(48 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 .
- Extrinsic Factors (II, V, VII, X) ●
- Intrinsic Factors (VIII, IX, XI, XII) ●
- Batroxobin .
- . Protein C
Chromogenic Analysis Parameters
- Antithrombin III .
- . Plasminogen
- Factor VIII .
Calculated Parameters
- PT Ratio .
- PT INR .
- Protein C .
- Heparin ●
- a2-Antiplasmin .
- Derived Fibrinogen .
- Factor Assays % Activity .
The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.
Here's a breakdown of the acceptance criteria and study information for the Sysmex® Automated Coagulation Analyzer CA-6000 based on the provided text:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria for this device are implicitly tied to its substantial equivalence to a predicate device, the Behring Coagulation Timer (BCT). This means the performance of the CA-6000 is deemed acceptable if it demonstrates similar performance to the BCT.
| Test | Acceptance Criteria (Implied - Similar to Predicate) | Reported Device Performance (Correlation with BCT) | Assay Precision (Total %CV) |
|---|---|---|---|
| Factor VIII Chromogenic Assay | Coefficient of Correlation (r) close to 1 | r = 0.931 | 4.4% (for CPN and CPP) |
| α2-Antiplasmin Chromogenic Assay | Coefficient of Correlation (r) close to 1 | r = 0.990 | 2.3% (CPN), 7.9% (CPP) |
Note: The document focuses primarily on correlation with the predicate device and precision, rather than specific numeric thresholds for accuracy. The "acceptance criteria" here are implied to be achieving strong correlation and acceptable precision, demonstrating similar performance to the established predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Factor VIII Chromogenic Assay: n = 92
- α2-Antiplasmin Chromogenic Assay: n = 128
- Precision Studies: 40 samples for each control level (CPN and CPP) for both Factor VIII and α2-Antiplasmin.
- Data Provenance: Retrospective and prospective. The studies "evaluated specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The location of these individuals and patients is not explicitly stated (e.g., country of origin), but given the applicant is Dade Behring Inc. Miami, FL, and Sysmex Corp. Japan, it's likely a mix, potentially with US-based clinical samples. The "in-house correlation studies" suggest internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For diagnostic devices like this, patient samples with known clinical conditions (pathological conditions) serve as the "ground truth" for evaluating accuracy and correlation. However, the specific process for establishing these "known clinical conditions" or whether expert review was involved is not detailed.
4. Adjudication Method for the Test Set
This information is not provided. As the study focuses on quantitative correlation with a predicate device and precision, inter-rater adjudication of results is not typically a direct component. The predicate device's results serve as the reference for comparison.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The Sysmex CA-6000 is an automated analyzer, not an AI-assisted diagnostic tool for human readers. Its primary function is to perform tests and output quantitative results, rather than to aid human interpretation of complex images or data in an MRMC setting.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the provided studies essentially represent standalone performance. The Sysmex® CA-6000 is an "Automated Coagulation Analyzer." The studies described (method comparison and precision) evaluate the device's performance in generating results directly from samples, independent of human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the device's internal methods for assay execution and result calculation.
7. Type of Ground Truth Used
The ground truth used for the method comparison studies was derived from the predicate device's measurements (Behring Coagulation Timer - BCT) and from patient specimens with "different pathological conditions" and "apparently healthy individuals". The BCT's results served as the reference for determining the CA-6000's correlation. For the precision studies, the "ground truth" is the inherent variability of the assay on control materials and patient samples under repeated measurements.
8. Sample Size for the Training Set
The document does not provide information on a "training set". This type of device (automated analyzer) is typically developed and validated using engineering principles, analytical studies, and comparison to existing, cleared devices, rather than machine learning models that require distinct training sets.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable in the context of this device's development as described, this information is not applicable.
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K993i74-
NOV - 9 1999
510(k) Summary of Safety and Effectiveness Information Sysmex ® Automated Coagulation Analyzer CA-6000 September 21, 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. The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.
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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 |
|---|---|---|---|
| Factor VIII Chromogenic Assay | 92 | 0.931 | Y = 1.02X + 0.96 |
| α2-Antiplasmin Chromogenic Assay | 128 | 0.990 | Y = 1.05X + 5.35 |
Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-6000
| Assay | Control Level | n | Mean | WithinRun %CV | BetweenRun %CV | Total %CV |
|---|---|---|---|---|---|---|
| Factor VIII | CPN | 40 | 96.1 | 1.8 | 4.1 | 4.4 |
| CPP | 40 | 28.7 | 2.7 | 3.6 | 4.4 | |
| α2-Antiplasmin | CPN | 40 | 100.1 | 2.0 | 1.2 | 2.3 |
| CPP | 40 | 41.5 | 7.1 | 4.3 | 7.9 |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features the department's name encircling a stylized symbol. The symbol consists of four abstract human profiles facing right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 1999
Mr. Radames Riesgo Manager, Regulatory Affairs Biology Dade Behring, Inc. 1851 Delaware Parkway Miami, Florida 33125
Re: K993174
Trade Name: Sysmex® Automated Coagulation Analyzer CA-6000 Regulatory Class: II Product Code: GKP Dated: September 21, 1999 Received: September 22, 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 QS 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.
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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 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 yours.
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
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K9931 24 510(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 .
- Extrinsic Factors (II, V, VII, X) ●
- Intrinsic Factors (VIII, IX, XI, XII) ●
- Batroxobin .
- . Protein C
Chromogenic Analysis Parameters
- Antithrombin III .
- . Plasminogen
-
Factor VIII .
Calculated Parameters
- PT Ratio .
- PT INR .
- Protein C .
- Heparin ●
- a2-Antiplasmin .
- Derived Fibrinogen .
- Factor Assays % Activity .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
isa E. Malini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1/693174
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.