Cleared Traditional

INDICARD TEST (K964015) - FDA 510(k) Clearance

Class I Microbiology device.

K964015 · Litmus Concepts, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 102d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.