Cleared Traditional

K862207 - QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)

K862207 is an FDA 510(k) clearance for QUIDEL BETA STICK PREGNANCY TEST (MODIF..., manufactured by Quidel Corp.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K862207 · Quidel Corp. · Chemistry device
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Jun 1986
Decision
7d
Days
Class 2
Risk

K862207 is an FDA 510(k) clearance for the QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION). Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Quidel Corp. (La Jolla, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 7 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 Quidel Corp. devices

FDA 510(k) Submission Details - K862207

510(k) Number K862207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date June 17, 1986
Days to Decision 7 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
81d faster than avg
Panel avg: 88d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

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 135
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K862207.
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · Leeco Diagnostics, Inc. · Jan 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · Unipath , Ltd. · Jan 1987
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · Hybritech, Inc. · Dec 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · Unipath , Ltd. · Apr 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986
ANSWER
K852274 · Armkel, LLC · Jun 1985