Cleared Special

MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY (K982709) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K982709 · Alexon - Trend, Inc. · Microbiology device
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Sep 1998
Decision
30d
Days
Class 2
Risk

K982709 is an FDA 510(k) clearance for the MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Alexon - Trend, Inc. (Ramsey, US). The FDA issued a Cleared decision on September 3, 1998 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alexon - Trend, Inc. devices

Submission Details

510(k) Number K982709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date September 03, 1998
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHJ Cryptosporidium 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.