(166 days)
Sysmex pocH-100i
No
The document describes a standard automated hematology analyzer and does not mention any AI or ML capabilities, image processing, or details about training/test sets typically associated with AI/ML devices.
No
The device is an automated hematology analyzer used for in vitro diagnostic (IVD) purposes to count blood cells and provide various blood parameters. It is an analytical tool used for diagnosis, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use."
No
The device description explicitly states it is an "automated hematology analyzer," which is a physical instrument, not solely software.
Yes, the provided text explicitly states that the Sysmex pocH-100i Automated Hematology Analyzer is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says:
"The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory..."
N/A
Intended Use / Indications for Use
The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). This instrument provides results for the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV.
Product codes
GKL, GKZ
Device Description
The Sysmex pocH-100i is an automated hematology analyzer for use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory).
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
CLIA non-waived 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
Correlation studies were performed to evaluate the equivalency Clinical Data: of the pocH-100i performance compared to the predicate device, the KX-21. The comparison results indicated equivalent performance of the two analyzers, therefore supporting the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Sysmex KX-21
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
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FEB 1 1 2004
Image /page/0/Picture/2 description: The image shows the word "Sysmex" in a stylized font. The letters are outlined with a double line, giving them a retro or futuristic appearance. To the right of the word, there is a superscript "TM" symbol, indicating a trademark.
SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 847-996-4500 847-996-4499 FACSIMILE
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K032677.
| 1. | Submitted By: | Chris Stukel
Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060
1-847-996-4523 (PHONE)
1-847-996-4499 (FAX)
February 4, 2004 |
|----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Name of Device: | Trade Name- Sysmex pocH-100i TM
Common Name- Automated Hematology Analyzer
Classification Name- Automated Cell Counter |
| 3. | Predicate Device: | Sysmex KX-21 TM |
| 4. | Device Description: | The Sysmex pocH-100i is an automated hematology
analyzer for use in CLIA non-waived clinical
laboratories (not for Point of Care use in a CLIA
waived laboratory). |
| 5. | Intended Use: | The Sysmex pocH-100i Automated Hematology
Analyzer is an automated cell counter intended for
in vitro diagnostic use in CLIA non-waived clinical
laboratories (not for Point of Care use in a CLIA
waived laboratory). |
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6. Comparison to Predicate:
| pocH-100i | KX-21 | |
|---|---|---|
| Analysis Parameters | WBC, RBC, HGB, HCT, | |
| MCV, MCH, MCHC, | ||
| PLT, Lym%, MXD%, | ||
| Neut%, Lym #,MXD #, | ||
| Neut #, RDW-SD, RDW- | ||
| CV, MPV. | WBC, RBC, HGB, HCT, MCV, | |
| MCH, MCHC, PLT, Lym%, | ||
| MXD%, Neut%, Lym #,MXD #, | ||
| Neut #, RDW-SD, RDW-CV, | ||
| MPV. | ||
| WBC Counting | ||
| Method | DC Detection | DC Detection |
| RBC/PLT Counting | ||
| Method | DC Detection | |
| w/Hydrodynamic | ||
| Focusing | DC Detection | |
| HGB Determination | ||
| Method | Non-Cyanide | |
| Hemoglobin Method | Non-Cyanide Hemoglobin | |
| Method | ||
| Sample Volume | ||
| Aspirated | 15 uL Whole Blood | 50 uL Whole Blood |
| Throughput | Approximately 30 | |
| samples/hour | Approximately 60 samples/hour |
- Correlation studies were performed to evaluate the equivalency Clinical Data: of the pocH-100i performance compared to the predicate device, the KX-21. The comparison results indicated equivalent performance of the two analyzers, therefore supporting the claim of substantial equivalence.
8. Conclusions: The performance data demonstrated substantial equivalence.
pocH-100i 510(k) Summary of Safety & Effectiveness
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 1 2004
Mr. Chris Stukel Regulatory Affairs Specialist Sysmex America, Inc. One Nelson C. White Parkway Mundelein, Illinois 60060
K032677 Trade/Device Name: Sysmex pocH-100iTM Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated Cell Counter (Particle Counter) Regulatory Class: II Product Code: GKL, GKZ Dated: January 26, 2004 Received: January 30, 2004
Dear Mr. Stukel:
Re:
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 docs 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 (OS) regulation (21 CFR Part 820). 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.
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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 L. Aralett
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
| 510(k) Number (if known) | K032677 |
|---|---|
| Device Name | Sysmex pocH-100i™ |
| Indications for Use | The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care Use in a CLIA waived laboratory). This instrument provides results for the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV. |
Concurrence of CDRH, Office of Device Evaluation (ODF)
Christine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032677
Prescription Use
ાર
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
pocH-100i 510(k) Attachment 4 Revised February 2, 2004
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