Cleared Traditional

K870318 - AMEBIASIS ELISA TEST KIT

K870318 is the FDA 510(k) clearance for AMEBIASIS ELISA TEST KIT by Lmd Laboratories. It is a Class 2 Microbiology device (product code KHW) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K870318 · Lmd Laboratories · Microbiology device
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Aug 1987
Decision
195d
Days
Class 2
Risk

K870318 is an FDA 510(k) clearance for the AMEBIASIS ELISA TEST KIT. Classified as Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (product code KHW), Class II - Special Controls.

Submitted by Lmd Laboratories (San Diego, US). The FDA issued a Cleared decision on August 11, 1987 after a review of 195 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

Submission Details

510(k) Number K870318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date August 11, 1987
Days to Decision 195 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 102d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. 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 - KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

All 8
Devices cleared under the same product code (KHW) and FDA review panel - the closest regulatory comparables to K870318.
E. HISTOLYTICA II
K994101 · Techlab, Inc. · Dec 1999
E. HISTOLYTICA TEST
K955895 · Techlab, Inc. · Aug 1996
ENTAMOEBA TEST
K944791 · Techlab, Inc. · Mar 1995
AMEBIASIS MICROASSAY
K863811 · Diamedix Corp. · Oct 1986
PDQ AMEBIASIS
K862473 · Diamedix Corp. · Aug 1986
HILLCREST AMEBIASIS IHA TEST
K853448 · Hillcrest Biologicals · Aug 1985