Cleared Traditional

K032159 - CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY

K032159 is an FDA 510(k) clearance for CARESTART-PREGNANCY AND CARESTART PLUS-..., manufactured by Access Bio Incorporate. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K032159 · Access Bio Incorporate · Chemistry device
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Sep 2003
Decision
52d
Days
Class 2
Risk

K032159 is an FDA 510(k) clearance for the CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Access Bio Incorporate (North Brunswick, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 52 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 Access Bio Incorporate devices

FDA 510(k) Submission Details - K032159

510(k) Number K032159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2003
Decision Date September 05, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
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 155
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K032159.
EPT CERTAINTY PREGNANCY TEST
K032939 · Unipath , Ltd. · Oct 2003
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ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · ACON Laboratories, Inc. · Sep 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · Unipath , Ltd. · May 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · Armkel, LLC · Feb 2003
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · Unipath , Ltd. · Nov 2002