Cleared Traditional

FEMEXAM TESTCARD (K962718) - FDA 510(k) Clearance

Class I Chemistry device.

K962718 · Litmus Concepts, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
210d
Days
Class 1
Risk

K962718 is an FDA 510(k) clearance for the FEMEXAM TESTCARD. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Litmus Concepts, Inc. (Front Royal, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 210 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Litmus Concepts, Inc. devices

Submission Details

510(k) Number K962718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date February 07, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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.