Cleared Traditional

K053257 - PARA-PRO FC50

K053257 is an FDA 510(k) clearance for PARA-PRO FC50, manufactured by Alpha-Tec Systems, Inc.. The device is a Class 1 Microbiology device with product code LKS cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K053257 · Alpha-Tec Systems, Inc. · Microbiology device
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May 2006
Decision
171d
Days
Class 1
Risk

K053257 is an FDA 510(k) clearance for the PARA-PRO FC50. Classified as Device, Parasite Concentration (product code LKS), Class I - General Controls.

Submitted by Alpha-Tec Systems, Inc. (Vancouver, US). The FDA issued a Cleared decision on May 12, 2006 after a review of 171 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Alpha-Tec Systems, Inc. devices

FDA 510(k) Submission Details - K053257

510(k) Number K053257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2005
Decision Date May 12, 2006
Days to Decision 171 days
Submission Type Traditional
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
69d slower than avg
Panel avg: 102d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

LKS Device Classification - Class 1, General Controls

Product Code LKS Device, Parasite Concentration
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LKS Device, Parasite Concentration

Devices cleared under the same product code (LKS) and FDA review panel - the closest regulatory comparables to K053257.
PARA-PAK SPINCON
K980077 · Meridian Diagnostics, Inc. · Apr 1998
PARAKIT
K941110 · Hardy Diagnostics · May 1994
STOOL TRANSPORT/PROCESSOR
K933370 · Sage Products, Inc. · Feb 1994
PARASAFE(R) FIXATIVE
K935316 · Scientific Device Laboratory, Inc. · Feb 1994
PARA-PAK MACRO-CON
K860034 · Meridian Diagnostics, Inc. · Feb 1986