Cleared Traditional

K911337 - PROSPEC T/GIARDIA RAPID ASSAY

K911337 is an FDA 510(k) clearance for PROSPEC T/GIARDIA RAPID ASSAY, manufactured by Alexon, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K911337 · Alexon, Inc. · Microbiology device
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Sep 1991
Decision
185d
Days
Class 2
Risk

K911337 is an FDA 510(k) clearance for the PROSPEC T/GIARDIA RAPID ASSAY. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Alexon, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 185 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - 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 Alexon, Inc. devices

FDA 510(k) Submission Details - K911337

510(k) Number K911337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date September 27, 1991
Days to Decision 185 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 102d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHI Device Classification - Class 2, Special Controls

Product Code MHI Giardia Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3220
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.