(192 days)
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
Not Found
This document does not contain the detailed study information required to fill out the table and answer all questions about acceptance criteria and device performance studies. The provided text is a 510(k) clearance letter from the FDA for the Medonic CA620/530 Analyzer, which confirms substantial equivalence to a predicate device.
The letter does not include:
- A table of specific acceptance criteria.
- Reported device performance data against those criteria.
- Details about sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods for ground truth.
- Information about MRMC or standalone studies.
- The type of ground truth used.
Therefore, many of the requested fields cannot be filled from the given text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Differential Cell Count Accuracy (e.g., specific cell types like Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils) | (Not specified in document) | (Not specified in document) |
| Precision/Reproducibility | (Not specified in document) | (Not specified in document) |
| Carryover | (Not specified in document) | (Not specified in document) |
| Linearity | (Not specified in document) | (Not specified in document) |
| Interfering Substances | (Not specified in document) | (Not specified in document) |
| Throughput | (Not specified in document) | (Not specified in document) |
| Substantial Equivalence (Overall Conclusion) | The device must be "substantially equivalent" to a legally marketed predicate device. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not specified. This device is an automated differential cell counter, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is described as a "fully automated hematology analyzer." This implies it operates in a standalone manner for producing results without human intervention in the analysis process. However, specific performance data from such a study is not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified in the document. For an automated differential cell counter, ground truth for performance studies would typically involve manual microscopic differentials performed by trained laboratorians or hematologists (often considered the "gold standard" for comparison).
8. The sample size for the training set
- Not applicable/Not specified. This document is for a traditional device clearance, not an AI/ML algorithm that typically requires a distinct training set. The "development" of the device would involve calibration and internal testing, but the term "training set" in the context of machine learning is not directly relevant here.
9. How the ground truth for the training set was established
- Not applicable/Not specified for the reasons above.
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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
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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)
§ 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.”