(192 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as an "in vitro diagnostic testing of whole blood specimens" and an "automated differential cell counter," which is used for analysis and classification, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states it is "used for in vitro diagnostic testing".
No
The device is described as a "fully automated hematology analyzer," which is a piece of hardware used for in vitro diagnostic testing. The summary does not mention any software-only component or function.
Yes, based on the provided information, the Medonic CA620/530 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use / Indications for Use: The description explicitly states it is "used for in vitro diagnostic testing of whole blood specimens." This is the defining characteristic of an IVD device – it's used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens. Automated differential cell counters are used to identify and classify one or more populations of formed elements in whole blood specimens.
Product codes
GKZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the 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 image of an eagle or other bird with three stylized wing segments.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andrew Swanson President Clinical Diagnostic Solutions, Inc. 1660 NW 65th Avenue, Suite 2 Plantation, Florida 33313
Re: K032214
Trade/Device Name: Medonic CA620/530 Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: December 22, 2003 Received: December 29, 2003
Dear Mr. Swanson:
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 for are wavenior 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.
JAN 2 9 2004
If your device is classified (see above) into cither 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 r lease of a reade a determination that your device complics 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). This letter roductions as been 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.
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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,
Joseph Z. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K032214 510(K) Number (if known):
Device Name:
Medonic CA620/530 Analyzer
Indication for Use:
The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens.
21 CFR 864.5220 Automated differential cell counter
Automated differential cell counters are used to identify and classify one or more populations of formed elements in whole blood specimens
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division sign-Off) |
|---|
| Division of Clinical Laboratory Devices |
| K Number | K032214 |
|---|---|
| ---------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | -------------------------------------------- | ---- | ---------------------- |
(Optional Form 1-2-96)