Cleared Special

K052932 - CRYPTOSPORIDIUM II (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052932 · Techlab, Inc. · Microbiology device
Nov 2005
Decision
16d
Days
Class 2
Risk

K052932 is an FDA 510(k) clearance for the CRYPTOSPORIDIUM II. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 16 days — a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 — the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K052932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2005
Decision Date November 04, 2005
Days to Decision 16 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Regulatory Context
Review time vs. panel average
158d faster than avg
Panel avg: 174d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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.