Cleared Traditional

K031059 - IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96

K031059 is an FDA 510(k) clearance for IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, manufactured by Ivd Research, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K031059 · Ivd Research, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
104d
Days
Class 2
Risk

K031059 is an FDA 510(k) clearance for the IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 10, 2003 after a review of 104 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 Ivd Research, Inc. devices

FDA 510(k) Submission Details - K031059

510(k) Number K031059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2003
Decision Date July 10, 2003
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 11
Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K031059.
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · Techlab, Inc. · Nov 2005
CRYPTOSPORIDIUM II
K052932 · Techlab, Inc. · Nov 2005
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · Remel, Inc. · Nov 2003
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · Alexon - Trend, Inc. · Sep 1998
CRYPTOSPORIDIUM TEST
K980354 · Techlab, Inc. · May 1998