Cleared Traditional

K897077 - ACCUPROBE MYCOBACTERIUM INTRACELLULARE ...

K897077 is an FDA 510(k) clearance for ACCUPROBE MYCOBACTERIUM INTRACELLULARE ..., manufactured by Gen-Probe, Inc.. The device is a Class 1 Microbiology device with product code LQF cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K897077 · Gen-Probe, Inc. · Microbiology device
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Aug 1990
Decision
244d
Days
Class 1
Risk

K897077 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE. Classified as Dna-reagents, Mycobacterium Spp. (product code LQF), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 244 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3370 - 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 - K897077

510(k) Number K897077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1989
Decision Date August 23, 1990
Days to Decision 244 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
142d slower than avg
Panel avg: 102d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

LQF Device Classification - Class 1, General Controls

Product Code LQF Dna-reagents, Mycobacterium Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3370
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 - LQF Dna-reagents, Mycobacterium Spp.

All 12
Devices cleared under the same product code (LQF) and FDA review panel - the closest regulatory comparables to K897077.
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
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ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
K904463 · Gen-Probe, Inc. · Nov 1990
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
K896494 · Gen-Probe, Inc. · Aug 1990
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K897078 · Gen-Probe, Inc. · May 1990
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
K896492 · Gen-Probe, Inc. · Apr 1990
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
K896493 · Gen-Probe, Inc. · Apr 1990