Cleared Traditional

K854719 - LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)

K854719 is an FDA 510(k) clearance for LUNG CARE (SPECIMEN TRANSPORT & STORAGE..., manufactured by Xsirius Scientific, Inc.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K854719 · Xsirius Scientific, Inc. · Microbiology device
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Feb 1986
Decision
94d
Days
Class 1
Risk

K854719 is an FDA 510(k) clearance for the LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER). Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Xsirius Scientific, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Xsirius Scientific, Inc. devices

FDA 510(k) Submission Details - K854719

510(k) Number K854719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date February 24, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 36
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K854719.
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1987
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607 · Boots-Celltech Diagnostics, Inc. · Aug 1986
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
SANI CATCH BA
K833814 · Concord Laboratories, Inc. · Mar 1984
PRESERV SAF FIXATIVE 15ML
K834566 · Preventive Diagnostics Corp. · Feb 1984