Cleared Traditional

K964015 - INDICARD TEST

K964015 is an FDA 510(k) clearance for INDICARD TEST, manufactured by Litmus Concepts, Inc.. The device is a Class 1 Microbiology device with product code MJM cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K964015 · Litmus Concepts, Inc. · Microbiology device
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Jun 1997
Decision
255d
Days
Class 1
Risk

K964015 is an FDA 510(k) clearance for the INDICARD TEST. Classified as Dna Probe, Gardnerella Vaginalis (product code MJM), Class I - General Controls.

Submitted by Litmus Concepts, Inc. (Front Royal, US). The FDA issued a Cleared decision on June 19, 1997 after a review of 255 days - an extended review cycle.

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 Litmus Concepts, Inc. devices

FDA 510(k) Submission Details - K964015

510(k) Number K964015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date June 19, 1997
Days to Decision 255 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 102d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

MJM Device Classification - Class 1, General Controls

Product Code MJM Dna Probe, Gardnerella Vaginalis
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.