Cleared Traditional

K914304 - FIRST RESPONSE ONE-STEP

K914304 is the FDA 510(k) clearance for FIRST RESPONSE ONE-STEP by Armkel, LLC. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K914304 · Armkel, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
22d
Days
Class 2
Risk

K914304 is an FDA 510(k) clearance for the FIRST RESPONSE(R) ONE-STEP. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Armkel, LLC devices

Submission Details

510(k) Number K914304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1991
Decision Date October 17, 1991
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K914304.
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · Quidel Corp. · Dec 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
CLEARBLUE EASY
K911566 · Unipath , Ltd. · May 1991
CLEARBLUE EASY
K905742 · Unipath , Ltd. · Feb 1991
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981 · Abbott Laboratories · Aug 1990