(67 days)
The intended use of the Sysmex® CA-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT)
- Activated Partial Thromboplastin Time (APTT)
- Fibrinogen (Clauss)
- Thrombin Time
Chromogenic Analysis Parameters
- Antithrombin III
- Plasminogen
- Extrinsic Factors (II, V, VII, X)
- Intrinsic Factors (VIII, IX, XI, XII)
- Batroxobin
- Protein C
- Protein C
- Heparin
Calculated Parameters
- PT Ratio
- PT INR
- Derived Fibrinogen
The Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer. It is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
1. Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Coefficient of Correlation (r)) | Reported Performance (Coefficient of Correlation (r)) |
|---|---|---|
| Batroxobin | Not explicitly stated, implied by predicate equivalence | 0.949 |
| Protein C, Chromogenic | Not explicitly stated, implied by predicate equivalence | 0.956 |
| Heparin, Chromogenic | Not explicitly stated, implied by predicate equivalence | 0.995 |
| Protein C, Coagulometric | Not explicitly stated, implied by predicate equivalence | 0.950 |
Note: The document states the performance claims of the proposed device are "similar to the predicate device" based on correlation studies. There are no explicit numeric acceptance criteria provided in the given text for the coefficient of correlation, but the high values reported (all above 0.949) indicate a strong correlation, satisfying the broad "similar" claim.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Sizes:
- Batroxobin: 173 samples
- Protein C, Chromogenic: 113 samples
- Heparin, Chromogenic: 59 samples
- Protein C, Coagulometric: 88 samples
- Data Provenance: The studies were "in-house correlation studies." Specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but the manufacturing site is Kobe, Japan, and the importer is in Long Grove, IL, USA, and the distributor is in Newark, DE, USA. The study design is prospective in the sense that specimens were "evaluated" for the purpose of the comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This study is a method comparison study between a new device and a predicate device, not a diagnostic accuracy study requiring expert adjudication for ground truth. The "ground truth" for each sample is the measurement produced by the predicate device (BCT or BFA).
4. Adjudication Method for the Test Set:
Not applicable. See point 3. This was a direct comparison between the new device's readings and the predicate device's readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study focuses on the instrumental performance of an automated coagulation analyzer compared to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the context of comparing the new device (Sysmex CA-6000) against predicate devices (BCT and BFA). The provided data represents the performance of the Sysmex CA-6000 in measuring various coagulation parameters, showing its direct correlation with established methods.
7. Type of Ground Truth Used:
The "ground truth" for the method comparison studies was the measurements obtained from the established predicate devices: the Dade Behring Coagulation Timer (BCT) and the Behring Fibrintimer A (BFA). This is a form of comparative measurement against a recognized standard.
8. Sample Size for the Training Set:
Not applicable. This device is an automated coagulation analyzer, not an AI/machine learning algorithm requiring a separate "training set" in the conventional sense for model development. The study described is a validation of the instrument's measurement performance against predicate devices.
9. How Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
{0}------------------------------------------------
SEP 17 1999
510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-6000 July 9, 1999
Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 Contact Person: Radames Riesgo at 305.636.7727 or by facsimile at 305.637.6887.
| Trade or Proprietary Name: | Sysmex® Automated Coagulation Analyzer CA-6000 | |
|---|---|---|
| Common or Usual Name: | Automated Coagulation Instruments | |
| Classification Name: | Coagulation instrument (21 CFR §864.5400) | |
| Registration Number: | Manufacturing SiteSysmex CorporationKobe, Japan | 9613959 |
| ImporterSysmex Corporation of AmericaOne Wildlife WayLong Grove, IL 60047-9596 | 1422681 | |
| DistributorDade Behring Inc.Glasgow SiteP.O. Box 6101Newark, DE 19714-6101 | 2517506 |
The Sysmex® CA-6000 is substantially equivalent in intended use to the Behring Coagulation Timer (BCT), which was previously cleared under Document Control No. K955278; or to the Behring Fibrintimer A (BFA), which was previously cleared under Document Control No. K924124. The Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.
{1}------------------------------------------------
510(k) Summary of Safety and Effectiveness Information Sysmex® Automated Coagulation Analyzer CA-6000 Attachment 4, Page 2
As demonstrated by in-house correlation studies, the performance claims of the proposed device are similar to the predicate device. During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. The following summary shows the results of the comparison studies between the proposed and the predicate devices.
Summary of Method Comparison Studies between CA-6000 and BCT
| Test | SampleNumber(n) | Coefficient ofCorrelation(r) | RegressionEquation |
|---|---|---|---|
| Batroxobin | 173 | 0.949 | Y = 0.93X + 4.14 |
| Protein C, Chromogenic | 113 | 0.956 | Y = 1.00X - 3.18 |
| Heparin, Chromogenic | 59 | 0.995 | Y = 0.90X + 0.00 |
Summary of Method Comparison Studies between CA-6000 and BFA
| Test | SampleNumber(n) | Coefficient ofCorrelation(r) | RegressionEquation |
|---|---|---|---|
| Protein C, Coagulometric | 88 | 0.950 | $Y = 0.98X - 6.26$ |
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a black and white seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized depiction of an eagle with three lines representing its wings.
SEP 1 7 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Radames Riesgo Manager, Regulatory Affairs Biology Dade Behring, Inc. 1851 Delaware Parkway Miami, Florida 33125
Re: K992321
Trade Name: Sysmex® Automated Coagulation Analyzer CA-6000 Regulatory Class: II Product Code: GKP Dated: July 9, 1999 Received: July 12, 1999
Dear Mr. Riesgo:
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 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). 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 (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. A 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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"(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/dsma/dsmamain.html".
Sincerely vours.
Steven Sutman
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}------------------------------------------------
99232 510(k) Number (if known):
Device Name: Sysmex® Automated Coagulation Analyzer CA-6000
Indications For Use:
The intended use of the Sysmex® CA-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
The instrument uses citrated human plasma to perform the following parameters and calculated parameters:
Clotting Analysis Parameters
- Prothrombin Time (PT) ●
- Activated Partial Thromboplastin Time (APTT) .
- Fibrinogen (Clauss)
- Thrombin Time
Chromogenic Analysis Parameters
- Antithrombin III ●
- Plasminogen .
- Extrinsic Factors (II, V, VII, X) .
- Intrinsic Factors (VIII, IX, XI, XII) .
- Batroxobin ●
- . Protein C
- . Protein C
- . Heparin
Calculated Parameters
-
PT Ratio ●
-
. PT INR
-
. Derived Fibrinogen
(PLEASE DO NOT WITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992321 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.