Cleared Traditional

K102760 - ATLAS HOME PREGNANCY TEST (MIDSTREAM FO...

K102760 is the FDA 510(k) clearance for ATLAS HOME PREGNANCY TEST (MIDSTREAM FO... by Atlas Medical. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K102760 · Atlas Medical · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
314d
Days
Class 2
Risk

K102760 is an FDA 510(k) clearance for the ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Atlas Medical (Amman, JO). The FDA issued a Cleared decision on August 3, 2011 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K102760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2010
Decision Date August 03, 2011
Days to Decision 314 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 88d · This submission: 314d
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 112
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K102760.
ACRO HCG Pregnancy Rapid Test
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Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2015
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006
ACON +/- MIDSTREAM PREGNANCY TEST
K050546 · ACON Laboratories, Inc. · May 2005