(67 days)
The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.
The XT-Series is an automated hematology analyzer which consists of four principle units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies samples to the Main Unit automatically: (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system: (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
The provided document is a 510(k) summary for the Sysmex® XT-Series Automated Hematology Analyzer. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Sysmex® XE-2100). However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for performance. Instead, it claims "Studies were performed to evaluate the equivalency of the XT-Series to the XE-2100. Results indicated equivalent performance." This implies the acceptance criterion was "equivalent performance" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent to Sysmex® XE-2100 | "Results indicated equivalent performance" |
The comparison table on page 1 of the document focuses on features and parameters rather than specific performance metrics (e.g., accuracy, precision, sensitivity, specificity). It states "Performance: Same" for the XT-Series compared to the XE-2100, which has "Proven performance in FDA submission." This is a high-level statement rather than specific numerical performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For an automated hematology analyzer, the "ground truth" would typically be established by reference methods, pathologist review of slides, or other established laboratory techniques, rather than "experts" in the context of image interpretation. However, the document doesn't detail how the truth was established for the comparison studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This type of study is not applicable to this device. This is an automated hematology analyzer, not an AI-assisted diagnostic tool that humans would use for interpretation. The comparison is between two automated devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device. The entire purpose of the 510(k) is to demonstrate the performance of the XT-Series analyzer itself. The "Clinical Performance Data" section on page 0 describes studies "to evaluate the equivalency of the XT-Series to the XE-2100," indicating a standalone performance comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state how "ground truth" was established for the performance studies. For hematology analyzers, "ground truth" for parameters like WBC, RBC, HGB, PLT, and differential counts would typically involve:
- Reference methods (e.g., manual differential counts, international reference standards for HGB).
- Correlation with clinically relevant patient outcomes (less likely for a 510(k) for an analyzer).
- Cross-validation with known control materials.
The document only states that "Studies were performed to evaluate the equivalency of the XT-Series to the XE-2100." This implies the predicate device (XE-2100) itself served as a de facto reference or a well-established standard against which the new device was compared.
8. The sample size for the training set
This information is not applicable and not provided. This device is not described as using machine learning or AI that would require a separate "training set." It is an automated analyzer based on physical principles like flow cytometry and DC detection (as described in the "Principles" section).
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set for an AI/ML model.
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Image /page/0/Picture/0 description: The image shows the word "Sysmex" in a stylized font. The letters are outlined with a pattern that resembles small, irregular shapes, giving the word a textured appearance. The overall design is simple and monochromatic, with the word standing out against a plain background.
SYSMEX CORPORATION OF AMERICA 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile
JUN 2 5 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: KO312-41
| 1. Submitted by: | Sysmex Corporation of America6699 Wildlife Way | ||||
|---|---|---|---|---|---|
| Long Grove, IL 60047-9596 | |||||
| Phone: (847) 726-3675; FAX: (847) 726-3559 | |||||
| Contact person: Nina Gamperling | |||||
| Date prepared: April 18, 2002 | |||||
| 2. Name of Device: | Trade or proprietary name: Sysmex® XT-Series | ||||
| Common name: Automated Hematology Analyzer | |||||
| Classification name: Automated Differential Cell Counter21 CFR 864.5220 | |||||
| 3. Predicate Device: | Sysmex® XE-2100 | ||||
| 4. Device Description: | The XT-Series is an automated hematology analyzer whichconsists of four principle units: (1) Main Unit which aspirates,dilutes, mixes, and analyzes whole blood samples; (2) SamplerUnit which supplies samples to the Main Unit automatically: (3)IPU (Information Processing Unit) which processes data from theMain Unit and provides the operator interface with the system:(4) Pneumatic Unit which supplies pressure and vacuum from theMain Unit. Additional information on the XT is presented in thefollowing table. | ||||
| 5. Intended Use: | The Sysmex® XT-Series is intended for in vitro diagnostic use inthe clinical laboratory as a multi-parameter hematology analyzer. | ||||
| 6. Substantial | The following table compares the XT-Series with the XE- | ||||
| equivalence-similarities | 2100. | ||||
| and differences | |||||
| 7. Clinical Performance | Studies were performed to evaluate the equivalency of the | ||||
| Data: | XT-Series to the XE-2100. Results indicated equivalent | ||||
| performance. | |||||
| 8. Conclusions: | The performance data demonstrated substantial equivalence. | ||||
| Page 9 |
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Image /page/1/Picture/0 description: The image shows the word "SYSMEX" in a stylized font. The letters are made up of multiple parallel lines, giving them a layered or circuit board-like appearance. The overall design is simple and monochromatic.
SYSMEX CORPORATION
of america 6699 Wildlife Way Long Grove IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsımıle
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) Comparison Table to Predicate Device
| Features | XT-Series | XE-2100 | SF-3000 | |
|---|---|---|---|---|
| (Submission #) | (K992875) | (K950508) | ||
| FDA Clearance | 3-Nov-99 | 3-Nov-95 | ||
| Intended Use | Automated blood cell | Automated blood cell | Automated blood cell | |
| analyzer | analyzer | analyzer | ||
| Sample Type | Whole blood | Whole blood | Whole blood | |
| Sample Volume | 150uL- Cap piercer | 200 L- Cap piercer | 270uL- Cap piercer | |
| 85 µL -Manual | 130uL -Manual | 170uL -Manual | ||
| 40 L-Capillary dilution | 40uL-Capillary dilution | 40uL-Capillary dilution | ||
| Performance | Same | Proven performance in | Proven performance in | |
| FDA submission | FDA submission | |||
| Parameters | WBC, Neut%/#, | WBC, Neut%/#, | WBC, Neut%/#. | |
| Lymph%/ #, Mono%/#, | Lymph%/ #, Mono%/#, | Lymph%/#, Mono%/#, | ||
| Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | Eos%/#, Baso%/#, | ||
| RBC, HGB, HCT, | NRBC%/#, RBC, HGB, | RBC, HGB, HCT, | ||
| MCV, MCH, MCHC, | HCT, MCV, MCH, | MCV, MCH, MCHC, | ||
| RDW-CV, RDW-SD, | MCHC, RDW-CV, | RDW-CV, RDW-SD, | ||
| RET%/#, IRF, HFR*, | RDW-SD, RET%/#, | PLT, PDW, MPV, P- | ||
| MFR*, LFR*, PLT, | IRF, HFR*, MFR*, | LCR. | ||
| MPV, PDW*, P-LCR*, | LFR*, PLT, MPV, | |||
| PCT* | PDW*, P-LCR*, PCT* | |||
| *Not reportable in USA | *Not reportable in USA | |||
| Reagents | Cellpack. | Cellpack, Cellsheath | Cellpack, Sulfolyzer, | |
| Stromatolyser-FB, | Stromatolyser-FB, | StromatolyserFD(I), | ||
| Stromatolyser-4DL, | Stromatolyser-4DL, | StromatolyserFD(II). | ||
| Stromatolyser-4DS, | Stromatolyser-4DS, | Stromatolyser-FB | ||
| Sulfolyser, | Stromatolyser, NR, | |||
| Ret-Search II | Stromatolyser-IM, | |||
| Sulfolyser, | ||||
| Ret-Search II | ||||
| Principles | RBC, PLT: DC | RBC, PLT: Sheath-flow | RBC, PLT: DC | |
| detection method, | DC detection method, | detection method. | ||
| WBC: Flow Cytometrymethod using | WBC: Flow Cytometry | WBC: Flow using | ||
| semiconductor laser | method usingsemiconductor laser | semiconductor laser | ||
| detection method | detection method | |||
| HGB: SLS-Hgb method | HGB: SLS-Hgb method | HGB: SLS-Hgb method | ||
| Dimensions | 630x520x720 | 711x706x912 | 600x580x450 | |
| (HxWxD) (mm) | ||||
| Weight (kg) | ਟ ਰੇ | ਹੇਤੇ | 60 | |
| QC System | L-J: 20 Files with 300 | L-J: 10 Files with 300 | L-J: 12 Files with 180 | |
| points per file | points per file | points per file | ||
| Bar Code | Yes | Yes | Yes | |
| No. of Test / Hr | Approx 80 | Approx 113-150 | Approximately 80 |
- Page 10
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DEPARTMENT OF HEALTH & HUMAN SERVICES
'JUN 2 5 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling, MBA, MT (ASCP), RAC Manager, Regulatory Affairs Sysmex Corporation of America 6699 Wildlife Way Long Grove, Illinois 60047-9596
Re: K021241
Trade/Device Name: Sysmex® XT-Series Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: June 17, 2002 Received: June 18, 2002
Dear Ms. Gamperling:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 does 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 questions 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: XT-Series, Automated Hematology Analyzer
Indications For Use:
The Sysmex® XT-Series is intended for in vitro diagnostic use in the clinical laboratory as a multi-parameter hematology analyzer.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | -------------- | ---- | ---------------------- | -- |
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices K121241 |
510(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------
XT-Series, Automated Hematology Analyzer 510(k) FDA Submission
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”