(43 days)
No
The summary describes a reagent for a coagulation assay, which is a biochemical test. There is no mention of AI/ML in the device description, intended use, or performance studies. The performance metrics are standard for laboratory assays and do not suggest the use of AI/ML algorithms.
No
This device is a reagent for in vitro diagnostic testing of protein S activity, not a therapeutic device designed to treat or mitigate a disease.
Yes
The device is a reagent for the quantitative determination of the functional activity of protein S in human plasma, which is used to diagnose conditions related to protein S levels.
No
The device description clearly states it is a "reagent," which is a chemical substance used in a laboratory test. This is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "Reagent for the quantitative determination of the functional activity of protein S in human plasma." This indicates it is used to test a sample taken from the human body (plasma) in vitro (outside the body) to provide diagnostic information (quantitative determination of protein S activity).
- Device Description: The description details how the reagent interacts with human plasma to measure protein S activity through a coagulation assay. This process is performed in vitro.
- Performance Studies: The performance studies describe testing with "patient samples," further confirming its use with human biological material for diagnostic purposes.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reagent for the quantitative determination of the functional activity of protein S in human plasma.
Product codes
GGP
Device Description
Protein S Ac is a reagent intended for the quantitative determination of the functional activity of protein S in human plasma.
Protein Ca proteolytically cleaves F Va which is generated during the activation of the coagulation cascade by RVV (venom of Vipera russelli). In this reaction protein S acts as a cofactor which accelerates the reaction. As a result, the coagulation time increases proportionally to the activity of protein S in the sample. The addition of deficient plasma ensures that the test mixture has a sufficient supply of fibrinogen, Factor V and the other necessary coagulation factors.
Coagulation is triggered at the level of Factor X by the FX activator of RVV. FXa forms thrombin from prothrombin under the action of the remaining Factor Va. The resulting thrombin finally converts fibrinogen to fibrin.
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)
Split sample comparison between the Protein S Ac and the STA® StaClot® Protein S kit (K913424) gave a correlation coefficient of 0.919, slope of 0.961, and an intercept of +1.534 when tested with 239 patient samples spanning the range of the target population.
For normal plasma samples measured using the Sysmex® CA 1500, the resulting variation coefficients ranged between 3.6% and 5.1% within the series of measurements, and between 2.0% and 4.1% from day to day. Total precision ranged from 4.6 to 5.5%. For pathologically deficient plasma samples which were measured using the Sysmex® CA 1500, the resulting variation coefficients ranged between 4.7% and 9.2% within the series of measurements, and between 1.9% and 7.7% from day to day. Total precision ranged from 4.8 to 11.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient: 0.919
Slope: 0.961
Intercept: +1.534
Variation coefficients (normal plasma): 3.6% and 5.1% (within series), 2.0% and 4.1% (day to day)
Total precision (normal plasma): 4.6 to 5.5%
Variation coefficients (deficient plasma): 4.7% and 9.2% (within series), 1.9% and 7.7% (day to day)
Total precision (deficient plasma): 4.8 to 11.6%
Predicate Device(s)
STA® Staclot® Protein S kit (K913424)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
K02290
Dade Behring Inc Protein S AC, K022290 Response to Questions
AUG 2 7 2002
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Donna A. Wolf
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|------------------------------------------------------------------------------|
| Date of Preparation: | August 7, 2002 |
| Name of Product: | Protein S Ac |
| FDA Classification Name: | Factor Deficiency Test |
| Predicate Device: | STA® Staclot® Protein S kit (K913424) |
Device Description:
Protein S Ac is a reagent intended for the quantitative determination of the functional activity of protein S in human plasma.
Protein Ca proteolytically cleaves F Va which is generated during the activation of the coagulation cascade by RVV (venom of Vipera russelli). In this reaction protein S acts as a cofactor which accelerates the reaction. As a result, the coagulation time increases proportionally to the activity of protein S in the sample. The addition of deficient plasma ensures that the test mixture has a sufficient supply of fibrinogen, Factor V and the other necessary coagulation factors.
Coagulation is triggered at the level of Factor X by the FX activator of RVV. FXa forms thrombin from prothrombin under the action of the remaining Factor Va. The resulting thrombin finally converts fibrinogen to fibrin.
Intended Use: For the quantitative determination of the functional activity of protein S in human plasma.
Comparison to Predicate Device:
Conclusion:
Split sample comparison between the Protein S Ac and the STA® StaClot® Protein S kit (K913424) gave a correlation coefficient of 0.919, slope of 0.961, and an intercept of +1.534 when tested with 239 patient samples spanning the range of the target population.
For normal plasma samples measured using the Sysmex® CA 1500, the resulting variation coefficients ranged between 3.6% and 5.1% within the series of measurements, and between 2.0% and 4.1% from day to day. Total precision ranged from 4.6 to 5.5%. For pathologically deficient plasma samples which were measured using the Sysmex® CA 1500, the resulting variation coefficients ranged between 4.7% and 9.2% within the series of measurements, and between 1.9% and 7.7% from day to day. Total precision ranged from 4.8 to 11.6%.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, with three lines above them that resemble wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 27 2002
Ms. Donna Wolf Senior Regulatory Affairs Specialist Dade Behring, Inc. 514 GBC Drive Newark, Delaware 19702
K022290 Trade/Device Name: Protein S Ac Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: July 12, 2002 Received: July 13, 2002
Dear Ms. Wolf:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Autman
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
3
Dade Behring Inc. Protein S AC, K022290 Response to Questions
Indications For Use Statement
Device Name: Protein S Ac
Indications for Use:
Reagent for the quantitative determination of the functional activity of protein S in human plasma.
Josephine Bautista
(Division Sign Division of Clinical Laboratory Devices
510(k) Number K022290
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-the-counter Use
(Optional format 1-2-96)