(125 days)
The CS-400™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
The provided text describes the 510(k) summary for the Sigma Diagnostics Inc. CS-400™ Coagulation Analyzer. The acceptance criteria and the study proving the device meets them are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance characteristics from comparison studies and precision studies. The comparison studies establish the device's correlation with a predicate device, while precision studies demonstrate its reproducibility.
| Test (Method) | Acceptance Criteria (from comparison study with Amelung AMAX CS-190™) | Reported Device Performance (r-value) | Reported Device Performance (Regression Equation) | Acceptance Criteria (from precision study) | Reported Device Performance (Within Run CV) | Reported Device Performance (Total CV) |
|---|---|---|---|---|---|---|
| PT (optical) | N/A (regression statistics provided to show substantial equivalence) | r = 0.921 | y = 1.061x + 0.6 | ≤ (implied acceptable precision) | <2.2% | <4.5% |
| PT (mechanical) | N/A | r = 0.924 | y = 1.038x - 0.5 | ≤ (implied acceptable precision) | <3.2% | <6.5% |
| APTT (optical) | N/A | r = 0.964 | y = 1.072x - 0.5 | ≤ (implied acceptable precision) | <2.5% | <3.5% |
| APTT (mechanical) | N/A | r = 0.972 | y = 0.938x + 1.0 | ≤ (implied acceptable precision) | <2.3% | <3.5% |
| Factor IX (optical) | N/A | r = 0.945 | y = 0.943x + 4.6 | ≤ (implied acceptable precision) | <5.3% | <7.3% |
| Factor IX (mechanical) | N/A | r = 0.924 | y = 0.977x + 3.7 | ≤ (implied acceptable precision) | <6.3% | <9.5% |
| Factor X (optical) | N/A | r = 0.966 | y = 0.920x + 9.5 | ≤ (implied acceptable precision) | <5.7% | <7.8% |
| Factor X (mechanical) | N/A | r = 0.974 | y = 0.898x + 8.7 | ≤ (implied acceptable precision) | <3.8% | <7.0% |
| Fibrinogen (optical) | N/A | r = 0.967 | y = 1.064x - 11.3 | ≤ (implied acceptable precision) | <5.1% | <8.1% |
| Fibrinogen (mechanical) | N/A | r = 0.977 | y = 1.074x - 2.2 | ≤ (implied acceptable precision) | <5.9% | <9.0% |
| AT III (chromogenic) | N/A | r = 0.972 | y = 0.920x + 11.7 | ≤ (implied acceptable precision) | <5.9% | <9.3% |
Note: The document states "The safety and effectiveness of the CS-400™ Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices." This implies that the acceptance criteria for the comparison studies were that the regression statistics (r-value and regression equation) were similar enough to the predicate device to establish substantial equivalence. For precision, the "less than" symbols indicate that the reported %CV values met the acceptance criteria for precision.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the comparison or precision studies. It only refers to "comparison studies of assays" and "precision studies." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is an in vitro diagnostic (IVD) instrument, and its performance is evaluated against a predicate device (for comparison) and through its own precision/reproducibility (for precision). The "ground truth" for such devices is typically established through direct measurement against a reference method or validated calibrators, not through expert consensus in the way image-based diagnostic aids might be.
4. Adjudication method for the test set:
Not applicable for an in vitro diagnostic device assessing analytical performance.
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:
Not applicable. This is an automated coagulation analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The studies described are standalone performance studies of the device itself (CS-400™ Coagulation Analyzer) compared to a predicate device (Amelung AMAX CS-190™ Coagulation Analyzer) and its own reproducibility. There is no mention of an "algorithm" in the context of AI, but rather the performance of an analytical instrument.
7. The type of ground truth used:
- For comparison studies: The "ground truth" was established by the measurements obtained from the predicate device, the Amelung AMAX CS-190™ Coagulation Analyzer. The CS-400™ device's results were compared against these.
- For precision studies: The "ground truth" for precision is the expected result of a measurement and the inherent variability of the analytical process. This is assessed by repeatedly measuring samples and calculating the coefficient of variation.
8. The sample size for the training set:
Not applicable. This device is an analytical instrument, not an AI/machine learning model that requires a training set in the conventional sense. Its design and operational parameters are established through engineering and analytical chemistry principles.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set in the context of AI/machine learning for this type of device.
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000 20 1997
510(k) NOTIFICATION
Sigma Diagnostics Inc. June 12, 1997
2019
CS-400™ Coagulation Analyzer Catalog No. A1208
510(k) Summary of Safety and Effectiveness
The Amelung CS-400™ Coagulation Analyzer is an automated random access multipurpose analyzer. The CS-400™ Coagulation Analyzer can be used for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles to perform clot based tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, factor assays, and other clotting tests. In addition, the CS-400™ Coagulation Analyzer can be used for chromogenic assays such as antithrombin III (AT III).
In comparison studies of assays between the CS-400™ Coagulation Analyzer and the Amelung AMAX CS-190™ Coagulation Analyzer, the following regression statistics were obtained:
| PT (optical) | r = 0.921 | y = 1.061x + 0.6 |
|---|---|---|
| PT (mechanical) | r = 0.924 | y = 1.038x - 0.5 |
| APTT (optical) | r = 0.964 | y = 1.072x - 0.5 |
| APTT (mechanical) | r = 0.972 | y = 0.938x + 1.0 |
| Factor IX (optical) | r = 0.945 | y = 0.943x + 4.6 |
| Factor IX (mechanical) | r = 0.924 | y = 0.977x + 3.7 |
| Factor X (optical) | r = 0.966 | y = 0.920x + 9.5 |
| Factor X (mechanical) | r = 0.974 | y = 0.898x + 8.7 |
| Fibrinogen (optical) | r = 0.967 | y = 1.064x - 11.3 |
| Fibrinogen (mechanical) | r = 0.977 | y = 1.074x - 2.2 |
| AT III (chromogenic) | r = 0.972 | y = 0.920x + 11.7 |
The following coefficients of variation were obtained from precision studies:
| Within Run | Total | |
|---|---|---|
| PT (optical) | <2.2% | <4.5% |
| PT (mechanical) | <3.2% | <6.5% |
| APTT (optical) | <2.5% | <3.5% |
| APTT (mechanical) | <2.3% | <3.5% |
| Factor IX (optical) | <5.3% | <7.3% |
| Factor IX (mechanical) | <6.3% | <9.5% |
| Factor X (optical) | <5.7% | <7.8% |
| Factor X (mechanical) | <3.8% | <7.0% |
| Fibrinogen (optical) | <5.1% | <8.1% |
| Fibrinogen (mechanical) | <5.9% | <9.0% |
| AT III (chromogenic) | <5.9% | <9.3% |
The safety and effectiveness of the CS-400™ Coagulation Analyzer is demonstrated by its substantial equivalency to the predicate devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures intertwined, representing health and well-being. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 20 1997
William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
K972260 Re : CS-400™ Coaqulation Analyzer System Requlatory Class: II Product Code: JPA Dated: Auqust 21, 1997 Received: August 22, 1997
Dear Dr. Gilbert:
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, Drug, 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 Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
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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 requlation (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 Other general premarket notification" (21 CFR 807.97). 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 Gutman
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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Page 1 of 1
510(k) Number (if known): _
Device Name: CS-400™ Coagulation Analyzer
Indications For Use:
The CS-400™ Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
(PLEASE DO NOT WRITE 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. K972260
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
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§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.