Cleared Special

K982709 - MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

K982709 is an FDA 510(k) clearance for MODIFICATION TO PROSPECT CRYPTOSPORIDIU..., manufactured by Alexon - Trend, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Special 510(k) pathway after a 30-day FDA review.

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.

FDA 510(k) Submission Details - K982709

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MHJ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MHJ Cryptosporidium Spp.

All 14
Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K982709.
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · Remel, Inc. · Nov 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
K031059 · Ivd Research, Inc. · Jul 2003
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
CRYPTOSPORIDIUM TEST
K980354 · Techlab, Inc. · May 1998
CRYPTO-CEL IF TEST
K955852 · Techlab, Inc. · Aug 1996
TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
K955755 · Trend Scientific, Inc. · Jul 1996
K982709 · MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
Download PDF Alexon - Trend, Inc.