Cleared Traditional

K841415 - BETA STICK

K841415 is the FDA 510(k) clearance for BETA STICK by Quidel Corp.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K841415 · Quidel Corp. · Chemistry device
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Jul 1984
Decision
97d
Days
Class 2
Risk

K841415 is an FDA 510(k) clearance for the BETA STICK, PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Quidel Corp. (Walker, US). The FDA issued a Cleared decision on July 11, 1984 after a review of 97 days - within the typical 510(k) review window.

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: 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 Quidel Corp. devices

Submission Details

510(k) Number K841415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1984
Decision Date July 11, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 98
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K841415.
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986
ANSWER
K852274 · Armkel, LLC · Jun 1985
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984
EARLY PREGNANCY DETECTION TEST KIT
K833466 · Quidel Corp. · Nov 1983
HOME PREGNANCY TEST KIT HPK #1
K831051 · Quidel Corp. · May 1983
HOME PREGNANCY TEST KIT
K831108 · Quidel Corp. · May 1983