Cleared Traditional

K941355 - PREGNANCY CHECK

K941355 is an FDA 510(k) clearance for PREGNANCY CHECK, manufactured by Sa Scientific, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K941355 · Sa Scientific, Inc. · Chemistry device
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Jul 1994
Decision
107d
Days
Class 2
Risk

K941355 is an FDA 510(k) clearance for the PREGNANCY CHECK. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 107 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.

FDA 510(k) Submission Details - K941355

510(k) Number K941355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date July 06, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
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 218
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K941355.
ADVANCE(R) PREGNANCY TEST
K945846 · Advanced Care Products · Jan 1995
HCG MIDSTREAM PREGNANCY TEST
K945568 · Mizuho USA, Inc. · Jan 1995
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
K941765 · Tcpi, Inc. · Oct 1994
BODYWISE PREGNANCEY TEST
K941771 · Charlton Assoc. · Jul 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
ANI BIOCARD(TM) HCG TEST
K933794 · Canadian Bioclinical, Ltd. · May 1994
K941355 · PREGNANCY CHECK
Download PDF Sa Scientific, Inc.