(62 days)
Not Found
No
The summary describes a standard hematology analyzer and does not mention any AI or ML components, image processing, or training/test sets typically associated with AI/ML devices.
No
The device is described as an analyzer used for diagnostic purposes (hematology analysis), not for treating or preventing a disease or condition.
Yes
The device is a hematology analyzer that measures 26 parameters, including a five-part leukocyte differential. This type of analysis provides information used for the diagnosis of various medical conditions, as it analyzes "blood, bone marrow, or other body fluids."
No
The device description explicitly states that it consists of an analyzer, a personal computer (PC) workstation, and a printer, indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "hematology analyzer" that analyzes "samples in a closed vial or open vial mode." Hematology analysis involves testing blood samples in vitro (outside the body) to diagnose or monitor medical conditions.
- Anatomical Site: The specified anatomical site is "blood, bone marrow, or other body fluids," which are all biological samples analyzed in vitro.
- Device Description: It's described as a "5-part differential hematology analyzer," which is a type of instrument used for in vitro diagnostic testing of blood.
These points strongly indicate that the device is designed to perform diagnostic tests on biological samples outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The COULTER® A • T™ 5diff Cap Pierce (CP) hematology analyzer is a 26parameter, fully automated hematology analyzer including a five-part leukocyte differential counter capable of analyzing samples in a closed vial or open vial mode.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The COULTER® A • T™ 5diff Cap Pierce (CP) is a moderate cost 5-part differential hematology analyzer that consists of the analyzer, a personal computer (PC) workstation and a printer.
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 studies of the COULTER® A^T™ 5diff Cap Pierce (CP) Hematology Analyzer to products already in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
0007 1 2 2004
Summary of Safety & Effectiveness COULTER® A • T™ 5diff Cap Pierce (CP)
1.0 Submitted By:
Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-3618
2.0 Date Submitted:
August 10, 2004
3.0 Device Name:
3.1 Proprietary Name
COULTER® Aº T™ 5diff Cap Pierce (CP)
3.2 Classification Name
Automated Differential Cell Counter (21 CFR § 864.5220)
The special control for this submission is the FDA document "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counter for Immature or Abnormal Blood Cells: Final Guidance for Industry and FDA".
4.0 Predicate Device(s):
| Candidate | Predicate #1 | Manufacturer | Docket
Number |
|------------------------------------------|----------------------------------------------------------|-----------------------|--------------------|
| COULTER® Ac•TTM
5diff Cap Pierce (CP) | COULTER® HmX
with Autoloader | Beckman Coulter, Inc. | K922704/A1 |
| | Predicate #2
COULTER® Ac•TTM
5diff Autoloader (AL) | Beckman Coulter, Inc. | K030291
K032013 |
1
5.0 Description:
The COULTER® A • T™ 5diff Cap Pierce (CP) is a moderate cost 5-part differential hematology analyzer that consists of the analyzer, a personal computer (PC) workstation and a printer.
6.0 Intended Use:
The COULTER® A . TM 5diff Cap Pierce (CP) hematology analyzer is a 26parameter, fully automated hematology analyzer including a five-part leukocyte differential counter capable of analyzing samples in a closed vial or open vial mode.
Clinical Significance:
The purpose of the A · TM 5diff CP is to separate the normal patient, with all normal system-qenerated parameters from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size, and/or distribution, manual WBC differential or any other derivative test that helps diagnosis of the patient's condition.
Comparison to Predicate(s): 7.0
The COULTER® A ° T™ 5diff Cap Pierce (CP) is substantially equivalent to the COULTER® HmX with Autoloader and the COULTER® A -T™ 5diff Autoloader (AL) from Beckman Coulter, Inc.
| | Predicate Device (1)
Beckman Coulter
HmX with AL | Predicate Device (2)
Beckman Coulter
A•T 5diff AL | Device
Beckman Coulter
A•T 5diff CP |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | 24
WBC, RBC, Hgb, Hct, MCV,
MCH, MCHC, RDW, Plt,
MPV, PDW*, Pct*, Lymphocyte % & #,
Monocyte % & #
Neutrophil % & #
Eosinophil % & #
Basophil % & #
Reticulocyte % & #
- These parameters are for
Research Use Only (RUO).
Not for use in diagnostic
procedures | 26
WBC, RBC, Hgb, Hct,
MCV, MCH, MCHC,
RDW, Plt, MPV, PDW*, Pct*, Lymphocyte % & #,
Monocyte % & #
Neutrophil % & #
Eosinophil % & #
Basophil % & #
Atypical Lymph % & # *
Immature cell % & # *
N/A - These parameters are
for Research Use Only
(RUO). Not for use in
diagnostic procedures | 26
WBC, RBC, Hgb, Hct,
MCV, MCH, MCHC,
RDW, Plt, MPV, PDW*, Pct*, Lymphocyte % & #,
Monocyte % & #
Neutrophil % & #
Eosinophil % & #
Basophil % & #
Atypical Lymph % & # *
Immature cell % & # *
N/A - These parameters are
for Research Use Only
(RUO). Not for use in
diagnostic procedures |
2
| Principles of
| Measurement | |||
|---|---|---|---|
| WBC | Aperture Impedance | Aperture Impedance | Aperture Impedance |
| RBC | Aperture Impedance | Aperture Impedance | Aperture Impedance |
| Hgb | Spectrophotometric | Spectrophotometric | Spectrophotometric |
| MCV | Aperture Impedance | Calculated from Hct | Calculated from Hct |
| Hct | Calculated from MCV | Aperture Impedance | Aperture Impedance |
| Plt | Aperture Impedance | Aperture Impedance | Aperture Impedance |
| Differential | Aperture Impedance | ||
| Conductivity, Laser Light | |||
| Scatter (VCS) | Aperture Impedance | ||
| Light Scattering | Aperture Impedance | ||
| Light Scattering | |||
| Retics | Laser Light Scatter | N/A | N/A |
| Sample | |||
| Volume | Closed Vial Mode - 185μL | ||
| Open Vial Mode- 125μL | Open and Closed Vial | ||
| Modes | |||
| CBC profile - 30μL | |||
| CBC/DIFF profile - 53μL | Open and Closed Vial | ||
| Modes | |||
| CBC profile - 30μL | |||
| CBC/DIFF profile - 53μL | |||
| Throughput | Closed and Open Vial | ||
| Modes - 75 samples/hour | |||
| Retics - 30 samples/hour | Closed and Open Vial | ||
| Modes - | |||
| Up to 80 samples/hour | Closed and Open Vial | ||
| Modes - | |||
| Up to 60 samples/hour |
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies of the COULTER® A^T™ 5diff Cap Pierce (CP) Hematology Analyzer to products already in commercial distribution.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147th Avenue MC: 31-B06 Miami, Florida 33196-2500
OCT 1 2 2004
K042173 Re:
Ro 12773
Trade/Device Name: COULTER® Af*T™ 5diff Cap Pierce (CP) Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 10, 2004 Received: August 11, 2004
Dear Mr. Coba:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va mayy are sever sions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 6017, laborning (QS) regulation (QS) regulation (21 CFR Part 820). This letter requirences as be rent arketing your device as described in your Section 510(k) premarket while and of your to organizatial 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.
4
Page 2
If you desire specific information about the application of labeling requirements to your device, of In II you desire specific information acceded the of your device, please contact the Office of In or questions on the promotion and Safety at (301) 594-3084. Also, please note the VIIIO Diagnostic Device Device and the mail and the motification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket and a des Art from the You may obtain other general information on your responsibilities under the Act from the You may outan other general mormational and Consumer 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
of page
510(k) Number (if known): KOYJ / 73
COULTER® Aº•T™ 5diff Cap Pierce (CP) Hematology Device Name: Analyzer
Indications for Use:
The COULTER® A°•T™ 5diff Cap Pierce (CP) hematology analyzer is a 26-The COUL fLK® A v -----------------------------------------------------------------------------------------------------------------------------------------------------------parameter, fully adtomation nomalyzing samples in a closed vial or open vial mode.
864.5240 Automated Differential Cell Counter
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 one of the or the formou classify immature or abnormal hematopoietic cells of capability to liag, ooun, or other body fluids. These devices may combine an the blood, bone marrow, or eathor, optical method, or a flow cytometric method electionic partiolo obanting mothers, spiration) markers. The device includes accessory CD markers.
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K042173