Cleared Traditional

K882588 - BLUE DOT(TM) TEST FOR PREGNANCY

K882588 is the FDA 510(k) clearance for BLUE DOT(TM) TEST FOR PREGNANCY by V-Tech, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K882588 · V-Tech, Inc. · Chemistry device
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Oct 1988
Decision
105d
Days
Class 2
Risk

K882588 is an FDA 510(k) clearance for the BLUE DOT(TM) TEST FOR PREGNANCY. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 105 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 V-Tech, Inc. devices

Submission Details

510(k) Number K882588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1988
Decision Date October 06, 1988
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K882588.
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
CLEARBLUE EASY
K882416 · Unipath , Ltd. · Jul 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823 · Tambrands, Inc. · Apr 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069 · Leeco Diagnostics, Inc. · Feb 1988