Cleared Traditional

K936191 - PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

K936191 is an FDA 510(k) clearance for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY, manufactured by Alexon Biomedical, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K936191 · Alexon Biomedical, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K936191

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.

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.