Cleared Traditional

K940637 - PREDICTOR HOME PREGNANCY TEST

K940637 is an FDA 510(k) clearance for PREDICTOR HOME PREGNANCY TEST, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K940637 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
108d
Days
Class 2
Risk

K940637 is an FDA 510(k) clearance for the PREDICTOR HOME PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 2, 1994 after a review of 108 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K940637

510(k) Number K940637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date June 02, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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 125
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K940637.
CAMEO HOME PREGNANCY TEST
K954364 · Quidel Corp. · Oct 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514 · Princeton BioMeditech Corp. · Feb 1995
PREGNANCY CHECK
K941355 · Sa Scientific, Inc. · Jul 1994
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488 · Syntron Bioresearch, Inc. · Apr 1993
PRECISE PREGNANCY
K930640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · Quidel Corp. · Dec 1992