Cleared Traditional

K833829 - TOXOPLASMA GOND II IGG DIA TEST KIT

K833829 is an FDA 510(k) clearance for TOXOPLASMA GOND II IGG DIA TEST KIT, manufactured by Labsystems, Inc.. The device is a Class 2 Microbiology device with product code LGD cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K833829 · Labsystems, Inc. · Microbiology device
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Apr 1984
Decision
173d
Days
Class 2
Risk

K833829 is an FDA 510(k) clearance for the TOXOPLASMA GOND II IGG DIA TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Labsystems, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 173 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Labsystems, Inc. devices

FDA 510(k) Submission Details - K833829

510(k) Number K833829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1983
Decision Date April 24, 1984
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGD Device Classification - Class 2, Special Controls

Product Code LGD Enzyme Linked Immunoabsorbent Assay, 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 Microbiology devices follow this clearance model.