SYSMEX POCH-100I

K032677 · Sysmex America, Inc. · GKL · Feb 11, 2004 · Hematology

Device Facts

• Record ID: K032677
• Device Name: SYSMEX POCH-100I
• Applicant: Sysmex America, Inc.
• Product Code: GKL · Hematology
• Decision Date: Feb 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended 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).

Device Story

Compact automated hematology analyzer for clinical laboratory use; processes whole blood or pre-diluted samples. Uses DC detection and hydrodynamic focusing (electric impedance) to count particles; employs non-cyanide method for hemoglobin measurement. Sample aspirated, diluted, and lysed in mixing chamber; lysed sample passes through single transducer for cell volume/number determination. Microprocessor calculates remaining parameters from measured values. Output provided to laboratory personnel for hematological assessment. Benefits include automated, quantitative blood cell analysis to support clinical decision-making regarding patient health status.

Clinical Evidence

Correlation studies performed comparing pocH-100i to predicate KX-21. Results demonstrated equivalent performance between the two analyzers.

Technological Characteristics

Compact automated hematology analyzer; DC detection and hydrodynamic focusing; non-cyanide hemoglobin measurement. Single transducer architecture. Reagents: pocH-pack D (diluent), pocH-pack L (lyse). Microprocessor-based calculation of hematology parameters.

Indications for Use

Indicated for in vitro diagnostic use in CLIA non-waived clinical laboratories for automated cell counting and hematological analysis. Not for point-of-care use in CLIA-waived laboratories.

Regulatory Classification

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.

Predicate Devices

• Sysmex KX-21™ Automated Hematology Analyzer (K981761)

Submission Summary (Full Text)

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K032677

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<br>Sysmex America, Inc.<br>One Nelson C. White Parkway<br>Mundelein, IL 60060<br>1-847-996-4523 (PHONE)<br>1-847-996-4499 (FAX)<br>February 4, 2004 |
|----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Name of Device: | Trade Name- Sysmex pocH-100i ^TM<br>Common Name- Automated Hematology Analyzer<br>Classification Name- Automated Cell Counter |
| 3. | Predicate Device: | Sysmex KX-21 ^TM |
| 4. | Device Description: | The Sysmex pocH-100i is an automated hematology<br>analyzer for use in CLIA non-waived clinical<br>laboratories (not for Point of Care use in a CLIA<br>waived laboratory). |
| 5. | Intended Use: | The Sysmex pocH-100i Automated Hematology<br>Analyzer is an automated cell counter intended for<br><i>in vitro</i> diagnostic use in CLIA non-waived clinical<br>laboratories (not for Point of Care use in a CLIA<br>waived laboratory). |

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## 6. Comparison to Predicate:

| | pocH-100i | KX-21 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Analysis Parameters | WBC, RBC, HGB, HCT,<br>MCV, MCH, MCHC,<br>PLT, Lym%, MXD%,<br>Neut%, Lym #,MXD #,<br>Neut #, RDW-SD, RDW-<br>CV, MPV. | WBC, RBC, HGB, HCT, MCV,<br>MCH, MCHC, PLT, Lym%,<br>MXD%, Neut%, Lym #,MXD #,<br>Neut #, RDW-SD, RDW-CV,<br>MPV. |
| WBC Counting<br>Method | DC Detection | DC Detection |
| RBC/PLT Counting<br>Method | DC Detection<br>w/Hydrodynamic<br>Focusing | DC Detection |
| HGB Determination<br>Method | Non-Cyanide<br>Hemoglobin Method | Non-Cyanide Hemoglobin<br>Method |
| Sample Volume<br>Aspirated | 15 uL Whole Blood | 50 uL Whole Blood |
| Throughput | Approximately 30<br>samples/hour | Approximately 60 samples/hour |

7. 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.

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pocH-100i 510(k) Summary of Safety & Effectiveness

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. 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 [phone] or [phone] 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 <i>in vitro</i> 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

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

pocH-100i 510(k) Attachment 4 Revised February 2, 2004

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