Cleared Traditional

K832069 - TOXO IPA KIT IAN INDIRECT FLUORESCENT

K832069 is an FDA 510(k) clearance for TOXO IPA KIT IAN INDIRECT FLUORESCENT, manufactured by Bionetic Laboratory Products. The device is a Class 2 Immunology device with product code LJK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K832069 · Bionetic Laboratory Products · Immunology device
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Sep 1983
Decision
91d
Days
Class 2
Risk

K832069 is an FDA 510(k) clearance for the TOXO IPA KIT IAN INDIRECT FLUORESCENT. Classified as Antisera, If, Toxoplasma Gondii (product code LJK), Class II - Special Controls.

Submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 91 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 Bionetic Laboratory Products devices

FDA 510(k) Submission Details - K832069

510(k) Number K832069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date September 26, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 105d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJK Device Classification - Class 2, Special Controls

Product Code LJK Antisera, If, 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.