SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER

K981761 · Sysmex Corp. · GKL · Aug 14, 1998 · Hematology

Device Facts

• Record ID: K981761
• Device Name: SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
• Applicant: Sysmex Corp.
• Product Code: GKL · Hematology
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The intended use of the Sysmex KX-21 is as an automated cell counter for in vitro diagnostic use in clinical laboratories.

Device Story

Sysmex KX-21 is an automated hematology analyzer for clinical laboratory use. It processes whole blood samples (50µL or 40µL capillary dilution) to measure hematological parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, platelets, and differential counts. The device utilizes DC detection methods for cell counting and a non-cyanide method for hemoglobin analysis. It provides automated results to clinicians to assist in diagnosing and monitoring various pathological conditions. The system includes integrated quality control (L-J, SD, CV) and barcode scanning. It is designed for high-throughput testing (approx. 60 tests/hour) in a clinical setting, operated by laboratory personnel. The output allows healthcare providers to assess patient blood health and disease states.

Clinical Evidence

Correlation studies compared the KX-21 to the K-1000 using 150-198 patient specimens. Results showed high correlation (r values 0.829–0.997) across parameters including WBC (r=0.990), RBC (r=0.996), HGB (r=0.997), and Platelets (r=0.996). Regression equations confirmed performance similarity.

Technological Characteristics

Automated hematology analyzer; DC detection method for RBC, PLT, and WBC; non-cyanide hemoglobin analysis. Dimensions: 480x420x355 mm; Weight: 28 kg. Throughput: ~60 tests/hour. Integrated QC system (L-J, SD, CV, 6 files). Barcode reader included. Reagents: Cellpack, Stromatolyser-WH.

Indications for Use

Indicated for use as an automated blood cell counter in clinical laboratories for the analysis of whole blood specimens from patients to provide hematological parameters.

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™ K-1000 (K882370)

Reference Devices

• Sysmex™ SF-3000 (K950508)

Submission Summary (Full Text)

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AUG / 4 1998

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L981761

## 510(k) Summary of Safety and Effectiveness Information SYSMEX™ Automated Hematology Analyzer KX-21 May 18, 1998

Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, IL 60047-9596 Contact Person: Nina Gamperling at 847-726-3675 or by facsimile at 847-726-3505

| Trade or Proprietary Name: | Sysmex™ Automated Hematology Analyzer KX-21 | |
|----------------------------|----------------------------------------------------------------------------------------|---------|
| Common or Usual Name: | Automated Hematology Analyzer | |
| Classification Name: | Automated Cell Counter | |
| Registration Number: | Manufacturer Site<br>TOA Medical Electronics Co. Ltd,<br>Kobe, Japan | 7010360 |
| | Importer and Distributor<br>Sysmex Corporation of America<br>Long Grove, IL 60047-9596 | 1422681 |

The Sysmex™ KX-21 is substantially equivalent in intended use and technological characteristics to the Sysmex™ K-1000. The KX-21 is an automated blood cell counter intended for in vitro diagnostic use in clinical laboratories.

As demonstrated by correlation studies, the performance claims of the proposed device are similar to the predicate device, the K-1000. During these studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for particular parameters. The following table shows the results of the correlation studies between the proposed and the predicate device.

| | Correlation Studies to the Sysmex™ K-100 | | | |
|--|------------------------------------------|--|--|--|
|--|------------------------------------------|--|--|--|

| Parameter | n | r | r2 | Regression Equation |
|-----------|-----|-------|-------|---------------------|
| WBC | 194 | 0.990 | 0.981 | y = 0.944x + 0.265 |
| RBC | 195 | 0.996 | 0.993 | y = 1.002x + 0.053 |
| HGB | 195 | 0.997 | 0.995 | y = 0.979x + 0.405 |
| HCT | 195 | 0.996 | 0.992 | y = 0.989x + 1.025 |
| MCV | 195 | 0.997 | 0.995 | y = 0.95x + 4.846 |
| MCH | 195 | 0.967 | 0.934 | y = 0.989x + 0.297 |
| MCHC | 195 | 0.829 | 0.688 | y = 0.813x + 5.935 |
| Platelet | 193 | 0.996 | 0.993 | y = 1.079x - 12.881 |
| Lymph% | 150 | 0.995 | 0.991 | y = 1.017x - 0.072 |
| Mixed% | 150 | 0.874 | 0.763 | y = 1.055x + 1.35 |
| Neut% | 150 | 0.984 | 0.968 | y = 1.011x - 0.292 |
| RDW-SD | 198 | 0.976 | 0.953 | y = 0.942x + 5.96 |
| MPV | 179 | 0.961 | 0.924 | y = 0.947x + 0.611 |

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The following table shows the comparative features of the KX-21 to the Sysmex™ K-1000 and SF-3000.

| Features | KX-21 | K-1000 | SF-3000 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| (Submission #) | | (K882370) | (K950508) |
| FDA Clearance | --- | 25-Aug-88 | 3-Nov-95 |
| Intended Use | Automated blood<br>cell counter for in<br>vitro diagnostic use<br>in clinical<br>laboratories | Automated blood<br>cell counter for in<br>vitro diagnostic use<br>in clinical<br>laboratories | Automated blood<br>cell differential<br>analyzer for in vitro<br>diagnostic use in<br>clinical laboratories |
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 50µL whole blood<br>40µL- cap dilution | 100µL whole blood<br>40µL- cap dilution | 270µL- Cap piercer<br>170µL -Manual<br>40µL-capillary dil |
| Performance | Similar to K-1000 | Proven performance<br>in FDA submission | Proven performance<br>in FDA submission |
| Parameters | WBC, Lym%/#,<br>MXD%/ # Neu%/ #,<br>RBC, HGB, HCT,<br>MCV, MCH,<br>MCHC, RDW-CV,<br>RDW-SD, PLT,<br>PDW, MPV, P-LCR | WBC, Lym%/#,<br>MXD%/ # Neu%/ #,<br>RBC, HGB, HCT,<br>MCV, MCH,<br>MCHC, RDW-CV,<br>RDW-SD, PLT,<br>PDW, MPV | WBC, Lym%/#,<br>Mono%/#, Eos%/#,<br>Baso%/#, Neu%/#,<br>RBC, HGB, HCT,<br>MCV, MCH,<br>MCHC, RDW-CV<br>& SD, PLT, PDW,<br>MPV, P-LCR |
| Reagents | Cellpack,<br>Stromatolyser-WH | Cellpack,<br>Stromatolyser-3WP,<br>Sulfolyzer | Cellpack,<br>Sulfolyzer,<br>StromatolyserFD(I),<br>Stromatolyser-<br>FD(II),<br>Stromatolyser-FB |
| Principles | RBC, PLT: DC<br>detection method,<br>WBC: DC<br>detection method<br>HGB: Non-cyanide<br>hgb analysis<br>method | RBC, PLT: DC<br>detection method,<br>WBC: DC<br>detection method<br>HGB: Non-cyanide<br>hgb analysis<br>method | RBC, PLT: DC<br>detection method,<br>WBC: Flow using<br>semiconductor laser<br>HGB: SLS-Hgb<br>method |
| Dimensions<br>(HxWxD) (mm) | 480x420x355 | 555x480x298 | 600x580x450 |
| Weight (kg) | 28 | 28 | 60 |
| QC System | L-J, SD,CV<br>6 Files, 60 points<br>per file | X bar, 6 Files | L-J, SD,CV<br>12 Files; 180 points<br>per file |
| Bar Code | Yes | No | Yes |
| No. of Tests / Hour | Approximately 60 | Approximately 80 | Approximately 80 |

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Comparative Features to K-1000 and SF-3000

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Public Health Service

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AUG 1 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nina Gamperling, MBA, MT (ASCP) Supervisor, Clinical and Regulatory Affairs Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, Illinois 60047-9596

Re : K981761 Sysmex™ Automated Hematology Analyzer KX-21 Regulatory Class: II GKL, GKZ Product Code: Dated: July 27, 1998 Received: July 28, 1998

Dear Ms. Gamperling:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for guestions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Sysmex ™ Automated Hematology Analyzer KX-21

Indications For Use:

The intended use of the Sysmex KX-21 is as an automated cell counter for in vitro diagnostic use in clinical laboratories.

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Concurrence of CHRD, Office of Device Evaluation (ODE)

Presription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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(Division Sign-Cff) Division of Clincel Labora 510(k) Number ________________________________________________________________________________________________________________________________________________________________