(245 days)
Not Found
No
The device description and performance studies focus on a chemical reagent and its clotting time measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used for diagnostic purposes by determining prothrombin time for various indications, not for treating a disease or condition.
Yes
The device "detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors," which indicates its use in diagnosing or monitoring medical conditions.
No
The device description clearly states it is a "lyophilized preparation" and includes physical components like "purified recombinant human tissue factor," "synthetic phospholipids," "calcium," and "stabilizers." This indicates it is a physical reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's "For use in prothrombin time determinations and prothrombin time-based assays." Prothrombin time determinations are performed on biological samples (blood plasma) outside of the body to assess coagulation function. This is a hallmark of an in vitro diagnostic test.
- Device Description: The description details a "lyophilized preparation of purified recombinant human tissue factor... combined with synthetic phospholipids, calcium and stabilizers." This is a reagent designed to be added to a biological sample (plasma) to initiate a reaction (clotting) for diagnostic purposes.
- Function: The reagent "initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT)." This describes a test performed on a sample to provide diagnostic information about a patient's coagulation system.
- Diagnostic Purpose: The description explicitly states the test "detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors." These are all diagnostic applications.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
For use in prothrombin time determinations and prothrombin time-based assays.
Product codes
GJS
Device Description
The product is an in vitro diagnostic test for the determination of prothrombin time and prothrombin time-based assays. Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
In a comparative performance study, specimens were tested using both reagents. The correlation coefficient in PT seconds between the two products was 0.975 and the regression equation was Y = 1.32X - 8.3. When results were converted into INR (International Normalized Ratio) values, the correlation coefficient was 0.98 and the regression equation was Y = 0.99X -0.09.
Key Metrics
Correlation coefficient in PT seconds: 0.975
Regression equation (PT seconds): Y = 1.32X - 8.3
Correlation coefficient (INR): 0.98
Regression equation (INR): Y = 0.99X -0.09
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).
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510(k) Summary of Safety and Effectiveness Dade® Innovin® November 18, 1997
Dade International Inc. 2173 NW 99th Avenue Miami, FL 33172 Contact Person: Radames Riesgo at 305-392-5615 or by facsimile at 305-392-5622.
| Trade or Proprietary Name: | Dade® Innovin® | |
|---|---|---|
| Common or Usual Name: | Prothrombin time assay | |
| Classification Name: | Prothrombin Time Test (21 CFR § 864.7750) | |
| Registration Number: | Dade International Inc. | |
| 1851 Delaware Pkwy. | ||
| Miami, FL 33125 | 1017272 | |
| Dade International Inc. | ||
| 2173 NW 99th Avenue | ||
| Miami, FL 33172 | 1025506 |
The product is an in vitro diagnostic test for the determination of prothrombin time and prothrombin time-based assays. Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.
Dade® Innovin® is substantially equivalent in intended use and performance to Dade® Thromboplastin IS (K891169). Both the proposed product and the predicate device are formulated to provide high sensitivity to factor deficiencies and can be used for monitoring patients on oral anticoagulants. In a comparative performance study, specimens were tested using both reagents. The correlation coefficient in PT seconds between the two products was 0.975 and the regression equation was Y = 1.32X - 8.3. When results were converted into INR (International Normalized Ratio) values, the correlation coefficient was 0.98 and the regression equation was Y = 0.99X -0.09.
We believe the documentation included in this premarket notification demonstrates that Dade® Innovin® reagent is substantially equivalent to Dade® Thromboplastin IS.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2 1998
Radames Riesqo Manager Regulatory Affairs DADE Behring Inc. P.O. Box 520672 Miami, Florida 33152-0672
K974343 Re : Dade® Innovin® Requlatory Class: II Product Code: GJS Dated: July 1, 1998 Received: July 2, 1998
Dear Mr. Riesgo:
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 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 beqin 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 regulation (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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510(k) Number (if known): _
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For use in prothrombin time determinations and prothrombin time-based assays.
(PLEASE DO NOT WITE 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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K974343