(87 days)
SF-3000, K950508
No
The document describes a standard automated blood cell counter and does not mention any AI or ML components or capabilities.
No.
The device is described as an automated cell counter for in vitro diagnostic use, which means it analyzes samples outside of a living organism for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "for in vitro diagnostic use in clinical laboratories."
No
The device description explicitly states it is an "automated blood cell counter," which is a hardware device. The summary also describes performance studies comparing it to predicate hardware devices.
Yes, the Sysmex KX-21 is an IVD (In Vitro Diagnostic) device.
This is explicitly stated in both the "Intended Use / Indications for Use" and the "Device Description" sections:
- Intended Use / 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."
- Device Description: "The Sysmex™ KX-21 is an automated blood cell counter intended for in vitro diagnostic use in clinical laboratories."
N/A
Intended Use / 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.
Product codes
GKL, GKZ
Device Description
Not Found
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
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 demonstrate that the performance claims of the proposed device are similar to the predicate device, the K-1000. Specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions. The study included 194 samples for WBC, 195 for RBC, HGB, HCT, MCV, MCH, MCHC, 193 for Platelet, 150 for Lymph%, Mixed%, Neut%, 198 for RDW-SD, and 179 for MPV. Key results include correlation coefficients (r) for various parameters: WBC (0.990), RBC (0.996), HGB (0.997), HCT (0.996), MCV (0.997), MCH (0.967), MCHC (0.829), Platelet (0.996), Lymph% (0.995), Mixed% (0.874), Neut% (0.984), RDW-SD (0.976), and MPV (0.961).
Key Metrics
Correlation coefficients (r) for various parameters:
WBC: 0.990
RBC: 0.996
HGB: 0.997
HCT: 0.996
MCV: 0.997
MCH: 0.967
MCHC: 0.829
Platelet: 0.996
Lymph%: 0.995
Mixed%: 0.874
Neut%: 0.984
RDW-SD: 0.976
MPV: 0.961
Predicate Device(s)
Sysmex K-1000, K882370
Reference Device(s)
SF-3000, K950508
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).
0
AUG / 4 1998
ﺪ:
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 | |
| TOA Medical Electronics Co. Ltd, | ||
| Kobe, Japan | 7010360 | |
| Importer and Distributor | ||
| Sysmex Corporation of America | ||
| 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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1
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 | ||
| cell counter for in | |||
| vitro diagnostic use | |||
| in clinical | |||
| laboratories | Automated blood | ||
| cell counter for in | |||
| vitro diagnostic use | |||
| in clinical | |||
| laboratories | Automated blood | ||
| cell differential | |||
| analyzer for in vitro | |||
| diagnostic use in | |||
| clinical laboratories | |||
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 50µL whole blood | ||
| 40µL- cap dilution | 100µL whole blood | ||
| 40µL- cap dilution | 270µL- Cap piercer | ||
| 170µL -Manual | |||
| 40µL-capillary dil | |||
| Performance | Similar to K-1000 | Proven performance | |
| in FDA submission | Proven performance | ||
| in FDA submission | |||
| Parameters | WBC, Lym%/#, | ||
| MXD%/ # Neu%/ #, | |||
| RBC, HGB, HCT, | |||
| MCV, MCH, | |||
| MCHC, RDW-CV, | |||
| RDW-SD, PLT, | |||
| PDW, MPV, P-LCR | WBC, Lym%/#, | ||
| MXD%/ # Neu%/ #, | |||
| RBC, HGB, HCT, | |||
| MCV, MCH, | |||
| MCHC, RDW-CV, | |||
| RDW-SD, PLT, | |||
| PDW, MPV | WBC, Lym%/#, | ||
| Mono%/#, Eos%/#, | |||
| Baso%/#, Neu%/#, | |||
| RBC, HGB, HCT, | |||
| MCV, MCH, | |||
| MCHC, RDW-CV | |||
| & SD, PLT, PDW, | |||
| MPV, P-LCR | |||
| Reagents | Cellpack, | ||
| Stromatolyser-WH | Cellpack, | ||
| Stromatolyser-3WP, | |||
| Sulfolyzer | Cellpack, | ||
| Sulfolyzer, | |||
| StromatolyserFD(I), | |||
| Stromatolyser- | |||
| FD(II), | |||
| Stromatolyser-FB | |||
| Principles | RBC, PLT: DC | ||
| detection method, | |||
| WBC: DC | |||
| detection method | |||
| HGB: Non-cyanide | |||
| hgb analysis | |||
| method | RBC, PLT: DC | ||
| detection method, | |||
| WBC: DC | |||
| detection method | |||
| HGB: Non-cyanide | |||
| hgb analysis | |||
| method | RBC, PLT: DC | ||
| detection method, | |||
| WBC: Flow using | |||
| semiconductor laser | |||
| HGB: SLS-Hgb | |||
| method | |||
| Dimensions | |||
| (HxWxD) (mm) | 480x420x355 | 555x480x298 | 600x580x450 |
| Weight (kg) | 28 | 28 | 60 |
| QC System | L-J, SD,CV | ||
| 6 Files, 60 points | |||
| per file | X bar, 6 Files | L-J, SD,CV | |
| 12 Files; 180 points | |||
| per file | |||
| Bar Code | Yes | No | Yes |
| No. of Tests / Hour | Approximately 60 | Approximately 80 | Approximately 80 |
Comparative Features to K-1000 and SF-3000
2
Public Health Service
Image /page/2/Picture/2 description: The image shows a black and white logo. The logo is a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The logo is associated with the Department of Health & Human Services.
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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Page 2
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 (770) 488-7655.
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 (301) 594-4588. Additionally, for guestions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
Presription Use (Per 21 CFR 801.109)
. -
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
000012
(Division Sign-Cff) Division of Clincel Labora 510(k) Number ________________________________________________________________________________________________________________________________________________________________