COULTER GEN-S SYSTEM

K962988 · Coulter Corp. · GKL · Oct 30, 1996 · Hematology

Device Facts

• Record ID: K962988
• Device Name: COULTER GEN-S SYSTEM
• Applicant: Coulter Corp.
• Product Code: GKL · Hematology
• Decision Date: Oct 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The COULTER® GEN·S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN·S System also provides automated Reticulocyte analysis. The COULTER GEN·S SMTM INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.

Device Story

Automated hematology analyzer; processes whole blood samples; uses Coulter impedance method for particle counting/sizing; flow cell analysis via low-frequency current (volume), high-frequency current (internal content), and laser light scatter (surface/shape/reflectivity). Reticulocyte analysis uses New Methylene Blue dye to precipitate RNA; differentiates via light scatter, DC, and opacity. Integrated slidemaker option prepares blood films. Used in clinical laboratories by trained personnel. Output includes hematological parameters, leukocyte differentials, and reticulocyte counts. Assists clinicians in diagnosing/monitoring hematological conditions.

Clinical Evidence

Bench testing only. Evaluated precision, accuracy, linearity, and carryover. All testing met acceptance criteria.

Technological Characteristics

Automated hematology analyzer; impedance-based particle counting/sizing; flow cell with low/high-frequency current and laser light scatter; beam photometer for hemoglobinometry; on-line sample preparation for reticulocytes; integrated slidemaker option.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for quantitative automated hematology analysis, leukocyte differential counting, and reticulocyte analysis in whole blood samples.

Regulatory Classification

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.

Predicate Devices

• COULTER® STKS Analyzer with Reticulocyte Analysis (K885093, K932030)

Submission Summary (Full Text)

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K962988
OCT 30 1996

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# 510(k) Summary
## COULTER® GEN·STM System

**Date of Summary:** July 30, 1996

**Company/Institution name:** Coulter Corporation, 11800 SW 147 Ave. 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® GEN·STM System
**C.F.R. Section:** 864.5220
**Device Class:** Class II

**Optional Device Name:** COULTER GEN·S SMTM INTEGRATED SLIDEMAKER Option
**C.F.R. Section:** 864.5850
**Device Class:** Class I, Exempt

510(k) numbers of Coulter devices to which substantial equivalence is claimed:
COULTER® STKS Analyzer with Reticulocyte Analysis, K885093 and K932030

The product is an Automated Differential Cell Counter which like the predicate device COULTER® STKS Analyzer with Reticulocyte Analysis 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 particle count, the size of the electrical pulse is proportional to the cell volume.

WBC differential analysis and classification occurs in the flow cell where low-frequency current measures volume, high-frequency current senses cellular internal content, and light from the laser bouncing off the individual WBC cells characterizes cellular surface, shape and reflectivity.

To measure the number of Reticulocytes in the sample, a supravital dye, New Methylene Blue, is incubated with whole blood samples. The dye precipitates the basophilic RNA network found in reticulocytes. Hemoglobin and unbound stain are removed by adding a clearing reagent, leaving clear spherical mature RBCs and darkly stained reticulocytes. Stained Reticulocytes are differentiated from mature red cells and other cell populations by light scatter, direct current measurements and opacity characteristics when using the GEN·S with volume, conductivity, light scatter and reticulocyte counting technology.

**Intended Use:** The COULTER® GEN·S system is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The GEN·S System also provides automated Reticulocyte analysis. The COULTER GEN·S SMTM INTEGRATED SLIDEMAKER Option prepares a blood film on a clean microscope slide.

The GEN·S System has the same intended use as the predicate device and measures the same hematological parameters. Both systems utilize the Coulter principle for enumeration and sizing of blood cells, in combination with automatic diluting and mixing for sample processing and a beam photometer for hemoglobinometry. The same reagent system is used consisting of an isotonic diluent, lytic reagents and instrument cleaner. Both systems measure Reticulocytes utilizing New Methylene Blue. For reticulocyte analysis on the GEN·S System, a portion of aspirated sample is used for on-line preparation. Sample preparation for reticulocyte analysis on the STKS Analyzer is done off-line.

Testing included in this submission focuses on attributes of precision, accuracy, linearity and carryover. Testing met all acceptance criteria.

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