Cleared Traditional

K031965 - XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY

K031965 is an FDA 510(k) clearance for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, manufactured by Remel, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K031965 · Remel, Inc. · Microbiology device
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Nov 2003
Decision
141d
Days
Class 2
Risk

K031965 is an FDA 510(k) clearance for the XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 141 days - within the typical 510(k) review window.

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 Remel, Inc. devices

FDA 510(k) Submission Details - K031965

510(k) Number K031965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2003
Decision Date November 14, 2003
Days to Decision 141 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K031965.
TRI-COMBO PARASITE SCREEN
K171078 · Techlab, Inc. · Jul 2017
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · Techlab, Inc. · Nov 2005
CRYPTOSPORIDIUM II
K052932 · Techlab, Inc. · Nov 2005
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
CRYPTOSPORIDIUM TEST
K980354 · Techlab, Inc. · May 1998
CRYPTO-CEL IF TEST
K955852 · Techlab, Inc. · Aug 1996