Cleared Traditional

K982764 - PREMIER CRYPTOSPORIDIUM

K982764 is an FDA 510(k) clearance for PREMIER CRYPTOSPORIDIUM, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K982764 · Meridian Diagnostics, Inc. · Microbiology device
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Dec 1998
Decision
119d
Days
Class 2
Risk

K982764 is an FDA 510(k) clearance for the PREMIER CRYPTOSPORIDIUM. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 3, 1998 after a review of 119 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K982764

510(k) Number K982764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date December 03, 1998
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
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.

All 10
Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K982764.
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
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · Alexon - Trend, Inc. · Sep 1998
CRYPTOSPORIDIUM TEST
K980354 · Techlab, Inc. · May 1998
CRYPTO-CEL IF TEST
K955852 · Techlab, Inc. · Aug 1996