Cleared Traditional

K955345 - LMD CRYPTOSPORIDIUM ANTIGEN DETECTION

K955345 is an FDA 510(k) clearance for LMD CRYPTOSPORIDIUM ANTIGEN DETECTION, manufactured by Lmd Laboratories. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K955345 · Lmd Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
199d
Days
Class 2
Risk

K955345 is an FDA 510(k) clearance for the LMD CRYPTOSPORIDIUM ANTIGEN DETECTION. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Lmd Laboratories (Carlsbad, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 199 days - an extended review cycle.

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. 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 Lmd Laboratories devices

FDA 510(k) Submission Details - K955345

510(k) Number K955345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date June 07, 1996
Days to Decision 199 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 102d · This submission: 199d
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.