(24 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard hematology analyzer components and functions.
No.
The device is an In Vitro Diagnostic (IVD) quantitative, automated hematology analyzer used in clinical laboratories to provide complete blood counts and leukocyte differential counts. It is used for diagnosis, not for therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use."
No
The device description explicitly states it is a "bench top laboratory instrument" and a "microprocessor driven with a PC," indicating it is a hardware device with integrated software, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use in clinical laboratories."
The "Device Description" also confirms this: "designed for In Vitro diagnostic use in clinical laboratories."
N/A
Intended Use / Indications for Use
The COULTER® AcT™ 5diff AL hematology analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.
Product codes
GKZ
Device Description
The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro diagnostic use in clinical laboratories.
The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts.
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
In Vitro Diagnostic Use in clinical laboratories.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.”
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Summary of Safety and Effectiveness for COULTER® AcT™ 5diff Autoloader (AL) Hemalogy Analyzer with Version 1.10 Software
1.0 General Information
Device Generic Name(s): Automated differential cell counter
COULTER® AcT™ 5diff AL Hematology Analyzer Device Trade Name(s): The COULTER® AcT™ 5diff AL Hematology Device Classification: Analyzer is a Class II medical device.
Beckman Coulter, Inc. Applicant Name and Address: Cellular Analysis Division 11800 SW 147 Avenue Miami, FL 33196-2500
June 27, 2003 Date:
2.0 Legally Marketed Device(s)
The modified COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.10 Software claims substantial equivalence to the previously cleared COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.00 Software. FDA 510 (k) Number: K030291
The use of a second predicate device the COULTER® LH 750 Hematology Analyzer was used to show substantial equivalence of the extended Platelet Count linearity capability. FDA 510(k) Number: K022161.
3.0 Device Description
The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro diagnostic use in clinical laboratories.
The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts.
1
The following reagents, with 510(k) numbers indicated where applicable, are qualified for use on the COULTER® AcT™ 5diff AL Hematology Analyzer with Version 1.10 software:
| Reagent | FDA Docket |
|---|---|
| COULTER® AcT™ 5diff Diluent -- used in the dilution | |
| of blood for counting and differentiation of cells. | Class I Exempt |
| COULTER® AcT™ 5diff WBC Lyse - used to lyse | |
| RBC for WBC enumeration and differentiation | Class I Exempt |
| COULTER® AcT™ 5diff Fix - used to lyse RBC, fix | |
| and differentially stain WBC | Class I Exempt |
| COULTER® AcT™ 5diff Hgb Lyse - used to lyse RBC | |
| for hemoglobin determination | Class I Exempt |
| COULTER® AcT™ 5diff Rinse - enzymatic solution | |
| for rinsing | Class I Exempt |
| Calibrator and Control | FDA Docket |
|---|---|
| COULTER® AcT™ 5diff Control Plus control – | |
| manufactured and labeled for BCI by R&D Systems Inc. | K003534 |
| COULTER® AcT™ 5diff Cal calibrator - manufactured | |
| and labeled for BCI by R&D Systems Inc. | K912357 |
Principle of Method: 4.0
The Beckman Coulter, Inc. (BCI) Coulter® Ac•T™ 5diff Autoloader Hematology Analyzer (AcT™ 5diff AL) is a bench top laboratory instrument, designed for In Vitro Diagnostic Use in clinical laboratories, capable of analyzing samples in a closed vial Autoloader mode or a Stat mode (open or closed vial).
The AcT™ 5diff AL provides automated complete blood counts (CBC) and leukocyte differential counts. The purpose of the AcT™ 5diff AL is to separate the normal patient, with all normal system-generated 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, biochemical investigations, manual WBC differential or any other derivative test that helps diagnosis of the patient's condition.
The CBC analysis is based on the established Coulter Principle of automated cell counting and spectrophotometric hemoglobin determination.
The differential analysis uses the princibles of aperture impedance, cvtochemistry, focused flow impedance, and light transmission from a halogen light source.
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The instrument is microprocessor driven with a PC that performs data processing and data management activities.
5.0 Indications for Use:
The COULTER® AcT™ 5diff AL hematology analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.
Description of the modification: 6.0
The currently marketed COULTER® AcT™ 5diff AL hematology analyzer with Version 1.00 software release was modified with software changes to improve performance characteristics and provide additional Workstation functionality.
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 4 2003
Ms. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. Cellular Analysis Division 11800 SW 147 Avenue Miami, FL 33196-2500
Re: K032013
Trade/Device Name: COULTER® AcT™ Sdiff AL Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: June 27, 2003 Received: June 30, 2003
Dear Ms. 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 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 (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 comply 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)."
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
COULTER® AcT™ 5diff Autoloader (AL) Device:
Indications For Use:
The COULTER® AcT™ 5diff AL Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.
21 CFR 864.5220 Automated differential cell counter
An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.
intere of . Michan () mis. FOR ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ BAUTOSTA Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
(PLEASE DO NOT WRITE BE ONTINUE 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