Cleared Traditional

K863841 - TANDEM OTC HCG PREGNANCY TEST FOR CONSU...

K863841 is the FDA 510(k) clearance for TANDEM OTC HCG PREGNANCY TEST FOR CONSU... by Hybritech, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K863841 · Hybritech, Inc. · Chemistry device
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Dec 1986
Decision
82d
Days
Class 2
Risk

K863841 is an FDA 510(k) clearance for the TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 82 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 Hybritech, Inc. devices

Submission Details

510(k) Number K863841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1986
Decision Date December 22, 1986
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K863841.
ABBOTT BIOTELL PREGNANCY TEST
K871996 · Abbott Laboratories · Aug 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · Leeco Diagnostics, Inc. · Jan 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · Unipath , Ltd. · Jan 1987
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · Quidel Corp. · Jun 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · Unipath , Ltd. · Apr 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · Armkel, LLC · Apr 1986