Cleared Traditional

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY (K936191) - FDA 510(k) Clearance

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

K936191 · Alexon Biomedical, Inc. · Microbiology device
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Nov 1994
Decision
329d
Days
Class 2
Risk

K936191 is an FDA 510(k) clearance for the PROSPECT CRYPTOSPORIDIUM RAPID ASSAY. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Alexon Biomedical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - 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. Elevated predicate reliance profile. 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 Alexon Biomedical, Inc. devices

Submission Details

510(k) Number K936191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date November 17, 1994
Days to Decision 329 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
227d slower than avg
Panel avg: 102d · This submission: 329d
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.