(179 days)
The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model). Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.
The provided text primarily focuses on the regulatory approval of the STA® D-Di Calibrator Kit and its intended use as a calibration plasma. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than providing detailed performance studies against specific acceptance criteria for a new device's efficacy or diagnostic accuracy.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text only offers the following relevant details:
- Device Name: STA® D-Di Calibrator Kit
- Intended Use: To be used as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (STA® full-size model and STA® Compact model).
- Regulatory Status: 510(k) cleared (K964718), found substantially equivalent to predicate devices.
- Product Description: Citrated human plasma containing D-dimer at a known level, supplied in 6 x 1-ml vials in lyophilized form.
- Stability: Freeze-dried reagent is stable for 24 months at 2°-8°C. Reconstituted plasma is stable for 4 hours on board STA® analyzers.
To obtain the information requested, a detailed performance study report or design validation document would be necessary, which is not present in the provided text.
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AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA® D-Di Calibrator Kit
MAY 23 1997
VII. Safety and Effectiveness Summary
The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model).
964718
Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 3 1997
Andrew Loc B. Le., Ph.D. Director, Regulatory Affairs and Quality Assurance American BioProducts-Company ------Five Century Drive Parsippany, New Jersey 07054
Re : K964718 STA® D-Di Calibrator Kit Requlatory Class: II Product Code: DAP March 12, 1997 Dated: March 14, 1997 Received:
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 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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/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 ___ of_l
(k) Number (if known):_
STA® D-Di Calibrator Kit Drice Name: _
cations for Use:
The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).
(Division Sign-Off)
Division of evices
510(k) Number K964718
OLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF SEEDED)
(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).