COULTER AC.T SERIES ANALYZER

K964988 · Coulter Corp. · GKZ · Mar 6, 1997 · Hematology

Device Facts

• Record ID: K964988
• Device Name: COULTER AC.T SERIES ANALYZER
• Applicant: Coulter Corp.
• Product Code: GKZ · Hematology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The COULTER® AC-T Series Analyzers are quantitative, automated hematology analyzers. The AC-T 10 Series is also a leukocyte differential counter. Both instruments are For In Vitro Diagnostic Use in clinical laboratories.

Device Story

Automated hematology analyzer; utilizes Coulter impedance method for particle counting/sizing; blood cells passing through orifice create impedance change proportional to cell volume; uses beam photometer for hemoglobinometry; automated diluting/mixing for sample processing; operates in Whole Blood and Predilute modes; provides quantitative results for WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt; AC-T 10 provides LY# and LY%; used in clinical laboratories by trained personnel; results printed or transmitted; aids clinicians in hematological assessment.

Clinical Evidence

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

Technological Characteristics

Impedance-based particle counting/sizing; beam photometer for hemoglobinometry; automated diluting/mixing; reagent system (isotonic diluent, lytic reagent, cleaning agent); parameters: WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt, LY# (AC-T 10), LY% (AC-T 10).

Indications for Use

Indicated for use in clinical laboratories as quantitative, automated hematology analyzers for cell counting and sizing; AC-T 10 model includes leukocyte differential counting. Used for in vitro diagnostic testing of blood samples.

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® COUNTER® S-PLUS IV and LYSE S PLUS D (K823355)

Submission Summary (Full Text)

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K964988

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510(k) Summary

COULTER® AC-T Series Analyzer

Date of Summary: December 10, 1996

MAR - 6 1997

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 Cell Counter and Automated Differential Cell Counter

Product name: COULTER® AC-T Series Analyzer

C.F.R. Section: 864.5200 and 864.5220

Device Class: Class II

510(k) numbers of Coulter devices to which substantial equivalence is claimed: COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D, K823355.

The product is a hematology Automated Cell Counter and Automated Differential Cell Counter which like the predicate device, 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.

Under the controlled condition of lysis, a chemical reaction demonstrates one distinct population of leukocytes: lymphocytes. Mature normal lymphocytes and variant atypical lymphocytes are the smallest of the WBC cells, and tend to occupy the size range from 35 to 90 fL.

Intended Use: The COULTER® AC-T Series Analyzers are quantitative, automated hematology analyzers. The AC-T 10 Series is also a leukocyte differential counter. Both instruments are For In Vitro Diagnostic Use in clinical laboratories.

The COULTER® AC-T Series Analyzers have the same intended use as the predicate device. Both the AC-T Series and the predicate device 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 both systems. Both the AC-T Series and the predicate device have the ability to print and transmit results if the instrument has been setup to do. Like the predicate device, the COULTER® AC-T Series Analyzers determine the following parameters WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, and Plt. The AC-T 10 Analyzer determines LY # and LY %. Unlike the predicate device the AC-T Series Analyzers do not measure MPV and RDW and Monocyte and Granulocyte number and percent. Unlike the predicate device the AC-T Series Analyzers operate in two sample modes: Whole Blood Mode and Predilute Mode.

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

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