Cleared Traditional

K974021 - SIGNAL PREGNANCY TEST KIT

K974021 is the FDA 510(k) clearance for SIGNAL PREGNANCY TEST KIT by Sa Scientific, Inc.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K974021 · Sa Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
58d
Days
Class 2
Risk

K974021 is an FDA 510(k) clearance for the SIGNAL PREGNANCY TEST KIT. 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 December 19, 1997 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sa Scientific, Inc. devices

Submission Details

510(k) Number K974021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1997
Decision Date December 19, 1997
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
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 109
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K974021.
QUIDEL HOME PREGNANCY TEST
K981722 · Quidel Corp. · Jun 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532 · Phamatech · Mar 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · Quidel Corp. · Jan 1998
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · Sa Scientific, Inc. · Dec 1997
QUICK CARD HCG ONE STEP PREGNANCY TEST
K973570 · Phamatech · Oct 1997
BRAND NAME *1-STEP PREGNANCY
K973352 · Armkel, LLC · Oct 1997