Cleared Traditional

K962718 - FEMEXAM TESTCARD

K962718 is an FDA 510(k) clearance for FEMEXAM TESTCARD, manufactured by Litmus Concepts, Inc.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K962718 · Litmus Concepts, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K962718

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 89d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

CEN Device Classification - Class 1, General Controls

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.

Regulatory Peers - CEN Dye-indicator, Ph (urinary, Non-quantitative)

All 10
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K962718 · FEMEXAM TESTCARD
Download PDF FDA Summary Litmus Concepts, Inc.