Cleared Traditional

K890048 - QUIK-DOT TOXOPLASMOSIS

K890048 is an FDA 510(k) clearance for QUIK-DOT TOXOPLASMOSIS, manufactured by Ampcor, Inc.. The device is a Class 2 Microbiology device with product code LLA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K890048 · Ampcor, Inc. · Microbiology device
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Jun 1989
Decision
154d
Days
Class 2
Risk

K890048 is an FDA 510(k) clearance for the QUIK-DOT TOXOPLASMOSIS. Classified as Direct Agglutination Test, Toxoplasma Gondii (product code LLA), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 154 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 Ampcor, Inc. devices

FDA 510(k) Submission Details - K890048

510(k) Number K890048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1989
Decision Date June 09, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
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 Microbiology devices follow this clearance model.