Cleared Special

K052932 - CRYPTOSPORIDIUM II

K052932 is an FDA 510(k) clearance for CRYPTOSPORIDIUM II, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Special 510(k) pathway after a 16-day FDA review.

K052932 · Techlab, Inc. · Microbiology device
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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.

View all Techlab, Inc. devices

FDA 510(k) Submission Details - K052932

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K052932.
TRI-COMBO PARASITE SCREEN
K171078 · Techlab, Inc. · Jul 2017
UNI-GOLD CRYPTOSPORIDIUM
K121565 · Trinity Biotech · Feb 2013
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · Techlab, Inc. · Nov 2005
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · Remel, Inc. · Nov 2003
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · Alexon - Trend, Inc. · Sep 1998