Cleared Traditional

PARAPREP (K931849) - FDA 510(k) Clearance

Class I Microbiology device.

K931849 · Medastat Scientific Corp. · Microbiology device
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Dec 1993
Decision
233d
Days
Class 1
Risk

K931849 is an FDA 510(k) clearance for the PARAPREP. Classified as Device, Parasite Concentration (product code LKS), Class I - General Controls.

Submitted by Medastat Scientific Corp. (Pittsburgh, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 233 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.

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Submission Details

510(k) Number K931849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1993
Decision Date December 02, 1993
Days to Decision 233 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 102d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.