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K Number
K132130
Device Name
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
Manufacturer
DSRV, INC.
Date Cleared
2014-01-10

(184 days)

Product Code
GIR
Regulation Number
864.8950
Type
Special
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets or data provenance.
  3. Number or qualifications of experts used for ground truth.
  4. Adjudication method for the test set.
  5. Information about MRMC comparative effectiveness studies or effect sizes.
  6. Information about standalone algorithm performance.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. 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.

§ 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).