(43 days)
STA-R® Automated Multi-Parametric Analyzer is a fully automatic 311 TV Tratomated for the performance of tests on human ellinear in the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The STA-R® instrument is a fully automatic laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once test samples and reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA-R® instrument a true "walk-away" system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization. The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently commercially available from third-party manufacturers. Bar-coding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the utilization of non barcoded reagents. The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.
The provided text contains limited information regarding acceptance criteria and a study to prove the device meets these criteria. The document is primarily a 510(k) clearance letter and a summary of the device's characteristics, focusing on its substantial equivalence to a predicate device.
Here's an attempt to answer your questions based only on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific performance metrics (e.g., accuracy, precision, correlation with a gold standard). The primary "acceptance criteria" for 510(k) clearance here is substantial equivalence to the predicate device. | "Sample-to-sample carry-over has been demonstrated to be so low as to be undetectable." |
| Substantial equivalence to the commercially available STA® analyzer (K942117). | The STA-R® instrument is substantially equivalent to the commercially available STA® analyzer, also from the same manufacturer (Diagnostica Stago, France), that received 510(k) clearance under K942117. |
2. Sample size used for the test set and the data provenance
This information is not available in the provided text. The document refers to the demonstration of "sample-to-sample carry-over" but does not specify the sample size or details about the test set used for this demonstration or for establishing substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text. The evaluation for substantial equivalence would have been performed by the FDA, but the internal studies by the manufacturer or the specific ground truth establishment methods are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 MRMC study is not applicable here. The device is an automated laboratory analyzer, designed to perform tests, not to assist human readers in interpreting images or complex data in the same way an AI diagnostic tool would. The product itself automates the analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "fully automatic" and a "true 'walk-away' system" that performs "sample handling, reagent delivery, analysis and reporting of test results... automatically." This suggests that its performance is standalone, without human intervention in the analysis process itself. However, a specific "standalone study" with detailed metrics is not described beyond the general statement of functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for establishing the performance or substantial equivalence is not explicitly stated. For a coagulation analyzer, ground truth would typically refer to reference methods or established assays for coagulation measurements.
8. The sample size for the training set
This information is not available in the provided text. The device is a physical instrument, not a machine learning algorithm in the typical sense that would require a "training set" of data for model development. Its development likely involved engineering, calibration, and testing against known standards and samples, but not "training data" in the AI context.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its "ground truth" as relevant to AI algorithm development is not applicable here. The development would have involved engineering design, adherence to technical specifications, and validation against established scientific and laboratory standards.
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NOV 1 2 1998
AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA-R® Automated Multi-Parametric Analyzer
Page 53 of 53
SAFETY AND EFFECTIVENESS SUMMARY IX.
The STA-R® instrument is a fully automatic laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once test samples and reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA-R® instrument a true "walk-away" system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization.
The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently commercially available from third-party manufacturers. Bar-coding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the utilization of non barcoded reagents.
The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.
Sample-to-sample carry-over has been demonstrated to be so low as to be undetectable.
The STA-R® instrument is substantially equivalent to the commercially available STA® analyzer, also from the same manufacturer (Diagnostica Stago, France), that received 510(k) clearance under K942117.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the caduceus. The caduceus is depicted in black and white, and the text is also in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 2 1998 Andrew Loc B. Le, Ph.D. Director, Regulatory Affairs and Quality Assurance American Bioproducts Company Five Century Drive Parsippany, New Jersey 07054
Re : K983460 STA-R® Automated Multiparametric Analyzer Trade Name: Requlatory Class: II Product Code: JPA Dated: September 30, 1998 Received: September 30, 1998
Dear Dr. Le:
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, Druq, 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 aqainst 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 obliqation 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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Paqe 2
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 requlation 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 Butman
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
Attachment A
510(k) Number (if known):_K983460
Device Name: STA-R® Automated Multi-Parametric Analyzer
Indications for Use:
STA-R® Automated Multi-Parametric Analyzer is a fully automatic 311 TV Tratomated for the performance of tests on human ellinear in the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
(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 | K983460 |
| Prescription Use | ✓ | OR | Over-The-Counter Use_ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.