Cleared Traditional

K873565 - SNAP ROTAVIRUS DIAGNOSTIC KIT

K873565 is the FDA 510(k) clearance for SNAP ROTAVIRUS DIAGNOSTIC KIT by Molecular Biosystems, Inc.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K873565 · Molecular Biosystems, Inc. · Microbiology device
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May 1988
Decision
254d
Days
Class 1
Risk

K873565 is an FDA 510(k) clearance for the SNAP(R) ROTAVIRUS DIAGNOSTIC KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 254 days - an extended review cycle.

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 Molecular Biosystems, Inc. devices

Submission Details

510(k) Number K873565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date May 13, 1988
Days to Decision 254 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 102d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 17
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K873565.
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
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