Cleared Traditional

K831930 - TOXO-SCREEN DA TEST

K831930 is an FDA 510(k) clearance for TOXO-SCREEN DA TEST, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Immunology device with product code LLA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K831930 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
103d
Days
Class 2
Risk

K831930 is an FDA 510(k) clearance for the TOXO-SCREEN DA TEST. Classified as Direct Agglutination Test, Toxoplasma Gondii (product code LLA), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3780 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K831930

510(k) Number K831930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1983
Decision Date September 26, 1983
Days to Decision 103 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 105d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLA Device Classification - Class 2, Special Controls

Product Code LLA Direct Agglutination Test, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.