(87 days)
The intended use of the Sysmex KX-21 is as an automated cell counter for in vitro diagnostic use in clinical laboratories.
The Sysmex™ KX-21 is an automated blood cell counter intended for in vitro diagnostic use in clinical laboratories.
The Sysmex™ Automated Hematology Analyzer KX-21's acceptance criteria and performance are detailed through correlation studies against a predicate device, the Sysmex™ K-1000. The study aimed to demonstrate substantial equivalence by comparing the results of various hematological parameters.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly uses the correlation coefficient (r) and coefficient of determination (r²) as the acceptance criteria for substantial equivalence to the predicate device. A high 'r' value (close to 1) indicates good correlation. While explicit numerical thresholds for acceptance (e.g., r > 0.95) are not stated, the reported values are presented as evidence of meeting performance claims.
| Parameter | n | Expected Acceptance Criteria (Implicit: High r/r²) | Reported Device Performance (r) | Reported Device Performance (r²) | Regression Equation |
|---|---|---|---|---|---|
| WBC | 194 | High (close to 1.0) | 0.990 | 0.981 | y = 0.944x + 0.265 |
| RBC | 195 | High (close to 1.0) | 0.996 | 0.993 | y = 1.002x + 0.053 |
| HGB | 195 | High (close to 1.0) | 0.997 | 0.995 | y = 0.979x + 0.405 |
| HCT | 195 | High (close to 1.0) | 0.996 | 0.992 | y = 0.989x + 1.025 |
| MCV | 195 | High (close to 1.0) | 0.997 | 0.995 | y = 0.95x + 4.846 |
| MCH | 195 | High (close to 1.0) | 0.967 | 0.934 | y = 0.989x + 0.297 |
| MCHC | 195 | High (close to 1.0) | 0.829 | 0.688 | y = 0.813x + 5.935 |
| Platelet | 193 | High (close to 1.0) | 0.996 | 0.993 | y = 1.079x - 12.881 |
| Lymph% | 150 | High (close to 1.0) | 0.995 | 0.991 | y = 1.017x - 0.072 |
| Mixed% | 150 | High (close to 1.0) | 0.874 | 0.763 | y = 1.055x + 1.35 |
| Neut% | 150 | High (close to 1.0) | 0.984 | 0.968 | y = 1.011x - 0.292 |
| RDW-SD | 198 | High (close to 1.0) | 0.976 | 0.953 | y = 0.942x + 5.96 |
| MPV | 179 | High (close to 1.0) | 0.961 | 0.924 | y = 0.947x + 0.611 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The sample sizes vary by parameter:
- WBC: 194
- RBC, HGB, HCT, MCV, MCH, MCHC: 195
- Platelet: 193
- Lymph%, Mixed%, Neut%: 150
- RDW-SD: 198
- MPV: 179
- Data Provenance: The study evaluated "specimens from apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but the manufacturer is based in Kobe, Japan, and the importer/distributor is in Long Grove, IL, USA. The study design is prospective in the sense that specimens were evaluated using both devices for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study relies on correlation with a predicate device (Sysmex™ K-1000) rather than a separate expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. As the study focuses on device-to-device correlation, an adjudication method for human-interpreted results is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study is about the performance of an automated hematology analyzer, not about human reader performance or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was implicitly done in the form of correlation studies comparing the KX-21 to the K-1000. These are automated devices; their performance is measured directly, not in conjunction with human interpretation for the primary parameters.
7. The type of ground truth used:
The "ground truth" for the test set was the measurements obtained from the Sysmex™ K-1000 predicate device. The study aims to show that the new device (KX-21) produces results that correlate strongly with the established device (K-1000).
8. The sample size for the training set:
The document does not specify a separate training set. The study appears to be a performance evaluation against a predicate, where the algorithms of both the KX-21 and K-1000 are presumably already "trained" or designed.
9. How the ground truth for the training set was established:
As no separate training set is explicitly mentioned for the KX-21's development or the K-1000, this information is not provided. The ground truth for this correlation study is the predicate device's output.
{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 SiteTOA Medical Electronics Co. Ltd,Kobe, Japan | 7010360 |
| Importer and DistributorSysmex Corporation of AmericaLong 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 |
000014
{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 bloodcell counter for invitro diagnostic usein clinicallaboratories | Automated bloodcell counter for invitro diagnostic usein clinicallaboratories | Automated bloodcell differentialanalyzer for in vitrodiagnostic use inclinical laboratories |
| Sample Type | Whole blood | Whole blood | Whole blood |
| Sample Volume | 50µL whole blood40µL- cap dilution | 100µL whole blood40µL- cap dilution | 270µL- Cap piercer170µL -Manual40µL-capillary dil |
| Performance | Similar to K-1000 | Proven performancein FDA submission | Proven performancein 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: DCdetection method,WBC: DCdetection methodHGB: Non-cyanidehgb analysismethod | RBC, PLT: DCdetection method,WBC: DCdetection methodHGB: Non-cyanidehgb analysismethod | RBC, PLT: DCdetection method,WBC: Flow usingsemiconductor laserHGB: SLS-Hgbmethod |
| Dimensions(HxWxD) (mm) | 480x420x355 | 555x480x298 | 600x580x450 |
| Weight (kg) | 28 | 28 | 60 |
| QC System | L-J, SD,CV6 Files, 60 pointsper file | X bar, 6 Files | L-J, SD,CV12 Files; 180 pointsper 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.
{3}------------------------------------------------
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 ________________________________________________________________________________________________________________________________________________________________
§ 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).