(83 days)
No
The device description relies on the Coulter method of impedance measurement and does not mention AI or ML technologies.
No
This device is for in vitro diagnostic use, specifically for counting and sizing blood cells in clinical laboratories. It provides quantitative measurements for diagnosis and monitoring, rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the instruments are "For In Vitro Diagnostic Use in clinical laboratories," and the "Device Description" explains that it's a hematology analyzer that counts and sizes blood cells, which are diagnostic functions.
No
The device description explicitly states it is a "hematology Automated Cell Counter and Automated Differential Cell Counter" that uses the "Coulter method of impedance measurement for particle counting and sizing." This method relies on physical interaction with blood cells and electrical pulses, indicating a hardware component for measurement and analysis, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Both instruments are For In Vitro Diagnostic Use in clinical laboratories."
- Device Description: The description details how the device analyzes blood cells in vitro (outside the body) using the Coulter method of impedance measurement. This is a standard technique for in vitro hematology analysis.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories," which is a typical setting for IVD devices.
N/A
Intended Use / Indications for Use
The COULTER® ACT Series Analyzers are quantitative, automated hematology analyzers. Intended Use: The A . T 10 Series is also a leukocyte differential counter. Both instruments are For In Vitro Diagnostic Use in clinical laboratories.
Product codes
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Device Description
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 WBC cells, and tend to occupy the size range from 35 to 90 fL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Testing included in this submission focuses on attributes of precision, accuracy and carryover. Testing met all acceptance criteria
Key Metrics
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Predicate Device(s)
COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D, K823355
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
0
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 Thomas J. English, Phone 1-305-380-4331 Contact Name:
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 WBC cells, and tend to occupy the size range from 35 to 90 fL.
The COULTER® ACT Series Analyzers are quantitative, automated hematology analyzers. Intended Use: The A . T 10 Series is also a leukocyte differential counter. Both instruments are For In Vitro Diagnostic Use in clinical laboratories.
The COULTER® A. T Series Analyzers have the same intended use as the predicate device. Both the A. 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 ACT 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, MCH, MCH, and Plt. The ACT 10 Analyzer determines LY # and LY %. Unlike the predicate device the A · T Series Analyzers do not measure MPV and RDW and Monocyte and Granulocyte number and percent. Unlike the predicate device the ACT Series Analyzers operate in two sample modes: Whole Blood Mode and Predilute Mode.
Testing included in this submission focuses on attributes of precision, accuracy and carryover. Testing met all acceptance criteria