Cleared Traditional

K831918 - LA-STAPH IDENTIFICATION SYSTEM

K831918 is an FDA 510(k) clearance for LA-STAPH IDENTIFICATION SYSTEM, manufactured by Immuno-Mycologics, Inc.. The device is a Class 1 Microbiology device with product code JWX cleared through the Traditional 510(k) pathway .

K831918 · Immuno-Mycologics, Inc. · Microbiology device
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Jun 1983
Decision
-
Days
Class 1
Risk

K831918 is an FDA 510(k) clearance for the LA-STAPH IDENTIFICATION SYSTEM. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Immuno-Mycologics, Inc. devices

FDA 510(k) Submission Details - K831918

510(k) Number K831918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1983
Decision Date June 08, 1983
Days to Decision -
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence.

JWX Device Classification - Class 1, General Controls

Product Code JWX Kit, Screening, Staphylococcus Aureus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

All 12
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K831918.
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · American Micro Scan · Mar 1986
V-TREND KIT STAPH LATEX TEST
K855220 · Texas Immunology, Inc. · Mar 1986
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LSM AGAR
K822558 · Granite Diagnostics, Inc. · Sep 1982
BBL STAPHYSLIDE TEST
K821962 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1982
STAPH TRAC
K813614 · Dms Laboratories · Feb 1982