(184 days)
Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.
Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants.
This product is for in-vitro diagnostic use only.
Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Frozen Format LA Screen" device does not contain the detailed information necessary to answer your request.
Specifically, the document focuses on the regulatory clearance process and substantial equivalence determination, and it does not include any study data, acceptance criteria, or performance metrics for the device.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication method for the test set.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Information about standalone algorithm performance.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) clearance process generally focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of device characteristics and intended use, rather than a full clinical study with detailed performance metrics and ground truth establishment as you've described for AI/CADe devices. This document is a clearance letter, not a full study report or technical specification.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or flowing water.
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
DSRV, Inc. c/o Ms. Lawanda Washington 780 Park North Boulevard, Suite100 Clarkston. GA 30021
Re: K132130 Trade/Device Name: Frozen Format LA Screen Regulation Number: 21 CFR 864.8950 Regulation Name: Russell viper venom reagent Regulatory Class: I Product Code: GIR Dated: December 10, 2013 Received: December 11, 2013
Dear Ms. Washington:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
Page 2 - Ms. Lawanda Washington
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K132130
Device Name: Frozen Format LA Screen
Indications For Use:
IFU Frozen Format LA Screen
Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.
Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anticoagulants.
This product is for in-vitro diagnostic use only.
Prescription Use
(Part 21 CFR 801 Subpart D) ✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Leonthena R. Carrington -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K132130
§ 864.8950 Russell viper venom reagent.
(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).