Cleared Traditional

K963135 - GIARDIA CELISA

K963135 is an FDA 510(k) clearance for GIARDIA CELISA, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K963135 · Techlab, Inc. · Microbiology device
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Nov 1996
Decision
109d
Days
Class 2
Risk

K963135 is an FDA 510(k) clearance for the GIARDIA CELISA. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 109 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 Techlab, Inc. devices

FDA 510(k) Submission Details - K963135

510(k) Number K963135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date November 29, 1996
Days to Decision 109 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
7d slower than avg
Panel avg: 102d · This submission: 109d
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 K963135.
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · Genzyme Diagnostics · Jan 1999
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
CRYPTO/GIARDIA-CEL IF TEST
K955897 · Techlab, Inc. · Aug 1996
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
K955157 · Alexon Biomedical, Inc. · Feb 1996
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408 · Meridian Diagnostics, Inc. · Jul 1991