Cleared Traditional

PLATELIA TOXO IGG KIT (K894947) - FDA 510(k) Clearance

Class I Microbiology device.

K894947 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology device
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Mar 1990
Decision
232d
Days
Class 1
Risk

K894947 is an FDA 510(k) clearance for the PLATELIA TOXO IGG KIT. Classified as Test, Leukocyte Typing (product code LGO), Class I - General Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 232 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.7675 - 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K894947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date March 23, 1990
Days to Decision 232 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 102d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGO Test, Leukocyte Typing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.