(213 days)
No
The description focuses on a laboratory test kit and its use with specific analyzers, employing an immuno-turbidimetric method. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.
No
The device is a diagnostic test kit used to quantify D-dimer antigen levels, which helps in diagnosis, not in treating or alleviating a disease.
Yes
The device is intended for quantitative determinations of D-dimer antigen levels in citrated plasma, which is a measurement used in diagnosing various medical conditions.
No
The device description clearly states that the device is a "test kit" and includes physical components such as vials of Tris buffer and microlatex particles. It is intended for use with specific hardware analyzers.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for use with STA® analyzers... to perform quantitative determinations of D-dimer antigen levels in citrated plasma". This indicates that the device is used to test a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information (quantitative levels of D-dimer).
- Device Description: The description further clarifies that it's a "test kit" used to perform "quantitative assays of D-dimer antigen in citrated plasma". This reinforces its function as a diagnostic tool for analyzing a biological sample.
- Predicate Device: The mention of a "Predicate Device" with a K number (K862156; ASSERACHROM® D-Di kit) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The core function of the device is to analyze a biological sample (plasma) outside the body to provide information about a specific analyte (D-dimer) for diagnostic purposes. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DAP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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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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 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)