Cleared Traditional

K851271 - LEGIONELLA CULTURE CONFIRMATIN KIT

K851271 is an FDA 510(k) clearance for LEGIONELLA CULTURE CONFIRMATIN KIT, manufactured by Gen-Probe, Inc.. The device is a Class 2 Microbiology device with product code GRO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K851271 · Gen-Probe, Inc. · Microbiology device
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Jul 1985
Decision
98d
Days
Class 2
Risk

K851271 is an FDA 510(k) clearance for the LEGIONELLA CULTURE CONFIRMATIN KIT. Classified as Antisera, Fluorescent, All Types, Hemophilus Spp. (product code GRO), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on July 8, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - 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 Gen-Probe, Inc. devices

FDA 510(k) Submission Details - K851271

510(k) Number K851271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date July 08, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GRO Device Classification - Class 2, Special Controls

Product Code GRO Antisera, Fluorescent, All Types, Hemophilus Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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.