Cleared Traditional

K980532 - QUICKSTREAM ONE STEP PREGNANCY TEST MOD...

K980532 is the FDA 510(k) clearance for QUICKSTREAM ONE STEP PREGNANCY TEST MOD... by Phamatech. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K980532 · Phamatech · Chemistry device
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Mar 1998
Decision
28d
Days
Class 2
Risk

K980532 is an FDA 510(k) clearance for the QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012. 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 March 11, 1998 after a review of 28 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 K980532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date March 11, 1998
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K980532.
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
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K981722 · Quidel Corp. · Jun 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · Quidel Corp. · Jan 1998
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K974021 · Sa Scientific, Inc. · Dec 1997
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · Sa Scientific, Inc. · Dec 1997