Cleared Traditional

K863341 - CARDS(TM) - EARLY PREGNANCY TEST

K863341 is an FDA 510(k) clearance for CARDS(TM) - EARLY PREGNANCY TEST, manufactured by Pacific Biotech, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K863341 · Pacific Biotech, Inc. · Chemistry device
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Jan 1987
Decision
139d
Days
Class 2
Risk

K863341 is an FDA 510(k) clearance for the CARDS(TM) - EARLY PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 14, 1987 after a review of 139 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 Pacific Biotech, Inc. devices

FDA 510(k) Submission Details - K863341

510(k) Number K863341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1986
Decision Date January 14, 1987
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
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 173
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K863341.
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · Leeco Diagnostics, Inc. · Feb 1988
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
K874248 · Syntron Bioresearch, Inc. · Nov 1987
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
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · Hybritech, Inc. · Dec 1986