Cleared Traditional

K882232 - DISCOVER

K882232 is an FDA 510(k) clearance for DISCOVER, manufactured by Carter Products. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K882232 · Carter Products · Chemistry device
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Oct 1988
Decision
151d
Days
Class 2
Risk

K882232 is an FDA 510(k) clearance for the DISCOVER(R). Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Carter Products (Cranbury, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 151 days - an extended review 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: 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 Carter Products devices

FDA 510(k) Submission Details - K882232

510(k) Number K882232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1988
Decision Date October 25, 1988
Days to Decision 151 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
63d slower than avg
Panel avg: 88d · This submission: 151d
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 129
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K882232.
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981 · Abbott Laboratories · Aug 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482 · Pacific Biotech, Inc. · Mar 1990
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430 · Disease Detection International, Inc. · Jan 1989
BLUE DOT(TM) TEST FOR PREGNANCY
K882588 · V-Tech, Inc. · Oct 1988
CLEARBLUE EASY
K882416 · Unipath , Ltd. · Jul 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823 · Tambrands, Inc. · Apr 1988