Cleared Traditional

K053138 - MYSET PREGNANCY TEST

K053138 is an FDA 510(k) clearance for MYSET PREGNANCY TEST, manufactured by Ani Biotech OY. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K053138 · Ani Biotech OY · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
112d
Days
Class 2
Risk

K053138 is an FDA 510(k) clearance for the MYSET PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Ani Biotech OY (Beverly, US). The FDA issued a Cleared decision on March 1, 2006 after a review of 112 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 - K053138

510(k) Number K053138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2005
Decision Date March 01, 2006
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
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 213
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K053138.
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · Mizuho USA, Inc. · Jun 2006
PURE-AID PREGNANCY TEST
K053452 · Bio Focus Co., Lt. · May 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019 · Artron Laboratories, Inc. · Feb 2006
BE-CERTAIN PREGNANCY TEST
K051963 · Natureplex, LLC · Nov 2005
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
K050305 · Bioscreen Medical, Inc. · May 2005
K053138 · MYSET PREGNANCY TEST
Download PDF FDA Summary Ani Biotech OY