Cleared Traditional

K983399 - GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

K983399 is an FDA 510(k) clearance for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY, manufactured by Genzyme Diagnostics. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K983399 · Genzyme Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
105d
Days
Class 2
Risk

K983399 is an FDA 510(k) clearance for the GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Genzyme Diagnostics (Cambridge, US). The FDA issued a Cleared decision on January 11, 1999 after a review of 105 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 Genzyme Diagnostics devices

FDA 510(k) Submission Details - K983399

510(k) Number K983399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1998
Decision Date January 11, 1999
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHI Device Classification - Class 2, Special Controls

Product Code MHI Giardia 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 - MHI Giardia Spp.

All 11
Devices cleared under the same product code (MHI) and FDA review panel - the closest regulatory comparables to K983399.
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · Remel, Inc. · Nov 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · Remel, Inc. · Nov 2003
GIARDIA II
K033274 · Techlab, Inc. · Nov 2003
PREMIER GIARDIA
K982711 · Meridian Diagnostics, Inc. · Nov 1998
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
K982245 · Biosite Incorporated · Oct 1998
GIARDIA CELISA
K963135 · Techlab, Inc. · Nov 1996