Cleared Traditional

K051929 - GIARDIA/CRYPTOSPORIDIUM CHEK (FDA 510(k) Clearance)

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

K051929 · Techlab, Inc. · Microbiology device
Nov 2005
Decision
127d
Days
Class 2
Risk

K051929 is an FDA 510(k) clearance for the GIARDIA/CRYPTOSPORIDIUM CHEK. This device is classified as a Cryptosporidium Spp. (Class II - Special Controls, product code MHJ).

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 17, 2005, 127 days after receiving the submission on July 13, 2005.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K051929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date November 17, 2005
Days to Decision 127 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 174d · This submission: 127d
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.