Cleared Traditional

K031965 - XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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.