Cleared Traditional

K972682 - QUICKSTICK ONE STEP HCG PREGNANCY TEST

K972682 is the FDA 510(k) clearance for QUICKSTICK ONE STEP HCG PREGNANCY TEST by Phamatech. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K972682 · Phamatech · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
15d
Days
Class 2
Risk

K972682 is an FDA 510(k) clearance for the QUICKSTICK ONE STEP HCG PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 15 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 Phamatech devices

Submission Details

510(k) Number K972682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1997
Decision Date August 01, 1997
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K972682.
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
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · Abbott Laboratories · Jan 1997
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · Phamatech · Jul 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183 · Armkel, LLC · Jul 1996