Cleared Traditional

K912242 - PROSPECT(TM/CRYPTOSPORIDIUM

K912242 is an FDA 510(k) clearance for PROSPECT(TM/CRYPTOSPORIDIUM, manufactured by Alexon, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K912242 · Alexon, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
307d
Days
Class 2
Risk

K912242 is an FDA 510(k) clearance for the PROSPECT(TM/CRYPTOSPORIDIUM. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Alexon, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 307 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, Inc. devices

FDA 510(k) Submission Details - K912242

510(k) Number K912242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date March 23, 1992
Days to Decision 307 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
205d slower than avg
Panel avg: 102d · This submission: 307d
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.