to provide the operator with on-screen/printed graphs of channelized size distribution data.

Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle

sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

6.0. Intended use:

The COULTER® Z Series Analyzers is a semi-automated device that may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Pit). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

This submission provides information concerning the safety and effectiveness principally of the two parameters added to the instrument.

7.0 Comparison to Predicate(s):

The following tables outline the basic similarities and differences between the Z2 and the predicate devices.

SIMILARITIES to the PREDICATES

COULTER® Z2	COULTER® Z1	COULTER® STKS
Utilizes the Coulter principle for enumeration
and sizing of blood cells.	Utilizes the Coulter principle for enumeration
and sizing of blood cells.	Utilizes the Coulter principle for enumeration
and sizing of blood cells.
Reagent system includes an isotonic diluent,
lytic reagent and instrument cleaner.	Reagent system includes an isotonic diluent,
lytic reagent and instrument cleaner.	Reagent system includes an isotonic diluent,
lytic reagent and instrument cleaner.
Ability to print sample results.	Ability to print sample results.	Ability to print sample results.
Uses coincidence correction. The frequency
of coincidence is a statistically predictable
function of particle concentration and is
corrected by the instrument.	Uses coincidence correction. The frequency
of coincidence is a statistically predictable
function of particle concentration and is
corrected by the instrument.	Uses coincidence correction. The frequency
of coincidence is a statistically predictable
function of particle concentration and is
corrected by the instrument.
The ability to provide the operator with on-
screen/printed graphs of channelized size
distribution data.	See DIFFERENCES table	The ability to provide the operator with on-
screen/printed graphs of channelized size
distribution data.
Separate measurement of RBC, WBC and PLT
is required.	Separate measurement of RBC, WBC and PLT
is required.	See DIFFERENCES table
Uses a single aperture each for WBC and
RBC counting and sizing.	Uses a single aperture each for WBC and
RBC counting and sizing.	See DIFFERENCES table
No ability to store data.	No ability to store data.	See DIFFERENCES table
Automated Calibration calculation but operator
intervention required for Control calculations.	Automated Calibration calculation but operator
intervention required for Control calculations.	See DIFFERENCES table
Sample probe requires manually cleaning	Sample probe requires manually cleaning	See DIFFERENCES table
Uses detachable keypad for operator
interface.	Uses detachable keypad for operator
interface.	See DIFFERENCES table.
System does not measure hemoglobin	System does not measure hemoglobin	See DIFFERENCES table
Requires external dilutor to supply the proper
volume of diluent for predilute samples.	Requires external dilutor to supply the proper
volume of diluent for predilute samples.	See DIFFERENCES table

COULTER® Z2	COULTER® Z1	COULTER® STKS
Can be used For In Vitro Diagnostic Use for
Red Blood Cell Count (RBC), White Blood Cell
Count (RBC), Platelet (Plt), Mean Cell Volume
(MCV), Mean Platelet Volume (MPV).	Can be used For In Vitro Diagnostic Use for
Red Blood Cell Count (RBC), White Blood Cell
Count(WBC), Platelet (Plt),. Does not measure
Mean Cell Volume (MCV), Mean Platelet
Volume.	Can be used For In Vitro Diagnostic Use for
Red Blood Cell Count (RBC), White Blood Cell
Count (WBC), Platelet (Plt), Mean Cell Volume
(MCV), Mean Platelet Volume (MPV). Other
parameters include a five-part leukocyte
differential count, hemoglobin, hematocrit,
mean cell hemoglobin, mean cell hemoglobin
concentration and red cell distribution width.
See SIMILARITIES table
The ability to provide the operator with on-
screen/printed graphs of channelized size
distribution data.	No channelizing capability	See SIMILARITIES table
Manual dilution of blood samples.	See SIMILARITIES table	Automated dilution of blood samples.
Uses a single aperture each for WBC and RBC
counting and sizing.	See SIMILARITIES table	Uses three apertures each for WBC and RBC
counting and sizing.
System does not measure hemoglobin	See SIMILARITIES table	The system uses the lysed WBC dilution to
measure Hgb in the WBC bath. A beam of
incandescent light passes through the WBC
bath and then through a 525-nm optical filter
and is measured by a photodiode.
No ability to store data.	See SIMILARITIES table	Ability to store data.
Requires external dilutor to supply the proper
volume of diluent for predilute samples.	See SIMILARITIES table	Ability to dispense the proper volume of diluent
for predilute samples.
Automated Calibration calculation but operator
intervention required for Control calculations.	See SIMILARITIES table	Automated Calibration and Control
calculations.
Uses detachable keypad for operator interface.	See SIMILARITIES table	Uses Universal Icons for operator interface.
Sample probe requires manually cleaning	See SIMILARITIES table	Automated, self-cleaning probe.
Separate mesurement of RBC, WBC and PLT
is required.	See SIMILARITIES table	Simultaneous measurement of all parameters.

DIFFERENCES from the PREDICATES

8.0 Summary of Performance Data:

PARAMETER	UNITS	MEAN	SD	CV%
RBC	X 106 cells/µL	4.77	.0981	2.06
PLT	x 103 cells/µL	153.8	4.54	2.95
MPV	fL	7.99	0.12	1.48
MCV	fL	83.14	0.73	0.87

COULTER Z2 Analyzer Imprecision Analysis by Reproducibility

COULTER Z2 Analyzer ACCURACY ANALYSIS: COMPARED SAMPLES

| PARAMETER | UNITS | N | POP.
MIN | POP.
MAX | MEAN
DIFF. | SD | MEAN
%
DIFF | CORR
COEFF |
|-----------|-------------------|----|-------------|-------------|---------------|-------|-------------------|---------------|
| RBC | x 106
cells/µL | 31 | 3.50 | 6.02 | 0.16 | 0.24 | 3.51 | 0.90 |
| MCV | fL | 31 | 78.00 | 97.46 | 0.54 | 2.7 | 0.65 | 0.82 |
| PLT | x 103
cells/µL | 31 | 134 | 483 | 56.23 | 50.09 | 23.13 | 0.82 |
| MPV | FL | 31 | 7.15 | 11.27 | 0.55 | 0.43 | 6.52 | 0.89 |

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized abstract image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES 'USA'" is arranged in a circular fashion around the bird image.

MAY 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Thomas J. English Manager, Premarket Product Regulatory Compliance Coulter Corporation 11800 SW 147 Avenue, MC 31-B06 Miami, Florida 33196

Re: K991070 Trade Name: COULTER® Z2 Analyzer Regulatory Class: II Product Code: GKL Dated: March 30, 1999 Received: March 31, 1999

Dear Mr. English:

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.

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 Dutman

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

INTENDED USE STATEMENT

K991070

FO BE ASSIGNED 510(k) Number (if known):

Device Name: COULTER® Z2 Analyzer

Intended Use:

21 CFR 864.5200 Automated cell counter

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patients peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Malins

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Form 1-2-96)