(166 days)
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.
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).
The provided 510(k) summary for the Sysmex pocH-100i (K032677) does not contain explicit acceptance criteria tables or detailed study results demonstrating performance against specific thresholds. Instead, it focuses on demonstrating substantial equivalence to a predicate device through correlation studies.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined. The submission states "The comparison results indicated equivalent performance of the two analyzers, therefore supporting the claim of substantial equivalence." | Equivalent performance of the pocH-100i when compared to the predicate device, Sysmex KX-21, for all listed analysis parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lym%, MXD%, Neut%, Lym #, MXD #, Neut #, RDW-SD, RDW-CV, MPV). |
Note: The submission does not provide numerical values for accuracy, precision, or correlation coefficients that would typically be associated with acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "Correlation studies were performed."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The study performed was a correlation study comparing the new device against a predicate device, not against an expert-established ground truth. Therefore, no experts were used for this purpose in the context described.
4. Adjudication Method for the Test Set
- Not applicable, as the study was a correlation study against a predicate device, not an assessment requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretive devices where human readers are involved in diagnosis and interpretation. The Sysmex pocH-100i is an automated hematology analyzer, meaning it directly outputs numerical parameters and does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, implicitly. The comparison study between the pocH-100i and the predicate device (KX-21) demonstrates the standalone performance of the algorithm. Automated hematology analyzers operate as standalone systems, generating results without human intervention for each test. The correlation study evaluates the output of the pocH-100i itself against the output of the predicate device.
7. Type of Ground Truth Used
- Predicate device results. The "ground truth" in this context was established by the performance of the legally marketed predicate device, the Sysmex KX-21. The study aimed to show that the pocH-100i provided "equivalent performance" to the KX-21.
8. Sample Size for the Training Set
- Not applicable. As this is a 510(k) submission for a traditional automated medical device, not an AI/ML device, there is no mention of a "training set" in the context of machine learning model development. The device's operational parameters would have been established through engineering design and calibration, not through data-driven training of an algorithm in the modern sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The device's function is based on established physical and chemical detection methods (DC Detection, Non-Cyanide Hemoglobin Method).
{0}------------------------------------------------
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 StukelSysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 600601-847-996-4523 (PHONE)1-847-996-4499 (FAX)February 4, 2004 |
|---|---|---|
| 2. | Name of Device: | Trade Name- Sysmex pocH-100i TMCommon Name- Automated Hematology AnalyzerClassification Name- Automated Cell Counter |
| 3. | Predicate Device: | Sysmex KX-21 TM |
| 4. | Device Description: | The Sysmex pocH-100i is an automated hematologyanalyzer for use in CLIA non-waived clinicallaboratories (not for Point of Care use in a CLIAwaived laboratory). |
| 5. | Intended Use: | The Sysmex pocH-100i Automated HematologyAnalyzer is an automated cell counter intended forin vitro diagnostic use in CLIA non-waived clinicallaboratories (not for Point of Care use in a CLIAwaived laboratory). |
{1}------------------------------------------------
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 CountingMethod | DC Detection | DC Detection |
| RBC/PLT CountingMethod | DC Detectionw/HydrodynamicFocusing | DC Detection |
| HGB DeterminationMethod | Non-CyanideHemoglobin Method | Non-Cyanide HemoglobinMethod |
| Sample VolumeAspirated | 15 uL Whole Blood | 50 uL Whole Blood |
| Throughput | Approximately 30samples/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
{2}------------------------------------------------
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.
{3}------------------------------------------------
Page 2
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
{4}------------------------------------------------
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
Page 9
§ 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).