(213 days)
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.
Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it describes a 510(k) premarket notification for a medical device, the STA®-Liatest® D-Di Test Kit, which indicates it has been found "substantially equivalent" to a predicate device. This substantial equivalence determination generally means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.
Here's a breakdown of the requested information based on the provided text, and where the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The document focuses on substantial equivalence, not explicit performance criteria for the new device. | The STA®-Liatest® D-Di test kit "demonstrated substantial equivalence" to the commercially available ASSERACHROM® D-Di kit. This implies performance is comparable to the predicate, but specific metrics are not detailed for the new device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
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)
- Not applicable/Not specified. The substantial equivalence claim is made against a predicate device, not by establishing ground truth based on expert consensus for the new device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The document does not describe a test set or an adjudication process for such a set.
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
- No. This device is an in-vitro diagnostic test kit (an immuno-turbidimetric method), not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an automated laboratory test kit; its performance is inherently "standalone" in the sense that the analyzer performs the measurement. However, it's not an "algorithm only" in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for chemical assays like D-dimer is typically established through reference methods or validated standards. The document states the new device is "substantially equivalent" to the ASSERACHROM® D-Di kit, which is a "microtiter ELISA-based procedure." This implies the predicate device's established performance serves as the benchmark. The inherent ground truth for D-dimer measurements relates to the actual concentration of D-dimer antigen in the plasma, which would be determined by a highly accurate and precise analytical method. The document does not specify details on how the accuracy of either device was independently validated against a gold standard.
8. The sample size for the training set
- Not applicable/Not specified. This device is a reagent kit and analyzer system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As mentioned above, there is no "training set" in the context of an AI algorithm for this device.
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AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA®-Liatest® D-Di Test Kit
JUN 26 1997
Page 33 of 33
VIII. Safety and Effectiveness Summary
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.
Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.
The proposed STA®-Liatest® D-Di test kit has demonstrated substantial equivalence to the commercially available ASSERACHROM® D-Di kit (Diagnostica Stago, France; K862156) which is a microtiter ELISA-based procedure for the quantitative determination of D-dimer antigen levels in citrated plasma.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & SERVICES - USA" is arranged around the top of the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 26 1997
Andrew Loc B. Le., Ph.D. · Director, Regulatory Affairs and Quality Assurance American BioProducts Company Five Century Drive Parsippany, New Jersey 07054
K964728 Re : STA®-Liatest® D-Di Test Kit Regulatory Class: II Product Code: DAP April 16, 1997 Dated: Received: April 18, 1997
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 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 requirement, 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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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 diaqnostic 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/dsmamain.html".
Sincerely yours,
Steven Litman
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):
STA®-Liatest® D-Di Test Kit Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K964728 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).