Cleared Traditional

K980354 - CRYPTOSPORIDIUM TEST

K980354 is an FDA 510(k) clearance for CRYPTOSPORIDIUM TEST, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K980354 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
109d
Days
Class 2
Risk

K980354 is an FDA 510(k) clearance for the CRYPTOSPORIDIUM TEST. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on May 18, 1998 after a review of 109 days - within the typical 510(k) review window.

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 Techlab, Inc. devices

FDA 510(k) Submission Details - K980354

510(k) Number K980354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1998
Decision Date May 18, 1998
Days to Decision 109 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
7d slower than avg
Panel avg: 102d · This submission: 109d
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.

Regulatory Peers - MHJ Cryptosporidium Spp.

All 10
Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K980354.
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · Remel, Inc. · Nov 2003
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · Alexon - Trend, Inc. · Sep 1998
CRYPTO-CEL IF TEST
K955852 · Techlab, Inc. · Aug 1996
TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
K955755 · Trend Scientific, Inc. · Jul 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K955345 · Lmd Laboratories · Jun 1996