Cleared Traditional

K870318 - AMEBIASIS ELISA TEST KIT

K870318 is an FDA 510(k) clearance for AMEBIASIS ELISA TEST KIT, manufactured by Lmd Laboratories. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K870318

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.

KHW Device Classification - Class 2, Special Controls

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 9
Devices cleared under the same product code (KHW) and FDA review panel - the closest regulatory comparables to K870318.
E. HISTOLYTICA TEST
K955895 · Techlab, Inc. · Aug 1996
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
K954996 · Trend Scientific, 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